For US Healthcare Professionals Important Safety Information Full Prescribing Information

CroFab^®: The only FDA-approved product derived exclusively from US snakes and approved to treat all North American pit viper envenomations in adult and pediatric patients.^1,2

•Proven to control local, systemic, and hematologic effects of envenomation^1,3*

•Established performance backed by over 15 years of clinical experience²

•Over 50,000 patients treated to date²

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INITIAL CONTROL FOR SNAKE ENVENOMATION INVOLVES
HALTING LOCAL, SYSTEMIC, AND HEMATOLOGIC EFFECTS¹

Select an image to explore the effects.

Local effects

SYMPTOMS⁴

Swelling, tenderness, and pain
Redness
Ecchymosis
Bullae or blebs
Soft-tissue necrosis

CONSEQUENCES^4-7

Partial or complete loss of affected limbs
Loss of joint functionality
Loss or impairment of tactile sensation
Infection
Cosmetic issues

Systemic effects

SYMPTOMS⁴

Hypotension
Bleeding beyond the puncture site
Refractory vomiting
Diarrhea
Angioedema
Neurotoxicity

CONSEQUENCES^4,8

Death is a possibility
Irreversible damage
Respiratory compromise/failure
Neurologic deficits
Cardiovascular/pulmonary collapse due to shock
End organ damage

Hematologic effects

SYMPTOMS⁴

Decreased fibrinogen
Elevated prothrombin time or international normalized ratio
Thrombocytopenia

CONSEQUENCES^4,8

Coagulation abnormalities
Increased risk of bleeding complications (0.5%)
Significant ecchymosis
Anemia

Crofab^® Patient Testimonials

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Caitlyn

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Daniel

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Jessica

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Julia and Laura

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Julie and Haley

PREPARE TO STRIKE BACK AGAINST PIT VIPER ENVENOMATION

Gain triple control with CroFab®^*

CroFab® is proven to halt local effects, resolve systemic effects, and reduce coagulation abnormalities.^1,3

LEARN MORE >

How to treat a snakebite

Use the interactive guide with step-by-step instructions on how to treat a snakebite.

TREAT NOW > LEARN MORE >

Dosing and administration

Dose CroFab® appropriately to gain and continue control of envenomation.^1,4

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How to Order CroFab®

Expert consensus guidelines for stocking of antidotes in
hospitals that provide emergency care⁹

• All hospitals that provide emergency care should stock 12 to 18 vials of CroFab®—enough antidote to treat
one patient for 8 to 24 hours

Learn how to order CroFab® >

*Efficacy determined using the snakebite severity score (SSS), a validated objective tool for the clinical evaluation of North American pit viper snakebite in adults. The total score reflects patient evaluation on 6 dimensions: cardiovascular system, local wound, gastrointestinal system, hematologic symptoms, pulmonary system, and central nervous system. The higher the total score, the more severe the snakebite.¹

References:

1. CroFab® [prescribing Information]. BTG International Inc; January 2018. 2. Data on file. Conshohocken, PA; BTG International Inc. 2019. 3. 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. 4. Lavonas EJ, Ruha AM, 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. 5. Nelson L, Lewin N, Howland M, et al. Goldfrank’s Toxicologic Emergencies. 9^th ed. McGraw Hill Medical; 2010:1601-1609. 6. Ruha AM, Kleinschmidt KC, Greene S, et al. The epidemiology, clinical course, and management of snakebites in the North American Snakebite Registry. J Med Toxicol. 2017;13(4):309-320. 7. Mackessy SP, ed. Handbook of Venoms and Toxins of Reptiles. Boca Raton, FL: CRC Press; 2010. 8. Gold BS, Dard RC, Barish RA. Bites of venomous snakes. N Engl J Med. 2002;347(5):347-356. 9. Dart RC, Goldfrank LR, Erstad BL, et al. Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care. Ann Emerg Med. 2018;71(3):314-325.

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.

© 2021 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

CroFab®: The only FDA-approved product derived exclusively from US snakes and approved to treat all North American pit viper envenomations in adult and pediatric patients.1,2

INITIAL CONTROL FOR SNAKE ENVENOMATION INVOLVES HALTING LOCAL, SYSTEMIC, AND HEMATOLOGIC EFFECTS1

Local effects

SYMPTOMS4

CONSEQUENCES4-7

Systemic effects

SYMPTOMS4

CONSEQUENCES4,8

Hematologic effects

SYMPTOMS4

CONSEQUENCES4,8

Crofab® Patient Testimonials

Caitlyn

Daniel

Jessica

Julia and Laura

Julie and Haley

PREPARE TO STRIKE BACK AGAINST PIT VIPER ENVENOMATION

Gain triple control with CroFab®*

How to treat a snakebite

Dosing and administration

How to Order CroFab®

Expert consensus guidelines for stocking of antidotes in hospitals that provide emergency care9

References:

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATION

BTG Specialty Solutions CenterTM

24-hour Medical Information:

CroFab^®: The only FDA-approved product derived exclusively from US snakes and approved to treat all North American pit viper envenomations in adult and pediatric patients.^1,2

INITIAL CONTROL FOR SNAKE ENVENOMATION INVOLVES
HALTING LOCAL, SYSTEMIC, AND HEMATOLOGIC EFFECTS¹

SYMPTOMS⁴

CONSEQUENCES^4-7

SYMPTOMS⁴

CONSEQUENCES^4,8

SYMPTOMS⁴

CONSEQUENCES^4,8

Crofab^® Patient Testimonials

Gain triple control with CroFab®^*

Expert consensus guidelines for stocking of antidotes in
hospitals that provide emergency care⁹

BTG Specialty Solutions Center^TM