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`bsCr
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`eAw Os
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`tD
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`G(
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`---------------------------WARNINGS AND PRECAUTIONS-------------------------
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`See Boxed WARNINGS
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`Respiratory depression: Increased risk in elderly, debilitated patients, and those
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`suffering from conditions accompanied by hypoxia, hypercapnia, or decreased
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`respiratory reserve. (5.2)
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`Misuse, abuse, and diversion: OPANA ER is an opioid agonist and a Schedule
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`II controlled substance with an abuse liability similar to morphine. (5.3)
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` WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF
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`CNS effects: Additive CNS-depressive effects when used in conjunction with
` PROPER PATIENT SELECTION AND LIMITATIONS OF USE
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`alcohol, other opioids, or illicit drugs. (5.4)
`See full prescribing information for complete boxed warning.
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`Head Injury: Effects may be markedly exaggerated. Administer with extreme
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` OPANA ER contains oxymorphone which is an opioid agonist and a
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`caution. (5.5)
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`Schedule II controlled substance with an abuse liability similar to
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`Hypotensive effect: Increased risk with compromised ability to maintain blood
`oth
` er opioid analgesics. (9)
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`pressure. Administer with caution to patients in circulatory shock. (5.6)
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` Oxymorphone can be abused in a manner similar to other opioid
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`Mild hepatic impairment: Use with caution and at lower doses due to higher
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`ago
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` nists, legal or illicit. This should be considered when prescribing or
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`plasma concentrations than in patients with normal hepatic function. (5.7)
`dis
` pensing OPANA ER in situations where the physician or
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`Prolonged gastric obstruction: May occur in patients with gastrointestinal
`ph
` armacist is concerned about an increased risk of misuse, abuse, or
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`obstruction. (5.9)
`div
` ersion. (9)
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`Sphincter of Oddi: Administer with caution in patients with biliary tract
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` OPANA ER is NOT intended for use as an as needed analgesic. (1)
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`disease. (5.11)
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` OPANA ER tablets are to be swallowed whole and are not to be
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`Impaired mental/physical abilities: Caution must be used with potentially
`bro
` ken, chewed, dissolved, or crushed as this leads to rapid release
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`hazardous activities (5.12)
`and
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` absorption of a potentially fatal dose of oxymorphone. (2)
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`---------------------------------ADVERSE REACTIONS---------------------------------
`
`
` Patients must not consume alcoholic beverages, prescription or non-
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`Adverse reactions in ≥2% of patients in placebo-controlled trials: nausea,
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`pre
` scription medications containing alcohol. Co-ingestion of alcohol
`
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`constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating
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`wit
` h OPANA ER may result in a potentially fatal overdose of
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`increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased,
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`oxy
` morphone. (2)
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`and abdominal pain. (6.1)
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` -------------------------------INDICATIONS AND USAGE-------------------------------
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`PANA ER is an opioid agonist indicated for the relief of moderate to severe pain
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`To report SUSPECTED ADVERSE REACTIONS, contact Endo
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` patients requiring continuous around-the-clock opioid treatment for an extended
`n
`Pharmaceuticals Inc. at (1-800-462-3636) or FDA at 1-800 FDA-1088 or
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`eriod of time. (1)
`www.fda.gov/medwatch.
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`ot intended for use as an as needed analgesic. Not indicated in the immediate post-
`------------------------------------DRUG INTERACTIONS------------------------------
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`operative period or if the pain is mild or not expected to persist for an extended
`NS depressants: Increased risk of respiratory depression, hypotension,
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`period of time. (1)
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`rofound sedation, coma or death. When combined therapy with CNS
`-------------------------DOSAGE AND ADMINISTRATION--------------------------
`
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`epressant is contemplated, the dose of one or both agents should be reduced.
