Ovine digoxin immune fab

Postpone re-digitalization, 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. 5.2 Hypersensitivity Reactions Anaphylaxis and hypersensitivity reactions are possible. Carefully monitor all patients treated with DigiFab ® for signs and symptoms of an acute allergic reaction (e.g., urticaria, pruritus, erythema, angioedema, bronchospasm with wheezing or cough, stridor, laryngeal edema, hypotension, tachycardia) and treat immediately with appropriate emergency medical care (e.g., oxygen, diphenhydramine, corticosteroids, volume expansion and airway management), if one occurs.

To date, there have been no clinical reports of human anti-ovine immunoglobulin antibodies causing a reduction in binding of ovine digoxin immune Fab or neutralization response to ovine digoxin immune Fab. 5.3 Use of DigiFab ® in Renal Failure The elimination half-life of DigiFab ® in renal failure has not been clearly defined.

Monitor patients with severe renal failure who receive DigiFab ® for digitalis toxicity for a prolonged period for possible recurrence of toxicity. Monitoring of free (unbound) digoxin concentrations after the administration may be appropriate in order to establish recrudescent toxicity in renal failure patients. 5 5.4 Laboratory Tests DigiFab ® may interfere with digitalis immunoassay measurements.

Thus, standard serum digoxin concentration measurements may be clinically misleading until the Fab fragments are eliminated from the body. This may take several days or a week or more in patients with markedly impaired renal function. Therefore, serum samples for digoxin concentration should be obtained before DigiFab ® administration, if at all possible.

Preparation and Administration Each vial contains 40 mg of digoxin immune Fab protein and is intended for one time use only as it contains no preservatives Reconstitute each vial of DigiFab ® with 4 mL of Sterile Water for Injection USP and gently mix to provide a solution containing approximately 10 mg/mL of digoxin immune Fab protein.

Use the reconstituted product promptly. If not used immediately, store under refrigeration at 2° to 8°C (36° to 46°F) for up to 4 hours. Add the reconstituted product to an appropriate volume of 0.9% sodium chloride for injection. Visually inspect reconstituted vials for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if the solution is cloudy, turbid or if it contains particulates. Administer DigiFab ® slowly as an intravenous infusion over at least 30 minutes. Stop the infusion if infusion rate-related anaphylactoid-type reactions occur, such as hypotension, wheezing, or urticaria. The infusion can be re-started at a slower rate.

Give DigiFab ® by bolus injection, if cardiac arrest is imminent. An increased incidence of infusion-related reactions may be expected with bolus injection. For infants and small children who may require very small doses, reconstitute the 40 mg vial as directed and administer 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.