Products

Indication

North American Crotalid snake envenomation

Description

CroFab^® (crotalidae polyvalent immune fab (ovine)) is approved in the US. In other territories where marketing authorisation has not been granted, CroFab^® is available on a named patient basis. CroFab^® is a venom-specific antibody fragment (Fab) that works by binding and neutralising venom toxins, facilitating their redistribution away from target tissues and their elimination from the body.

Visit the CroFab^® US product website

The information accessible through this link is intended for US Healthcare Professionals only.

Indications and Use

CroFab^®is indicated for the management of patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes that includes rattlesnakes, copperheads, and cottonmouths/water moccasins. Early use of CroFab^® (within 6 hours of snakebite) is advised to prevent clinical deterioration and the occurrence of systemic coagulation abnormalities.

Important Safety Information

The most common adverse events reported in clinical studies were mild or moderate reactions involving the skin and appendages (primarily urticaria, rash, or pruritus), which occurred in 14 out of 42 patients. Three patients experienced a serious adverse event. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment. One patient had a recurrent coagulopathy due to envenomation, which required rehospitalisation and additional antivenin administration. In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenin), characterised by decreased fibrinogen, decreased platelets, and elevated prothrombin time, occurred in approximately half of the patients studied. Recurrent coagulopathy may persist for 1 to 2 weeks or more. One patient discontinued CroFab^® therapy due to an allergic reaction. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab^®.

Reference:

• CroFab^® prescribing information. Brentwood, TN. September 2010

Indication

Life-threatening, or potentially life-threatening, digoxin (digitalis) toxicity or overdose.

Description

DigiFab^® (digoxin immune fab (ovine)) is approved in the US, Canada, UK and Switzerland. In other territories where marketing authorisation has not been granted DigiFab^® is available on a named patient basis. DigiFab^® lowers the amount of digoxin in the blood which is capable of binding to its receptor thereby reducing its cardio-toxic effects.

Visit the DigiFab^® US product website

The information accessible through this link is intended for US Healthcare Professionals only.

Indications and Use

DigiFab^® is indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab^® is indicated for the same conditions as Digibind^®*. Clinical claims, indications, and usage of DigiFab^® are identical to Digibind^®. Neither product is indicated for milder cases of digitalis toxicity.

Important Safety Information

Based on experience with Digibind^®*, the following adverse reactions could occur with the use of DigiFab^®: Exacerbation of low cardiac output states and congestive heart failure due to the withdrawal of the inotropic effect of digitalis; hypokalaemia due to reactivation of the sodium-potassium ATPase; rapid ventricular response in patients with atrial fibrillation due to the withdrawal of the effects of digitalis on the atrioventricular node; and rare allergic reactions. Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may be at risk for an allergic reaction to DigiFab^®. DigiFab^® is an animal protein; monitor for delayed allergic reactions and hypersensitivity. Suicidal ingestion may involve more than 1 drug. Toxic effects of other drugs or poisons should not be overlooked. In the clinical trials of DigiFab^®, 6 of 15 patients in the digoxin overdose study had a total of 17 adverse experiences; most were mild to moderate in nature and all were deemed "remotely associated" with DigiFab^®. Three events were deemed "severe"; all occurred in 1 patient and consisted of the following: pulmonary edema, bilateral pleural effusion, and renal failure. After reviewing the case, it was determined that these events were likely due to the loss of digoxin inotropic support in combination with the patient’s underlying medical condition. Of 8 healthy volunteers who received DigiFab^®, only 2 experienced an adverse reaction that was considered to be associated with DigiFab^®. The reactions were 1 episode of phlebitis of the infusion vein and 1 episode of moderate postural hypotension, which became mild prior to resolving.
*Digibind^® is a registered trademark of GlaxoSmithKline. Neither GlaxoSmithKline nor Digibind^® are related or affiliated with BTG International Inc.

Reference:

DigiFab^® prescribing information. Brentwood, TN:. September 2010

Indications and Use
Voraxaze^® (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. It works by breaking down methotrexate into its inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver).

Safety Information
The most common adverse reactions (incidence ≥1%) were paresthesias, flushing, nausea and/or vomiting, hypotension and headache.

Healthcare providers should note that:

Methotrexate concentrations within 48 hours following glucarpidase administration can only be reliably measured by a chromatographic method due to interference from metabolites [4-deoxy-4-amino-N¹⁰-methylpteroic acid (DAMPA)].  Measurement of methotrexate concentrations within 48 hours of glucarpidase administration using immunoassays can overestimate the methotrexate concentration.

Leucovorin should not be administered within 2 hours before or after a glucarpidase dose because leucovorin is a substrate for glucarpidase.

Reference:

Voraxaze^® (glucarpidase) prescribing information January 2012