EXALGO® (hydromorphone HCl) Extended-Release Tablets, CII 12 mg

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 taking 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, misuse, overdose, and death 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 RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL WITHDRAWAL SYNDROME

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 or 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 Exposure
Accidental ingestion of even one dose of EXALGO, especially in 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.

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
    • Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
    • Patients with known or suspected 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 or sulfite-containing medications

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. With intravenous abuse, the tablet excipients, especially polyethylene oxide, can be expected to result in necrosis and inflammation of cardiac tissues. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV. 
  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of EXALGO, the risk is greatest during the initiation of therapy or following a dose increase.  Overestimating the EXALGO dose when converting patients from another opioid product can result in fatal overdose with the first dose.  Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, EXALGO may decrease respiratory drive to the point of apnea, particularly when initiating therapy and titrating with EXALGO, even at usual therapeutic doses. 
  • Hypotension, profound sedation, coma, respiratory depression, and death may result if EXALGO is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). 
  • EXALGO may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised.
  • In patients with head injury or increased intracranial pressure, EXALGO may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.
  • EXALGO may cause spasm of the sphincter of Oddi.
  • May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings.
  • Do not abruptly discontinue EXALGO.  The use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving EXALGO may reduce the analgesic effect and/or may precipitate withdrawal symptoms.
  • EXALGO may impair the ability to drive a car or operate machinery. 
ADVERSE REACTIONS
  • Serious adverse events include respiratory depression, overdose, and death. Hypersensitivity reactions, angioedema, and urticaria have been identified during post-approval use of EXALGO. 
  • The most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation, nausea, vomiting, somnolence, headache, asthenia/fatigue, and dizziness.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Opioids cross the placenta and may produce respiratory depression in neonates. Prolonged use of EXALGO during pregnancy can result in withdrawal syndrome in the neonate, which can be life threatening.
  • Breastfeeding: Nursing should not be undertaken while a patient is receiving EXALGO since hydromorphone is excreted in the milk.
  • Pediatrics: The safety and effectiveness of EXALGO in patients 17 years of age and younger have not been established.
  • Patients with moderate renal or hepatic impairment have been shown to have increased plasma concentrations of hydromorphone.  These patients should be closely monitored for respiratory and central nervous system depression.  Use of alternate analgesics is recommended in patients with severe hepatic impairment and alternate analgesics which permit greater dosing flexibility should be considered in patients with severe renal impairment.

Description Dark yellow tablet
Generic Name Hydromorphone HCl Extended-Release Tablets, CII
Dosage Strength 12 mg
Identification Code dark yellow, round tablet printed with “EXH 12” on one side

Order Information

NDC # Package Size Case Quantity
23635-412-01 100's 12

For additional information on EXALGO® (hydromorphone HCl) Extended-Release Tablets, CII 12 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.