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XTAMPZA ER (Oxycodone) Extended-Release Capsules, for Oral Use, CII Initial U.S

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XTAMPZA ER (Oxycodone) Extended-Release Capsules, for Oral Use, CII Initial U.S HIGHLIGHTS OF PRESCRIBING INFORMATION • Instruct patients to take XTAMPZA ER capsules with food in order to These highlights do not include all the information needed to use ensure consistent plasma levels are achieved. For patients who have XTAMPZA ER safely and effectively. See full prescribing information difficulty swallowing, XTAMPZA ER can also be taken by sprinkling the for XTAMPZA ER. capsule contents on soft foods or into a cup and then administering directly into the mouth, or through a gastrostomy or nasogastric feeding tube. (2.6) XTAMPZA ER (oxycodone) extended-release capsules, for oral use, CII Initial U.S. Approval: 1950 DOSAGE FORMS AND STRENGTHS • Extended-release capsules: WARNING: ADDICTION, ABUSE, AND MISUSE; o 9 mg (equivalent to 10 mg oxycodone HCl) LIFE-THREATENING RESPIRATORY DEPRESSION; o 13.5 mg (equivalent to 15 mg oxycodone HCl) ACCIDENTAL INGESTION; NEONATAL OPIOID o 18 mg (equivalent to 20 mg oxycodone HCl) WITHDRAWAL SYNDROME; and CYTOCHROME o 27 mg (equivalent to 30 mg oxycodone HCl) 36 mg (equivalent to 40 mg oxycodone HCl). (3) P450 3A4 INTERACTION o See full prescribing information for complete boxed warning. • XTAMPZA ER exposes users to risks of addiction, abuse, and CONTRAINDICATIONS misuse, which can lead to overdose and death. Assess each patient’s • Significant respiratory depression (4) risk before prescribing and monitor regularly for development of • Acute or severe bronchial asthma (4) these behaviors and conditions. (5.1) • Known or suspected gastrointestinal obstruction, including paralytic ileus • Serious, life-threatening, or fatal respiratory depression may occur. (4) Monitor closely, especially upon initiation or following a dose • Hypersensitivity to oxycodone (4) increase. (5.2) • Accidental ingestion of XTAMPZA ER, especially by children, can WARNINGS AND PRECAUTIONS result in fatal overdose of oxycodone. (5.2) • Risk of life-threatening respiratory depression in patients with chronic • Prolonged maternal use of XTAMPZA ER during pregnancy can pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor result in neonatal opioid withdrawal syndrome, which may be life- closely, particularly during initiation and titration. (5.6) threatening if not recognized and treated. If prolonged opioid use is • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of required in a pregnant woman, advise the patient of the risk of corticosteroids, and wean patient off of the opioid. (5.7) neonatal opioid withdrawal syndrome and ensure that appropriate • treatment will be available. (5.3) Severe hypotension: Monitor during dosage initiation and titration. Avoid use of XTAMPZA ER in patients with circulatory shock (5.8) • Concomitant use with CYP3A4 inhibitors (or discontinuation of • CYP3A4 inducers) can result in a fatal overdose of oxycodone from Risks of use in patients with increased intracranial pressure, brain tumors, XTAMPZA ER. (5.4, 12.3) head injury, or impaired consciousness: Monitor for sedation and respiratory depression. Avoid use of XTAMPZA ER in patients with impaired consciousness or coma. (5.9) INDICATIONS AND USAGE XTAMPZA ER is an opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid ADVERSE REACTIONS treatment and for which alternative treatment options are inadequate. (1) Most common adverse reactions (>5%) were nausea, headache, constipation, Limitations of Use somnolence, pruritus, vomiting, and dizziness. (6.1). • Because of the risks of addiction, abuse, and misuse with opioids, even at To report SUSPECTED ADVERSE REACTIONS, contact Collegium recommended doses, and because of the greater risks of overdose and Pharmaceutical, Inc. at 1-855-331-5615 or FDA at 1-800-FDA-1088 or death with extended-release opioid formulations, reserve XTAMPZA ER www.fda.gov/medwatch. for use in patients for whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient DRUG INTERACTIONS management of pain. (1) • Interactions with CNS depressants: Concomitant use may cause profound • XTAMPZA ER is not indicated as an as-needed (prn) analgesic. (1) sedation, respiratory depression, coma, and death. If coadministration is required, consider dose reduction of one or both drugs because of additive DOSAGE AND ADMINISTRATION pharmacological effects and monitor closely. (5.5, 7) • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. • XTAMPZA ER at a total daily dose greater than 72 mg (equivalent to 80 Discontinue XTAMPZA ER if serotonin syndrome is suspected. (7) mg oxycodone hydrochloride [HCl]) or a single dose greater than 36 mg • (equivalent to 40 mg oxycodone HCl) is only for use in patients in whom Mixed agonist/antagonist and partial agonist opioid analgesics: Avoid use with XTAMPZA ER because they may reduce analgesic effect of tolerance to an opioid of comparable potency has been established. (2.1) XTAMPZA ER or precipitate withdrawal symptoms. (7) • Patients considered opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone HCl per day, 8 mg oral hydromorphone USE IN SPECIFIC POPULATIONS per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per • Pregnancy: May cause fetal harm. (8.1) day, or an equianalgesic dose of another opioid. (2.1) • Lactation: Not recommended. (8.2) • Use the lowest effective dose for the shortest duration consistent with • Geriatrics: Start at the low end of the dosing range and monitor closely for individual patient treatment goals (2.1) respiratory depression. (8.5) • For opioid-naïve and opioid non-tolerant patients, initiate with 9 mg (equivalent to 10 mg oxycodone HCl) capsules orally every 12 hours with food. (2.2) See 17 for PATIENT COUNSELING INFORMATION and • The daily dose of XTAMPZA ER must be limited to a maximum of 288 Medication Guide. mg per day (equivalent to 320 mg oxycodone HCl per day) (2.1) • Hepatic impairment: Initiate therapy at 1/3 to 1/2 the usual dosage and Revised: 04/2016 titrate carefully. Monitor carefully. Use alternate analgesia for patients requiring less than 9 mg. (2.3, 8.6) • Do not abruptly discontinue XTAMPZA ER in a physically dependent patient. (2.5) Reference ID: 3922771 FULL PRESCRIBING INFORMATION: CONTENTS* 6 ADVERSE REACTIONS 6.1 Clinical Trial Experience WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- 6.2 Postmarketing Experience THREATENING RESPIRATORY DEPRESSION; 7 DRUG INTERACTIONS ACCIDENTAL INGESTION; NEONATAL OPIOID 8 USE IN SPECIFIC POPULATIONS WITHDRAWAL SYNDROME; and CYTOCHROME P450 8.1 Pregnancy 3A4 INTERACTION 8.2 Lactation 1 INDICATIONS AND USAGE 8.3 Females and Males of Reproductive Potential 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Important Dosage and Administration Instructions 8.5 Geriatric Use 2.2 Initial Dosing 8.6 Hepatic Impairment 2.3 Dosage Modifications in Patients with Hepatic 8.7 Renal Impairment Impairment 8.8 Sex Differences 2.4 Titration and Maintenance of Therapy 9 DRUG ABUSE AND DEPENDENCE 2.5 Discontinuation of XTAMPZA ER 9.1 Controlled Substance 2.6 Administration of XTAMPZA ER 9.2 Abuse 3 DOSAGE FORMS AND STRENGTHS 9.3 Dependence 4 CONTRAINDICATIONS 10 OVERDOSAGE 5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION 5.1 Addiction, Abuse, and Misuse 12 CLINICAL PHARMACOLOGY 5.2 Life-Threatening Respiratory Depression 12.1 Mechanism of Action 5.3 Neonatal Opioid Withdrawal Syndrome 12.2 Pharmacodynamics 5.4 Risks of Concomitant Use or Discontinuation of 12.3 Pharmacokinetics Cytochrome P450 3A4 Inhibitors and Inducers 13 NONCLINICAL TOXICOLOGY 5.5 Risks Due to Interactions with Central Nervous System 13.1 Carcinogenesis, Mutagenesis, Impairment of Depressants Fertility 5.6 Risk of Life-Threatening Respiratory Depression in 13.2 Animal Toxicology Patients with Chronic Pulmonary Disease or in Elderly, 14 CLINICAL STUDIES Cachectic, or Debilitated Patients 16 HOW SUPPLIED/STORAGE AND HANDLING 5.7 Adrenal Insufficiency 17 PATIENT COUNSELING INFORMATION 5.8 Severe Hypotension 5.9 Risks of Use in Patients with Increased Intracranial *Sections or subsections omitted from the full prescribing Pressure, Brain Tumors, Head Injury or Impaired information are not listed. Consciousness 5.10 Risks of Use in Patients with Gastrointestinal Conditions 5.11 Risk of Use in Patients with Seizure Disorders 5.12 Withdrawal 5.13 Risks of Driving and Operating Machinery 5.14 Laboratory Monitoring Reference ID: 3922771 FULL PRESCRIBING INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION Addiction, Abuse, and Misuse XTAMPZA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing XTAMPZA ER and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of XTAMPZA ER. Monitor for respiratory depression, especially during initiation of XTAMPZA ER or following a dose increase [see Warnings and Precautions (5.2)]. Accidental Ingestion Accidental ingestion of even one dose of XTAMPZA ER, especially by children, can result in
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