September 8—12, 2015 The Cosmopolitan of Las Vegas Program Guide
Program guide is sponsored by PRESCRIBE NUCYNTA® ER FOR ONE SOURCE OF RELIEF • Proven efficacy in chronic low back pain and DPN1,2 - Based on efficacy demonstrated in a prospective, randomized, double-blind, active- and COVERED FOR placebo-controlled, multicenter phase 3 chronic low back pain study (N=981) showing TWO significant change in mean pain intensity from baseline in Week 15 (Week 12 of the 1 94% maintenance phase) vs placebo OF COMMERCIALLY SOURCES - Based on efficacy demonstrated in a double-blind, parallel-group, enriched-enrollment INSURED PATIENTS.‡ randomized phase 3 DPN study (N=977) showing significant change in mean pain 2 PREFERRED FOR intensity over the last week of the 12-week, double-blind, maintenance phase vs placebo UNITEDHEALTH • 5 dosage strengths: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg3* GROUP AND OF PAIN Individualize dosing based on patient’s prior analgesic treatment experience and risk SILVERSCRIPT/ factors for addiction, abuse, and misuse; titrate as needed to provide adequate analgesia CVS CAREMARK ‡ and minimize adverse reactions PART D PLANS • Administer NUCYNTA® ER ~q12h3 VISIT NUCYNTA.COM FOR MORE INFORMATION AND TO DOWNLOAD A NUCYNTA® ER SAVINGS CARD† • $0 co-pay for first prescription of NUCYNTA® ER with a $25 co-pay on each additional ONE prescription if eligible† SOURCE WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL OF RELIEF See full prescribing information for complete boxed warning. ® NUCYNTA ER is the first and only FDA-approved ® long-acting opioid designed to control both • NUCYNTA ER exposes users to risks of addiction, abuse, and misuse, which can lead to nociceptive pain and the neuropathic pain associated overdose and death. Assess each patient’s risk before prescribing, and monitor regularly with diabetic peripheral neuropathy (DPN). for development of these behaviors or conditions. (5.1) NUCYNTA® ER is an opioid agonist indicated for • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, the management of: especially upon initiation or following a dose increase. Instruct patients to swallow ® • pain severe enough to require daily, around-the- NUCYNTA ER tablets whole to avoid exposure to a potentially fatal dose of tapentadol. (5.2) ® clock, long-term opioid treatment and for which • Accidental ingestion of NUCYNTA ER, especially in children, can result in fatal overdose alternative treatment options are inadequate of tapentadol. (5.2) • neuropathic pain associated with diabetic peripheral • Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal neuropathy (DPN) in adults severe enough to syndrome, which may be life-threatening if not recognized and treated. If opioid use is require daily, around-the-clock, long-term opioid required for a prolonged period in a pregnant woman, advise the patient of the risk treatment and for which alternative treatment of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will options are inadequate Not an actual patient. be available. (5.3) Limitations of Use • Instruct patients not to consume alcohol or any products containing alcohol while taking • Because of the risks of addiction, abuse, and ® misuse with opioids, even at recommended doses, NUCYNTA ER because co-ingestion can result in fatal plasma tapentadol levels. (5.4) and because of the greater risks of overdose and death with extended-release opioid formulations, ® reserve NUCYNTA ER for use in patients for CONTRAINDICATIONS: Significant respiratory depression; acute or severe bronchial asthma whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; are ineffective, not tolerated, or would be known or suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, angioedema) to otherwise inadequate to provide sufficient tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase management of pain inhibitors (MAOIs) or use within the last 14 days. • NUCYNTA® ER is not indicated as an as-needed *Please see full Prescribing Information for DOSAGE AND ADMINISTRATION. (prn) analgesic † Some restrictions and limitations apply. See full terms and conditions available at NUCYNTA.com. Available to commercially insured and cash-paying patients only. Patients covered by Medicare, Medicaid, or any other state- or federally funded benefit program are excluded. Patients must be 18 years of age or older. This promotion cannot be combined with any other programs, offers, or discounts. Depomed reserves the right to rescind, revoke, or amend this offer without further notice. ‡Source: MMIT 2.0, May 2015.
Please see additional Important References: 1. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase Ill study. Expert Opin Pharmocother. 2010;11(11):1787- Safety Information and Brief 1804. 2. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results Summary, including BOXED of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27(1):151-162. 3. NUCYNTA® ER [package insert]. Titusville, NJ: Janssen WARNING, on the following pages. Pharmaceuticals, Inc; 2014. TIME TO DUAL
Nuc_PainWeekJourn.indd 1 7/27/15 11:40 AM PRESCRIBE NUCYNTA® ER FOR ONE SOURCE OF RELIEF • Proven efficacy in chronic low back pain and DPN1,2 - Based on efficacy demonstrated in a prospective, randomized, double-blind, active- and COVERED FOR placebo-controlled, multicenter phase 3 chronic low back pain study (N=981) showing TWO significant change in mean pain intensity from baseline in Week 15 (Week 12 of the 1 94% maintenance phase) vs placebo OF COMMERCIALLY SOURCES - Based on efficacy demonstrated in a double-blind, parallel-group, enriched-enrollment INSURED PATIENTS.‡ randomized phase 3 DPN study (N=977) showing significant change in mean pain 2 PREFERRED FOR intensity over the last week of the 12-week, double-blind, maintenance phase vs placebo UNITEDHEALTH • 5 dosage strengths: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg3* GROUP AND OF PAIN Individualize dosing based on patient’s prior analgesic treatment experience and risk SILVERSCRIPT/ factors for addiction, abuse, and misuse; titrate as needed to provide adequate analgesia CVS CAREMARK ‡ and minimize adverse reactions PART D PLANS • Administer NUCYNTA® ER ~q12h3 VISIT NUCYNTA.COM FOR MORE INFORMATION AND TO DOWNLOAD A NUCYNTA® ER SAVINGS CARD† • $0 co-pay for first prescription of NUCYNTA® ER with a $25 co-pay on each additional ONE prescription if eligible† SOURCE WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL OF RELIEF See full prescribing information for complete boxed warning. ® NUCYNTA ER is the first and only FDA-approved ® long-acting opioid designed to control both • NUCYNTA ER exposes users to risks of addiction, abuse, and misuse, which can lead to nociceptive pain and the neuropathic pain associated overdose and death. Assess each patient’s risk before prescribing, and monitor regularly with diabetic peripheral neuropathy (DPN). for development of these behaviors or conditions. (5.1) NUCYNTA® ER is an opioid agonist indicated for • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, the management of: especially upon initiation or following a dose increase. Instruct patients to swallow ® • pain severe enough to require daily, around-the- NUCYNTA ER tablets whole to avoid exposure to a potentially fatal dose of tapentadol. (5.2) ® clock, long-term opioid treatment and for which • Accidental ingestion of NUCYNTA ER, especially in children, can result in fatal overdose alternative treatment options are inadequate of tapentadol. (5.2) • neuropathic pain associated with diabetic peripheral • Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal neuropathy (DPN) in adults severe enough to syndrome, which may be life-threatening if not recognized and treated. If opioid use is require daily, around-the-clock, long-term opioid required for a prolonged period in a pregnant woman, advise the patient of the risk treatment and for which alternative treatment of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will options are inadequate Not an actual patient. be available. (5.3) Limitations of Use • Instruct patients not to consume alcohol or any products containing alcohol while taking • Because of the risks of addiction, abuse, and ® misuse with opioids, even at recommended doses, NUCYNTA ER because co-ingestion can result in fatal plasma tapentadol levels. (5.4) and because of the greater risks of overdose and death with extended-release opioid formulations, ® reserve NUCYNTA ER for use in patients for CONTRAINDICATIONS: Significant respiratory depression; acute or severe bronchial asthma whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; are ineffective, not tolerated, or would be known or suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, angioedema) to otherwise inadequate to provide sufficient tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase management of pain inhibitors (MAOIs) or use within the last 14 days. • NUCYNTA® ER is not indicated as an as-needed *Please see full Prescribing Information for DOSAGE AND ADMINISTRATION. (prn) analgesic † Some restrictions and limitations apply. See full terms and conditions available at NUCYNTA.com. Available to commercially insured and cash-paying patients only. Patients covered by Medicare, Medicaid, or any other state- or federally funded benefit program are excluded. Patients must be 18 years of age or older. This promotion cannot be combined with any other programs, offers, or discounts. Depomed reserves the right to rescind, revoke, or amend this offer without further notice. ‡Source: MMIT 2.0, May 2015.
