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26 September 2018
BTG plc (LSE: BTG) today announced a policy for replacement of expired vials of CroFab® Crotalidae Polyvalent Immune Fab (Ovine), allowing customers to return the product for replacement up to 90 days after expiration. This change goes into effect immediately, and provides CroFab®customers with a process for replacing their expired product at no charge. CroFab® is the only available FDA-approved product for the management of all North American pit viper envenomations in adult and pediatric patients.1
Expired, unused product purchased through the company's authorized distributors of record (ADR), is eligible for replacement when requested for return between the month of expiration and up to 90 days after the product expires. Any expired returns provisions mandated by individual state laws that are in conflict will supersede this policy.
"BTG is committed to ensuring that the hospitals that rely on CroFab®, the only available antivenom in the US to treat all species of pit viper envenomations, have adequate supplies for patients in a potentially life-threatening situation," said Geoffrey Coy, Vice President of Sales & Marketing for BTG Pharmaceuticals. "In addition to ensuring the quality, safety, and efficacy of our products, we are also constantly looking for ways to improve the customer experience. With this updated policy, we are making it easier for hospitals to meet the needs of patients and the physicians who treat them."
Before returning product to BTG, customers must contact BTG Specialty Solutions Center™ at firstname.lastname@example.org or 1-844-293-0007. BTG will review submitted requests and, if approved, will provide a Return Goods Authorization ("RGA") number. All products returned to BTG without an RGA number will be refused. RGAs are issued upon unconfirmed representations made to BTG and are not intended to be a guarantee that a replacement will be issued, or a basis for relying upon the issuance of a replacement. Replacement for returned goods is subject to verification by BTG or its agent that the returned product falls within BTG's guidelines for returned goods.
This replacement policy applies only to CroFab® and does not cover other BTG products.
CroFab® is indicated for the management of adults 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.
IMPORTANT SAFETY INFORMATION
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).
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.
For further information contact:
Andy Burrows, VP Corporate & Investor Relations
+44 (0)20 7575 1741; Mobile: +44 (0)7990 530 605
Stuart Hunt, Investor Relations Manager
+44 (0)20 7575 1582; Mobile: +44 (0)7815 778 536
Chris Sampson, Corporate Communications Director
+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178
Elisia Canna, Executive Vice President
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; 2018.
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