EXALGO is available in
8 mg, 12 mg, 16 mg, and 32 mg tablets that can be used in combination to achieve the desired dosage strength; tablets should be swallowed whole.
EFFECTIVELY TRANSITION PATIENTS to EXALGO.
- There is no immediate-release component; plasma levels rise for the first 6 to 8 hours after the initial dose.1
- It takes 3 to 4 days to reach steady state.1,2
- Prescribe supplemental pain medication to help your patients get to steady state, through titration, and as
START with an appropriate dose
- Consider the reasons for switching when calculating a starting dose.
- Generally, reduce the calculated equianalgesic dose by 25% to 50% to obtain the starting dose.*1,3,4
- EXALGO is available in 8, 12, 16, and 32 mg tablets to provide flexibility when determining a
starting dose; all tablets should be taken together once daily.1
TITRATE to an effective dose
- Titration should not occur more frequently than every 3 to 4 days.1
- If more than 2 doses of supplemental medication are needed for 2 consecutive days, it may be
time to titrate upward.1
- When titrating, consider a 25% to 50% increase in dose.1
- It may take multiple titration steps to achieve effective pain control with tolerable side effects.
* In the pivotal trial, a 25% dose reduction of equianalgesic dose was used to determine a starting dose.1,3
- EXALGO® Prescribing Information.
- Moore KT, St-Fleur D, Marricco NC, et al. Steady-state pharmacokinetics of extended-release hydromorphone (OROS®
hydromorphone): a randomized study in healthy volunteers. J Opioid Manag. 2010;6(5):351-358.
- 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(6):1505-1518.
- 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(3):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
EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII) is 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: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE
EXALGO contains hydromorphone, an opioid agonist and a 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 EXALGO. 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 EXALGO for signs of misuse, abuse, and addiction during treatment.
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of EXALGO, even when the drug has been used as recommended and not misused or abused. EXALGO is for use in opioid tolerant patients only. Proper dosing and titration are essential and EXALGO should be prescribed only 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 EXALGO or following a dose increase. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of hydromorphone.
Accidental ingestion of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.
- 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
- EXALGO is indicated for opioid tolerant patients only. 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 not intended for use as an as-needed analgesic and is not indicated for the management of acute or postoperative pain. It is contraindicated in patients who need management of mild pain or pain not expected to persist.
- 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. Post marketing events include hypersensitivity reactions, angioedema and urticaria.
- Use EXALGO with extreme caution in patients susceptible to intracranial effects of CO2 retention.
- Do not abruptly discontinue EXALGO.