`Administered on an empty stomach, at least 1 hour prior to or 2 hours after
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`.2)
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`7
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`eating. (2.2)
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`Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and
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`Symmetrical, every 12h dosing is appropriate for the majority of patients. (2.1)
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`utorphanol): May reduce analgesic effect and/or precipitate withdrawal
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`Opioid-Naïve Patients: Initiate treatment with 5 mg every 12 hours. (2.2)
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`ymptoms. (7.3)
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`Opioid-Experienced Patients: Ratios as a guide to convert only from other
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`imetidine: Combination use may precipitate confusion, disorientation,
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`opioids to OPANA ER. (2.2)
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`spiratory depression, apnea, seizures. (7.4)
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`Individualize treatment; titrate to effective and tolerable dose. (2.1)
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`nticholinergics: May result in urinary retention and/or severe constipation,
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`Don’t stop abruptly (9.3); taper gradually to stop treatment (2.8)
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`hich may lead to paralytic ileus. (7.5)
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`Monoamine oxidase inhibitors (MAOIs): Potentiate the action of opioids.
`
`-------------------------DOSAGE FORMS AND STRENGTHS-----------------------
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`PANA ER should not be used in patients taking MAOIs or within 14 days of
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`Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
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`opping such treatment. (7.6)
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`---------------------------------CONTRAINDICATIONS---------------------------------
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`ose adjustment for CYP3A450 or 2C9-mediated drug-drug interactions is not
`
`Known hypersensitivity to oxymorphone, any other ingredients in OPANA ER, or
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`required. (7.1)
`
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`morphine analogs. (4)
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`------
`---------------------USE IN SPECIFIC POPULATIONS-------------------------
`
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`Respiratory depression (4)
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`egnancy: Not recommended during labor and delivery, pregnancy, or nursing.
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`Pr
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`Acute or severe bronchial asthma or hypercarbia (4)
`
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`.1)
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`(8
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`Paralytic ileus (4)
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`eriatric Patients – OPANA ER should be used with caution in elderly patients.
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`Moderate or severe hepatic impairment (4)
`
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`8
`.5)
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`See 17 for PATIENT COUNSELING INFORMATION and FDA – approved
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`patient labeling
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`Revised: 09/2010
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`____________________________________________________________________________________________________________________________________________
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`5.3 Misuse, Abuse and Diversion of Opioids
`FULL PRESCRIBING INFORMATION: CONTENTS*
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`5.4
`Interactions with Alcohol and other CNS Depressants
`BOXED WARNING
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`5.5 Use in Patients with Head Injury and Increased Intracranial
`INDICATIONS AND USAGE
`1
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`Pressure
`2
`DOSAGE AND ADMINISTRATION
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`5.6 Hypotensive Effect
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`2.1 Safe Administration Instructions
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`5.7 Hepatic Impairment
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`2.2
`Initiation of Therapy with OPANA ER
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`5.8 Special Risk Groups
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`2.3 Patients with Hepatic Impairment
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`5.9 Gastrointestinal Effects
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`2.4 Patients with Renal Impairment
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`5.10 Ambulatory Surgery and Post Operative Use
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`2.5 Use with Central Nervous System Depressants
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`5.11 Use in Pancreatic/Biliary Tract Disease
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`2.6 Geriatric Patients
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`5.12 Driving and Operating Machinery
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`2.7 Maintenance of Therapy
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`ADVERSE REACTIONS
`
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`2.8 Cessation of Therapy
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`6.1 Clinical Trial Experience
`DOSAGE FORMS AND STRENGTHS
`3
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`CONTRAINDICATIONS
`4
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`5 WARNINGS AND PRECAUTIONS
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`Information Essential for Safe Administration
`5.1
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`5.2 Respiratory Depression
`
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`HIGHLIGHTS OF PRESCRIBING INFORMATION
`These highlights do not include all the information needed to use OPANA® ER
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`safely and effectively. See full prescribing information for OPANA® ER.
