Digoxin immune Fab: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Intravenous
Life-threatening digoxin intoxication

Adult: Each vial containing 38 mg of purified lyophilised digoxin-specific Fab fragments. For acute ingestion of unknown amount: Usually, 20 vials is adequate to treat most life-threatening ingestions, may give as a single dose or give 10 vials, observe response, then give a second 10-vial dose if needed. For acute ingestion of known amount: Based on number of tablets/capsules ingested, the number of vials needed can be calculated by taking the total amount of digoxin ingested (mg) divided by 0.5. Dose to be given via IV inj over 30 min; bolus inj may be used if cardiac arrest is imminent. For more detailed information: Refer to full prescribing information.
Child: Each vial containing 38 mg of purified lyophilised digoxin-specific Fab fragments. For acute ingestion of unknown amount: Usually, 20 vials is adequate to treat most life-threatening ingestions, may give as a single dose or give 10 vials, observe response, then give a second 10-vial dose if needed. For acute ingestion of known amount: Based on number of tablets/capsules ingested, the number of vials needed can be calculated by taking the total amount of digoxin ingested (mg) divided by 0.5. Dose to be given via IV inj over 30 min; bolus inj may be used if cardiac arrest is imminent. For more detailed information: Refer to full prescribing information.

Reconstitution

Contents of each vial should be dissolved in 4 ml of sterile water for inj. Reconstituted product should be used immediately; otherwise, it may be kept for up to 4 hr at 2-8°C. Reconstituted product may be further diluted with sterile isotonic saline to a convenient volume. Visually inspect solution for discolouration or particulate matter prior to admin.

Contraindications

Hypersensitivity to sheep products.

Special Precautions

Monitor serum potassium levels regularly especially during the 1st few hr of treatment. BP and ECG should also be monitored regularly. Caution when used in renal impairment as excretion of the complex may be reduced. Pregnancy and lactation. Infusion should be stopped and restarted at a slower rate if infusion-related reactions occur.

Adverse Reactions

May exacerbate heart failure, postural hypotension, hypokalaemia, phlebitis at site of inj. Allergic reactions and serum sickness.

Pregnancy Category (US FDA)

IV/Parenteral: C

Lab Interference

May interfere with digitalis immunoassay measurements.

Action

Description: Digoxin immune fab are specific antibodies used in the treatment of digitalis intoxication. It binds with molecules of digoxin or digitoxin. The digoxin-antibody complex is then excreted renally in the urine and removed from the body. It is generally reserved for use in life-threatening digoxin or digitoxin intoxication cases whereby conventional treatment is ineffective.
Pharmacokinetics:
Excretion: Half-life elimination: 15-20 hr; may be prolonged with renal impairment. Excreted in the urine.

Storage

Store at 2-8°C.

MIMS Class

Antidotes & Detoxifying Agents

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