"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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CroFab (crotalidae polyvalent immune fab ovine) is indicated for the management of patients with minimal or moderate North American crotalid envenomation (see Table 3 in Clinical Studies section for definitions). 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.
DOSAGE AND ADMINISTRATION
Each vial of CroFab (crotalidae polyvalent immune fab ovine) should be reconstituted with 10 mL of Sterile Water for Injection USP (diluent not included) and mixed by continuous gentle swirling. The contents of the reconstituted vials should be further diluted in 250 mL of 0.9% Sodium Chloride USP and mixed by gently swirling. The reconstituted and diluted product should be used within 4 hours.
Administration of antivenin should be initiated as soon as possible after crotalid snakebite in patients who develop signs of progressive envenomation (e.g., worsening local injury, coagulation abnormality, or systemic signs of envenomation). CroFab (crotalidae polyvalent immune fab ovine) was shown in the clinical studies to be effective when given within 6 hours of snakebite.
Antivenin dosage requirements are contingent upon an individual patient's response; however, based on clinical experience with CroFab (crotalidae polyvalent immune fab ovine) , the recommended initial dose is 4 to 6 vials. The patient should be observed for up to 1 hour following the completion of this first dose to determine if initial control of the envenomation has been achieved (as defined by complete arrest of local manifestations, and return of coagulation tests and systemic signs to normal). If initial control is not achieved by the first dose, an additional dose of 4 to 6 vials should be repeated until initial control of the envenomation syndrome has been achieved. After initial control has been established, additional 2-vial doses of CroFab (crotalidae polyvalent immune fab ovine) every 6 hours for up to 18 hours (3 doses) is recommended. Optimal dosing following the 18-hour scheduled dose of CroFab (crotalidae polyvalent immune fab ovine) has not been determined. Additional 2-vial doses may be administered as deemed necessary by the treating physician, based on the patient's clinical course.
The initial dose of CroFab (crotalidae polyvalent immune fab ovine) diluted in 250 mL of saline should be infused intravenously over 60 minutes. However, the infusion should proceed slowly over the first 10 minutes at a 25- 50 mL/hour rate with careful observation for any allergic reaction. If no such reaction occurs, the infusion rate may be increased to the full 250 mL/hour rate until completion. Close patient monitoring is necessary.
Additional Patient Care (Supportive and Adjunctive Therapy)
Supportive measures are often utilized to treat certain manifestations of crotalid snake envenomation, such as pain, swelling, hypotension, and wound infection. Poison control centers are a helpful resource for individual treatment advice.
CroFab (crotalidae polyvalent immune fab ovine) is supplied as a sterile, nonpyrogenic, purified, lyophilized preparation. Each vial contains up to 1 g of total protein, a maximum of 0.11 mg of mercury, and not less than the indicated number of mouse LD50 neutralizing units:
|C. atrox (Western Diamondback rattlesnake)||1350|
|C. adamanteus (Eastern Diamondback rattlesnake)||800|
|C. scutulatus (Mojave rattlesnake)||5210|
|A. piscivorus (Cottonmouth or Water Moccasin)||460|
Each box contains 2 vials of CroFab (crotalidae polyvalent immune fab ovine) (diluent not included).
The product should be stored at 2° to 8°C (36° to 46° F). Do not freeze. The product must be used within 4 hours after reconstitution.
Manufactured by: Protherics Inc. Brentwood, TN 37027. Distributed by: SAVAGE LABORATORIES®, a division of Altana Inc. Melville, NY 11747. Revised January 2006. FDA Rev date: 12/1/2006
Last reviewed on RxList: 9/11/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Crofab Information
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