This site is intended for US Healthcare Professionals Only

Prescribing Information
Important Safety Information
Acquia CMS logo

Reconstitution and Administration

Reconstitute in 3 Simple Steps Before CroFab Administration 

Watch this video to learn more about how to reconstitute and administer CroFab.

CroFab reconstitution 

1

Select and fill syringe with 18 mL of 0.9% sterile saline

2

Inject sterile saline solution slowly into CroFab vial

3

Rotate vial 180 degrees and manually invert up to twice per second until no solid material remains in the vial. The entire dose should then be further diluted in 0.9% sterile saline to a total volume of 250 mL.

  • Each batch of CroFab is tested for reconstitution time and must reconstitute in <7 minutes 
    • Based on data from 72 batches of CroFab, the median time to reconstitute CroFab is 3 minutes


Administer CroFab to Achieve Control 

  • After reconstitution, infuse the dose intravenously over 60 minutes 
    • The infusion should proceed slowly over the first 10 minutes with careful observation for any allergic reaction
  • If no such reaction occurs, the infusion rate may be increased to the full rate until completion 
CroFab dosing vial icon

Appropriate dosing achieves initial and sustained control of envenomation 

Learn How to Dose CroFab
CroFab efficacy checkmark icon

CroFab is clinically proven to achieve initial control of envenomation 

Examine the Data
CroFab patient experience icon

Real-world use supports improved outcomes with CroFab 

Hear Real Patient Experiences
References

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

  2. Data on file. BTG International Inc.

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.

Please see full Prescribing Information.