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INDICATION

OPANA® ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.

IMPORTANT SAFETY INFORMATION
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
Abuse Potential

OPANA® ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing OPANA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA® ER for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of OPANA® ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and OPANA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA® ER or following a dose increase. Instruct patients to swallow OPANA® ER tablets whole. Crushing, dissolving, or chewing OPANA® ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Exposure

Accidental ingestion of OPANA® ER, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with Alcohol

The co-ingestion of alcohol with OPANA® ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA® ER.

LIMITATIONS OF USAGE

OPANA® ER is not intended for use as an as-needed (PRN) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

CONTRAINDICATIONS

OPANA ER is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; moderate and severe hepatic impairment; hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in OPANA ER, or to morphine analogs such as codeine; and conditions that increase the risk of life-threatening respiratory depression.

WARNINGS AND PRECAUTIONS
  • Respiratory depression is the primary risk of OPANA ER. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status.
  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OPANA ER, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with OPANA ER, following dose increases, and when OPANA ER is given concomitantly with other drugs that depress respiration. Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting, or altered clearance compared to younger, healthier patients.
  • Monitor patients for respiratory depression who have significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, particularly when initiating therapy and titrating with OPANA ER, as in these patients, even usual therapeutic doses of OPANA ER may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible.
  • Hypotension, profound sedation, coma, or respiratory depression may result if OPANA ER is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). Additionally, consider the patient's use, if any, of alcohol or illicit drugs that cause CNS depression. If OPANA ER therapy is to be initiated in a patient taking a CNS depressant, start with a lower OPANA ER dose than usual and monitor patients for signs of hypotension, sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.
  • There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dose of OPANA ER.
  • Monitor patients taking OPANA ER who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with OPANA ER. Opioids may obscure the clinical course in a patient with a head injury.
  • Avoid the use of OPANA ER in patients with circulatory shock; with impaired consciousness or coma; or with GI obstruction.
  • The oxymorphone in OPANA ER may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • The oxymorphone in OPANA ER may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during OPANA ER therapy.
  • Do not abruptly discontinue OPANA ER. If OPANA ER is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Use a gradual downward titration of the dose every two to four days to prevent signs and symptoms of withdrawal.
  • Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
  • Chronic maternal use of oxymorphone during pregnancy can affect the fetus with subsequent withdrawal signs. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts.
  • OPANA ER is not recommended during labor and delivery, pregnancy, or nursing.
  • OPANA ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of OPANA ER and know how they will react to the medication.
  • Patients 65 years of age or older, patients with mild hepatic impairment, and patients with moderate to severe renal impairment have an increase in oxymorphone bioavailability. For these patients on prior opioid therapy, start at 50% of the starting dose for a younger patient or a patient with normal hepatic or renal function and titrate slowly and monitor closely for respiratory and central nervous system depression.
  • In opioid-naïve patients initiate OPANA ER using the 5 mg dose and monitor closely for respiratory and central nervous system depression.
  • OPANA ER can be abused and is subject to criminal diversion. The high drug content in extended release formulations adds to the risk of adverse outcomes from abuse and misuse. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests as required by state law, is strongly advised.
  • OPANA ER is administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Risks Specific to Abuse of OPANA ER
  • OPANA ER is for oral use only. Abuse of OPANA ER poses a risk of overdose and death. This risk is increased with concurrent abuse of OPANA ER with alcohol and other substances. OPANA ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Taking cut, broken, chewed, crushed, or dissolved OPANA ER enhances drug release and increases the risk of overdose and death.
ADVERSE REACTIONS
  • Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.
  • In clinical trials there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.
  • Post-marketing Experience - The following adverse reactions have been identified during post approval use of OPANA ER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous system disorder: amnesia, convulsion, memory impairment.
DRUG INTERACTIONS
  • Concurrent use of OPANA ER and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, hypotension, profound sedation, or coma. Monitor patients receiving CNS depressants and OPANA ER for signs of respiratory depression and hypotension. When such combined therapy is contemplated, reduce the initial dose of one or both agents.
  • Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, or buprenorphine) may reduce the analgesic effect of OPANA ER or may precipitate withdrawal symptoms in these patients. Avoid the use of mixed agonist/antagonist analgesics in patients receiving OPANA ER.
  • Cimetidine can potentiate opioid-induced respiratory depression. Monitor patients for respiratory depression when OPANA ER and cimetidine are used concurrently.
  • Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of respiratory and central nervous system depression when OPANA ER is used concurrently with anticholinergic drugs.

Please see full Prescribing Information, including boxed WARNING and Medication Guide for OPANA® ER.

Oxymorphone is also available in immediate release tablets and injectable form. For more information, please see full Prescribing Information for OPANA® Tablets and OPANA® Injection.

Vermont prescribers, please see additional information for OPANA® ER.

MORE SAFETY INFO

Intended for U.S. Residents Only

Rx Only

DEA Order Form Required.

OPANA® is a registered trademark of Endo Pharmaceuticals Inc.

INTAC® is a registered trademark of the Grünenthal Group.

