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Guidelines for Administering DigiFab®

For instruction on administering DigiFab® Digoxin Immune Fab (Ovine), follow these guidelines1:

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.

General Precautions

Standard management of digitalis intoxication includes withdrawal of the intoxicating agent, correction of electrolyte disturbances (especially hyperkalemia), acid-base imbalances, hypoxia and treatment of cardiac arrhythmias.

Massive digitalis intoxication can cause hyperkalemia; administration of potassium supplements in the setting of digitalis intoxication may be hazardous. After treatment with DigiFab® Digoxin Immune Fab (Ovine), the serum potassium concentration may drop rapidly and must be monitored frequently, especially after the first several hours after DigiFab® Digoxin Immune Fab (Ovine) is given.

Patients with poor cardiac function may deteriorate secondary to the withdrawal of the inotropic action of digoxin by DigiFab® Digoxin Immune Fab (Ovine). If needed, additional support can be provided by using other intravenous inotropes such as dopamine, dobutamine, or vasodilators.

However, care must be taken not to aggravate the digitalis-induced rhythm disturbances. Re-digitalization should be postponed, if possible, until the Fab fragments have been eliminated from the body, which may require several days, and patients with impaired renal function may require a week or longer.

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References

  1. DigiFab® [prescribing information]. BTG International Inc. January 2012.

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