Digoxin immune Fab


Concise Prescribing Info
Indications/Uses
Life-threatening digoxin intoxication.
Dosage/Direction for Use
Adult : IV Each vial containing 38 mg of purified lyophilised digoxin-specific Fab fragments. For acute ingestion of unknown amount: Usually, 20 vials 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 tab/cap ingested, the number of vials needed can be calculated by taking the total amount of digoxin ingested (mg) divided by 0.5.
Dosage Details
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.
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.
Disclaimer: This information is independently developed by MIMS based on Digoxin immune Fab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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