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GREENSTONE LLC INTRODUCES
DOFETILIDE CAPSULES
Authorized Generic of TIKOSYN® (dofetilide capsules)

PEAPACK, NJ, June 2016—Greenstone LLC, a US-based subsidiary of Pfizer Inc. (NYSE: PFE), is pleased to announce the introduction of Dofetilide Capsules to its ever-expanding generic pharmaceutical product line. The product is offered and available in dosage strengths of 125 mcg (0.125 mg) x 60 capsules per bottle, 250 mcg (0.250 mg) x 60 capsules per bottle and 500 mcg (0.5 mg) x 60 capsules per bottle.

Greenstone's Dofetilide Capsules is the authorized generic of, and equivalent to the innovator's product, TIKOSYN® (dofetilide capsules). This new authorized generic adds to Greenstone's consistently growing line of products and is backed by the distribution and customer service support of Pfizer Inc., one of the world's premier biopharmaceutical companies. As a subsidiary of Pfizer Inc., Greenstone operates under the same values and commitment to bring quality pharmaceutical products to customers, payers, and the patients it serves.

See the Full Prescribing Information, including boxed warning, for Greenstone’s Dofetilide Capsules at http://www.greenstonellc.com/product-list.aspx. For more information about Greenstone LLC and its products, visit http://greenstonellc.com.

Indications

Dofetilide capsules is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFL]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because Dofetilide capsules can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients.

Dofetilide capsules is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide capsules has not been shown to be effective in patients with paroxysmal atrial fibrillation.

IMPORTANT SAFETY INFORMATION

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on dofetilide capsules should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation.

Dofetilide capsules is contraindicated in patients with congenital or acquired long QT syndromes, a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities), severe renal impairment (calculated creatinine clearance <20 mL/min), or known hypersensitivity to Dofetilide capsules.

Dofetilide capsules is also contraindicated with verapamil, hydrochlorothiazide (alone or in combination, such as with triamterene), and cation transport system inhibitors such as cimetidine, ketoconazole, trimethoprim (alone or in combination with sulfamethoxazole), prochlorperazine, megestrol, and dolutegravir because these drugs may cause an increase in dofetilide plasma concentration.

Dofetilide capsules can cause serious ventricular arrhythmias, primarily Torsade de Pointes type ventricular tachycardia, a polymorphic ventricular tachycardia associated with QT interval prolongation. QT interval prolongation is directly related to dofetilide plasma concentrations. Factors such as reduced creatinine clearance or certain dofetilide drug interactions will increase dofetilide plasma concentration. The risk of TdP can be reduced by controlling the plasma concentration through adjustment of the initial dofetilide dose according to creatinine clearance and by monitoring the ECG for excessive increases in the QT interval. Calculation of creatinine clearance and QTc for all patients must precede administration of the first dose of dofetilide capsules. Renal function and QTc should be re-evaluated every 3 months or as medically warranted.

The most common adverse events reported were headache, chest pain, dizziness, respiratory tract infection, dyspnea, and nausea.

TIKOSYN is a registered trademark of Pfizer Inc.

PP-GRE-USA-0120