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New Beginning Kit materials

Ask your EXALGO sales representative
for a supply of these patient education kits
or request them by clicking the link above.

True 24-hour once-daily dosing is just
one way we support you and your patients.

We are committed to making sure you and your patients have the resources you need to enable pain management that meets both your expectations.

The EXALGO New Beginning Kit

The kit can be a great resource for your office and the patients you are considering switching to EXALGO.
It contains important information your patients will need to know to take EXALGO safely and effectively.

  • An EXALGO educational brochure that also includes a pain diary to track pain levels,
    symptoms, and triggers for pain
  • An educational video that is informative and easy to understand
  • The EXALGO Co-pay Card
  • The Dose-Alert® reminder tool


Dose-Alert is a registered trademark of Pharmaceutical Direct, Inc.


The EXALGO Co-pay Card

Relief can come in many forms. And the EXALGO Co-pay Card can give patients who are eligible the additional help they may need to manage costs.

Managed Care Coverage

Find out all about the acceptance of EXALGO on major medical health plans.

Patient Assistance Program

We may be able to help patients who meet certain income requirements and lack prescription drug coverage.*

*Restrictions apply.

Pharmacy Locator

We know access is key. Find out the pharmacies in your area that stock EXALGO.

Please click the play button to view the introduction video.

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® (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

Abuse Potential

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 Exposure

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.
  • 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:ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

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