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`
` OPANA® ER (oxymorphone hydrochloride) Extended-Release tablets, CII
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`Initial U.S. Approval: 1959
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`Cpd(
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`1
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`6
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`

`

`7
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`8
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`9
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`DRUG INTERACTIONS
`
`7.1 Drug-Drug Interactions
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`7.2 Use in CNS Depressants
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`7.3
`Interactions with Mixed Agonist/Antagonist Opioid Analgesics
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`7.4 Cimetidine
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`7.5 Anticholinergics
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`7.6 MAO Inhibitors
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`USE IN SPECIFIC POPULATIONS
`
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`8.1 Pregnancy
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`8.2 Labor and Delivery
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`8.3 Nursing Mothers
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`8.4 Pediatric Use
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`8.5 Geriatric Use
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`8.6 Hepatic Impairment
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`8.7 Renal Impairment
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`DRUG ABUSE AND DEPENDENCE
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`9.1 Controlled Substance
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`9.2 Abuse
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`9.3 Dependence
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`10 OVERDOSAGE
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`10.1 Symptoms
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`10.2 Treatment
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`11 DESCRIPTION
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`12 CLINICAL PHARMACOLOGY
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`12.1 Mechanism of Action
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`12.2 Pharmacodynamics
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`12.3 Pharmacokinetics
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`13 NONCLINICAL TOXICOLOGY
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`13.1 Carcinogenesis, mutagenesis, impairment of fertility
`
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`14 CLINICAL STUDIES
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`14.1 12-Week Study in Opioid-Naïve Patients with Low Back Pain
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`14.2 12-Week Study in Opioid-Experienced Patients with Low Back Pain
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`16 HOW SUPPLIED/STORAGE AND HANDLING
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`17 PATIENT COUNSELING INFORMATION
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`*Sections or subsections omitted from the full prescribing information are not
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`listed.
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`__________________________________________________________________________________________________________________________________________
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`2
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`

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` FULL PRESCRIBING INFORMATION
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` WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND
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`
`
` LIMITATIONS OF USE
` Potential for Abuse
`
`
`
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`
`
` OPANA ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled
` substance, with an abuse liability similar to other opioid analgesics. (9)
`
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`
` Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be
`
` considered when prescribing or dispensing OPANA ER in situations where the physician or pharmacist is
`
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`
`
` concerned about an increased risk of misuse, abuse, or diversion. (9.2)
`
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`
`
` Proper Patient Selection
`
`
`
` OPANA ER is an extended-release oral formulation of oxymorphone indicated for the management of
`
` moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended
`
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`
`
` period of time. (1)
`
`
`
`
` Limitations of Use
`
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`
`
` OPANA ER is NOT intended for use as an as needed analgesic. (1)
`
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`
` OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or
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` crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and
`
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`
`
`
`
` absorption of a potentially fatal dose of oxymorphone. (2)
`
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`
`
` Patients must not consume alcoholic beverages, or prescription or non-prescription medications
`
`
`
`
` containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result
`
`
` in increased plasma levels and a potentially fatal overdose of oxymorphone. (2)
`
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`
`INDICATIONS AND USAGE
`1
`
`
`OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock
`
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`opioid treatment for an extended period of time.
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`Limitations of Usage
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`OPANA ER is not intended for use as an as needed analgesic.
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`OPANA ER is not indicated for pain in the immediate post-operative period if the pain is mild, or not expected to
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`persist for an extended period of time.
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`OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if
`
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`the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians
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`should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain
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`Society guidelines).
`
`
`
`
`2 DOSAGE AND ADMINISTRATION
`
`
`
`2.1 Safe Administration Instructions
`
`
`
`OPANA ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed.
`
`
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`Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption
`
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`of a potentially fatal dose of oxymorphone.
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`Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing
`
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`
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`alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased
`
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`
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`plasma levels and a potentially fatal overdose of oxymorphone.
`
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`While symmetric (same dose AM and PM), around-the-clock, every 12 hours dosing is appropriate for the majority
`
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`of patients, some patients may benefit from asymmetric (different dose given in AM than in PM) dosing, tailored to
`
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`their pain pattern. It is usually appropriate to treat a patient with only one extended-release opioid for around-the-
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`clock therapy.
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`Selection of patients for treatment with OPANA ER should be governed by the same principles that apply to the use
`
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`of other extended-release opioid analgesics [see Indications and Usage (1)]. Physicians should individualize
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`treatment in every case, using non-opioid analgesics, opioids on an as needed basis, combination products, and
`
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`chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health
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`Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare
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` 3
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` professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring
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` [see Boxed Warning].
