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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 0–4 hours after bite A woman was bitten on her right index finger while in her yard. She was doing yardwork with her parents when she felt a pinprick on her finger. A few hours later, she noticed that her hand had started to swell and she was experiencing pain. Her parents decided to call 911 after noticing two puncture marks on her right index finger and then brought her to the emergency department. Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical center

Tiffany - CroFab › CroFab › media › CroFab › Case Studies PD… · Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical

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Page 1: Tiffany - CroFab › CroFab › media › CroFab › Case Studies PD… · Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical

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 0–4 hours after bite

A woman was bitten on her right index � nger while in her yard.She was doing yardwork with her parents when she felt a pinprick on her fi nger. A few hours later, she noticed that her hand had started to swell and she was experiencing pain. Her parents decided to call 911 after noticing two puncture marks on her right index fi nger and then brought her to the emergency department.

TiffanyPit viper envenomationAn 18-year-old victim

Bitten at:Macon, GeorgiaTreated at:Regional medical center

Page 2: Tiffany - CroFab › CroFab › media › CroFab › Case Studies PD… · Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical

Presentation at hospital 4–7 hours after the bite

• Patient had no signifi cant medical history or known allergies to medications or food• General assessment: Patient having issues with pain control, able to answer questions, appeared mildly anxious• Puncture marks on right index fi nger, pain and swelling halfway up the forearm• Upon initial evaluation, facility unsure of species and questioned whether to treat

with antivenom

Local effects: Edema noted up to forearm; no evidence of bleeding; pain rating 8 out of 10 Vital signs: Blood Pressure 122/76 mm Hg, heart rate 84/min, respiratory rate 20/minLab values: Prothrombin time 11 seconds, INR 1.1, fi brinogen 314 mg/dL, platelets 176,000/mm3

• Hospital staff noticed that swelling had progressed towards the elbow since admission to the emergency department

• No toxicologist on staff at hospital; called their local poison control center to speakwith their on-call toxicologist

• Toxicologist suspected a pit viper envenomation and recommended administration of antivenom due to progression of swelling

Start of treatment 7–9 hours

• Based off the toxicologist consult, hospital staff decided to administer CroFab® according to thetreatment algorithm

– Initial dose: 6 vials via IV infusion over 1 hour, monitoring patient closely for any allergic reactions

• After 6 vial initial dose, monitored for swelling• Continued progression of swelling and pain noted at Hour 8• Initial control not achieved due to continued progression of swelling• Hospital staff consulted local poison control center again and was advised to give an additional

4 to 6 vials to gain initial control • Additional 4 vials of CroFab® administered ~1 hour after end of � rst infusion according

to the toxicologist recommendation and treatment algorithm

INR=international normalized ratio.

6VIALS HOUR

OVERONE 4

VIALS

ADDITIONAL

HOURAFTER

ONE

Page 3: Tiffany - CroFab › CroFab › media › CroFab › Case Studies PD… · Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical

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

Continuing control 10–41 hours

• Administered scheduled maintenance dosing regimen of 2 vials of CroFab® at 6, 12, and 18 hours after initial control was achieved

• Discharge criteria: – Swelling had diminished; still minimal swelling surrounding bite site – Vital signs and lab values were within normal limits – Improved range of motion – Pain had resolved• Patient discharged 12 hours after last dose of CroFab®. Instructions included to contact physician

immediately if signs of recurrent coagulopathy or delayed allergic reaction occur

Outcome 10 days–14 days• Outpatient follow up – Patient doing well – No visible edema• 2nd follow up – No further treatment needed

Achieving initial control 9–10 hours

• Observed patient, swelling no longer progressing after second dose of CroFab®

• Lab values and vital signs within normal limits• Initial control achieved at 10 hours post envenomation

2VIALS

HOURSLATER

SIX 2VIALS

HOURSLATER

SIX2VIALS

HOURSLATER

SIX

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.

Reference: 1. CroFab® [prescribing information]. BTG International Inc; May 2017.

Page 4: Tiffany - CroFab › CroFab › media › CroFab › Case Studies PD… · Tiffany Pit viper envenomation An 18-year-old victim Bitten at: Macon, Georgia Treated at: Regional medical

© 2018 BTG International Inc. All rights reserved.NA-CRF-2018-0710 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.

Strike early. Strike with con� dence.

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.

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

Key considerationsTreat the symptoms, not the species of snake — CroFab® is indicated to treat all North American pit viper envenomation

Consulted medical expert when unsure of when and how to treat— Call local poison control center at 1-800-222-1222 to consult on-call toxicologist

Administered additional vials of CroFab® to gain initial control— Initial control was not established after the initial dose and required another dose

Followed recommended dosing for continued control1

— Scheduled maintenance dosing ensured envenomation did not worsen