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Strike early. Strike with confidence. Based on an actual case study; details changed to preserve patient confidentiality. Individual results may vary. These educational patient case studies are brought to you by BTG International Inc. The purpose of these case studies is to educate healthcare professionals about the potential benefits, potential risks, and potential uses of BTG products. Photo shown above is not an actual patient. Please see Important Safety Information on back cover and enclosed full Prescribing Information. History 0–1 hour after bite A man was bitten on a toe on his right foot while in his yard. He was moving lawn furniture when he felt a sharp prick on the third toe of his right foot. When he looked down, he noticed a copperhead snake slithering away. He then decided to drive himself to the emergency department at his local hospital. Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center

Brandon - CroFab Studies...Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center Presentation at hospital

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Page 1: Brandon - CroFab Studies...Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center Presentation at hospital

Strike early. Strike with con� dence.

Based on an actual case study; details changed to preserve patient confi dentiality.

Individual results may vary.

These educational patient case studies are brought to you by BTG International Inc.

The purpose of these case studies is to educate healthcare professionals about the potential benefi ts, potential risks, and potential uses of BTG products.

Photo shown above is not an actual patient.

Please see Important Safety Information on back cover and enclosed full Prescribing Information.

History 0–1 hour after bite

A man was bitten on a toe on his right foot while in his yard.He was moving lawn furniture when he felt a sharp prick on the third toe of his right foot. When he looked down, he noticed a copperhead snake slithering away. He then decided to drive himself to the emergency department at his local hospital.

BrandonPit viper envenomationA 38-year-old victim

Bitten at:Tyler, TexasTreated at:Emergency room at regional medical center

Page 2: Brandon - CroFab Studies...Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center Presentation at hospital

Presentation at hospital 1–4 hours after the bite

• Patient had no signifi cant medical history or known allergies• Patient appeared well, complained of local pain around bite site

Local effects: Two puncture marks noted on third toe of right foot; no signifi cant edema of affected toe; tenderness noted around bite site

Vital signs: Blood pressure 115/80 mm Hg, heart rate 74/min, respiratory rate 17/min

Lab values: Prothrombin time 11.5 seconds, INR 1.1, fi brinogen 250 mg/dL, platelets 191,000 /mm3

• Patient not given antivenom because swelling “did not cross a major joint”• Foot elevated• Observed for 4 hours and discharged from hospital and sent home

Day 2: Patient seeks additional medical attention• Patient experienced continued pain and swelling at the bite site; visited his primary care physician• Primary care physician prescribed an antibiotic

Day 3: Symptoms remain unresolved and worsen• Experienced continued pain• Toe has swelled signifi cantly, developed hemmorhagic bulla,

discoloration (purple)• Primary care physician prescribed medication for pain and infl ammation

Day 4: Medical expert consulted• Patient continued to experience swelling at the bite site and pain; called his primary physician

who referred him to the local snakebite expert • Snakebite expert recommended patient visit the local wound care clinic

Presentation at the time:

Presentation at the time:

Page 3: Brandon - CroFab Studies...Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center Presentation at hospital

Day 7–15: Medical expert consulted• Hemorrhagic bulla was drained from affected toe• Patient experienced intense hypersensitivity and extreme pain in toe• Wound care clinic drained and debrided toe• Patient experienced dif� culty walking• Patient unable to attend work during this time

Days 15–30: Continued wound care visits

Post Day 30: Additional treatment modalities considered• Continued visiting a wound care specialist• Skin graft considered for affected toe, however, not performed• Signifi cant pain and sensitivity continued• Toenail turned purple and black before falling off (6 weeks post-envenomation)

Recovery 4 months–3 years

• Pain medication discontinued 60 days post envenomation• Wound healed 4 months after bite• Numbness and tingling at bite site continued up to 12 months post-envenomation• Scarring and toenail deformity persists after 3 years

Please see Important Safety Information on back cover and enclosed full Prescribing Information. Strike early. Strike with con� dence.

Presentation at the time:

IndicationCroFab® 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.

Photos used with permission

References: 1. Lavonas EJ, Ruha AM, Banner W, et al. Unifi ed treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med. 2011;11:2-15. 2. Bozkurt M, Kulahci Y, Zor F, Kapi E. The management of pit viper envenomation of the hand. Hand. 2008;3:324-331.

Page 4: Brandon - CroFab Studies...Brandon Pit viper envenomation A 38-year-old victim Bitten at: Tyler, Texas Treated at: Emergency room at regional medical center Presentation at hospital

© 2018 BTG International Inc. All rights reserved.NA-CRF-2018-0709 May 2018

BTG and the BTG roundel logo are registered trademarks of BTG International Ltd.CroFab® is a registered trademark of BTG International Inc.

Please see enclosed full Prescribing Information.

Key considerationsInsuf� cient duration of observation for a snakebite patient1

— Patients should be observed for at least 8 hours prior to discharge to determine if a bite is a dry bite or an envenomation

Decision not to treat what appeared to be a mild snakebite with antivenom may have contributed to progression and severity of the envenomation— After initially appearing as a mild envenomation, the envenomation continued to progress with unresolved severe

pain and affected activities of daily living

Consider location of bite in decision to treat— Envenomation in digits and the hand can result in amplifi ed local tissue damage and adverse long-term outcomes2

Consult an expert if symptoms of envenomation persist— Call your local poison control center at 1-800-222-1222 if an expert is needed to consult for snakebite treatment

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 benefi ts 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 fi brinogen, 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.

Strike early. Strike with con� dence.

When envenomation strikes, strike back with CroFab®. www.crofab.com