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`2.2 Initiating Therapy with OPANA ER
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`It is necessary to adjust the dosing regimen for each patient individually, taking into account the patient’s prior
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`analgesic treatment experience. In the selection of the initial dose of OPANA ER, attention should be given to the
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`following:
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`total daily dose, potency and specific characteristics of the opioid the patient has been taking
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`previously;
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` relative potency estimate used to calculate the equivalent oxymorphone dose needed;
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` patient’s degree of opioid tolerance;
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` age, general condition, and medical status of the patient;
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` concurrent non-opioid analgesics and other medications;
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` type and severity of the patient’s pain;
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` balance between pain control and adverse experiences;
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` risk factors for abuse or addiction, including a prior history of abuse or addiction.
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`Once therapy is initiated, frequently assess pain relief and other opioid effects. Base the titration of the total daily
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`OPANA ER dose upon the amount of supplemental opioid utilization, severity of the patient’s pain, and the patient’s
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`ability to tolerate the opioid. Titrate dose to generally mild or no pain with the regular use of no more than two
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`doses of supplemental analgesia, i.e. “rescue,” per 24 hours. Patients who experience breakthrough pain may require
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`dosage adjustment.
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`If signs of excessive opioid-related adverse experiences are observed, the next dose may be reduced. If this
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`adjustment leads to inadequate analgesia, a supplemental dose of an immediate-release opioid, or a non-opioid
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`analgesic may be administered. Adjust dosing to obtain an appropriate balance between pain relief and opioid-
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`related adverse experiences. If significant adverse events occur before the therapeutic goal of mild or no pain is
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`achieved, the events should be treated aggressively. Once adverse events are adequately managed, continue upward
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`titration to an acceptable level of pain control.
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`During periods of changing analgesic requirements, including initial titration, frequent contact is recommended
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`between physician, other members of the healthcare team, the patient and the caregiver/family. Advise patients and
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`caregivers/family members of the potential adverse reactions.
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`The dosing recommendations below, therefore, can only be considered as suggested approaches to what is actually a
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`series of clinical decisions over time in the management of the pain of each individual patient.
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`Titrate dose to adequate pain relief (generally mild or no pain).
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`Administer OPANA ER on an empty stomach, at least one hour prior to or two hours after eating [see Clinical
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`Pharmacology (12.3)].
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`Opioid-Naïve Patients
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`The initial dose for patients who are not opioid-experienced and who are being initiated on chronic around-the-clock
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`opioid therapy with OPANA ER is 5 mg every 12 hours. Thereafter, titrate the dose individually at increments of 5-
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`10 mg every 12 hours every 3-7 days, to a level that provides adequate analgesia and minimizes side effects under
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`the close supervision of the prescribing physician.
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`Opioid-Experienced Patients
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`Conversion from OPANA to OPANA ER
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`Patients receiving OPANA may be converted to OPANA ER by administering half the patient's total daily oral
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`OPANA dose as OPANA ER, every 12 hours.
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`Conversion from Parenteral Oxymorphone to OPANA ER
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`Given OPANA ER’s absolute oral bioavailability of approximately 10%, patients receiving parenteral oxymorphone
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`may be converted to OPANA ER by administering 10 times the patient's total daily parenteral oxymorphone dose as
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`OPANA ER in two equally divided doses (e.g., [IV dose x 10] divided by 2). Due to patient variability with regards
`
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` 4
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`

`

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` to opioid analgesic response, upon conversion monitor patients closely to evaluate for adequate analgesia and side
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` effects.
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`Conversion from Other Oral Opioids to OPANA ER
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`For conversion from other opioids to OPANA ER, physicians and other healthcare professionals are advised to refer
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`to published relative potency information, keeping in mind that conversion ratios are only approximate. In general,
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`it is safest to start the OPANA ER therapy by administering half of the calculated total daily dose of OPANA ER
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`(see conversion ratio table below) in 2 divided doses, every 12 hours. Gradually adjust the initial dose of OPANA
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`ER until adequate pain relief and acceptable side effects have been achieved.
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`The following table provides approximate equivalent doses, which may be used as a guideline for conversion. The
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`conversion ratios and approximate equivalent doses in this conversion table are only to be used for the
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`conversion from current opioid therapy to OPANA ER. In a Phase 3 clinical trial with an open-label titration
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`period, patients were converted from their current opioid to OPANA ER using the following table as a guide. There
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`is substantial patient variation in the relative potency of different opioid drugs and formulations.
