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Product Monograph Including Patient PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NOxyNEO® Oxycodone Hydrochloride Controlled Release Tablets Tablets, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, Oral Purdue Pharma Standard Opioid Analgesic Purdue Pharma Date of Initial Approval: 3381 Steeles Avenue East Suite 310 August 22, 2011 Toronto, ON M2H 3S7 Date of Revision: July 7, 2021 Submission Control No: 237808 OxyNEO® and HTR Technology™ are trademarks of Purdue Pharma OxyNEO® (oxycodone hydrochloride controlled release tablets) Page 1 of 41 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity / Serotonin Syndrome, August 2020 7 WARNINGS AND PRECAUTIONS, Respiratory, Sleep Apnea, August 2020 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS ................................................................................................................... 4 1.1 Pediatrics ................................................................................................................. 4 1.2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 6 4.1 Dosing Considerations ............................................................................................ 6 4.2 Recommended Dose and Dosage Adjustment ....................................................... 7 4.3 Administration .......................................................................................................... 9 4.4 Missed Dose ............................................................................................................ 9 5 OVERDOSAGE ................................................................................................................ 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 11 7.1 Special Populations ............................................................................................... 19 7.1.1 Pregnant Women ............................................................................................... 19 7.1.2 Breast-feeding ................................................................................................... 19 7.1.3 Pediatrics (<18 years of age) ............................................................................. 19 7.1.4 Geriatrics (>65 years of age) ............................................................................. 20 7.1.5 Hepatic Impairment ............................................................................................ 20 7.1.6 Renal Impairment .............................................................................................. 20 8 ADVERSE REACTIONS ................................................................................................. 20 8.1 Adverse Reaction Overview .................................................................................. 20 8.2 Adverse Reactions ................................................................................................ 21 8.3 Post-Market Adverse Reactions ............................................................................ 23 9 DRUG INTERACTIONS .................................................................................................. 23 9.1 Serious Drug Interactions Box ............................................................................... 23 9.2 Overview ............................................................................................................... 24 9.3 Drug-Drug Interactions .......................................................................................... 24 9.4 Drug-Food Interactions .......................................................................................... 25 9.5 Drug-Herb Interactions .......................................................................................... 25 9.6 Drug-Laboratory Test Interactions ......................................................................... 25 9.7 Drug-Lifestyle Interactions ..................................................................................... 25 OxyNEO® (oxycodone hydrochloride controlled release tablets) Page 2 of 41 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 26 10.1 Mechanism of Action ......................................................................................... 26 10.2 Pharmacodynamics ........................................................................................... 26 10.3 Pharmacokinetics .............................................................................................. 27 11 STORAGE, STABILITY AND DISPOSAL ...................................................................... 30 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 30 13 PHARMACEUTICAL INFORMATION ............................................................................ 31 14 CLINICAL TRIALS ......................................................................................................... 32 14.1 Trial Design and Study Demographics .............................................................. 32 15 NON-CLINICAL TOXICOLOGY ..................................................................................... 32 PATIENT MEDICATION INFORMATION .................................................................................. 34 OxyNEO® (oxycodone hydrochloride controlled release tablets) Page 3 of 41 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS OxyNEO (oxycodone hydrochloride controlled release tablets) is indicated for the management of pain severe enough to require daily, continuous, long-term opioid treatment, and: • that is opioid-responsive; and • for which alternative options are inadequate. OxyNEO is not indicated as an as-needed (prn) analgesic. 1.1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of OxyNEO has not been studied in the pediatric population. Therefore OxyNEO is not recommended in patients under 18 years of age. 1.2 Geriatrics Geriatrics (>65 years of age): In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS OxyNEO is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. • Patients with known or suspected mechanical gastrointestinal obstruction (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type). • Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis). • Patients with mild, intermittent or short duration pain that can be managed with other pain medications. • The management of acute pain. • Patients with acute or severe bronchial asthma, chronic obstructive airway or status asthmaticus. • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood, and cor pulmonale. • Patients with acute alcoholism, delirium tremens, and convulsive disorders. • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury. • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). • Women who are breastfeeding, pregnant, or during labour and delivery (see SERIOUS OxyNEO® (oxycodone hydrochloride controlled release tablets) Page 4 of 41 WARNINGS AND PRECAUTIONS and WARNINGS AND PRECAUTIONS). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with controlled release opioid formulations, OxyNEO should only be used in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misuse OxyNEO poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient’s risk should be assessed prior to prescribing OxyNEO, and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). OxyNEO should be stored securely to avoid theft or misuse. Life-threatening Respiratory Depression: OVERDOSE Serious, life-threatening,
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