Is dofetilide a REMS drug?
Under the REMS program, Tikosyn (dofetilide) could only be prescribed by enrolled prescribers and dispensed by enrolled pharmacies and healthcare facilities.
Does Tikosyn have a black box warning?
Dofetilide (Tikosyn®)
Dofetilide has a Black Box Warning and may be subject to Risk Evaluation and Mitigation Strategy (REMS) under FDA safety regulations.
What class of drug is dofetilide?
Dofetilide is a class III antiarrhythmic agent (table 1) available for the acute termination of atrial fibrillation or flutter, as well as prevention of atrial fibrillation or flutter recurrence. Dofetilide has also been used in an off-label manner to treat paroxysmal supraventricular tachycardias.
What is the difference between Tikosyn and dofetilide?
Tikosyn is available as a generic drug called dofetilide. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be as safe and effective as the original drug.
Is dofetilide a safe drug?
Dofetilide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
Is Tikosyn safe?
Many people using this medication do not have serious side effects. Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, fainting, faster/more irregular heartbeat, severe dizziness. A very serious allergic reaction to this drug is rare.
Is Tikosyn a high risk medication?
As with other drugs that cause Torsade de Pointes, TIKOSYN was associated with a greater risk of Torsade de Pointes in female patients than in male patients. During the TIKOSYN clinical development program, the risk of Torsade de Pointes in females was approximately 3 times the risk in males.
Who should not take dofetilide?
TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities).
What drugs should not be taken with dofetilide?
Do not use this medicine together with cimetidine, dolutegravir, hydrochlorothiazide, hydrochlorothiazide/triamterene, ketoconazole, megestrol, prochlorperazine, trimethoprim, trimethoprim/sulfamethoxazole, or verapamil. Using these medicines together may cause serious unwanted effects.
What are the long term side effects of dofetilide?
Side Effects
- Chest pain.
- facial or flaccid paralysis.
- numbness or tingling of the hands, feet, or face.
- paralysis.
- pounding, slow heartbeat.
- slurred speech.
- swelling of the ankles, arms, face, feet, fingers, legs, lips, tongue, or throat.
- troubled breathing.
Who should not take Tikosyn?
What should you not take with dofetilide?