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` CONVERSION RATIOS TO OPANA ER
`
` Approximate Equivalent Dose
`
` Oral
`
` 10 mg
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`
`
` 20 mg
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` 20 mg
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` 20 mg
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` 30 mg
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` Oral
`
` Conversion Ratioa
`
` 1
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` 0.5
`
` 0.5
`
` 0.5
` 0.333
`
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`
` Opioid
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`
` Oxymorphone
`
` Hydrocodone
`
` Oxycodone
`
` Methadone b
`
` Morphine
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` aRatio for conversion of oral opioid dose to approximate oxymorphone equivalent dose. Select opioid and
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`
` multiply the dose by the conversion ratio to calculate the approximate oral oxymorphone equivalent.
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` The conversion ratios and approximate equivalent doses in this conversion table are only to be used for
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` the conversion from current opioid therapy to OPANA ER.
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` Sum the total daily dose for the opioid and multiply by the conversion ratio to calculate the oxymorphone total
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` daily dose.
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` For patients on a regimen of mixed opioids, calculate the approximate oral oxymorphone dose for each opioid
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` and sum the totals to estimate the total daily oxymorphone dose.
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` The dose of OPANA ER can be gradually adjusted, preferably at increments of 10 mg every 12 hours every 3-
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` 7 days, until adequate pain relief and acceptable side effects have been achieved [see Dosage and
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` Administration (2.1)].
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` b It is extremely important to monitor all patients closely when converting from methadone to other opioid
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` agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose
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` exposure. Methadone has a long half-life and tends to accumulate in the plasma.
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`No dose adjustment for CYP 3A4- or 2C9-mediated drug-drug interactions is required [see Clinical Pharmacology
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`(12.3)].
`
`
`2.3 Patients with Hepatic Impairment
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`Start patients with mild hepatic impairment with the lowest dose and titrate slowly while carefully monitoring side
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`effects. OPANA ER is contraindicated in patients with moderate or severe hepatic impairment [see Warnings and
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`Precautions (5.7) and Clinical Pharmacology (12.3)].
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`2.4 Patients with Renal Impairment
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`There are 57% and 65% increases in oxymorphone bioavailability in patients with moderate and severe renal
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`impairment, respectively [see Clinical Pharmacology (12.3)]. Accordingly, in patients with creatinine clearance
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`rates less than 50 mL/min, start OPANA ER with the lowest dose and titrate slowly while carefully monitoring side
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`effects.
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` 5
`
`

`

`
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`2.5 Use with Central Nervous System Depressants
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`In patients who are concurrently receiving other central nervous system (CNS) depressants including sedatives or
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`hypnotics, general anesthetics, phenothiazines, tranquilizers, and alcohol, start OPANA ER at 1/3 to 1/2 of the usual
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`dose because respiratory depression, hypotension, and profound sedation, coma or death may result [see Warnings
`
`
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`and Precautions (5.4) and Drug Interactions (7.2)].
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`Although no specific interaction between oxymorphone and monoamine oxidase inhibitors has been observed,
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`OPANA ER is not recommended for use in patients who have received MAO inhibitors within 14 days [see Drug
`
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`Interactions (7.6)].
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`2.6 Geriatrics Patients
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`The steady-state plasma concentrations of oxymorphone are approximately 40% higher in elderly subjects than in
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`young subjects. Exercise caution in the selection of the starting dose of OPANA ER for an elderly patient by
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`starting at the low end of the dosing range and slowly titrating to adequate analgesia [see Clinical Pharmacology
`
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`(12.3) and Use in Specific Populations (8.5)].
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`2.7 Maintenance of Therapy
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`During chronic therapy with OPANA ER, periodically reassess the continued need for around-the-clock opioid
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`therapy. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with
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`high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined in
`
`Initiating Therapy with OPANA ER.
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`
`Cessation of Therapy
`2.8
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`When the patient no longer requires therapy with OPANA ER tablets, gradually taper doses to prevent signs and
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`symptoms of withdrawal in the physically dependent patient.
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`
`
`3 DOSAGE FORMS AND STRENGTHS
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`The 5 mg dosage form is a pink, octagon shape, film coated, convex extended-release tablets debossed with “5” on
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`one side and plain on the other.
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`The 7.5 mg dosage form is a gray, octagon shape, film coated, convex extended-release tablets debossed with “7 ½”
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`on one side and plain on the other.