Please see additional Important References: 1. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase Ill study. Expert Opin Pharmocother. 2010;11(11):1787- Safety Information and Brief 1804. 2. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results Summary, including BOXED of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27(1):151-162. 3. NUCYNTA® ER [package insert]. Titusville, NJ: Janssen WARNING, on the following pages. Pharmaceuticals, Inc; 2014. TIME TO DUAL
Nuc_PainWeekJourn.indd 1 7/27/15 11:40 AM NUCYNTA® ER (tapentadol) IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS: Addiction, Use in Elderly, Cachectic, or Debilitated Patients: tachycardia, labile blood pressure, hyperthermia), DRUG INTERACTIONS Abuse, and Misuse: NUCYNTA® ER contains Life-threatening respiratory depression is more likely neuromuscular aberrations (e.g., hyperreflexia, tapentadol, an opioid agonist and a Schedule II to occur in elderly, cachectic, or debilitated patients incoordination), and/or gastrointestinal symptoms Alcohol: See BOXED WARNING. controlled substance that can be abused in a as they may have altered pharmacokinetics or (e.g., nausea, vomiting, diarrhea) and can be fatal. If Muscle Relaxants: Monitor patients receiving manner similar to other opioid agonists, legal altered clearance. Because elderly patients are more concomitant treatment with SSRIs, SNRIs, TCAs, or muscle relaxants and NUCYNTA® ER for signs of or illicit. There is a greater risk for overdose and likely to have decreased renal and hepatic function, triptans is clinically warranted, careful observation respiratory depression that may be greater than death due to the larger amount of tapentadol consideration should be given to starting elderly of the patient is advised, particularly when otherwise expected. Tapentadol may enhance the present in NUCYNTA® ER. Assess risk for patients in the lower range of recommended doses. initiating or titrating the dose. neuromuscular blocking action of skeletal muscle opioid abuse or addiction prior to prescribing Closely monitor these patients, particularly when Use in Patients With Gastrointestinal (GI) relaxants and produce an increased degree of NUCYNTA® ER. Addiction can occur in patients initiating and titrating NUCYNTA® ER and when Conditions: Contraindicated in patients with respiratory depression. appropriately prescribed NUCYNTA® ER at given concomitantly with other drugs that Gl obstruction including paralytic ileus; may Anticholinergics: Use with anticholinergic products recommended doses; in those who obtain the depress respiration. cause spasm of the sphincter of Oddi. Monitor may increase the risk of urinary retention and/or drug illicitly; and if the drug is misused or abused. Use in Patients With Chronic Pulmonary Disease: patients with biliary tract disease, including acute severe constipation, which may lead to paralytic Therefore, routinely monitor for signs of misuse, Patients with significant chronic obstructive pancreatitis, for worsening symptoms. ileus. abuse, and addiction. Patients at increased risk pulmonary disease or cor pulmonale and patients (e.g., patients with a personal or family history Avoidance of Withdrawal: Withdrawal symptoms USE IN SPECIFIC POPULATIONS having a substantially decreased respiratory reserve, (e.g., anxiety, sweating, insomnia, restlessness, of substance abuse or mental illness) may be Pregnancy/Nursing Mothers: Pregnancy Category C. hypoxia, hypercarbia, or pre-existing respiratory pain, nausea, tremors, diarrhea, upper respiratory prescribed NUCYNTA® ER, but use in such patients NUCYNTA® ER should be used during pregnancy depression, should be monitored for respiratory necessitates intensive counseling about the risks symptoms, piloerection) may occur: only if the potential benefit justifies the potential depression particularly when initiating therapy and • After abrupt discontinuation or a significant and proper use along with intensive monitoring for ® risk to the fetus. Neonates born to mothers titrating with NUCYNTA ER. Consider the use of ® signs of addiction, abuse, and misuse. dose reduction of NUCYNTA ER in physically physically dependent on opioids will also be alternative nonopioid analgesics in these patients. dependent patients. When discontinuing Life-threatening Respiratory Depression: physically dependent and may exhibit respiratory Hypotensive Effect: May cause severe NUCYNTA® ER, gradually taper the dose. Can occur at any time during the use of difficulties and withdrawal symptoms. Observe hypotension. There is an increased risk in patients NUCYNTA® ER even when used as recommended. • If mixed agonist/antagonist (e.g., butorphanol, newborns for symptoms of neonatal opioid whose ability to maintain blood pressure has Respiratory depression from opioid use, if not nalbuphine, pentazocine) and partial agonist withdrawal syndrome. Withdrawal symptoms can already been compromised by a reduced blood immediately recognized and treated, may lead (e.g., buprenorphine) analgesics are used in occur in breast-feeding infants when maternal volume or concurrent administration of certain ® to respiratory arrest and death. To reduce the patients who have received or are receiving administration of NUCYNTA ER is stopped. CNS depressant drugs (e.g., phenothiazines ® risk of respiratory depression, proper dosing and NUCYNTA ER. Avoid use with mixed agonists/ Labor and Delivery: Opioids cross the placenta or general anesthetics). Monitor for signs of titration are essential. Overestimating the dose antagonists and partial agonists. and may produce respiratory depression in hypotension during dose initiation or titration. when converting patients from another opioid neonates. NUCYNTA® ER is not for use in women Avoid use in patients with circulatory shock; may • If opioid antagonists (e.g., naloxone, nalmefene) product can result in fatal overdose with the first during and immediately prior to labor, when cause vasodilation that can further reduce cardiac are administered in physically dependent dose. Management of respiratory depression may shorter-acting analgesics or other analgesic output and blood pressure. patients. Administration of the antagonist should include close observation, supportive measures, be begun with care and by titration with smaller techniques are more appropriate. Use in Patients With Head Injury or Increased and use of opioid antagonists, depending on the than usual doses of the antagonist. Use in Elderly, Renal Impairment, and Hepatic Intracranial Pressure: Monitor patients who may patient’s clinical status. Impairment: See WARNINGS AND PRECAUTIONS. be susceptible to the intracranial effects of CO Driving and Operating Heavy Machinery: May Neonatal Opioid Withdrawal Syndrome: Prolonged 2 retention (e.g., those with evidence of increased impair the mental or physical abilities needed DRUG ABUSE AND DEPENDENCE: use of NUCYNTA® ER during pregnancy can intracranial pressure or brain tumors) for signs of to perform potentially hazardous activities such See BOXED WARNING result in withdrawal signs in the neonate, which sedation and respiratory depression, particularly as driving a car or operating machinery. Warn may be life-threatening and require management OVERDOSAGE: Institute supportive measures to when initiating therapy. NUCYNTA® ER may patients not to drive or operate dangerous according to protocols developed by neonatology manage respiratory depression, circulatory shock, reduce respiratory drive, and the resultant CO machinery unless they are tolerant to the effects experts. Neonatal opioid withdrawal syndrome 2 ® and pulmonary edema as required. The opioid retention can further increase intracranial pressure. of NUCYNTA ER and know how they will react to presents as poor feeding, irritability, hyperactivity antagonists, naloxone or nalmefene, are specific Opioids may also obscure the clinical course in a the medication. and abnormal sleep pattern, antidotes to respiratory depression. Hepatic Impairment: Avoid use in patients with high-pitched cry, tremor, rigidity, seizures, patient with a head injury. ADVERSE REACTIONS: In clinical studies, the most severe hepatic impairment (Child-Pugh Score 10 to vomiting, diarrhea, and failure to gain weight. Seizures: May aggravate convulsions in patients common ( 10%) adverse reactions were nausea, 15). In patients with moderate hepatic impairment ≥ with convulsive disorders and may induce or constipation, vomiting, dizziness, somnolence, and Interactions With Central Nervous System (Child-Pugh Score 7-9), initiate treatment with aggravate seizures. Monitor patients with a history headache. Depressants: Hypotension, profound sedation, NUCYNTA® ER 50 mg no more than once every of seizure disorders for worsened seizure control coma, respiratory depression, and death may 24 hours, with a maximum dose of 100 mg per day. Select Postmarketing Adverse Reactions: ® during therapy. result if NUCYNTA ER is used concomitantly Monitor for respiratory and CNS depression when Anaphylaxis, angioedema, and anaphylactic with alcohol or other central nervous system Serotonin Syndrome: Cases of life-threatening initiating and titrating NUCYNTA® ER. shock have been reported very rarely with (CNS) depressants (e.g., sedatives, anxiolytics, serotonin syndrome have been reported with the ingredients contained in NUCYNTA® ER. Advise Renal Impairment: Use in patients with severe renal hypnotics, tranquilizers, general anesthetics, concurrent use of NUCYNTA® ER and serotonergic patients how to recognize such reactions and impairment (CL <30 mL/min) is not recommended neuroleptics, other opioids). When considering the drugs. Serotonergic drugs comprise selective CR when to seek medical attention. Panic attack has due to accumulation of a metabolite formed by use of NUCYNTA® ER in a patient taking a CNS serotonin reuptake inhibitors (SSRIs), serotonin also been reported. glucuronidation of tapentadol. The clinical relevance depressant, assess the duration of use of the CNS and norepinephrine reuptake inhibitors (SNRIs), of the elevated metabolite is not known. depressant and the patient’s response, including tricyclic antidepressants (TCAs), triptans, drugs the degree of tolerance that has developed to CNS that affect the serotonergic neurotransmitter depression. If the decision to begin NUCYNTA® ER system, and drugs that impair metabolism of Please see Brief Summary, including BOXED WARNING, is made, start with NUCYNTA® ER 50 mg every serotonin (including MAOIs). This may occur within on the following pages. 12 hours, monitor patients for signs of sedation the recommended dose. Serotonin syndrome may and respiratory depression, and consider using a include mental-status changes (e.g., agitation, lower dose of the concomitant CNS depressant. hallucinations, coma), autonomic instability (e.g., © July 2015, Depomed, Inc. All rights reserved. APL-NUCX-0029 Rev.2
