IntravenousLife-threatening digoxin intoxicationAdult: Each vial of 40 mg digoxin immune Fab binds to approx 0.5 mg of digoxin. Doses are individualised based on the amount of digoxin to be neutralised. For acute ingestion of unknown amount and absence of serum digitalis concentration or estimated ingestion amount: 800 mg (20 vials) as a single dose; alternatively, give initial doses of 400 mg (10 vials) followed by an additional 400 mg (10 vials), if necessary. For chronic toxicity in the absence of serum digitalis concentration: 240 mg (6 vials). For acute ingestion of known amount and chronic toxicity with known serum digitalis concentration: Refer to detailed product guideline for specific dosage calculation. Doses are administered via slow infusion over 30 minutes; may also be given via bolus inj if cardiac arrest is imminent. Administration of additional dose may be considered based on clinical judgement if toxicity is not adequately reversed or appears to recur after several hours.
Child: Doses are individualised based on the amount of digoxin to be neutralised. For acute ingestion of unknown amount and absence of serum digitalis concentration or estimated ingestion amount: Same as adult dose; in children <20 kg, monitor for volume overload. For chronic toxicity in the absence of serum digitalis concentration: ≤20 kg: 40 mg (1 vial) given via slow infusion over 30 minutes; >20 kg: Same as adult dose. For acute ingestion of known amount and chronic toxicity with known serum digitalis level: Refer to detailed product guideline for specific dosage calculation.
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Reconstitute each vial labelled as 40 mg with 4 mL of sterile water for inj and gently mix to provide a final concentration of approx 10 mg/mL. Reconstituted solution may be diluted further to an appropriate volume of 0.9% NaCl solution for infusion.
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Hypersensitivity to digoxin immune Fab.
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Patient with known allergy to sheep-derived proteins (e.g. in cheese or meats), papain or other papaya extracts, bromelain (pineapple enzyme), dust mite, and latex; previous exposure to ovine antibodies or ovine Fab; poor cardiac function. Renal impairment. Children. Pregnancy and lactation.
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Significant: Infusion-related reactions or hypersensitivity reactions (e.g. anaphylactic or anaphylactoid reactions, delayed allergic reactions), hypokalaemia, worsening of cardiac failure.
Cardiac disorders: Chest pain, worsening atrial fibrillation.
Gastrointestinal disorders: Diarrhoea, constipation, nausea, vomiting, abdominal distension.
General disorders and administration site conditions: Influenza-like illness, fatigue, infusion site phlebitis.
Metabolism and nutrition disorders: Hyperkalaemia.
Nervous system disorders: Headache.
Psychiatric disorders: Confusional state.
Renal and urinary disorders: Renal failure.
Vascular disorders: Hypotension, orthostatic hypotension.
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Assess allergy history, serum K, serum digoxin concentration, and serum creatinine prior to 1st dose. Closely monitor ECG, serum K concentration, blood pressure, and temperature during and after administration; volume overload (in children <20 kg). Avoid checking of total serum digoxin concentrations until Fab fragments have been completely eliminated. Monitor for signs and symptoms of acute allergic reactions and recurrence of cardiac toxicity.
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May interfere with immunoassay measurements of digitalis, thereby causing a clinically misleading total serum digoxin levels until all Fab fragments are eliminated from the body.
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Description: Digoxin immune antigen-binding fragments (Fab), obtained from the blood of a sheep (ovine) immunised with a digoxin derivative, are specific antibodies that have high affinity for digoxin. They bind with molecules of digoxin to form an inactive complex, thus decreasing the concentration of free digoxin and reducing toxicity.
Synonym: digoxin-specific Fab antibody fragments, digoxin-specific antigen-binding fragments, antidigoxin Fab fragments.
Onset: 20-90 minutes.
Pharmacokinetics:
Distribution: Volume of distribution: 0.3 L/kg.
Excretion: Via urine. Elimination half-life: Approx 15-23 hours; may increase up to 10-fold (in patients with renal impairment).
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Store between 2-8°C. Do not freeze. Protect from light. Reconstituted solutions may be stored between 2-8°C for up to 4 hours.
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V03AB24 - digitalis antitoxin ; Belongs to the class of antidotes. Used in the management of digitalis overdose.
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Anon. Digoxin Immune Fab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 20/11/2020. Anon. Digoxin Immune Fab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/10/2020. Buckingham R (ed). Digoxin-Specific Antibody Fragments. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/10/2020. DigiFab 40 mg/vial Powder for Solution for Infusion (Protherics UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 08/10/2020. Digifab Injection, Powder, For Solution (BTG International, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/10/2020. Digoxin Immune Fab. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com/. Accessed 20/11/2020.
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