Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine)

CROFAB is indicated for the management of adult 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. CROFAB is a sheep-derived antivenin indicated for the management of adult and pediatric patients with North American crotalid envenomation.

CROFAB is a venom-specific Fab fragment of immunoglobulin G (IgG) that works by binding and neutralizing venom toxins, facilitating their redistribution away from target tissues and their elimination from the body.

For intravenous use only For intravenous use only Initiate administration as soon as possible after snake bite in patients who develop signs of envenomation (e.g. local injury, coagulation abnormality or systemic signs of envenomation) Dose: Recommended initial dose is between 4 and 6 vials Observe patient for up to one hour after the initial dose and give an additional 4-6 vial dose as needed to gain initial control of envenomation After initial control is established, administer additional 2-vial doses every 6 hours for 18 hours (total of 3 doses) Preparation and Administration: Reconstitute each vial of CROFAB with 18 mL of 0.9% Sodium Chloride and mix by continuous manual inversion at the rate of one to two inversions per second until no solid material is visible in the vial (contents will remain opalescent) Do not shake as this can cause foaming Further dilute the entire dose with…

Do not administer CROFAB 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. 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.

Monitor patients for recurrent coagulopathy for one week or longer following treatment of the bite. Hypersensitivity reactions, including anaphylaxis, may occur. Patients allergic to papain, chymopapain, papaya extracts, or bromelain (pineapple enzyme), may react to CROFAB

Most common adverse reactions (incidence ≥5% of subjects) were urticaria, rash, nausea, pruritus and back pain. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Most common adverse reactions (incidence ≥5% of subjects): urticaria, rash, nausea and pruritus. Allergic reaction (severe hives and a severe rash and pruritus) has occurred following treatment. Recurrent coagulopathy due to envenomation and requiring additional treatment may occur.

Store vials at 2° to 8°C (36° to 46°F). A temperature excursion for no longer than 7 days within the range of -20° to 25°C (-4° to 77°F) is permitted. Do not freeze.