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Prescribing Information
Important Safety Information
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Dosing

Appropriate Dosing of CroFab Achieves Initial and Sustained Control of Envenomation 


Snakebite treatment should be administered as soon as possible in patients with any sign of envenomation (e.g., local, systemic, or hematologic effects) to prevent clinical deterioration. 

Dosing Graphic

Administer an initial dose of 4-6 vials* and monitor for signs of progression.

  • Administer an additional 4-6 vials if initial control is not achieved ~1 hour after initial dose
  • Once initial control is achieved, administer an additional 2 vials every 6 hours for up to 18 hours (total of 3 doses)
  • Scheduled maintenance dosing reduced the incidence of coagulation abnormalities due to residual venom 


*Initial dose may vary from 4-12 vials based on clinical judgment and severity of envenomation. Dosing is the same in adult and pediatric patients. 

In pre- and postmarketing studies, 67-88% of patients achieved initial control with an initial dose of 4-6 vials when given according to recommended dosing. 

Initial Control Requires Addressing All 3 Components of Envenomation 

Arrest circle

Arrest

Local 
Effects



Progression of edema, ecchymosis, and leading edge of local injury has been arrested

Arrest circle

Resolve

Systemic 
Effects
 
  • Patient is normotensive and stable
  • Neurotoxicity is resolving or improving
  • Nausea, vomiting, dizziness, or tachycardia is resolving
Arrest circle

Reduce

Hematologic 
Effects
 


Coagulation abnormalities (e.g., thrombocytopenia, spontaneous bleeding) have normalized or are trending towards normal

Watch Dr. William Banner discuss his approach to dosing antivenom for children.

CroFab Clinical Studies


Review publications about achieving initial control of envenomation with CroFab

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CroFab is reconstituted in 3 simple steps 

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Real-world use supports improved outcomes with CroFab 

Hear Real Patient Experiences
CroFab efficacy checkmark icon

CroFab is clinically proven to achieve initial control of envenomation 

Examine the Data
References

  1. CroFab®. Prescribing information. BTG International Inc.; August 2018.

  2. Dart RC, Seifert SA, Boyer LV, et al. A randomized multicenter trial of crotalinae polyvalent immune Fab (ovine) antivenom for the treatment for crotaline snakebite in the United States. Arch Intern Med. 2001;161(16):2030-2036.

  3. Lavonas EJ, Gerardo CJ, O'Malley G, et al. Initial experience with Crotalidae polyvalent immune Fab (ovine) antivenom in the treatment of copperhead snakebite. Ann Emerg Med. 2004;43(2):200-206.

  4. Lavonas EJ, Ruha A-M, Banner W, et al. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med. 2011;11:2.

Indication and Important Safety Information
Indication

CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is a sheep-derived antivenin 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.

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.

Hypersensitivity Reactions: Severe hypersensitivity reactions may occur with CroFab®. In case of acute hypersensitivity reactions, including anaphylaxis and anaphylactoid reactions, discontinue infusion and institute appropriate emergency treatment. Patients allergic to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also have an allergic reaction to CroFab®. Follow-up all patients for signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia).

Adverse Reactions

The most common adverse reactions (incidence ≥ 5% of subjects) reported in the clinical studies were urticaria, rash, nausea, pruritus and back pain. Adverse reactions involving the skin and appendages (primarily rash, urticaria, and pruritus) were reported in 12 of the 42 patients. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment and one patient discontinued CroFab® due to an allergic reaction. Recurrent coagulopathy due to envenomation and requiring additional treatment may occur.

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