These reactions appear uncommon for example, in a study of 717 adults where only six patients (0.8%) exhibited any evidence of allergic response. It was not powered to detect a change in mortality and no deaths were noted.Īs with all foreign proteins, anaphylaxis, serum sickness or febrile reactions are a source of concern, especially with repeated administration.
Further, a retrospective case‐controlled study of chronic digoxin poisoning did not observe a beneficial effect of anti‐digoxin Fab on mortality.Īn RCT (n = 66) in yellow oleander poisoning showed an early improvement in cardiac rhythm and hyperkalaemia from anti‐digoxin Fab, prompting early termination of the trial.
DIGIFAB DOSE SERIES
In contrast, a higher mortality (7.6%) was noted in a case series of acute and chronic digoxin and digitoxin poisoning despite Fab being used first line. A case series of 147 patients showed that not all cases of acute digoxin overdose require anti‐digoxin Fab, nor should anti‐digoxin Fab dose be calculated based on ingested dose. Recent observational data support an effect in acute poisoning, but efficacy in chronic poisoning be minimally effective in alleviating cardiac toxicities in chronic digoxin poisoning.ĭata also support outcomes of acute digoxin poisoning without use of anti‐digoxin Fab. Regulatory information and clinical studies Ĭase series have reported benefits from anti‐digoxin Fab, but data regarding the response in acute or chronic poisoning are conflicting. The complexes accumulate in the blood and are expelled by the kidney. It works by binding to the digoxin, rendering it unable to bind to its action sites on target cells. Because it is relatively new, no drug interaction studies have been performed yet. The patient must be closely monitored for anaphylactic shock, and anyone allergic to sheep protein, papain, bromelain, or papaya extracts (papain is used to cleave the antibody into Fab and Fc fragments) should not use ovine digoxin immune fab. swelling of the lips, tongue, face, or throatĪvoid use in hypokalemia as this drug, while reversing the effects of digitalis, will further reduce serum potassium levels and could precipitate dangerous and even fatal cardiac arrhythmias.Side effects of digoxin immune fab may occur: digoxin level > 10 ng/ml if acute ingestion.digoxin level > 4 ng/ml if chronic ingestion.It can occur even when the serum digoxin concentration is within the therapeutic range when one of the following is present:
Digoxin toxicity can emerge during long-term therapy as well as after an overdose. Its brand names include Digibind ( GlaxoSmithKline) and DigiFab (BTG plc).
It is made from immunoglobulin fragments from sheep that have already been immunized with a digoxin derivative, digoxindicarboxymethoxylamine (DDMA). For acute ingestion of known amount and chronic toxicity with known serum digitalis level: Refer to detailed product guideline for specific dosage calculation.Digoxin immune fab or digoxin-specific antibody is an antidote for overdose of digoxin. For acute ingestion of unknown amount and absence of serum digitalis concentration or estimated ingestion amount: Same as adult dose in children 20 kg: Same as adult dose. Administration of additional dose may be considered based on clinical judgement if toxicity is not adequately reversed or appears to recur after several hours.Ĭhild: Doses are individualised based on the amount of digoxin to be neutralised. Doses are administered via slow infusion over 30 minutes may also be given via bolus inj if cardiac arrest is imminent. For acute ingestion of known amount and chronic toxicity with known serum digitalis concentration: Refer to detailed product guideline for specific dosage calculation. For chronic toxicity in the absence of serum digitalis concentration: 240 mg (6 vials). 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. Doses are individualised based on the amount of digoxin to be neutralised. Adult: Each vial of 40 mg digoxin immune Fab binds to approx 0.5 mg of digoxin.
0 kommentar(er)