Nuc_PainWeekJourn.indd 2 7/27/15 11:40 AM NUCYNTA® ER (tapentadol) IMPORTANT SAFETY INFORMATION (continued)
WARNINGS AND PRECAUTIONS: Addiction, Use in Elderly, Cachectic, or Debilitated Patients: tachycardia, labile blood pressure, hyperthermia), DRUG INTERACTIONS Abuse, and Misuse: NUCYNTA® ER contains Life-threatening respiratory depression is more likely neuromuscular aberrations (e.g., hyperreflexia, tapentadol, an opioid agonist and a Schedule II to occur in elderly, cachectic, or debilitated patients incoordination), and/or gastrointestinal symptoms Alcohol: See BOXED WARNING. controlled substance that can be abused in a as they may have altered pharmacokinetics or (e.g., nausea, vomiting, diarrhea) and can be fatal. If Muscle Relaxants: Monitor patients receiving manner similar to other opioid agonists, legal altered clearance. Because elderly patients are more concomitant treatment with SSRIs, SNRIs, TCAs, or muscle relaxants and NUCYNTA® ER for signs of or illicit. There is a greater risk for overdose and likely to have decreased renal and hepatic function, triptans is clinically warranted, careful observation respiratory depression that may be greater than death due to the larger amount of tapentadol consideration should be given to starting elderly of the patient is advised, particularly when otherwise expected. Tapentadol may enhance the present in NUCYNTA® ER. Assess risk for patients in the lower range of recommended doses. initiating or titrating the dose. neuromuscular blocking action of skeletal muscle opioid abuse or addiction prior to prescribing Closely monitor these patients, particularly when Use in Patients With Gastrointestinal (GI) relaxants and produce an increased degree of NUCYNTA® ER. Addiction can occur in patients initiating and titrating NUCYNTA® ER and when Conditions: Contraindicated in patients with respiratory depression. appropriately prescribed NUCYNTA® ER at given concomitantly with other drugs that Gl obstruction including paralytic ileus; may Anticholinergics: Use with anticholinergic products recommended doses; in those who obtain the depress respiration. cause spasm of the sphincter of Oddi. Monitor may increase the risk of urinary retention and/or drug illicitly; and if the drug is misused or abused. Use in Patients With Chronic Pulmonary Disease: patients with biliary tract disease, including acute severe constipation, which may lead to paralytic Therefore, routinely monitor for signs of misuse, Patients with significant chronic obstructive pancreatitis, for worsening symptoms. ileus. abuse, and addiction. Patients at increased risk pulmonary disease or cor pulmonale and patients (e.g., patients with a personal or family history Avoidance of Withdrawal: Withdrawal symptoms USE IN SPECIFIC POPULATIONS having a substantially decreased respiratory reserve, (e.g., anxiety, sweating, insomnia, restlessness, of substance abuse or mental illness) may be Pregnancy/Nursing Mothers: Pregnancy Category C. hypoxia, hypercarbia, or pre-existing respiratory pain, nausea, tremors, diarrhea, upper respiratory prescribed NUCYNTA® ER, but use in such patients NUCYNTA® ER should be used during pregnancy depression, should be monitored for respiratory necessitates intensive counseling about the risks symptoms, piloerection) may occur: only if the potential benefit justifies the potential depression particularly when initiating therapy and • After abrupt discontinuation or a significant and proper use along with intensive monitoring for ® risk to the fetus. Neonates born to mothers titrating with NUCYNTA ER. Consider the use of ® signs of addiction, abuse, and misuse. dose reduction of NUCYNTA ER in physically physically dependent on opioids will also be alternative nonopioid analgesics in these patients. dependent patients. When discontinuing Life-threatening Respiratory Depression: physically dependent and may exhibit respiratory Hypotensive Effect: May cause severe NUCYNTA® ER, gradually taper the dose. Can occur at any time during the use of difficulties and withdrawal symptoms. Observe hypotension. There is an increased risk in patients NUCYNTA® ER even when used as recommended. • If mixed agonist/antagonist (e.g., butorphanol, newborns for symptoms of neonatal opioid whose ability to maintain blood pressure has Respiratory depression from opioid use, if not nalbuphine, pentazocine) and partial agonist withdrawal syndrome. Withdrawal symptoms can already been compromised by a reduced blood immediately recognized and treated, may lead (e.g., buprenorphine) analgesics are used in occur in breast-feeding infants when maternal volume or concurrent administration of certain ® to respiratory arrest and death. To reduce the patients who have received or are receiving administration of NUCYNTA ER is stopped. CNS depressant drugs (e.g., phenothiazines ® risk of respiratory depression, proper dosing and NUCYNTA ER. Avoid use with mixed agonists/ Labor and Delivery: Opioids cross the placenta or general anesthetics). Monitor for signs of titration are essential. Overestimating the dose antagonists and partial agonists. and may produce respiratory depression in hypotension during dose initiation or titration. when converting patients from another opioid neonates. NUCYNTA® ER is not for use in women Avoid use in patients with circulatory shock; may • If opioid antagonists (e.g., naloxone, nalmefene) product can result in fatal overdose with the first during and immediately prior to labor, when cause vasodilation that can further reduce cardiac are administered in physically dependent dose. Management of respiratory depression may shorter-acting analgesics or other analgesic output and blood pressure. patients. Administration of the antagonist should include close observation, supportive measures, be begun with care and by titration with smaller techniques are more appropriate. Use in Patients With Head Injury or Increased and use of opioid antagonists, depending on the than usual doses of the antagonist. Use in Elderly, Renal Impairment, and Hepatic Intracranial Pressure: Monitor patients who may patient’s clinical status. Impairment: See WARNINGS AND PRECAUTIONS. be susceptible to the intracranial effects of CO Driving and Operating Heavy Machinery: May Neonatal Opioid Withdrawal Syndrome: Prolonged 2 retention (e.g., those with evidence of increased impair the mental or physical abilities needed DRUG ABUSE AND DEPENDENCE: use of NUCYNTA® ER during pregnancy can intracranial pressure or brain tumors) for signs of to perform potentially hazardous activities such See BOXED WARNING result in withdrawal signs in the neonate, which sedation and respiratory depression, particularly as driving a car or operating machinery. Warn may be life-threatening and require management OVERDOSAGE: Institute supportive measures to when initiating therapy. NUCYNTA® ER may patients not to drive or operate dangerous according to protocols developed by neonatology manage respiratory depression, circulatory shock, reduce respiratory drive, and the resultant CO machinery unless they are tolerant to the effects experts. Neonatal opioid withdrawal syndrome 2 ® and pulmonary edema as required. The opioid retention can further increase intracranial pressure. of NUCYNTA ER and know how they will react to presents as poor feeding, irritability, hyperactivity antagonists, naloxone or nalmefene, are specific Opioids may also obscure the clinical course in a the medication. and abnormal sleep pattern, antidotes to respiratory depression. Hepatic Impairment: Avoid use in patients with high-pitched cry, tremor, rigidity, seizures, patient with a head injury. ADVERSE REACTIONS: In clinical studies, the most severe hepatic impairment (Child-Pugh Score 10 to vomiting, diarrhea, and failure to gain weight. Seizures: May aggravate convulsions in patients common ( 10%) adverse reactions were nausea, 15). In patients with moderate hepatic impairment ≥ with convulsive disorders and may induce or constipation, vomiting, dizziness, somnolence, and Interactions With Central Nervous System (Child-Pugh Score 7-9), initiate treatment with aggravate seizures. Monitor patients with a history headache. Depressants: Hypotension, profound sedation, NUCYNTA® ER 50 mg no more than once every of seizure disorders for worsened seizure control coma, respiratory depression, and death may 24 hours, with a maximum dose of 100 mg per day. Select Postmarketing Adverse Reactions: ® during therapy. result if NUCYNTA ER is used concomitantly Monitor for respiratory and CNS depression when Anaphylaxis, angioedema, and anaphylactic with alcohol or other central nervous system Serotonin Syndrome: Cases of life-threatening initiating and titrating NUCYNTA® ER. shock have been reported very rarely with (CNS) depressants (e.g., sedatives, anxiolytics, serotonin syndrome have been reported with the ingredients contained in NUCYNTA® ER. Advise Renal Impairment: Use in patients with severe renal hypnotics, tranquilizers, general anesthetics, concurrent use of NUCYNTA® ER and serotonergic patients how to recognize such reactions and impairment (CL <30 mL/min) is not recommended neuroleptics, other opioids). When considering the drugs. Serotonergic drugs comprise selective CR when to seek medical attention. Panic attack has due to accumulation of a metabolite formed by use of NUCYNTA® ER in a patient taking a CNS serotonin reuptake inhibitors (SSRIs), serotonin also been reported. glucuronidation of tapentadol. The clinical relevance depressant, assess the duration of use of the CNS and norepinephrine reuptake inhibitors (SNRIs), of the elevated metabolite is not known. depressant and the patient’s response, including tricyclic antidepressants (TCAs), triptans, drugs the degree of tolerance that has developed to CNS that affect the serotonergic neurotransmitter depression. If the decision to begin NUCYNTA® ER system, and drugs that impair metabolism of Please see Brief Summary, including BOXED WARNING, is made, start with NUCYNTA® ER 50 mg every serotonin (including MAOIs). This may occur within on the following pages. 12 hours, monitor patients for signs of sedation the recommended dose. Serotonin syndrome may and respiratory depression, and consider using a include mental-status changes (e.g., agitation, lower dose of the concomitant CNS depressant. hallucinations, coma), autonomic instability (e.g., © July 2015, Depomed, Inc. All rights reserved. APL-NUCX-0029 Rev.2
