REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: On-demand treatment and control of bleeding episodes, Perioperative management of bleeding, Routine prophylaxis to reduce the frequency of bleeding episodes.
From the U.S. FDA-approved label for Coagulation factor IX. Full label: DailyMed.
REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate indicated for use in adults and children with hemophilia B (congenital Factor IX deficiency) for: On-demand treatment and control of bleeding episodes, Perioperative management of bleeding, Routine prophylaxis to reduce the frequency of bleeding episodes.
From the U.S. FDA-approved label for Coagulation factor IX. Full label: DailyMed.
For intravenous infusion after reconstitution only. For intravenous infusion after reconstitution only., Each carton and vial label for REBINYN states the actual Factor IX potency in international units (IU). On-demand treatment and control of bleeding episodes: 40 IU/kg body weight for minor and moderate bleeds, and 80 IU/kg body weight for major bleeds.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
REBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) Do not use in patients who have known hypersensitivity to REBINYN or its components, including hamster proteins.
Excerpt from the U.S. FDA-approved label. Talk to a pharmacist or doctor before use.
Hypersensitivity reactions, including anaphylaxis, have occurred. Should hypersensitivity reactions occur, discontinue REBINYN and administer appropriate treatment., Neutralizing antibodies (inhibitors) to Factor IX have occurred following administration of REBINYN.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
Common adverse reactions (incidence ≥ 1%) in PTPs reported in clinical trials for REBINYN were itching and injection site reactions. Common adverse reactions (incidence ≥ 1%) in PUPs reported in clinical trials for REBINYN were rash, FIX inhibitors, hypersensitivity, itching, injection site reaction, and anaphylactic reaction.
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
Store REBINYN in the original package in order to protect from light., Store REBINYN under refrigeration at a temperature of 36°F-46°F (2°C – 8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label., REBINYN may be stored at room temperature not to exceed 86°F (30°C) for up to 6 months within the 24-month time period.
Storage information from the U.S. FDA-approved label.
This page is information only and is not medical advice. Medicine details come from the sources listed above and may change — always confirm the medicine, strength and dose with a pharmacist or doctor before use. NLEM listing does not guarantee that a medicine is in stock at any pharmacy.
