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A 26-Year-Old Victim

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A 26-Year-Old Victim Considered local, systemic, and hematologic effects of envenomation when monitoring and evaluating patient1 Aggressive dosing strategy helped achieve initial control — Continuous monitoring of envenomation symptoms is critical to assessing if initial control has been achieved A 26-YEAR-OLD VICTIM Stock enough CroFab® to complete treatment and prepare a plan for how to obtain CroFab® quickly for additional doses ! — 18 vials were needed to achieve initial control, leaving no vials for scheduled maintenance dosing Important Safety Information hypersensitivity reactions, including anaphylaxis and Contraindications anaphylactoid reactions, discontinue infusion and institute Do not administer CroFab® to patients with a known appropriate emergency treatment. Patients allergic to history of hypersensitivity to any of its components, or papain, chymopapain, other papaya extracts, or the Bitten at: Treated at: to papaya or papain unless the benefits outweigh the pineapple enzyme bromelain may also have an allergic ® Lost Dutchman, State Park, Arizona Major medical center risks and appropriate management for anaphylactic reaction to CroFab . Follow-up all patients for signs reactions is readily available. and symptoms of delayed allergic reactions or serum sickness (e.g., rash, fever, myalgia, arthralgia). Warnings and Precautions Coagulopathy: In clinical trials, recurrent coagulopathy Adverse Reactions (the return of a coagulation abnormality after it has The most common adverse reactions (incidence ≥5% been successfully treated with antivenin), characterized of subjects) reported in the clinical studies were by decreased fibrinogen, decreased platelets, and urticaria, rash, nausea, pruritus and back pain. Adverse History elevated prothrombin time, occurred in approximately reactions involving the skin and appendages (primarily half of the patients studied; one patient required rash, urticaria, and pruritus) were reported in 12 of A man was bitten on his left calf by a rattlesnake while hiking re-hospitalization and additional antivenin administration. the 42 patients. Two patients had a severe allergic with 2 friends. reaction (severe hives and a severe rash and pruritus) Recurrent coagulopathy may persist for 1 to 2 weeks He heard a hiss in the brush and felt searing pain as the snake, estimated at 6’ to following treatment and one patient discontinued CroFab® or more. Patients who experience coagulopathy 8’ long, bit his left leg. He developed nausea, vomiting, and left leg swelling. After due to an allergic reaction. Recurrent coagulopathy due to snakebite should be monitored for recurrent his friends dialed 911, they helped him walk 1 hour to reach an emergency medical due to envenomation and requiring additional treatment coagulopathy for up to 1 week or longer. During this technician, who elevated and immobilized his leg, then transported him to an open may occur. period, the physician should carefully assess the need field, from which a medevac helicopter brought him to a major medical center. for re-treatment with CroFab® and use of any type of Please see enclosed full Prescribing Information. anticoagulant or anti-platelet drug. Reference: 1. CroFab® [prescribing information]. BTG International Inc; August 2018. Hypersensitivity Reactions: Severe hypersensitivity Based on an actual case study; details changed to preserve patient confidentiality. reactions may occur with CroFab®. In case of acute 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 © 2019 BTG International Inc. potential benefits, potential risks, and potential uses of BTG products. All rights reserved. US-CRF-1900255 January 2020 Photo shown above is not an actual patient. BTG and the BTG roundel logo are registered trademarks of BTG International Ltd. Please see Important Safety Information on back cover and enclosed CroFab® is a registered trademark of BTG International Inc. Strike early. Strike with confidence. full Prescribing Information. Strike early. Strike with confidence. Achieving initial control Presentation at hospital • Stabilization of local, systemic, and hematologic venom effects achieved within •Patient had no significant medical history or known allergies to medications or food 7 hours after bite • General assessment: patient in severe pain, anxious, able to answer questions; complained of dizziness and metallic taste in mouth Local effects Erythema, swelling, and tenderness began to resolve • Left leg showed blood oozing from bite site, fasciculations, and myokymia Vital signs Blood pressure 126/78 mm Hg, heart rate 88/min, respiratory rate 16/min Local effects Left leg erythematous, swollen, warm, and tender to