Nuc_PainWeekJourn.indd 2 7/27/15 11:40 AM products such as NUCYNTA® ER deliver the opioid over an Neonatal opioid withdrawal syndrome presents as Avoid the use of NUCYNTA® ER in patients with impaired extended period of time, there is a greater risk for overdose irritability, hyperactivity and abnormal sleep pattern, high consciousness or coma. and death due to the larger amount of tapentadol present. pitched cry, tremor, vomiting, diarrhea and failure to gain Seizures weight. The onset, duration, and severity of neonatal opioid Although the risk of addiction in any individual is unknown, it NUCYNTA® ER has not been evaluated in patients with withdrawal syndrome vary based on the specific opioid can occur in patients appropriately prescribed NUCYNTA® ER a predisposition to a seizure disorder, and such patients used, duration of use, timing and amount of last maternal BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION and in those who obtain the drug illicitly. Addiction can occur were excluded from clinical studies. The active ingredient use, and rate of elimination of the drug by the newborn. This does not include all the information needed to use at recommended doses and if the drug is misused or abused. tapentadol in NUCYNTA® ER may aggravate convulsions NUCYNTA® ER safely and effectively. See full Prescribing Interactions with Central Nervous System Depressants in patients with convulsive disorders, and may induce Assess each patient’s risk for opioid addiction, abuse, or Information for NUCYNTA® ER. Patients must not consume alcoholic beverages or or aggravate seizures in some clinical settings. Monitor misuse prior to prescribing NUCYNTA® ER, and monitor prescription or non-prescription products containing patients with a history of seizure disorders for worsened all patients receiving NUCYNTA® ER for the development INDICATIONS AND USAGE alcohol while on NUCYNTA® ER therapy. The co-ingestion seizure control during NUCYNTA® ER therapy. of these behaviors or conditions. Risks are increased in NUCYNTA® ER is indicated for the management of: of alcohol with NUCYNTA® ER may result in increased patients with a personal or family history of substance abuse Serotonin Syndrome • pain severe enough to require daily, around-the-clock, long- plasma tapentadol levels and a potentially fatal overdose (including drug or alcohol addiction or abuse) or mental Cases of life-threatening serotonin syndrome have term opioid treatment and for which alternative treatment of tapentadol. illness (e.g., major depression). The potential for these risks been reported with the concurrent use of tapentadol options are inadequate should not, however, prevent the prescribing of NUCYNTA® ER Hypotension, profound sedation, coma, respiratory and serotonergic drugs. Serotonergic drugs comprise • neuropathic pain associated with diabetic peripheral for the proper management of pain in any given patient. depression, and death may result if NUCYNTA® ER is used Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin neuropathy (DPN) in adults severe enough to require daily, Patients at increased risk may be prescribed modified-release concomitantly with alcohol or other central nervous system and Norepinephrine Reuptake Inhibitors (SNRIs), around-the-clock, long-term opioid treatment and for which opioid formulations such as NUCYNTA® ER, but use in such (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, tricyclic antidepressants (TCAs), triptans, drugs that alternative treatment options are inadequate. patients necessitates intensive counseling about the risks and neuroleptics, other opioids). affect the serotonergic neurotransmitter system (e.g. proper use of NUCYNTA® ER along with intensive monitoring mirtazapine, trazodone, and tramadol), and drugs that Limitations of Usage When considering the use of NUCYNTA® ER in a patient for signs of addiction, abuse, and misuse. impair metabolism of serotonin (including MAOIs). This • Because of the risks of addiction, abuse, and misuse with taking a CNS depressant, assess the duration of use of the may occur within the recommended dose. Serotonin opioids, even at recommended doses, and because of Abuse or misuse of NUCYNTA® ER by crushing, chewing, CNS depressant and the patient’s response, including the syndrome may include mental-status changes (e.g., the greater risks of overdose and death with extended- snorting, or injecting the dissolved product will result in degree of tolerance that has developed to CNS depression. agitation, hallucinations, coma), autonomic instability release opioid formulations, reserve NUCYNTA® ER for use the uncontrolled delivery of tapentadol and can result in Additionally, evaluate the patient’s use of alcohol or illicit (e.g., tachycardia, labile blood pressure, hyperthermia), in patients for whom alternative treatment options (e.g., overdose and death. drugs that cause CNS depression. If the decision to begin neuromuscular aberrations (e.g., hyperreflexia, nonopioid analgesics or immediate-release opioids) are NUCYNTA® ER is made, start with NUCYNTA® ER 50 mg Opioid agonists such as NUCYNTA® ER are sought by incoordination) and/or gastrointestinal symptoms (e.g., ineffective, not tolerated, or would be otherwise inadequate every 12 hours, monitor patients for signs of sedation and drug abusers and people with addiction disorders and are nausea, vomiting, diarrhea) and can be fatal. to provide sufficient management of pain. respiratory depression, and consider using a lower dose of subject to criminal diversion. Consider these risks when the concomitant CNS depressant. Use in Patients with Gastrointestinal Conditions • NUCYNTA ® ER is not indicated as an as-needed (prn) analgesic. prescribing or dispensing NUCYNTA® ER. Strategies to NUCYNTA® ER is contraindicated in patients with GI reduce these risks include prescribing the drug in the Use in Elderly, Cachectic, and Debilitated Patients WARNING: ADDICTION, ABUSE, obstruction, including paralytic ileus. The tapentadol in smallest appropriate quantity and advising the patient on Life-threatening respiratory depression is more likely to AND MISUSE; LIFE-THREATENING RESPIRATORY NUCYNTA® ER may cause spasm of the sphincter of Oddi. the proper disposal of unused drug. Contact local state occur in elderly, cachectic, or debilitated patients as they DEPRESSION; ACCIDENTAL INGESTION; Monitor patients with biliary tract disease, including acute professional licensing board or state controlled substances may have altered pharmacokinetics or altered clearance NEONATAL OPIOID WITHDRAWAL SYNDROME; pancreatitis, for worsening symptoms. AND INTERACTION WITH ALCOHOL authority for information on how to prevent and detect compared to younger, healthier patients. Therefore, closely abuse or diversion of this product. monitor such patients, particularly when initiating and Avoidance of Withdrawal See full prescribing information for complete boxed warning. titrating NUCYNTA® ER and when NUCYNTA® ER is given Avoid the use of mixed agonist/antagonist (i.e., pentazocine, Life-Threatening Respiratory Depression concomitantly with other drugs that depress respiration. nalbuphine, and butorphanol) or partial agonist • NUCYNTA ® ER exposes users to risks of addiction, abuse, Serious, life-threatening, or fatal respiratory depression has (buprenorphine) analgesics in patients who have received or and misuse, which can lead to overdose and death. Assess been reported with the use of modified release opioids, Use in Patients with Chronic Pulmonary Disease are receiving a course of therapy with a full opioid agonist each patient’s risk before prescribing, and monitor regularly even when used as recommended. Respiratory depression Monitor for respiratory depression those patients analgesic, including NUCYNTA® ER. In these patients, for development of these behaviors or conditions. (5.1) from opioid use, if not immediately recognized and treated, with significant chronic obstructive pulmonary disease mixed agonists/antagonists and partial agonist analgesics may lead to respiratory arrest and death. Management or cor pulmonale, and patients having a substantially • Serious, life-threatening, or fatal respiratory depression may may reduce the analgesic effect and/or may precipitate of respiratory depression may include close observation, decreased respiratory reserve, hypoxia, hypercarbia, or occur. Monitor closely, especially upon initiation or following withdrawal symptoms. supportive measures, and use of opioid antagonists, pre-existing respiratory depression, particularly when a dose increase. Instruct patients to swallow NUCYNTA® ER depending on the patient’s clinical status. Carbon dioxide initiating therapy and titrating with NUCYNTA® ER, as in When discontinuing NUCYNTA® ER, gradually taper the dose. tablets whole to avoid exposure to a potentially fatal dose of (CO ) retention from opioid-induced respiratory depression these patients, even usual therapeutic doses of NUCYNTA® ER tapentadol. (5.2) 2 Driving and Operating Heavy Machinery can exacerbate the sedating effects of opioids. may decrease respiratory drive to the point of apnea. NUCYNTA® ER may impair the mental or physical abilities • Accidental ingestion of NUCYNTA® ER, especially in children, Consider the use of alternative non-opioid analgesics in While serious, life-threatening, or fatal respiratory depression needed to perform potentially hazardous activities such can result in fatal overdose of tapentadol. (5.2) these patients if possible. can occur at any time during the use of NUCYNTA® ER, the as driving a car or operating machinery. Warn patients not • Prolonged use of NUCYNTA® ER during pregnancy can risk is greatest during the initiation of therapy or following a Hypotensive Effect to drive or operate dangerous machinery unless they are result in neonatal opioid withdrawal syndrome, which may dose increase. NUCYNTA® ER may cause severe hypotension. There is an tolerant to the effects of NUCYNTA® ER and know how they be life-threatening if not recognized