How CroFab® Is Produced
CroFab® Crotalidae Polyvalent Immune Fab (Ovine) has a unique, complex production process. Immunogens consisting of 1 of 4 North American pit viper venoms are produced in a laboratory and used to immunize sheep. These immunogens are recognized by the ovine immune system as foreign antigens, to which antibodies are produced. These antibodies are then collected, separated, purified, and formulated into the drug CroFab® Crotalidae Polyvalent Immune Fab (Ovine).1
Our Commitment to Ethical Practices
BTG is committed to strict adherence to ethical research and development practices. We believe the rights, safety, and well-being of the trial subjects prevail over the interests of science and society. Thus, we respect the safety of clinical research participants and our clinical trials are performed in accordance with the listed directives, regardless of where they are performed. We ensure that all medical care and medical decisions made on the behalf of research participants are the responsibility of a qualified physician. We ensure that all patient data is recorded confidentially and handled and stored in a way that allows accurate reporting, interpretation, and verification according to best practice, including reporting of adverse clinical events.
Our policy is that the use of animals in research will be performed to the highest standard of ethics, adhering to the three guiding principles of reduction, refinement and replacement. All animal studies are performed at external Clinical Research Organizations (CROs) and academic units, and we will only work with external parties that evaluate animal studies using a local ethical review process. In addition, we will only perform animal studies in territories where they are strictly regulated. Alternatives to animal use will always be assessed and in vitro testing performed as an alternative wherever possible.
To report an adverse event or for 24-hour medical information, call 1-877-377-3784.References
- Data on file, BTG International Inc.
CroFab® Crotalidae Polyvalent Immune Fab (Ovine) 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® Crotalidae Polyvalent Immune Fab (Ovine) (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 rehospitalization and additional antivenin administration. In clinical trials, recurrent coagulopathy (the return of a coagulation abnormalityafter it has been successfully treated with antivenin), characterized 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® Crotalidae Polyvalent Immune Fab (Ovine) 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® Crotalidae Polyvalent Immune Fab (Ovine).