Risk Evaluation and Mitigation Strategy

In order to ensure that the benefits of EXALGO outweigh the potential risks, a Risk Evaluation and Mitigation Strategy (REMS) has been implemented in response to a requirement of the U.S. Food and Drug Administration (FDA).

The goals of this REMS are to:

1. Inform patients and healthcare professionals about the potential for abuse,
   misuse, overdose, and addiction of EXALGO
2. Inform patients and healthcare professionals about the safe use of EXALGO

Education Program: Training and REMS Information

The EXALGO REMS requires that EXALGO should only be prescribed in accordance with the EXALGO REMS, including healthcare professional training on responsible prescribing and use.

The EXALGO REMS education can be completed in 3 easy steps.

You may download the EXALGO REMS information:

For additional information, please call Covidien at 1.888.9EXALGO (1.888.939.2546)

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 of oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg of 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.