DigiFab Side Effects

Generic Name: digoxin immune fab

Note: This page contains information about the side effects of digoxin immune fab. Some of the dosage forms included on this document may not apply to the brand name DigiFab.

Not all side effects for DigiFab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to digoxin immune fab: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking digoxin immune fab (the active ingredient contained in DigiFab) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever;

  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

  • shortness of breath (even with mild exertion); or

  • swelling, rapid weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to digoxin immune fab: injectable powder for injection, injectable solution

Hypersensitivity

Skin testing for allergy is rarely done, but may be beneficial in patients who have been exposed to or who are allergic to sheep proteins.[Ref]

Hypersensitivity side effects have rarely included general febrile state, urticarial rash, facial swelling and redness, and frank anaphylaxis. In cases of severe hypersensitivity side effects, prompt discontinuation of the drug is recommended.[Ref]

Cardiovascular

Cardiovascular side effects may arise as the clinical effectiveness of digoxin wanes (upon binding to Fab). Preexisting or new heart failure may require substitution of other inotropic agents and/or the addition of diuretics and/or vasodilators. Patients with atrial fibrillation become at increased risk for a rapid ventricular response rate in the absence of therapeutic serum digoxin concentrations.

Animal data have shown that decreased left ventricular contractility only slowly develops after digoxin immune Fab administration. Cardiac glycosides should NOT be used to treat decreased cardiac output in patients with documented cardiac glycoside intoxication!

While some inotropic agents may become necessary to maintain cardiac output, be cognizant that the catecholamine release associated with some drugs, such as dopamine or dobutamine, can exacerbate the significant risk of life-threatening arrhythmias associated with cardiac glycoside toxicity.[Ref]

Cardiovascular side effects have included new or exacerbation of existing physical and electrical cardiac conditions.[Ref]

Metabolic

A common metabolic problem associated with digoxin immune Fab therapy is the development of hypokalemia. Reversal of digoxin-mediated inhibition of the ATP-ase Na+/K+ pump enables potassium to shift back to the intracellular space, promoting the risk of hypokalemia. Patients with digoxin toxicity are usually total body potassium depleted, require close observation (serum potassium concentrations and ECG monitoring), and require cautious potassium replacement. (Rapid potassium replenishment can induce arrhythmias and easily cause hyperkalemia in this situation.)[Ref]

Metabolic side effects have included hypokalemia.[Ref]

Other

Other side effects have included interference with the standard radioimmunoassay for digoxin and digitoxin.[Ref]

Accurate laboratory serum measurements of free, unbound, active digoxin may not be available for days in patients with normal renal function or for at least one week in patients with reduced renal function.[Ref]

References

1. "Product Information. Digibind (digoxin immune FAB)." Glaxo Wellcome, Research Triangle Park, NC.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)