The Hospice Clinician Blog

The FDA has approved the 32 mg tablet strength of Mallinckrodt’s EXALGO® (hydromorphone HCI) Extended-Release Tablets for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time. The FDA approved the 8, 12 and 16 mg tablets of EXALGO in March 2010 and the Supplemental New Drug Application (sNDA) for the 32 mg tablet was submitted earlier this year. The EXALGO 32 mg tablet strength will be available in the next few weeks.

EXALGO is dosed just once per day and steady-state is reached in 3-4 days. It is a fairly expensive long-acting opioid, with a price per day in the $15-30 range (depending on tablet strength).

All EXALGO dosage strengths, including the new 32 mg tablet, are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids. Currently, Mallinckrodt maintains the EXALGO REMS program web site at www.exalgorems.com.

Hospira, Inc. has notified healthcare professionals of a recall of one lot of hydromorphone hydrochloride injection 1 mg/mL, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume.

The affected product is a prefilled glass cartridge for use with the Carpuject Syringe system. The affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed in September – October 2011. It was initially distributed to wholesalers and a limited number of hospitals throughout the United States.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-912-7093 to arrange for the return of the product. Replacement product from other lots is available. Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program (www.fda.gov/MedWatch/report.htm).

Old drug, new dosage form: Exalgo

The strong opioid, hydromorphone, is once again available as an extended release tablet providing long-acting opioid effects. The FDA recently approved Exalgo which is a once-a-day long-acting tablet providing hydromorphone in 8mg, 12mg, and 16mg strengths. It is indicated for the management of moderate to severe pain in opioid tolerant patients (such as hospice patients) who require continuous, around the clock opioid analgesia for an extended period of time. It is not intended for PRN use. Short-acting hydromorphone (Dilaudid) tablets, oral solution, or suppositories may be used on a PRN basis.

Patients must be able to swallow whole tablets since Exalgo cannot be crushed, chewed, or dissolved. It may be taken with or without food. Another long-acting hydromorphone product, Pallidone, was available for a brief time in the U.S. several years ago, but was pulled from the market in 2005 due to fatalities encountered when the drug was taken with alcohol. It was determined that alcohol hampered the extended release mechanism of Pallidone, resulting in dose dumping and subsequent toxic blood levels of the drug. An in vivo study examined the effect of alcohol on the bioavailability of a single dose of 16mg Exalgo in healthy, fasted or fed volunteers. The results showed that changes in the hydromorphone blood levels (mean AUC0.oc) were not statistically significant after co-administration with 40% alcohol. Recent advances in extended release tablet technology apparently have conferred better protection against alcohol interference with the drug release, however, patients are still advised to avoid alcohol while taking this drug.

The price will be in the range of $15.00 per tablet for the 12mg strength.

For More Information: http://exalgo.com/

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