Digoxin immune FAB

Name: Digoxin immune FAB

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

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 to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

How is digoxin immune FAB given?

Digoxin immune FAB is injected into a vein through an IV. A healthcare provider will give you this injection.

You may need frequent medical tests to help your doctor determine how long to treat you with digoxin immune FAB.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using digoxin immune FAB.

What happens if I miss a dose?

Since digoxin immune FAB is given in an emergency situation by a healthcare professional, it is not likely that you will miss a dose.

How is this medicine (Digoxin Immune Fab) best taken?

Use digoxin immune fab 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.

Pharmacologic Category

  • Antidote

Pharmacology

Digoxin immune antigen-binding fragments (Fab) are specific antibodies for the treatment of digitalis intoxication in carefully selected patients; binds with molecules of digoxin and is then excreted by the kidneys and removed from the body.

Distribution

Vd: 0.3 L/kg

Excretion

Urine (concentrations declining within 5 to 7 days)

Use Labeled Indications

Digoxin toxicity: Treatment of life-threatening or potentially life-threatening digoxin intoxication, including:

- Acute digoxin ingestion (≥10 mg in adults; 4 mg [>0.1 mg/kg] in children); resulting in serum concentration ≥10 ng/mL)

- Chronic ingestion leading to steady state digoxin concentrations >6 ng/mL in adults or >4 ng/mL in children

- Manifestations of life-threatening digoxin toxicity due to overdose (severe ventricular arrhythmias, progressive bradycardia, second or third degree heart block not responsive to atropine, serum potassium concentration >5.5 mEq/L in adults or >6 mEq/L in children)

Dosing Geriatric

Refer to adult dosing.

Administration

Administer by slow IV infusion over at least 30 minutes. May also be given by bolus injection if cardiac arrest is imminent (infusion-related reaction may occur). Infants and small children who require very small doses can be administered reconstituted digoxin immune fab undiluted using a tuberculin syringe. Stopping the infusion and restarting at a slower rate may help if an infusion-related reaction occurs.

Drug Interactions

There are no known significant interactions.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber severe dizziness, passing out, tachycardia, cough, or signs of low potassium (muscle pain or weakness, muscle cramps, or an abnormal heartbeat) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Usual Adult Dose for Digitalis Glycoside Toxicity

Unknown amount of ingestion: 800 mg IV infusion if acute ingestion, 240 mg IV infusion if chronic ingestion.

Dosing for Ingestion of a Single Large Dose:
Dose (in # of vials) = (Total digitalis body load in mg) / (0.5 mg of digitalis bound per vial).
Total digitalis body load in mg = (number of tablets/capsules ingested) x (mg strength of the tablet/capsule) x (bioavailability of tablet/capsule). Digoxin tablets and elixir are 80% bioavailable, digoxin capsules and injection are 100% bioavailable.

Dosing based on Serum Level:
Digoxin: Dose (in # of vials) = (Serum digoxin level in ng/mL) x (weight in kg) / (100).
Digitoxin: Dose (in # of vials) = (Serum digitoxin level in ng/mL) x (weight in kg) / (1000).

Digoxin immune Fab should be administered intravenously once over at least 30 minutes or, in the case of imminent cardiac arrest, as a bolus injection.

The above dosing scenarios are based on the following: each vial contains 40 mg of immune Fab; each vial will bind approximately 0.5 mg of cardiac glycoside.

Dose Adjustments

No adjustments recommended. However, since digoxin immune Fab is eliminated primarily by the kidneys, patients with moderate to severe renal dysfunction should remain under close clinical and cardiac monitoring for a prolonged period to ensure against the possibility of recrudescent digitalis toxicity.

Dialysis

Digoxin immune Fab is not cleared by hemodialysis.

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