A broad range of vial options
available with 3 mL diluent volume
- ELOCTATE offers single-vial dosing
- ELOCTATE is supplied as a lyophilized powder in single-use vials containing nominally 250; 500; 750; 1000; 1500; 2000; 3000; 4000; 5000; or 6000 international Units (IU) of ELOCTATE.
- Liquid diluent (sterile water for injection) is in a pre-filled syringe
- Store ELOCTATE in the original package to protect the ELOCTATE vials from light
- Store ELOCTATE in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the pre-filled diluent syringe
- ELOCTATE may be stored at room temperature, not to exceed 30°C (86°F), for a single period of up to 6 months, within the expiration date printed on the label
- If stored at room temperature, record the date that ELOCTATE is removed from refrigeration on the carton in the area provided. After storage at room temperature, do not return the product to the refrigerator
- Do not use beyond the expiration date printed on the vial or 6 months after the date that was written on the carton, whichever is earlier
- The reconstituted product may be stored at room temperature, not to exceed 30°C (86°F), for up to 3 hours. Protect from direct sunlight. After reconstitution, if the product is not used within 3 hours, it must be discarded
- Do not use ELOCTATE if the reconstituted solution is cloudy or has particulate matter
- Discard any unused ELOCTATE
- Dispose of all unused solution, empty vial(s), and other used medical supplies in an appropriate medical waste container
- Call MyELOCTATE at 1-855-MyELOCTATE (693-5628) Monday through Friday 8 AM - 8 PM, ET to speak to MyELOCTATE™ Coordinator about how to obtain a medical waste container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the correct way to dispose of it
For more information about safe sharps disposal, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Indications and Important Safety Information
ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Do not use ELOCTATE if you have had an allergic reaction to it in the past.
Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII.
Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.
Your body can also make antibodies called, "inhibitors," against ELOCTATE, which may stop ELOCTATE from working properly.
The most frequently occurring side effects of ELOCTATE are headache, rash, joint pain, muscle pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.