and treated. If opioid increased risk in patients whose ability to maintain blood will react to the medication. Closely monitor patients for respiratory depression when use is required for a prolonged period in a pregnant woman, pressure has already been compromised by a reduced initiating therapy with NUCYNTA® ER and following dose Hepatic Impairment advise the patient of the risk of neonatal opioid withdrawal blood volume or concurrent administration of certain increases. To reduce the risk of respiratory depression, A study with an immediate-release formulation of tapentadol syndrome and ensure that appropriate treatment will be CNS depressant drugs (e.g., phenothiazines or general proper dosing and titration of NUCYNTA® ER are essential. in subjects with hepatic impairment showed higher serum available. (5.3) anesthetics). Monitor these patients for signs of hypotension Overestimating the NUCYNTA® ER dose when converting concentrations of tapentadol than in those with normal after initiating or titrating the dose of NUCYNTA® ER. In • Instruct patients not to consume alcohol or any products patients from another opioid product can result in fatal hepatic function. Avoid use of NUCYNTA® ER in patients with patients with circulatory shock, NUCYNTA® ER may cause containing alcohol while taking NUCYNTA® ER because overdose with the first dose. severe hepatic impairment. Reduce the dose of NUCYNTA® ER vasodilation that can further reduce cardiac output and co-ingestion can result in fatal plasma tapentadol levels. (5.4) in patients with moderate hepatic impairment. Closely Accidental ingestion of even one dose of NUCYNTA® ER, blood pressure. Avoid the use of NUCYNTA® ER in patients monitor patients with moderate hepatic impairment for especially by children, can result in respiratory depression with circulatory shock. CONTRAINDICATIONS respiratory and central nervous system depression when and death due to an overdose of tapentadol. Significant respiratory depression; acute or severe Use in Patients with Head Injury or Increased initiating and titrating NUCYNTA® ER. bronchial asthma or hypercarbia in an unmonitored setting Neonatal Opioid Withdrawal Syndrome Intracranial Pressure Renal Impairment or in the absence of resuscitative equipment; known or Prolonged use of NUCYNTA® ER during pregnancy can Monitor patients taking NUCYNTA® ER who may be Use of NUCYNTA® ER in patients with severe renal suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, result in withdrawal signs in the neonate. Neonatal opioid susceptible to the intracranial effects of CO retention 2 impairment is not recommended due to accumulation of a angioedema) to tapentadol or to any other ingredients of withdrawal syndrome, unlike opioid withdrawal syndrome in (e.g., those with evidence of increased intracranial metabolite formed by glucuronidation of tapentadol. The the product; concurrent use of monoamine oxidase inhibitors adults, may be life threatening if not recognized and treated, pressure or brain tumors) for signs of sedation and clinical relevance of the elevated metabolite is not known. (MAOIs) or use within the last 14 days. and requires management according to protocols developed respiratory depression, particularly when initiating therapy with NUCYNTA® ER. NUCYNTA® ER may reduce WARNINGS AND PRECAUTIONS by neonatology experts. If opioid use is required for a ADVERSE REACTIONS prolonged period in a pregnant woman, advise the patient of respiratory drive, and the resultant CO retention can Addiction, Abuse, and Misuse 2 The following serious adverse reactions are discussed ® further increase intracranial pressure. Opioids may also NUCYNTA ER contains tapentadol, a Schedule II controlled the risk of neonatal opioid withdrawal syndrome and ensure elsewhere in the labeling: substance. As an opioid, NUCYNTA® ER exposes users to the that appropriate treatment will be available. obscure the clinical course in a patient with a head injury. risks of addiction, abuse, and misuse. As modified-release • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
Nuc_PainWeekJourn.indd 3 7/27/15 11:40 AM products such as NUCYNTA® ER deliver the opioid over an Neonatal opioid withdrawal syndrome presents as Avoid the use of NUCYNTA® ER in patients with impaired extended period of time, there is a greater risk for overdose irritability, hyperactivity and abnormal sleep pattern, high consciousness or coma. and death due to the larger amount of tapentadol present. pitched cry, tremor, vomiting, diarrhea and failure to gain Seizures weight. The onset, duration, and severity of neonatal opioid Although the risk of addiction in any individual is unknown, it NUCYNTA® ER has not been evaluated in patients with withdrawal syndrome vary based on the specific opioid can occur in patients appropriately prescribed NUCYNTA® ER a predisposition to a seizure disorder, and such patients used, duration of use, timing and amount of last maternal BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION and in those who obtain the drug illicitly. Addiction can occur were excluded from clinical studies. The active ingredient use, and rate of elimination of the drug by the newborn. This does not include all the information needed to use at recommended doses and if the drug is misused or abused. tapentadol in NUCYNTA® ER may aggravate convulsions NUCYNTA® ER safely and effectively. See full Prescribing Interactions with Central Nervous System Depressants in patients with convulsive disorders, and may induce Assess each patient’s risk for opioid addiction, abuse, or Information for NUCYNTA® ER. Patients must not consume alcoholic beverages or or aggravate seizures in some clinical settings. Monitor misuse prior to prescribing NUCYNTA® ER, and monitor prescription or non-prescription products containing patients with a history of seizure disorders for worsened all patients receiving NUCYNTA® ER for the development INDICATIONS AND USAGE alcohol while on NUCYNTA® ER therapy. The co-ingestion seizure control during NUCYNTA® ER therapy. of these behaviors or conditions. Risks are increased in NUCYNTA® ER is indicated for the management of: of alcohol with NUCYNTA® ER may result in increased patients with a personal or family history of substance abuse Serotonin Syndrome • pain severe enough to require daily, around-the-clock, long- plasma tapentadol levels and a potentially fatal overdose (including drug or alcohol addiction or abuse) or mental Cases of life-threatening serotonin syndrome have term opioid treatment and for which alternative treatment of tapentadol. illness (e.g., major depression). The potential for these risks been reported with the concurrent use of tapentadol options are inadequate should not, however, prevent the prescribing of NUCYNTA® ER Hypotension, profound sedation, coma, respiratory and serotonergic drugs. Serotonergic drugs comprise • neuropathic pain associated with diabetic peripheral for the proper management of pain in any given patient. depression, and death may result if NUCYNTA® ER is used Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin neuropathy (DPN) in adults severe enough to require daily, Patients at increased risk may be prescribed modified-release concomitantly with alcohol or other central nervous system and Norepinephrine Reuptake Inhibitors (SNRIs), around-the-clock, long-term opioid treatment and for which opioid formulations such as NUCYNTA® ER, but use in such (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, tricyclic antidepressants (TCAs), triptans, drugs that alternative treatment options are inadequate. patients necessitates intensive counseling about the risks and neuroleptics, other opioids). affect the serotonergic neurotransmitter system (e.g. proper use of NUCYNTA® ER along with intensive monitoring mirtazapine, trazodone, and tramadol), and drugs that Limitations of Usage When considering the use of NUCYNTA® ER in a patient for signs of addiction, abuse, and misuse. impair metabolism of serotonin (including MAOIs). This • Because of the risks of addiction, abuse, and misuse with taking a CNS depressant, assess the duration of use of the may occur within the recommended dose. Serotonin opioids, even at recommended doses, and because of Abuse or misuse of NUCYNTA® ER by crushing, chewing, CNS depressant and the patient’s response, including the syndrome may include mental-status changes (e.g., the greater risks of overdose and death with extended- snorting, or injecting the dissolved product will result in degree of tolerance that has developed to CNS depression. agitation, hallucinations, coma), autonomic instability release opioid formulations, reserve NUCYNTA® ER for use the uncontrolled delivery of tapentadol and can result in Additionally, evaluate the patient’s use of alcohol or illicit (e.g., tachycardia, labile blood pressure, hyperthermia), in patients for whom alternative treatment options (e.g., overdose and death. drugs that cause CNS depression. If the decision to begin neuromuscular aberrations (e.g., hyperreflexia, nonopioid analgesics or immediate-release opioids) are NUCYNTA® ER is made, start with NUCYNTA® ER 50 mg Opioid agonists such as NUCYNTA® ER are sought by incoordination) and/or gastrointestinal symptoms (e.g., ineffective, not tolerated, or would be otherwise inadequate every 12 hours, monitor patients for signs of sedation and drug abusers and people with addiction disorders and are nausea, vomiting, diarrhea) and can be fatal. to provide sufficient management of pain. respiratory depression, and consider using a lower dose of subject to criminal diversion. Consider these risks when the concomitant CNS depressant. Use in Patients with Gastrointestinal Conditions • NUCYNTA ® ER is not indicated as an as-needed (prn) analgesic. prescribing or dispensing NUCYNTA® ER. Strategies to NUCYNTA® ER is contraindicated in patients with GI reduce these risks include prescribing the drug in the Use in Elderly, Cachectic, and Debilitated Patients WARNING: ADDICTION, ABUSE, obstruction, including paralytic ileus. The tapentadol in smallest appropriate quantity and advising the patient on Life-threatening respiratory depression is more likely to AND MISUSE; LIFE-THREATENING RESPIRATORY NUCYNTA® ER may cause spasm of the sphincter of Oddi. the proper disposal of unused drug. Contact local state occur in elderly, cachectic, or debilitated patients as they DEPRESSION; ACCIDENTAL INGESTION; Monitor patients with