DigiFab

Generic name: digoxin immune FAB
Drug class: Antidotes

Medically reviewed by A Ras MD.

What is DigiFab?

DigiFab is a prescriptin medicine that is used to treat digoxin overdose.

Description

DIGIFAB [Digoxin Immune Fab (Ovine)] is a sterile, lyophilized preparation of digoxin-immune ovine Fab (monovalent) immunoglobulin fragments. These fragments are obtained from the blood of healthy sheep immunized with a digoxin derivative, digoxin-dicarboxymethoxylamine (DDMA), a digoxin analogue which contains the functionally essential cyclopentaperhydrophenanthrene: lactone ring moiety coupled to keyhole limpet hemocyanin (KLH).

The final product is prepared by isolating the immunoglobulin fraction of the ovine serum, digesting it with papain and isolating the digoxin-specific Fab fragments by affinity chromatography. These antibody fragments have a molecular weight of approximately 46,000 Da.

Each vial of DIGIFAB, which will bind approximately 0.5 mg digoxin, contains 40 mg of digoxin immune Fab, 75 mg (approx) of mannitol USP, and 2 mg (approx) sodium acetate USP as a buffering agent.

The product contains no preservatives and is intended for intravenous administration after reconstitution with 4 mL of Sterile Water for Injection USP.

Mechanism of Action

DIGIFAB has an affinity for digoxin in the range of 109 to 1010 M-1, which is greater than the affinity of digoxin for its sodium pump receptor, the presumed receptor for its therapeutic and toxic effects. When administered to the intoxicated patient, DIGIFAB binds to molecules of digoxin reducing free digoxin levels, which results in a shift in the equilibrium away from binding to the receptors, thereby reducing cardio-toxic effects. Fab-digoxin complexes are then cleared by the kidney and reticuloendothelial system.

Before taking DigiFab, tell your doctor:

If you are allergic to DigiFab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are allergic to sheep or sheep products.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take DigiFab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take DigiFab?

Tell all of your health care providers that you take DigiFab. This includes your doctors, nurses, pharmacists, and dentists.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take DigiFab.
This medicine is used to reverse the effects of digoxin. Heart failure or atrial fibrillation (afib) may get worse with DigiFab. Tell your doctor right away if your health problem gets worse.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is DigiFab best taken?

Use DigiFab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

Call your doctor to find out what to do.

What are the side effects of DigiFab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
Very bad dizziness or passing out.
Cough.
A fast heartbeat.

What are some other side effects of DigiFab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out DigiFab?

If you need to store DigiFab at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – NDC: 50633-120-11 – 40 MG CARTON LABEL

PRINCIPAL DISPLAY PANEL – NDC: 50633-120-12 – 40 MG VIAL LABEL

SRC: NLM .

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