Product
DigiFab™
Digoxin Immune Fabs (Ovine)

Indication
Life-threatening, or potentially life-threatening, digoxin toxicity

Description
DigiFab™ lowers the amount of digoxin in the blood which is capable of binding to its receptor thereby reducing its cardio-toxic effects.

Further Information
DigiFab™ is an antidote approved in the US to treat patients with life-threatening, or potentially life-threatening, digoxin toxicity or overdose. Digoxin (also known as digitalis) is a drug used to treat congestive heart failure and to slow heart rate in some cardiac disturbances, with 16 million digoxin prescriptions written annually in the US. It has a narrow therapeutic window, meaning it is easy to move from therapeutic levels to toxic levels as a result of overdose, slow elimination or interaction with other drugs. Digoxin toxicity, which occurred in 26% to 29% of patients in 2006,* can cause potentially life-threatening heart rhythm disturbances.

BTG have acquired the intellectual property for the use of polyclonal ovine antibody fragments, such as DigiFab™ and GSK’s Digibind®, being investigated for the treatment of severe pre-eclampsia and eclampsia, a life-threatening complication of pregnancy occurring in 10% of pregnancies worldwide per year. By conservative estimates, pre-eclampsia and other hypertensive disorders of pregnancy are responsible for 76,000 deaths each year in the US.** Pre-eclampsia is characterised by high blood pressure and can lead to renal failure and seizures. It typically results in the early delivery of the baby, with potential developmental abnormalities and the possible death of the mother and/or baby. Currently there are no approved therapies available to treat pre-eclampsia and few products in development.

*American Association of Poison Control Centers data
**BTG estimate

Important Safety Information
Adverse reactions that could occur with the use of DigiFab™ include exacerbation of low cardiac output states and congestive heart failure due to the withdrawal of inotropic effect of digitalis, hypokalemia due to reactivation of the sodium-potassium ATPase, rapid ventricular response in patients with atrial fibrillation due to withdrawal of the effects of digitalis on the atrioventricular node and rare allergic reactions.

Full Prescribing Information for Medical Professionals
Clinical Product Monograph
Product Supplies

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