biliary tract disease, including acute professional licensing board or state controlled substances may have altered pharmacokinetics or altered clearance NEONATAL OPIOID WITHDRAWAL SYNDROME; pancreatitis, for worsening symptoms. AND INTERACTION WITH ALCOHOL authority for information on how to prevent and detect compared to younger, healthier patients. Therefore, closely abuse or diversion of this product. monitor such patients, particularly when initiating and Avoidance of Withdrawal See full prescribing information for complete boxed warning. titrating NUCYNTA® ER and when NUCYNTA® ER is given Avoid the use of mixed agonist/antagonist (i.e., pentazocine, Life-Threatening Respiratory Depression concomitantly with other drugs that depress respiration. nalbuphine, and butorphanol) or partial agonist • NUCYNTA ® ER exposes users to risks of addiction, abuse, Serious, life-threatening, or fatal respiratory depression has (buprenorphine) analgesics in patients who have received or and misuse, which can lead to overdose and death. Assess been reported with the use of modified release opioids, Use in Patients with Chronic Pulmonary Disease are receiving a course of therapy with a full opioid agonist each patient’s risk before prescribing, and monitor regularly even when used as recommended. Respiratory depression Monitor for respiratory depression those patients analgesic, including NUCYNTA® ER. In these patients, for development of these behaviors or conditions. (5.1) from opioid use, if not immediately recognized and treated, with significant chronic obstructive pulmonary disease mixed agonists/antagonists and partial agonist analgesics may lead to respiratory arrest and death. Management or cor pulmonale, and patients having a substantially • Serious, life-threatening, or fatal respiratory depression may may reduce the analgesic effect and/or may precipitate of respiratory depression may include close observation, decreased respiratory reserve, hypoxia, hypercarbia, or occur. Monitor closely, especially upon initiation or following withdrawal symptoms. supportive measures, and use of opioid antagonists, pre-existing respiratory depression, particularly when a dose increase. Instruct patients to swallow NUCYNTA® ER depending on the patient’s clinical status. Carbon dioxide initiating therapy and titrating with NUCYNTA® ER, as in When discontinuing NUCYNTA® ER, gradually taper the dose. tablets whole to avoid exposure to a potentially fatal dose of (CO ) retention from opioid-induced respiratory depression these patients, even usual therapeutic doses of NUCYNTA® ER tapentadol. (5.2) 2 Driving and Operating Heavy Machinery can exacerbate the sedating effects of opioids. may decrease respiratory drive to the point of apnea. NUCYNTA® ER may impair the mental or physical abilities • Accidental ingestion of NUCYNTA® ER, especially in children, Consider the use of alternative non-opioid analgesics in While serious, life-threatening, or fatal respiratory depression needed to perform potentially hazardous activities such can result in fatal overdose of tapentadol. (5.2) these patients if possible. can occur at any time during the use of NUCYNTA® ER, the as driving a car or operating machinery. Warn patients not • Prolonged use of NUCYNTA® ER during pregnancy can risk is greatest during the initiation of therapy or following a Hypotensive Effect to drive or operate dangerous machinery unless they are result in neonatal opioid withdrawal syndrome, which may dose increase. NUCYNTA® ER may cause severe hypotension. There is an tolerant to the effects of NUCYNTA® ER and know how they be life-threatening if not recognized and treated. If opioid increased risk in patients whose ability to maintain blood will react to the medication. Closely monitor patients for respiratory depression when use is required for a prolonged period in a pregnant woman, pressure has already been compromised by a reduced initiating therapy with NUCYNTA® ER and following dose Hepatic Impairment advise the patient of the risk of neonatal opioid withdrawal blood volume or concurrent administration of certain increases. To reduce the risk of respiratory depression, A study with an immediate-release formulation of tapentadol syndrome and ensure that appropriate treatment will be CNS depressant drugs (e.g., phenothiazines or general proper dosing and titration of NUCYNTA® ER are essential. in subjects with hepatic impairment showed higher serum available. (5.3) anesthetics). Monitor these patients for signs of hypotension Overestimating the NUCYNTA® ER dose when converting concentrations of tapentadol than in those with normal after initiating or titrating the dose of NUCYNTA® ER. In • Instruct patients not to consume alcohol or any products patients from another opioid product can result in fatal hepatic function. Avoid use of NUCYNTA® ER in patients with patients with circulatory shock, NUCYNTA® ER may cause containing alcohol while taking NUCYNTA® ER because overdose with the first dose. severe hepatic impairment. Reduce the dose of NUCYNTA® ER vasodilation that can further reduce cardiac output and co-ingestion can result in fatal plasma tapentadol levels. (5.4) in patients with moderate hepatic impairment. Closely Accidental ingestion of even one dose of NUCYNTA® ER, blood pressure. Avoid the use of NUCYNTA® ER in patients monitor patients with moderate hepatic impairment for especially by children, can result in respiratory depression with circulatory shock. CONTRAINDICATIONS respiratory and central nervous system depression when and death due to an overdose of tapentadol. Significant respiratory depression; acute or severe Use in Patients with Head Injury or Increased initiating and titrating NUCYNTA® ER. bronchial asthma or hypercarbia in an unmonitored setting Neonatal Opioid Withdrawal Syndrome Intracranial Pressure Renal Impairment or in the absence of resuscitative equipment; known or Prolonged use of NUCYNTA® ER during pregnancy can Monitor patients taking NUCYNTA® ER who may be Use of NUCYNTA® ER in patients with severe renal suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, result in withdrawal signs in the neonate. Neonatal opioid susceptible to the intracranial effects of CO retention 2 impairment is not recommended due to accumulation of a angioedema) to tapentadol or to any other ingredients of withdrawal syndrome, unlike opioid withdrawal syndrome in (e.g., those with evidence of increased intracranial metabolite formed by glucuronidation of tapentadol. The the product; concurrent use of monoamine oxidase inhibitors adults, may be life threatening if not recognized and treated, pressure or brain tumors) for signs of sedation and clinical relevance of the elevated metabolite is not known. (MAOIs) or use within the last 14 days. and requires management according to protocols developed respiratory depression, particularly when initiating therapy with NUCYNTA® ER. NUCYNTA® ER may reduce WARNINGS AND PRECAUTIONS by neonatology experts. If opioid use is required for a ADVERSE REACTIONS prolonged period in a pregnant woman, advise the patient of respiratory drive, and the resultant CO retention can Addiction, Abuse, and Misuse 2 The following serious adverse reactions are discussed ® further increase intracranial pressure. Opioids may also NUCYNTA ER contains tapentadol, a Schedule II controlled the risk of neonatal opioid withdrawal syndrome and ensure elsewhere in the labeling: substance. As an opioid, NUCYNTA® ER exposes users to the that appropriate treatment will be available. obscure the clinical course in a patient with a head injury. risks of addiction, abuse, and misuse. As modified-release • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)]
Nuc_PainWeekJourn.indd 3 7/27/15 11:40 AM • Life-Threatening Respiratory Depression [see Warnings Serotonergic Drugs Geriatric Use Abuse and addiction are separate and distinct from physical and Precautions (5.2)] There have been post-marketing reports of serotonin Of the total number of patients in Phase 2/3 double-blind, dependence and tolerance. Physicians should be aware that • Neonatal Opioid Withdrawal Syndrome [see Warnings syndrome with the concomitant use of tapentadol and multiple-dose clinical studies of NUCYNTA® ER, 28% addiction may not be accompanied by concurrent tolerance and Precautions (5.3)] serotonergic drugs (e.g., SSRIs and SNRIs). Caution is advised (1023/3613) were 65 years and over, while 7% (245/3613) and symptoms of physical dependence in all addicts. In addition, ® • Interaction with Other CNS Depressants [see Warnings when NUCYNTA ER is coadministered with other drugs that were 75 years and over. No overall differences in abuse of opioids can occur in the absence of true addiction. may affect serotonergic neurotransmitter systems such as effectiveness or tolerability were observed between these and Precautions (5.4)] NUCYNTA® ER, like other opioids, can be diverted for SSRIs, SNRIs, MAOIs, and triptans. If concomitant treatment patients and younger patients. non-medical use into illicit channels of distribution. Careful • Hypotensive Effects [see Warnings and Precautions (5.7)] of NUCYNTA® ER with a drug affecting the serotonergic In general, recommended dosing for elderly patients record-keeping of prescribing information, including quantity, • Gastrointestinal Effects [see Warnings and Precautions (5.11)] neurotransmitter system is clinically warranted, careful with normal renal and hepatic function is the same as frequency, and renewal requests, as required by law, is • Seizures [see Warnings and Precautions (5.9)] observation of the patient is advised, particularly during for younger adult patients with normal renal and hepatic strongly advised. treatment initiation and dose increases. • Serotonin Syndrome [see Warnings and Precautions (5.10)] function. Because elderly patients are more likely to have Proper assessment of the patient, proper prescribing Muscle Relaxants decreased renal and hepatic function, consideration should Clinical Trial Experience practices, periodic re-evaluation of therapy, and proper Tapentadol may enhance the neuromuscular blocking action be given to starting elderly patients with the lower range of Commonly-Observed Adverse Reactions in Clinical Studies dispensing and storage are appropriate measures that help ® of skeletal muscle relaxants and produce an increased recommended doses. with NUCYNTA ER in Patients with Chronic Pain due to Low to limit