"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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Digoxin Immune Fab (Ovine)
DIGIBIND, Digoxin Immune Fab (Ovine), is a sterile lyophilized powder of antigen binding fragments (Fab) derived from specific antidigoxin antibodies raised in sheep. Production of antibodies specific for digoxin involves conjugation of digoxin as a hapten to human albumin. Sheep are immunized with this material to produce antibodies specific for the antigenic determinants of the digoxin molecule. The antibody is then papain-digested and digoxin-specific Fab fragments of the antibody are isolated and purified by affinity chromatography. These antibody fragments have a molecular weight of approximately 46,200.
Each vial, which will bind approximately 0.5 mg of digoxin (or digitoxin), contains 38 mg of digoxin-specific Fab fragments derived from sheep plus 75 mg of sorbitol as a stabilizer and 28 mg of sodium chloride. The vial contains no preservatives.
DIGIBIND (digoxin immune fab) is administered by intravenous injection after reconstitution with Sterile Water for Injection (4 mL per vial).
What are the possible side effects of digoxin immune FAB (Digibind, DigiFab)?
Get emergency medical help if you have any of these signs of an allergic reaction: 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:
- 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...
Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Digibind Information
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