touch, with Lab values Prothrombin time 13.6 seconds, INR 1.1, fibrinogen 148 mg/dL, ecchymosis and skin blisters surrounding the bite site; bleeding platelets 135,000/mm3 from the bite site; pain rating 9 out of 10; calf circumference: 46 cm INR=international normalized ratio. (40 cm for right leg), with swelling extending to popliteal fossa Vital signs Blood pressure 92/64 mm Hg, heart rate 136/min, respiratory rate 24/min Continuing control Lab values Prothrombin time 17.9 seconds, INR 2.4, fibrinogen 61 mg/dL, Patient transferred from ER to ICU with recommendation for continued dosing of 3 • platelets 35,000/mm 2 vials of CroFab® at 6, 12, and 18 hours after initial control to minimize the risk of recurrent or delayed venom effect • Medical staff marked leading edge of erythematous, swollen area of leg on initial • Deterioration of patient’s clinical condition 5 hours after ICU admission: progressive examination and reexamined area every 15-30 minutes to assess progression ! worsening of pain, tenderness, swelling, ecchymosis, blister formation, and oozing of of envenomation dark blood from bite site • Patient given normal saline for IV fluid hydration and morphine IV for pain as part • At 6 hours after ICU admission, staff prepared to administer next recommended of initial therapy CroFab® dose, but they discovered that hospital had exhausted its supply of 18 vials, causing a 12-hour delay in CroFab® treatment • Medical staff recognized that the patient was experiencing a severe envenomation. Severe envenomations are unpredictable and may lead to extreme outcomes • During this time, patient’s clinical course continued to deteriorate, with progressive local tissue effects, including severe myonecrosis adjacent to bite •Due to progressive myonecrosis and neurovascular compromise of the lower leg, a below-knee amputation was performed without incident on Day 4 after snakebite Start of treatment • CroFab® administered according to the treatment algorithm – Initial dose: 12 vials via IV infusion over 1 hour, monitoring the patient closely Outcome for any allergic reactions Patient’s post-op recovery was unremarkable – Progression of erythema, swelling, pain, and tenderness noted at hour 6, with • formation of skin blisters •Patient discharged on Day 8 post-op to a rehabilitation facility for physical therapy and amputee training • Initial control not achieved. Decision made to administer another dose of CroFab® according to the treatment algorithm •Patient recovered slowly, with more additional surgeries scheduled to optimize limb function • Additional 6 vials of CroFab® administered ~1 hour after end of first infusion Indication OVER ADDITIONAL CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is a sheep-derived antivenin indicated for the management of ONE adult and pediatric patients with North American crotalid envenomation. The term crotalid is used to describe 12 ONE HOUR 6 the Crotalinae subfamily (formerly known as Crotalidae) of venomous snakes which includes rattlesnakes, VIALS HOUR AFTER VIALS copperheads and cottonmouths/water moccasins. Please see Important Safety Information on back cover and enclosed full Prescribing Information. Strike early. Strike with confidence. Achieving initial control Presentation at hospital • Stabilization of local, systemic, and hematologic venom effects achieved within •Patient had no significant medical history or known allergies to medications or food 7 hours after bite • General assessment: patient in severe pain, anxious, able to answer questions; complained of dizziness and metallic taste in mouth Local effects Erythema, swelling, and tenderness began to resolve • Left leg showed blood oozing from bite site, fasciculations, and myokymia Vital signs Blood pressure 126/78 mm Hg, heart rate 88/min, respiratory rate 16/min Local effects Left leg erythematous, swollen, warm, and tender to touch, with Lab values Prothrombin time 13.6 seconds, INR 1.1, fibrinogen 148 mg/dL, ecchymosis and skin blisters surrounding the bite site; bleeding platelets 135,000/mm3 from the bite site; pain rating 9 out of 10; calf circumference: 46 cm INR=international normalized ratio. (40 cm for right leg), with swelling extending to popliteal fossa Vital signs Blood pressure 92/64 mm Hg, heart rate 136/min, respiratory rate 24/min Continuing control Lab values Prothrombin time 17.9 seconds, INR 2.4, fibrinogen 61 mg/dL, Patient transferred from ER to ICU with recommendation for continued dosing of 3 • platelets 35,000/mm 2 vials of CroFab® at 6, 12, and 18 hours after initial control to minimize the risk of recurrent or delayed venom effect • Medical staff marked leading edge of erythematous, swollen area of leg on initial • Deterioration of patient’s clinical condition
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