FDA label 0b8cf32f-64e4-4158-be21-9e7ab9154c56

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE 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. ( ) Potential for Abuse 9 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 concerned about an increased risk of misuse, abuse, or diversion. ( ) 9.2 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 period of time. ( ) Proper Patient Selection 1 OPANA ER is NOT intended for use as an as needed analgesic. ( ) Limitations of Use 1 OPANA ER TABLETS are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed OPANA ER TABLETS leads to rapid release and absorption of a potentially fatal dose of oxymorphone. ( ) 2 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 WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE See full prescribing information for complete boxed warning. • OPANA ER contains oxymorphone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. ( ) 9 • 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 concerned about an increased risk of misuse, abuse, or diversion. ( ) 9 • OPANA ER is NOT intended for use as an as needed analgesic. ( ) 1 • OPANA ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed as this leads to rapid release and absorption of a potentially fatal dose of oxymorphone. ( ) 2 • Patients must not consume alcoholic beverages, prescription or non-prescription medications containing alcohol. Co-ingestion of alcohol with OPANA ER may result in a potentially fatal overdose of oxymorphone. ( ) 2

5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Respiratory depression: Increased risk in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve. ( ) 5.2 Misuse, abuse, and diversion: OPANA ER is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. ( ) 5.3 CNS effects: Additive CNS-depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. ( ) 5.4 Head Injury: Effects may be markedly exaggerated. Administer with extreme caution. ( ) 5.5 Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock. ( ) 5.6 Mild hepatic impairment: Use with caution and at lower doses due to higher plasma concentrations than in patients with normal hepatic function. ( ) 5.7 Prolonged gastric obstruction: May occur in patients with gastrointestinal obstruction. ( ) 5.9 Sphincter of Oddi: Administer with caution in patients with biliary tract disease. ( ) 5.11 Impaired mental/physical abilities: Caution must be used with potentially hazardous activities ( ) 5.12 5.8 Special Risk Groups Use OPANA ER with caution in the following conditions: adrenocortical insufficiency (e.g., Addison's disease), prostatic hypertrophy or urethral stricture, severe impairment of pulmonary or renal function, and toxic psychosis. Opioids may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Respiratory depression [see Warnings and Precautions ( )] 5.2 Misuse and abuse [see Warning and Precautions ( ) and Drug Abuse and Dependence ( )] 5.3 9 CNS depressant effects [see Warnings and Precautions ( )] 5.4 Adverse reactions in ≥2% of patients in placebo-controlled trials: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain. ( ) 6.1 To report SUSPECTED ADVERSE REACTIONS, contact Endo Pharmaceuticals Inc. at (1-800-462-3636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.