Digoxin immune fab Side Effects

Some side effects of digoxin immune fab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking digoxin immune fab: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• 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);

• feeling short of breath, even with mild exertion; or

• swelling, rapid weight gain.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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.

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.

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.

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

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.)

Metabolic side effects have included hypokalemia.

Other

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

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.

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