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Guidelines for Administering DigiFab®

For instruction on administering DigiFab® Digoxin Immune Fab (Ovine), follow these guidelines:

Each vial of DigiFab® Digoxin Immune Fab (Ovine) should be reconstituted with 4 mL of Sterile Water for Injection USP and gently mixed to provide a solution containing approximately 10 mg/mL of digoxin immune Fab protein. The reconstituted product should be used promptly. If not used immediately, it may be stored under refrigeration at 2° to 8°C (36° to 46°F) for up to 4 hours. The reconstituted product may be added to an appropriate volume of 0.9% sodium chloride for injection.

DigiFab® Digoxin Immune Fab (Ovine) should be administered slowly as an intravenous infusion over at least 30 minutes. If infusion rate-related reactions occur, the infusion should be stopped and re-started at a slower rate. If cardiac arrest is imminent, DigiFab® Digoxin Immune Fab (Ovine) can be given by bolus injection. With bolus injection, an increased incidence of infusion-related reactions may be expected.

For infants and small children who may require very small doses, it is recommended that the 40 mg vial be reconstituted as directed and administered undiluted using a tuberculin syringe. For very small doses, a reconstituted vial can be diluted with an additional 36 mL of isotonic saline to achieve a concentration of 1 mg/mL.

For full guidelines, please see Prescribing Information.

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To report an adverse event or for 24-hour medical information, call 1-844-293-0007.

Indication
DigiFab® Digoxin Immune Fab (Ovine) is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab® is not indicated for milder cases of digitalis toxicity.

Important Safety Information
Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab®.  Rapid drop in serum potassium concentration may occur after treatment with DigiFab®. Patients with known allergies to sheep protein, papaya, or papain are at higher risk of an anaphylactic reaction. Suicidal ingestion may involve more than one drug. Toxic effects of other drugs or poisons should not be overlooked. The most common adverse reactions (>7%) related to DigiFab® are worsening congestive heart failure (13%), hypokalemia (13%) and worsening atrial fibrillation (7%). Please see full prescribing information, including events, precautions, or warnings.