abuse of opioid drugs. degree of respiratory depression. Monitor patients receiving Back Pain or Osteoarthritis Renal Impairment muscle relaxants and NUCYNTA® ER for signs of respiratory Dependence The safety and effectiveness of NUCYNTA® ER have not The most common adverse reactions (reported by ≥10 % in depression that may be greater than otherwise expected. Both tolerance and physical dependence can develop during ® been established in patients with severe renal impairment any NUCYNTA ER dose group) were: nausea, constipation, chronic opioid therapy. Tolerance is the need for increasing Mixed Agonist/Antagonist Opioid Analgesics (CL <30 mL/min). Use of NUCYNTA® ER in patients dizziness, headache, and somnolence. CR doses of opioids to maintain a defined effect such as Mixed agonist/antagonist analgesics (i.e., pentazocine, with severe renal impairment is not recommended due to analgesia (in the absence of disease progression or other The most common reasons for discontinuation due to nalbuphine, and butorphanol) and partial agonists (e.g., accumulation of a metabolite formed by glucuronidation external factors). Tolerance may occur to both the desired adverse reactions in eight Phase 2/3 pooled studies buprenorphine) may reduce the analgesic effect of of tapentadol. The clinical relevance of the elevated ® and undesired effects of drugs, and may develop at different reported by ≥1% in any NUCYNTA ER dose group for NUCYNTA® ER or precipitate withdrawal symptoms. Avoid metabolite is not known. ® rates for different effects. NUCYNTA ER- and placebo-treated patients were the use of mixed agonist/antagonist analgesics in patients Hepatic Impairment nausea (4 % vs. 1%), dizziness (3% vs. <1%), vomiting (3% receiving NUCYNTA® ER. Physical dependence results in withdrawal symptoms after Administration of tapentadol resulted in higher exposures vs. <1%), somnolence (2% vs. <1%), constipation (1% vs. abrupt discontinuation or a significant dose reduction of Anticholinergics and serum levels of tapentadol in subjects with impaired <1%), headache (1% vs. <1%), and fatigue (1% vs. <1%), a drug. Withdrawal also may be precipitated through the The use of NUCYNTA® ER with anticholinergic products hepatic function compared to subjects with normal hepatic respectively. administration of drugs with opioid antagonist activity, e.g., may increase the risk of urinary retention and/or severe function. The dose of NUCYNTA® ER should be reduced in naloxone, nalmefene, mixed agonist/antagonist analgesics Commonly-Observed Adverse Reactions in Clinical Studies constipation, which may lead to paralytic ileus. patients with moderate hepatic impairment (Child-Pugh ® (pentazocine, butorphanol, nalbuphine), or partial agonists with NUCYNTA ER in Patients with Neuropathic Pain Score 7 to 9). Associated with Diabetic Peripheral Neuropathy USE IN SPECIFIC POPULATIONS (buprenorphine). Physical dependence may not occur to a Pregnancy Use of NUCYNTA® ER is not recommended in severe hepatic clinically significant degree until after several days to weeks The most commonly reported ADRs (incidence ≥ 10% in Clinical Considerations impairment (Child-Pugh Score 10 to 15). of continued opioid usage. NUCYNTA® ER-treated subjects) were: nausea, constipation, ® vomiting, dizziness, somnolence, and headache. Fetal/neonatal adverse reactions DRUG ABUSE AND DEPENDENCE NUCYNTA ER should not be abruptly discontinued. If NUCYNTA® ER is abruptly discontinued in a physically- Prolonged use of opioid analgesics during pregnancy for Controlled Substance Postmarketing Experience dependent patient, an abstinence syndrome may occur. medical or nonmedical purposes can result in physical NUCYNTA® ER contains tapentadol, a Schedule II controlled The following adverse reactions, not above, have been Some or all of the following can characterize this syndrome: dependence in the neonate and neonatal opioid withdrawal substance with a high potential for abuse similar to fentanyl, identified during post approval use of tapentadol. restlessness, lacrimation, rhinorrhea, yawning, perspiration, syndrome shortly after birth. Observe newborns for methadone, morphine, oxycodone, and oxymorphone. Because these reactions are reported voluntarily from chills, piloerection, myalgia, mydriasis, irritability, anxiety, symptoms of neonatal opioid withdrawal syndrome, such NUCYNTA® ER can be abused and is subject to misuse, a population of uncertain size, it is not always possible backache, joint pain, weakness, abdominal cramps, insomnia, as poor feeding, diarrhea, irritability, tremor, rigidity, and addiction, and criminal diversion. The high drug content in to reliably estimate their frequency or establish a causal nausea, anorexia, vomiting, diarrhea, increased blood relationship to drug exposure. seizures, and manage accordingly. the extended release formulation adds to the risk of adverse outcomes from abuse and misuse. pressure, respiratory rate, or heart rate. Teratogenic Effects - Psychiatric disorders: hallucination, suicidal ideation, Pregnancy Category C Infants born to mothers physically dependent on opioids will panic attack Abuse There are no adequate and well-controlled studies in All patients treated with opioids require careful monitoring for also be physically dependent and may exhibit respiratory Anaphylaxis, angioedema, and anaphylactic shock have ® pregnant women. NUCYNTA ER should be used during signs of abuse and addiction, because use of opioid analgesic difficulties and withdrawal symptoms. been reported very rarely with ingredients contained in pregnancy only if the potential benefit justifies the potential ® products carries the risk of addiction even under appropriate OVERDOSAGE NUCYNTA ER. Advise patients how to recognize such risk to the fetus. reactions and when to seek medical attention. medical use. Clinical Presentation Labor and Delivery Acute overdosage with opioids can be manifested by DRUG INTERACTIONS Drug abuse is the intentional non-therapeutic use of an over- Opioids cross the placenta and may produce respiratory the-counter or prescription drug, even once, for its rewarding respiratory depression, somnolence progressing to stupor Alcohol depression in neonates. NUCYNTA® ER is not for use in or coma, skeletal muscle flaccidity, cold and clammy skin, Concomitant use of alcohol with NUCYNTA® ER can result in psychological or physiological effects. Drug abuse includes, women during and immediately prior to labor, when shorter but is not limited to the following examples: the use of a constricted pupils, and sometimes pulmonary edema, an increase of tapentadol plasma levels and potentially fatal acting analgesics or other analgesic techniques are more bradycardia, hypotension and death. Marked mydriasis overdose of tapentadol. Instruct patients not to consume prescription or over-the-counter drug to get “high,” or the use appropriate. Opioid analgesics can prolong labor through of steroids for performance enhancement and muscle build up. rather than miosis may be seen due to severe hypoxia in alcoholic beverages or use prescription or non-prescription actions that temporarily reduce the strength, duration, and overdose situations. products containing alcohol while on NUCYNTA® ER therapy. frequency of uterine contractions. However this effect is not Drug addiction is a cluster of behavioral, cognitive, and Treatment of Overdose consistent and may be offset by an increased rate of cervical physiological phenomena that develop after repeated Monoamine Oxidase Inhibitors In case of overdose, priorities are the re-establishment ® dilatation, which tends to shorten labor. substance use and include: a strong desire to take the NUCYNTA ER is contraindicated in patients who are of a patent and protected airway and institution of receiving monoamine oxidase inhibitors (MAOIs) or who have drug, difficulties in controlling its use, persisting in its use Nursing Mothers despite harmful consequences, a higher priority given to assisted or controlled ventilation if needed. Employ other taken them within the last 14 days due to potential additive There is insufficient/limited information on the excretion of supportive measures (including oxygen, vasopressors) in the effects on norepinephrine levels, which may result in drug use than to other activities and obligations, increased tapentadol in human or animal breast milk. Physicochemical tolerance, and sometimes a physical withdrawal. management of circulatory shock and pulmonary edema adverse cardiovascular events. and available pharmacodynamic/toxicological data on as indicated. Cardiac arrest or arrhythmias will require CNS Depressants tapentadol point to excretion in breast milk and risk to the “Drug-seeking” behavior is very common to addicts and advanced life support techniques. The concomitant use of NUCYNTA® ER with other CNS breastfeeding child cannot be excluded. drug abusers. Drug-seeking tactics include emergency depressants including sedatives, hypnotics, tranquilizers, calls or visits near the end of office hours, refusal to Because of the potential for adverse reactions in nursing undergo appropriate examination, testing or referral, general anesthetics, phenothiazines, other opioids, and ® © June 2015, Depomed, Inc. infants from NUCYNTA ER, a decision should be made repeated claims of loss of prescriptions, tampering with alcohol can increase the risk of respiratory depression, All rights reserved. APL-NUCX-0041 whether to discontinue nursing or discontinue the drug, prescriptions and reluctance to provide prior medical profound sedation, coma and death. Monitor patients taking into account the importance of the drug to the mother. receiving CNS depressants and NUCYNTA® ER for signs of records or contact information for other treating respiratory depression, sedation and hypotension. Withdrawal symptoms can occur in breast-feeding infants physician(s). “Doctor shopping” (visiting multiple when maternal administration of NUCYNTA® ER is stopped. prescribers) to obtain additional prescriptions is common When combined therapy with any of the above among drug abusers, and people suffering from untreated medications is considered, the dose of one or both Pediatric Use addiction. Preoccupation with achieving pain relief can be ® agents should be reduced. The safety and efficacy of NUCYNTA ER in pediatric patients appropriate behavior in a patient with poor pain control. less than 18 years of age have not been established.
