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CROFAB
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Drug Name:

CROFAB Rx

Generic Name and Formulations:
Crotalidae polyvalent immune Fab (Ovine) 1g/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains thimerosal.

Company:
BTG International

Therapeutic Use:

Indications for CROFAB:

To manage patients with minimal or moderate North American crotalid (eg, rattlesnakes, copperheads, cottonmouths/water moccasins) envenomation. See literature.

Adults and Children:

Administer as soon as possible after snakebite at first signs of envenomation (within 6 hours of bite). Give by IV infusion over 60 minutes. First 10 minutes, proceed slowly at 25–50mL/hr rate; monitor for any allergic reaction. If no reaction occurs, increase to 250mL/hr rate until complete. Initially: 4–6 vials. Observe up to 1 hour after completion of 1st dose; if no response, repeat additional dose of 4–6 vials until initial control achieved. After initially controlled, give additional 2-vial doses every 6 hours up to 18 hours (3 doses). May give additional 2-vial doses if necessary based on patient's clinical course.

Contraindications:

History of papaya or papain allergy.

Warnings/Precautions:

Coagulation defects (eg, cancer, collagen disease, CHF, diarrhea, elevated body temp, hepatic disorders, hyperthyroidism, poor nutritional state, steatorrhea, Vit. K deficiency). Monitor for signs/symptoms of recurrent coagulopathy for ≥1week; reevaluate for retreatment and consider using an anticoagulant or antiplatelet drug. Allergies to papain, chymopapain, papaya extracts, pineapple enzyme (bromelain), dust mites or latex allergens. Risk of anaphylactic reaction (esp. if allergic to sheep protein). Monitor for signs/symptoms of allergic reaction; discontinue if occurs. Have epinephrine, antihistamine and/or albuterol available. Developing fetuses and young children. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Antivenin (monovalent immunoglobulin G [IgG] fragments).

Adverse Reactions:

Urticaria, rash, pruritus, nausea, back pain; coagulation abnormalities, anaphylactic reactions, delayed allergic reactions, serum sickness, others.

How Supplied:

Vials—2

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