Intended for U.S. healthcare professionals only.
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Opioid Products

EXALGO® (hydromorphone HCl) extended-release tablets, CII 8 mg

This information is intended for U.S. healthcare professionals only.

INDICATIONS AND USAGE

EXALGO (hydromorphone HCI) extended-release tablets (CII) is indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid. 

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 extended-release opioid formulations, reserve EXALGO 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 management of pain. EXALGO is not indicated as an as-needed (prn) analgesic.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

EXALGO 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 EXALGO, and monitor all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of EXALGO. Monitor for respiratory depression, especially during initiation of EXALGO or following a dose increase. Instruct patients to swallow EXALGO tablets whole; crushing, chewing, or dissolving EXALGO tablets can cause rapid release and absorption of a potentially fatal dose of hydromorphone.

Accidental Ingestion

Accidental ingestion of even one dose of EXALGO, especially by children, can result in a fatal overdose of hydromorphone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of EXALGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of EXALGO and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

 

CONTRAINDICATIONS

EXALGO is contraindicated in:

  • Opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant.
  • Patients with significant respiratory depression.
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Patients who have had surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction.
  • Patients with hypersensitivity (e.g., anaphylaxis) to hydromorphone.

WARNINGS AND PRECAUTIONS

  • EXALGO contains hydromorphone, a Schedule II controlled substance. As an opioid, EXALGO exposes users to the risks of addiction, abuse, and misuse. As modified-release products such as EXALGO deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydromorphone present. Addiction can occur at recommended doses and if the drug is misused or abused.
  • Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing EXALGO, and monitor all patients receiving EXALGO for the development of these behaviors and conditions.
  • Abuse or misuse of EXALGO by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of hydromorphone and can result in overdose and death.
  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Patients with chronic pulmonary disease, elderly, cachectic, or debilitated patients may be at increased risk. Monitor closely, especially within first 24 to 72 hours of initiating therapy with EXALGO and following dosage increases.
  • Accidental ingestion of even one dose of EXALGO, especially by children, can result in respiratory depression and death due to an overdose of hydromorphone.
  • Neonatal opioid withdrawal syndrome (NOWS) may occur following prolonged use of opioids during pregnancy. Observe newborns for signs of NOWS and manage accordingly; NOWS may be life threatening if not recognized and treated in neonates.
  • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of EXALGO with benzodiazepines or other CNS depressants.
  • Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids and wean patient off of the opioid until adrenal function recovers.
  • EXALGO may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor during initiation and/or titration of EXALGO. Avoid use in patients with circulatory shock.
  • Use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Use of EXALGO should be avoided in patients with impaired consciousness or coma.
  • The hydromorphone in EXALGO may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
  • The hydromorphone in EXALGO may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control.
  • Avoid use of EXALGO with mixed agonist/antagonists or partial agonist analgesics due to risk of precipitation of withdrawal symptoms. When discontinuing EXALGO, gradually taper the dosage.
  • EXALGO contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
  • Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of EXALGO and know how they will react to the medication.

 

ADVERSE REACTIONS

The most common adverse reactions (>10%) are constipation, nausea, vomiting, somnolence, headache, and dizziness. The most common treatment-related serious adverse reactions from controlled and uncontrolled chronic pain studies were drug withdrawal syndrome, overdose, confusional state, and constipation. The overall incidence of adverse reactions was higher in patients greater than 65 years of age and in female patients.

This is not a complete list of potential adverse events associated with EXALGO. Please see Full Prescribing Information for a complete list.

 

 

Description Red tablet
Generic Name Hydromorphone HCl extended-release tablets, CII
Dosage Strength 8 mg
Identification Code red, round tablet printed with “EXH 8” on one side

ORDER INFORMATION

NDC # Package Size Case Quantity
23635-408-01 100's 12

For additional information on EXALGO® (hydromorphone HCl) extended-release tablets, CII 8 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.

10004708
Revised September 2018