• Dosing Conversion

EXALGO is available in several strengths for once-daily dosing.

Guidelines for converting your patients to EXALGO.*

Plasma Hydromorphone Line Chart

* The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to EXALGO.

† Ratio for conversion of oral opioid dose to approximate hydromorphone equivalent dose.

‡ It is extremely important to monitor all patients closely when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and tends to accumulate in the plasma.
  • Select opioid, sum the total daily dose, and then multiply the dose by the conversion ratio to calculate the approximate oral hydromorphone equivalent.
  • In general, reduce the calculated equianalgesic dose by 25%-50%.1-3
  • Dosing titration should occur gradually (25%-50% every 3 to 4 days).
    • - If EXALGO is discontinued, doses should also be tapered gradually (25%-50% every 2 or 3 days).
  • It is critical to initiate the dosing regimen individually for each patient. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose.

Switching from transdermal fentanyl patch.

EXALGO treatment can be initiated 18 hours after removal of patch. For each 25 mcg/hr fentanyl transdermal dose, the equianalgesic dose of EXALGO is 12 mg every 24 hours. Appropriate starting dose of EXALGO is 50% of the calculated total daily dose every 24 hours.

  1. EXALGO® Full Prescribing Information.
  2. Hale M, Khan A, Kutch M, Li S. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010;26:1505‑1518.
  3. Fine PG, Portenoy RK; Ad Hoc Expert Panel on Evidence Review and Guidelines for Opioid Rotation. Establishing "best practices" for opioid rotation: conclusions of an expert panel. J Pain Symptom Manage. 2009;38:418‑425.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Scroll down for Important Risk Information including boxed warning

INDICATION

EXALGO® is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

IMPORTANT RISK INFORMATION

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Proper Patient Selection

EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking 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, for a week or longer.

EXALGO is for use in opioid tolerant patients only.

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.

Limitations of Use

EXALGO is not indicated for the management of acute or postoperative pain.

EXALGO is not intended for use as an as-needed analgesic.

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.

  • EXALGO is also contraindicated in patients who:
    • - need management of mild pain or pain not expected to persist
    • - have significant impaired respiratory function including those with acute or severe bronchial asthma or hypercarbia.
    • - have or are suspected to have paralytic ileus
    • - have narrowed or obstructed gastrointestinal tract including those from previous surgery or "blind loops" in the GI tract
    • - have known hypersensitivity to any components including hydromorphone hydrochloride and sulfites.
  • Avoid concurrent use of alcohol and EXALGO. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. EXALGO may impair the ability to drive a car or operate machinery.
  • Not intended in patients who have received MAO inhibitors within 14 days of starting EXALGO.
  • Use with caution and in reduced doses in older or debilitated patients, as well as patients with renal or hepatic insufficiency, Addison's disease, delirium tremens, myxedema or hypothyroidism, prostatic hypertrophy or urethral stricture, toxic psychosis. May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings. Consider use of an alternate analgesic in patients with severe renal impairment.
  • Respiratory depression, which occurs more frequently in elderly or debilitated patients, is the chief hazard with EXALGO.
  • Serious adverse events could also include hypotensive effects, GI effects, cardiac arrest from overdose and precipitation of withdrawal. Most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation (31%), nausea (28%), vomiting, somnolence, headache, asthenia and dizziness.
  • Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention.
  • Do not abruptly discontinue EXALGO

Please see Full Prescribing Information, including boxed warning and Additional Important Risk Information.

IMPORTANT RISK INFORMATION

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

EXALGO® contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.
EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. Click here for more Important Risk Information, including boxed warning