Digibind

DRUG DESCRIPTION

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:

  • 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,...

Read All Potential Side Effects and See Pictures of Digibind


Digibind Patient Information Including Side Effects

Brand Names: Digibind, DigiFab

Generic Name: digoxin immune FAB (Pronunciation: di JOX in im MYOON FAB)

  • What is digoxin immune FAB (Digibind)?
  • What are the possible side effects of digoxin immune FAB (Digibind)?
  • What is the most important information I should know about digoxin immune FAB (Digibind)?
  • What should I discuss with my health care provider before receiving digoxin immune FAB (Digibind)?
  • How is digoxin immune FAB given (Digibind)?
  • What happens if I miss a dose (Digibind)?
  • What happens if I overdose (Digibind)?
  • What should I avoid after receiving digoxin immune FAB (Digibind)?
  • What other drugs will affect digoxin immune FAB (Digibind)?
  • Where can I get more information?

What is digoxin immune FAB (Digibind)?

Digoxin immune FAB is used as an antidote to treat a life-threatening overdose of digoxin or digitoxin.

Digoxin immune FAB is not for treating a mild digitalis overdose.

Digoxin immune FAB may also be used for other purposes not listed in this medication guide.

What are the possible side effects of digoxin immune FAB (Digibind)?

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:

  • 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about digoxin immune FAB (Digibind)?

If possible, before you receive digoxin immune FAB, tell your doctor if you have heart disease or kidney disease, or if you are allergic to antibiotics or papaya extracts such as papain or chymopapain.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you received this medication.

After treatment with digoxin immune FAB, you will be watched to make sure the medication has been effective and you no longer have any effects of the digitalis overdose.

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