CroFab - The Official Release Info

Approximately 7,000 to 8,000 of all snakebites involve venomous species of snakes, resulting in 12 to 15 fatalities each year. Poisonous snakebites in the United States predominantly involve the crotalid snakes. The most common side effect of envenomation is local tissue destruction, but severe coagulation abnormalities, other systemic side effects (hypertension, pulmonary edema, cardiovascular collapse and renal failure), and appendage loss can occur.

CroFabä is indicated for the management of patients with minimal or moderate North American crotalid envenomation. The administration of CroFabä antivenin should be initiated as soon as possible (within six hours) after poisonous snakebites in patients who develop signs of progressive envenomation, i.e. worsening of local injury, coagulation abnormality, or systemic signs of envenomation. The product is intended for intravenous administration after reconstitution with 10 mL of Sterile Water for Injection USP (diluent not included). The recommended number of vials will vary for each patient. In clinical trials the best results were achieved with an initial dose of six vials with the option to retreat with additional vials in 6-vial increments, followed by two vial doses every six hours for up to 18 hours.

CroFabä is a preparation of ovine monovalent immunoglobulin (Fab) fragments obtained from the blood of healthy sheep flocks immunized with one of the following North American snake venoms: Crotalus atrox (Western Diamondback rattlesnake), Crotalus adamanteus (Eastern Diamondback rattlesnake), Crotalus scutulatus (Mojave rattlesnake) and Agkistrodon piscivorus (Cottonmouth or Water Moccasin). Each batch of monospecific antivenin is prepared by fractionating the immunoglobulin from the ovine serum, digesting the antibodies with papain, and isolating the venom-specific Fab fragments on ion exchange and affinity chromatography columns. This proprietary process purifies the antivenin and discards unneeded portions of the antibodies. CroFabä is the first antivenin to be purified by such a process. To obtain the final antivenin, the four different monospecific antivenins are mixed. CroFabä is shipped in vials as a sterile, non-pyrogenic, purified, lyophilized preparation intended for intravenous administration. Each vial contains up to 1.0 g of total protein and not less than the indicated number of mouse LD₅₀ neutralizing units.

The majority of adverse reactions to CroFabä reported in clinical studies were mild or moderate in severity -- primarily rash, urticaria and pruritus. CroFabä should not be administered to patients with a known history of hypersensitivity to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available. It is not known whether CroFabä is excreted in human breast milk so caution should be exercised when CroFabä is administered to a nursing woman. Adverse events involving the skin and appendages were reported in 14 of the 42 patients. Three of the 25 patients who experienced adverse reactions experienced severe or serious adverse reactions. All adverse reactions resolved during the course of treatment. Full prescribing information is enclosed with the product and is available at www.savagelabs.com.

CroFabä was developed by Protherics Inc. (formerly Therapeutic Antibodies, Inc.) and was approved by the Food and Drug Administration on October 2, 2000. CroFabä was given Orphan Drug Designation by the Food and Drug Administration on January 12, 1994. The product will be manufactured at Protherics’ facility in Blaenwaun, Wales and marketed in the United States by Savage Laboratories. Protherics’ ordinary shares are listed on the Official List of the UK Listing Authority and are traded on the London Stock Exchange under the symbol PTI.L.

Located in New York, Savage Laboratories is the ethical pharmaceutical division of Altana Inc., the U.S. subsidiary of Byk-Gulden, a multi-national pharmaceutical company based in Konstanz, Germany. Savage Laboratories develops and markets products for use in dermatology, obstetrics/gynecology, emergency medicine, critical care, and pulmonary medicine. In addition to marketing products in the Savage Laboratories® and Byk-Gulden R&D pipelines, Savage Laboratories acquires and/or co-promotes products targeted to critical care, pulmonary, and emergency room physicians.

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