Nuc_PainWeekJourn.indd 4 7/27/15 11:40 AM • Life-Threatening Respiratory Depression [see Warnings Serotonergic Drugs Geriatric Use Abuse and addiction are separate and distinct from physical and Precautions (5.2)] There have been post-marketing reports of serotonin Of the total number of patients in Phase 2/3 double-blind, dependence and tolerance. Physicians should be aware that • Neonatal Opioid Withdrawal Syndrome [see Warnings syndrome with the concomitant use of tapentadol and multiple-dose clinical studies of NUCYNTA® ER, 28% addiction may not be accompanied by concurrent tolerance and Precautions (5.3)] serotonergic drugs (e.g., SSRIs and SNRIs). Caution is advised (1023/3613) were 65 years and over, while 7% (245/3613) and symptoms of physical dependence in all addicts. In addition, ® • Interaction with Other CNS Depressants [see Warnings when NUCYNTA ER is coadministered with other drugs that were 75 years and over. No overall differences in abuse of opioids can occur in the absence of true addiction. may affect serotonergic neurotransmitter systems such as effectiveness or tolerability were observed between these and Precautions (5.4)] NUCYNTA® ER, like other opioids, can be diverted for SSRIs, SNRIs, MAOIs, and triptans. If concomitant treatment patients and younger patients. non-medical use into illicit channels of distribution. Careful • Hypotensive Effects [see Warnings and Precautions (5.7)] of NUCYNTA® ER with a drug affecting the serotonergic In general, recommended dosing for elderly patients record-keeping of prescribing information, including quantity, • Gastrointestinal Effects [see Warnings and Precautions (5.11)] neurotransmitter system is clinically warranted, careful with normal renal and hepatic function is the same as frequency, and renewal requests, as required by law, is • Seizures [see Warnings and Precautions (5.9)] observation of the patient is advised, particularly during for younger adult patients with normal renal and hepatic strongly advised. treatment initiation and dose increases. • Serotonin Syndrome [see Warnings and Precautions (5.10)] function. Because elderly patients are more likely to have Proper assessment of the patient, proper prescribing Muscle Relaxants decreased renal and hepatic function, consideration should Clinical Trial Experience practices, periodic re-evaluation of therapy, and proper Tapentadol may enhance the neuromuscular blocking action be given to starting elderly patients with the lower range of Commonly-Observed Adverse Reactions in Clinical Studies dispensing and storage are appropriate measures that help ® of skeletal muscle relaxants and produce an increased recommended doses. with NUCYNTA ER in Patients with Chronic Pain due to Low to limit abuse of opioid drugs. degree of respiratory depression. Monitor patients receiving Back Pain or Osteoarthritis Renal Impairment muscle relaxants and NUCYNTA® ER for signs of respiratory Dependence The safety and effectiveness of NUCYNTA® ER have not The most common adverse reactions (reported by ≥10 % in depression that may be greater than otherwise expected. Both tolerance and physical dependence can develop during ® been established in patients with severe renal impairment any NUCYNTA ER dose group) were: nausea, constipation, chronic opioid therapy. Tolerance is the need for increasing Mixed Agonist/Antagonist Opioid Analgesics (CL <30 mL/min). Use of NUCYNTA® ER in patients dizziness, headache, and somnolence. CR doses of opioids to maintain a defined effect such as Mixed agonist/antagonist analgesics (i.e., pentazocine, with severe renal impairment is not recommended due to analgesia (in the absence of disease progression or other The most common reasons for discontinuation due to nalbuphine, and butorphanol) and partial agonists (e.g., accumulation of a metabolite formed by glucuronidation external factors). Tolerance may occur to both the desired adverse reactions in eight Phase 2/3 pooled studies buprenorphine) may reduce the analgesic effect of of tapentadol. The clinical relevance of the elevated ® and undesired effects of drugs, and may develop at different reported by ≥1% in any NUCYNTA ER dose group for NUCYNTA® ER or precipitate withdrawal symptoms. Avoid metabolite is not known. ® rates for different effects. NUCYNTA ER- and placebo-treated patients were the use of mixed agonist/antagonist analgesics in patients Hepatic Impairment nausea (4 % vs. 1%), dizziness (3% vs. <1%), vomiting (3% receiving NUCYNTA® ER. Physical dependence results in withdrawal symptoms after Administration of tapentadol resulted in higher exposures vs. <1%), somnolence (2% vs. <1%), constipation (1% vs. abrupt discontinuation or a significant dose reduction of Anticholinergics and serum levels of tapentadol in subjects with impaired <1%), headache (1% vs. <1%), and fatigue (1% vs. <1%), a drug. Withdrawal also may be precipitated through the The use of NUCYNTA® ER with anticholinergic products hepatic function compared to subjects with normal hepatic respectively. administration of drugs with opioid antagonist activity, e.g., may increase the risk of urinary retention and/or severe function. The dose of NUCYNTA® ER should be reduced in naloxone, nalmefene, mixed agonist/antagonist analgesics Commonly-Observed Adverse Reactions in Clinical Studies constipation, which may lead to paralytic ileus. patients with moderate hepatic impairment (Child-Pugh ® (pentazocine, butorphanol, nalbuphine), or partial agonists with NUCYNTA ER in Patients with Neuropathic Pain Score 7 to 9). Associated with Diabetic Peripheral Neuropathy USE IN SPECIFIC POPULATIONS (buprenorphine). Physical dependence may not occur to a Pregnancy Use of NUCYNTA® ER is not recommended in severe hepatic clinically significant degree until after several days to weeks The most commonly reported ADRs (incidence ≥ 10% in Clinical Considerations impairment (Child-Pugh Score 10 to 15). of continued opioid usage. NUCYNTA® ER-treated subjects) were: nausea, constipation, ® vomiting, dizziness, somnolence, and headache. Fetal/neonatal adverse reactions DRUG ABUSE AND DEPENDENCE NUCYNTA ER should not be abruptly discontinued. If NUCYNTA® ER is abruptly discontinued in a physically- Prolonged use of opioid analgesics during pregnancy for Controlled Substance Postmarketing Experience dependent patient, an abstinence syndrome may occur. medical or nonmedical purposes can result in physical NUCYNTA® ER contains tapentadol, a Schedule II controlled The following adverse reactions, not above, have been Some or all of the following can characterize this syndrome: dependence in the neonate and neonatal opioid withdrawal substance with a high potential for abuse similar to fentanyl, identified during post approval use of tapentadol. restlessness, lacrimation, rhinorrhea, yawning, perspiration, syndrome shortly after birth. Observe newborns for methadone, morphine, oxycodone, and oxymorphone. Because these reactions are reported voluntarily from chills, piloerection, myalgia, mydriasis, irritability, anxiety, symptoms of neonatal opioid withdrawal syndrome, such NUCYNTA® ER can be abused and is subject to misuse, a population of uncertain size, it is not always possible backache, joint pain, weakness, abdominal cramps, insomnia, as poor feeding, diarrhea, irritability, tremor, rigidity, and addiction, and criminal diversion. The high drug content in to reliably estimate their frequency or establish a causal nausea, anorexia, vomiting, diarrhea, increased blood relationship to drug exposure. seizures, and manage accordingly. the extended release formulation adds to the risk of adverse outcomes from abuse and misuse. pressure, respiratory rate, or heart rate. Teratogenic Effects - Psychiatric disorders: hallucination, suicidal ideation, Pregnancy Category C Infants born to mothers physically dependent on opioids will panic attack Abuse There are no adequate and well-controlled studies in All patients treated with opioids require careful monitoring for also be physically dependent and may exhibit respiratory Anaphylaxis, angioedema, and anaphylactic shock have ® pregnant women. NUCYNTA ER should be used during signs of abuse and addiction, because use of opioid analgesic difficulties and withdrawal symptoms. been reported very rarely with ingredients contained in pregnancy only if the potential benefit justifies the potential ® products carries the risk of addiction even under appropriate OVERDOSAGE NUCYNTA ER. Advise patients how to recognize such risk to the fetus. reactions and when to seek medical attention. medical use. Clinical Presentation Labor and Delivery Acute overdosage with opioids can be manifested by DRUG INTERACTIONS Drug abuse is the intentional non-therapeutic use of an over- Opioids cross the placenta and may produce respiratory the-counter or prescription drug, even once, for its rewarding respiratory depression, somnolence progressing to stupor Alcohol depression in neonates. NUCYNTA® ER is not for use in or coma, skeletal muscle flaccidity, cold and clammy skin, Concomitant use of alcohol with NUCYNTA® ER can result in psychological or physiological effects. Drug abuse includes, women during and immediately prior to labor, when shorter but is not limited to the following examples: the use of a constricted pupils, and sometimes pulmonary edema, an increase of tapentadol plasma levels and potentially fatal acting analgesics or other analgesic techniques are more bradycardia, hypotension and death. Marked mydriasis overdose of tapentadol. Instruct patients not to consume prescription or over-the-counter drug to get “high,” or the use appropriate. Opioid analgesics can prolong labor through of steroids for performance enhancement and muscle build up. rather than miosis may be seen due to severe hypoxia in alcoholic beverages or use prescription or non-prescription actions that temporarily reduce the strength, duration, and overdose situations. products containing alcohol while on NUCYNTA® ER therapy. frequency of uterine contractions. However this effect is not Drug addiction is a cluster of behavioral, cognitive, and Treatment of Overdose consistent and may be offset by an increased rate of cervical physiological phenomena that develop after repeated Monoamine Oxidase Inhibitors In case of overdose, priorities are the re-establishment ® dilatation, which tends to shorten labor. substance use and include: a strong desire to take the NUCYNTA ER is contraindicated in patients who are of a patent and protected airway and institution of receiving monoamine oxidase inhibitors (MAOIs) or who have drug, difficulties in controlling its use, persisting in its use Nursing Mothers despite harmful consequences, a higher priority given to assisted or controlled ventilation if needed. Employ other taken them within the last 14 days due to potential additive There is insufficient/limited information on the excretion of supportive measures (including oxygen, vasopressors) in the effects on norepinephrine levels, which may result in drug use than to other activities and obligations, increased tapentadol in human or animal breast milk. Physicochemical tolerance, and sometimes a physical withdrawal. management of circulatory shock and pulmonary edema adverse cardiovascular events. and available pharmacodynamic/toxicological data on as indicated. Cardiac arrest or arrhythmias will require CNS Depressants tapentadol point to excretion in breast milk and risk to the “Drug-seeking” behavior is very common to addicts and advanced life support techniques. The concomitant use of NUCYNTA® ER with other CNS breastfeeding child cannot be excluded. drug abusers. Drug-seeking tactics include emergency depressants including sedatives, hypnotics, tranquilizers, calls or visits near the end of office hours, refusal to Because of the potential for adverse reactions in nursing undergo appropriate examination, testing or referral, general anesthetics, phenothiazines, other opioids, and ® © June 2015, Depomed, Inc. infants from NUCYNTA ER, a decision should be made repeated claims of loss of prescriptions, tampering with alcohol can increase the risk of respiratory depression, All rights reserved. APL-NUCX-0041 whether to discontinue nursing or discontinue the drug, prescriptions and reluctance to provide prior medical profound sedation, coma and death. Monitor patients taking into account the importance of the drug to the mother. receiving CNS depressants and NUCYNTA® ER for signs of records or contact information for other treating respiratory depression, sedation and hypotension. Withdrawal symptoms can occur in breast-feeding infants physician(s). “Doctor shopping” (visiting multiple when maternal administration of NUCYNTA® ER is stopped. prescribers) to obtain additional prescriptions is common When combined therapy with any of the above among drug abusers, and people suffering from untreated medications is considered, the dose of one or both Pediatric Use addiction. Preoccupation with achieving pain relief can be ® agents should be reduced. The safety and efficacy of NUCYNTA ER in pediatric patients appropriate behavior in a patient with poor pain control. less than 18 years of age have not been established.
Nuc_PainWeekJourn.indd 4 7/27/15 11:40 AM
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