© 2013 Endo Pharmaceuticals Inc. All Rights Reserved. Malvern, PA 19355

  • Privacy/Legal
  • OP-02672/May 2013
  • www.opana.com
  • 1-800-462-ENDO (3636)
INDICATION

OPANA® ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.

IMPORTANT SAFETY INFORMATION
WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
Abuse Potential

OPANA® ER contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing OPANA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OPANA® ER for signs of misuse, abuse, and addiction during treatment.

Life-threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of OPANA® ER, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and OPANA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OPANA® ER or following a dose increase. Instruct patients to swallow OPANA® ER tablets whole. Crushing, dissolving, or chewing OPANA® ER can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Exposure

Accidental ingestion of OPANA® ER, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with Alcohol

The co-ingestion of alcohol with OPANA® ER may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on OPANA® ER.

LIMITATIONS OF USAGE

OPANA® ER is not intended for use as an as-needed (PRN) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

CONTRAINDICATIONS

OPANA ER is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; moderate and severe hepatic impairment; hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in OPANA ER, or to morphine analogs such as codeine; and conditions that increase the risk of life-threatening respiratory depression.

WARNINGS AND PRECAUTIONS
  • Respiratory depression is the primary risk of OPANA ER. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status.
  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OPANA ER, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with OPANA ER, following dose increases, and when OPANA ER is given concomitantly with other drugs that depress respiration. Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting, or altered clearance compared to younger, healthier patients.
  • Monitor patients for respiratory depression who have significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, particularly when initiating therapy and titrating with OPANA ER, as in these patients, even usual therapeutic doses of OPANA ER may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible.
  • Hypotension, profound sedation, coma, or respiratory depression may result if OPANA ER is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). Additionally, consider the patient's use, if any, of alcohol or illicit drugs that cause CNS depression. If OPANA ER therapy is to be initiated in a patient taking a CNS depressant, start with a lower OPANA ER dose than usual and monitor patients for signs of hypotension, sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.
  • There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dose of OPANA ER.
  • Monitor patients taking OPANA ER who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with OPANA ER. Opioids may obscure the clinical course in a patient with a head injury.
  • Avoid the use of OPANA ER in patients with circulatory shock; with impaired consciousness or coma; or with GI obstruction.
  • The oxymorphone in OPANA ER may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • The oxymorphone in OPANA ER may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during OPANA ER therapy.
  • Do not abruptly discontinue OPANA ER. If OPANA ER is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Use a gradual downward titration of the dose every two to four days to prevent signs and symptoms of withdrawal.
  • Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
  • Chronic maternal use of oxymorphone during pregnancy can affect the fetus with subsequent withdrawal signs. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts.
  • OPANA ER is not recommended during labor and delivery, pregnancy, or nursing.
  • OPANA ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of OPANA ER and know how they will react to the medication.
  • Patients 65 years of age or older, patients with mild hepatic impairment, and patients with moderate to severe renal impairment have an increase in oxymorphone bioavailability. For these patients on prior opioid therapy, start at 50% of the starting dose for a younger patient or a patient with normal hepatic or renal function and titrate slowly and monitor closely for respiratory and central nervous system depression.
  • In opioid-naïve patients initiate OPANA ER using the 5 mg dose and monitor closely for respiratory and central nervous system depression.
  • OPANA ER can be abused and is subject to criminal diversion. The high drug content in extended release formulations adds to the risk of adverse outcomes from abuse and misuse. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests as required by state law, is strongly advised.
  • OPANA ER is administered at a frequency of twice daily (every 12 hours). Administer on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Risks Specific to Abuse of OPANA ER
  • OPANA ER is for oral use only. Abuse of OPANA ER poses a risk of overdose and death. This risk is increased with concurrent abuse of OPANA ER with alcohol and other substances. OPANA ER tablets must be taken whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth. Taking cut, broken, chewed, crushed, or dissolved OPANA ER enhances drug release and increases the risk of overdose and death.
ADVERSE REACTIONS
  • Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain.
  • In clinical trials there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.
  • Post-marketing Experience - The following adverse reactions have been identified during post approval use of OPANA ER. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous system disorder: amnesia, convulsion, memory impairment.
DRUG INTERACTIONS
  • Concurrent use of OPANA ER and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, hypotension, profound sedation, or coma. Monitor patients receiving CNS depressants and OPANA ER for signs of respiratory depression and hypotension. When such combined therapy is contemplated, reduce the initial dose of one or both agents.
  • Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, or buprenorphine) may reduce the analgesic effect of OPANA ER or may precipitate withdrawal symptoms in these patients. Avoid the use of mixed agonist/antagonist analgesics in patients receiving OPANA ER.
  • Cimetidine can potentiate opioid-induced respiratory depression. Monitor patients for respiratory depression when OPANA ER and cimetidine are used concurrently.
  • Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of respiratory and central nervous system depression when OPANA ER is used concurrently with anticholinergic drugs.

Please see full Prescribing Information, including boxed WARNING and Medication Guide for OPANA® ER.

Oxymorphone is also available in immediate release tablets and injectable form. For more information, please see full Prescribing Information for OPANA® Tablets and OPANA® Injection.

Vermont prescribers, please see additional information for OPANA® ER.