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`The 10 mg dosage form is a light orange, octagon shape, film coated, convex extended-release tablets debossed with
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`“10” on one side and plain on the other.
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`The 15 mg dosage form is a white, octagon shape, film coated, convex extended-release tablets debossed with “15”
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`on one side and plain on the other.
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`The 20 mg dosage form is a light green, octagon shape, film coated, convex extended-release tablets debossed with
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`“20” on one side and plain on the other.
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`The 30 mg dosage form is a red, octagon shape, film coated, convex extended-release tablets debossed with “30” on
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`one side and plain on the other.
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`The 40 mg dosage form is a yellow, octagon shape, film coated, convex extended-release tablets debossed with “40”
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`on one side and plain on the other.
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`
`
`4 CONTRAINDICATIONS
`
`
`OPANA ER is contraindicated in patients who have:
`
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`
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` 6
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`significant respiratory depression
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`
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`or are suspected of having paralytic ileus
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`
`
`acute or severe bronchial asthma or hypercarbia
`
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`
`
` moderate and severe hepatic impairment [see Clinical Pharmacology (12.3), Warnings and Precautions
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`(5.7),].
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` known hypersensitivity to any of its components or the active ingredient, oxymorphone or with known
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` hypersensitivity to morphine analogs such as codeine.
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`

`

`
`
`
`5 WARNINGS AND PRECAUTIONS
`
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`5.1 Information Essential for Safe Administration
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`OPANA ER tablets are to be swallowed whole, and are not to be broken, chewed, crushed or dissolved.
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`
`Taking broken, chewed, crushed or dissolved OPANA ER tablets could lead to the rapid release and
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`absorption of a potentially fatal dose of oxymorphone [see Boxed Warning].
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`Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing
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`alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased
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`plasma levels and a potentially fatal overdose of oxymorphone [see Pharmacokinetics (12.3)].
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`Instruct patients against use by individuals other than the patient for whom OPANA ER was prescribed, as
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`such inappropriate use may have severe medical consequences, including death.
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`
`
`5.2 Respiratory Depression
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`Respiratory depression is the chief hazard of OPANA ER. Respiratory depression is a potential problem in elderly
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`or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when
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`even moderate therapeutic doses may dangerously decrease pulmonary ventilation.
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`Administer OPANA ER with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or
`
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`decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe
`
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`obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma. In these patients, even usual
`
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`therapeutic doses of oxymorphone may decrease respiratory drive while simultaneously increasing airway resistance
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`to the point of apnea. Consider alternative non-opioid analgesics and use OPANA ER only under careful medical
`
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`supervision at the lowest effective dose in such patients.
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`
`
`Misuse, Abuse and Diversion of Opioids
`5.3
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`OPANA ER contains oxymorphone, a mu opioid agonist and a Schedule II controlled substance with an abuse
`
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`liability similar to morphine. Opioid agonists are sought by drug abusers and people with addiction disorders and
`
`
`are subject to criminal diversion.
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`Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This issue should be
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`
`considered when prescribing or dispensing oxymorphone in situations where the physician or pharmacist is
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`concerned about an increased risk of misuse, abuse, or diversion.
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`OPANA ER tablets may be abused by crushing, chewing, snorting or injecting the product. These practices will
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`result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose
`
`
`
`and death [see Drug Abuse and Dependence (9)].
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`OPANA ER may be targeted for theft and diversion. Healthcare professionals should contact their State Medical
`
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`Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of
`
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`this product, and security requirements for storing and handling of OPANA ER.
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`Healthcare professionals should advise patients to store OPANA ER in a secure place, preferably locked and out of
`
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`the reach of children and other non-caregivers.
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`Concerns about abuse, misuse, diversion and addiction should not prevent the proper management of pain.
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`5.4 Interactions with Alcohol and other CNS Depressants
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`Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives,
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`hypnotics, or other CNS depressants (including alcohol) concomitantly with oxymorphone may experience
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`respiratory depression, hypotension, profound sedation, coma and death [see Drug Interactions (7.2]). Avoid
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`concurrent use of alcohol and OPANA ER [see Pharmacokinetics (12.3)].
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` 7
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`5.5 Use in Patients with Head Inju