Trial Finds Patients Receiving CroFab Antivenom Less Likely to Use Opioids for Pain Control - Seite 2

Real world safety data has also been published in two studies, “Acute Adverse Events Associated with the Administration of Crotalidae Polyvalent Immune Fab Antivenom within the North American Snakebite Registry,” and “Incidence of Allergic Reactions to Crotalidae Polyvalent Immune Fab,” in Clinical Toxicology in 2018. These studies demonstrated a low rate of adverse reactions (between 1.4 – 2.7%) in patients treated with CroFab.

Between 5,000 and 9,000 people in the U.S. seek treatment in an emergency department due to a snakebite each year. There were 2,048 calls to U.S. poison centers in 2016 for copperhead bites. There were close to another 2,000 calls in which the type of snake was not identified.

About CroFab

CroFab is the only FDA-approved treatment for all North American pit viper envenomations in adult and pediatric patients. Since 2001, CroFab has been used to treat more than 50,000 patients. It is developed through a unique manufacturing process for exceptional quality and purity. It is derived from Australian sheep, is free of prions and viruses, and produced exclusively from U.S. snakes. CroFab has been proven to halt local effects including edema, ecchymosis, and treat the source of pain. It has been found to resolve systemic effects such as nausea, vomiting, dizziness and tachycardia. CroFab has also been found to reduce coagulation abnormalities, such as thrombocytopenia, hyperfibrinogenemia and spontaneous bleeding.

INDICATION

CroFab is indicated for the management of adults and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, copperheads, and cottonmouths/water moccasins.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer CroFab to patients with a known history of hypersensitivity to any of its components, or to papaya or papain unless the benefits outweigh the risks and appropriate management for anaphylactic reactions is readily available.

WARNINGS AND PRECAUTIONS

Coagulopathy: In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after 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; one patient required re-hospitalization and additional antivenin administration. Recurrent coagulopathy may persist for 1 to 2 weeks or more. Patients who experience coagulopathy due to snakebite should be monitored for recurrent coagulopathy for up to 1 week or longer. During this period, the physician should carefully assess the need for re-treatment with CroFab and use of any type of anticoagulant or anti-platelet drug.