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Biopharmaceuticals FDA

 News Release - September 13, 2018

FDA Approves CroFab(R) Product Improvements

Updated label describes extended shelf life and removal of mercury

WEST CONSHOHOCKEN, Pa., Sept. 13, 2018 -- (Healthcare Sales & Marketing Network) -- BTG plc (LSE : BTG ) announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab® Crotalidae Polyvalent Immune Fab (Ovine) to 60 months and the removal of mercury from the product's manufacturing process. The changes are part of the third update to the CroFab® Prescribing Information in three years. CroFab® is the only available FDA-approved product for the management of all North American pit viper envenomations in adult and pediatric patients.1

The new 60-month shelf life for CroFab® is a 24-month increase over the current 36-month shelf life. Increasing the shelf life will reduce the need to return expired product and help to ensure that hospitals have an adequate supply of the antivenom on hand for use in a potentially life-threatening situation.

The updated CroFab® Prescribing Information approved by the FDA also removes all references to the product containing mercury and all warnings regarding mercury toxicity. The manufacturing process for CroFab® previously involved the use of thimerosal, an ethyl mercury-containing compound, and trace amounts were carried into the final product. While this amounted to no more than 0.6 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab®), the manufacturing process was changed to completely eliminate mercury-containing compounds.

"BTG continues to make investments in CroFab® to help improve its safety, quality and efficacy," said Suzanne Ward, Senior Director of Medical Strategy for BTG Pharmaceuticals. "This is the latest in a series of label updates we've made over the last three years, and we continue to look for ways to meet the needs of patients and healthcare professionals. As the maker of the only available antivenom in the US to treat all species of pit viper envenomations, we feel it is critical to focus on the safety and reliability of our product."

Important Note: These product improvements do not apply to earlier batches of CroFab®. Customers should refer to the labeled expiration date and package insert included with their product to review their product's shelf life and inclusion of thimerosal. For any questions, please contact BTG Medical Information at 1-877-377-3784.

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.

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

Please see the full Prescribing Information for CroFab.

About BTG

BTG is a global healthcare company focused on Interventional Medicine. Our innovative medical technology helps physicians treat their patients through minimally invasive procedures. We have a growing portfolio of products that advance the treatment of cancer, vascular conditions and severe emphysema. BTG's Pharmaceuticals business provides products that help patients overexposed to certain medications or toxins. To learn more about BTG, please visit: btgplc.com.

1 CroFab® [prescribing information]. BTG International Inc.; August 2018.

© 2018 BTG International Inc.


Source: BTG

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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