Dofetilide Capsule

04 February 2008

Products Affected - Description

Tikosyn 0.25 mg capsules, Pfizer
40-count unit dose package (NDC 00069-5810-43)
60-count bottle (NDC 00069-5810-60)

Reason for the Shortage

Pfizer had been experiencing manufacturing delays with Tikosyn 0.25 and 0.5 mg capsules.^1-3

Estimated Resupply Dates

• Pfizer has the Tikosyn capsules available in all strengths (0.125 mg, 0.25, 0.5 mg).^1,3

Implications for Patient Care

• Dofetilide is labeled for converting atrial fibrillation/atrial flutter to normal sinus rhythm. It is also labeled for delaying recurrence of atrial fibrillation/atrial flutter in patients with arrhythmia lasting more than 1 week, although it is usually reserved for highly symptomatic patients.⁴
• Because dofetilide may cause life-threatening arrhythmias, there are special precautions for its use. Dofetilide is distributed through a restrictive program and may be prescribed only by registered prescribers. In addition, patients must have continuous electrocardiograph monitoring and access to cardiac resuscitation for at least 3 days when starting or resuming therapy.⁴

Safety

Ensure that patients have sufficient supply to continue dofetilide therapy without interruption.⁴

Alternative Agents & Management

• Consult an arrhythmia or cardiology specialist for potential alternatives to Tikosyn. The appropriate alternative varies with the patient's specific arrhythmia and clinical situation.
• During this shortage, Pfizer recommends prescribers avoid starting new patients on Tikosyn therapy and contact current Tikosyn patients to discuss alternative treatment options.¹
• Registered pharmacies may consider limiting refill quantities to no more than a 4-week supply to help ensure equitable medication distribution among current Tikosyn patients.
• Pfizer has data establishing the bioequivalence of administering four of the 0.125 mg capsules in place of a single 0.5 mg capsule. There are no data establishing the bioequivalence of administering two of the 0.25 mg capsules in place of a single 0.5 mg capsule, or the bioequivalence of administering two of the 0.125 mg capsules in place of a single 0.25 mg capsule.¹

1. Pfizer, Customer Service (personal communications). January 9, 10, 15, 22, and 29, 2008.
2. Dear Healthcare Professional Letter. January 9, 2008. New York, NY: Pfizer Inc.
3. Dear Healthcare Professional Letter, Tikosyn Product Outage Resolved. February 4, 2008. New York, NY: Pfizer Inc.
4. Tikosyn (dofetilide) capsules. Product information. New York, NY: Pfizer Inc; 2004 March.

Updated

Updated February 4, 2008 by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Created January 10, 2008 by M. Christina Beckwith, Pharm.D., Drug Information Specialist. Copyright 2008, Drug Information Service, University of Utah, Salt Lake City, UT.

Back to Drug Shortage Product Bulletins