For US Healthcare Professionals Important Safety Information Full Prescribing Information

Efficacy

CroFab^® Is Proven to Control Envenomation in Pediatric and Adult Patients

Gaining Initial Control With CroFab^®

In 2 open-label trials with 42 patients with mild or moderate envenomation^1,2*:

98% of patients administered CroFab^® gained initial control
95% of patients showed a clinical response^† 1 hour after initial control

*This study excluded envenomation by copperhead snakes. In study 1, patients were given up to 2 doses of 4 vials each to gain initial control. In study 2, patients were given up to 6 vials each to gain initial control. Initial control is achieved when local signs of envenomation are arrested (leading edge of local injury is not progressing), systemic symptoms are resolved, and coagulation parameters have normalized or are trending toward normal.

^†Clinical response = pretreatment signs and symptoms of envenomation were arrested or improved.

Demonstrated efficacy in gaining initial control

In a placebo-controlled trial of 74 patients with copperhead envenomation published in 2017^‡, CroFab^® administration resulted in improved limb function vs placebo on Day 14 post envenomation.³

^‡Trial data was drawn specifically from patients suffering from mild or moderate copperhead snake envenomation.

Watch Dr. Rutherfoord Rose discuss using CroFab® to treat copperhead envenomation.

Continuing Control With CroFab^®

Scheduled maintenance dosing after initial control lowered incidence of coagulation abnormalities due to residual venom.¹

Fewer coagulation abnormalities with scheduled maintenance dosing¹

Chart demonstrating fewer abnormalities with scheduled maintenance dosing

No local progression with scheduled maintenance dosing⁴

Chart demonstrating no logical progression with scheduled maintenance dosing

^§P=0.04.
^||Not statistically significant vs placebo.
^¶Follow-up data not available for 1 patient.
^♯P=0.002.

Review the safety profile you can count on.

CroFab® Safety >

References:

1. CroFab^® [prescribing Information]. BTG International Inc; January 2018. 2. Data on file. Conshohocken, PA; BTG International Inc. 2019. 3. Gerardo CJ, Quackenbush E, Lewis B, et al. The efficacy of crotalidae polyvalent immune fab (ovine) antivenom versus placebo plus optional rescue therapy on recovery from copperhead snake envenomation: A randomized, double-blind, placebo-controlled clinical trial. Ann Emerg Med. 2017;70(2):233-244. 4. 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.

Algorithm

Review the expert consensus for managing pit viper snakebites.

Dosing + Administration

Learn how to dose CroFab® to gain and continue control of pit viper envenomation.

Patient Experiences

Watch testimonials and review case studies to learn from patient experiences.

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.

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.

BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.
CroFab ^® is a registered trademark of BTG International Inc.
TIME IS TISSUE^® is a trademark of Protherics Medicines Development Ltd., a BTG International group company. BTG Specialty Solutions Center^™ is a trademark of BTG International Ltd. SnakeBite911 and the snakehead logo are trademarks of Protherics UK Ltd. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. ‭Google Play and the Google Play logo are trademarks of Google Inc.

© 2020 BTG International Inc. All rights reserved.
US-CRF-1900219 October 2019

To report suspected adverse reactions, contact BTG at
1-877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

BTG Specialty Solutions Center^TM

	1-844-293-0007 (Voice)
	1-877-626-9910 (Fax)

24-hour Medical Information:

1-877-377-3784

Efficacy

CroFab® Is Proven to Control Envenomation in Pediatric and Adult Patients

Gaining Initial Control With CroFab®

Continuing Control With CroFab®

Fewer coagulation abnormalities with scheduled maintenance dosing1

No local progression with scheduled maintenance dosing4