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Safe practice with the potent once daily opioid Exalgo

From the May 20, 2010 issue

On March 1, 2010, FDA approved the Schedule II controlled substance EXALGO, a once daily hydromorphone hydrochloride extended-release tablet. Exalgo 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. The drug is not indicated for use as an “as needed” analgesic or for the management of acute or postoperative pain. Exalgo is available in 8, 12, and 16 mg tablet strengths that should be swallowed whole, and not broken, chewed, dissolved, crushed, or injected. Exalgo is contraindicated in patients who are not opioid-tolerant or those with impaired pulmonary function, paralytic ileus, or a narrowed or obstructed gastrointestinal tract.

Exalgo will be launched with a Risk Evaluation and Mitigation Strategy (REMS) program, which includes a Medication Guide and educational materials to ensure appropriate patient selection and dosing. The product packaging contains an encased statement“For opioid-tolerant patients only” to emphasize this point. Patients are considered opioid-tolerant if they have been taking at least one of the following for 1 week or longer:

  • 8 mg of oral hydromorphone/day
  • 25 mg of oral oxymorphone/day
  • 30 mg of oral oxycodone/day
  • 60 mg of oral morphine/day
  • 25 mcg of transdermal fentanyl/hour
  • Equianalgesic dose of another opioid.
The product package also highlights the words “Once Daily” to remind dispensing pharmacists of the dosing frequency for this medication.

Dose conversion to Exalgo requires calculation, and guidance is provided in the prescribing information to help ensure safe conversion from other opioids to Exalgo. The starting dose for Exalgo depends on the specific dose of opioid the patient is taking and the calculated total daily dose of oral hydromorphone. Prescribers should refer to the full prescribing information for dosage and instructions for administration.

Physicians may prescribe Exalgo 8 mg tablets as an initial daily dose. The 8 mg strength of Exalgo overlaps with currently
marketed hydromorphone immediaterelease products. This overlap in strength may contribute to medication errors if
inadvertent substitution between the two hydromorphone products occurs. Confusion between the immediate- and
extended-release products could result in an overdose, which may lead to serious adverse events such as respiratory depression and death. Confusion between immediate- and extended-release products could also result in an underdose, leading to poor efficacy. To prevent mix-ups and other types of medication errors with Exalgo, consider the safety recommendations provided below.

Prescribers
  • To help minimize the risk of confusion between hydromorphone products, include the proprietary name Exalgo on prescriptions, which may provide greater differentiation than simply using the established name alone.
  • If the established name is included or used alone, spell out “hydromorphone extended-release” instead of “hydromorphone ER.” Pharmacists may overlook the modifier “ER” and dispense hydromorphone immediate-release tablets instead of the extended-release tablets, resulting in inadequate around-the-clock pain control.
  • When prescribing the immediaterelease hydromorphone product by the established name, include just “hydromorphone.” Do not attach modifiers such as“IR” for immediate-release. Pharmacists may misinterpret “IR” for “ER,” especially with handwritten orders, and dispense Exalgo in error, resulting in dispensing the wrong formulation.
  • Review the patient’s medication history and verify that the patient is opioid-tolerant before prescribing Exalgo.
Pharmacists and Nurses
  • Verify the prescribed hydromorphone product with the order or prescription. Exalgo is dosed once daily while the usual dosing frequency for immediate-release hydromorphone is every 4 to 6 hours as needed.
  • Verify opioid tolerance by asking the patient for his/her medication history and checking the patient’s pharmacy profile and medication administration record. Build alerts into the pharmacy computer system to remind the pharmacist to verify opioid tolerance.
  • Counsel patients to take Exalgo once daily, to swallow the tablets whole without chewing or crushing them, and to avoid alcohol while taking this medication. Also advise patients to inform their healthcare provider if Exalgo does not provide adequate pain control.
  • Verify patient understanding about how to take the tablets at home by asking openended questions.
  • Advise patients to read the Medication Guide and call their healthcare provider if they have any questions.
  • Instruct patients to check the appearance of each Exalgo tablet before taking it to ensure it matches the product description or image when this information is provided on the pharmacygenerated label or in the pharmacy leaflet.

FDA Advise-ERR was provided by the FDA Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis, in cooperation with ISMP.

Editor’s note: ISMP urges clinicians to ensure Exalgo is prescribed, dispensed, and administered only to opioid-tolerant patients with chronic pain, not acute pain.

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