País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
COAGULATION FACTOR IX RECOMBINANT HUMAN (UNII: 382L14738L) (COAGULATION FACTOR IX RECOMBINANT HUMAN - UNII:382L14738L)
Takeda Pharmaceuticals America, Inc.
COAGULATION FACTOR IX RECOMBINANT HUMAN
COAGULATION FACTOR IX RECOMBINANT HUMAN 250 [iU] in 5 mL
RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B for: - On-demand treatment and control of bleeding episodes - Perioperative management of bleeding - Routine prophylaxis to reduce the frequency of bleeding episodes. RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B [see Warnings and Precautions (5.3)] . RIXUBIS is contraindicated in patients who have: - Known hypersensitivity to RIXUBIS or its excipients including hamster protein - Disseminated Intravascular Coagulation (DIC) [see Warnings and Precautions (5.4)] - Signs of fibrinolysis [see Warnings and Precautions (5.4)] Risk Summary There are no data with RIXUBIS use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with RIXUBIS. It is also not known whether RIXUBIS can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population,
How Supplied RIXUBIS is available as single-dose vials containing the following product strengths: Actual factor IX activity in international units is stated on the unit carton and vial label. Each kit also contains 5 mL of Sterile Water for Injection and a BAXJECT II transfer device. Not made with natural rubber latex. Storage and Handling
Biologic Licensing Application
RIXUBIS- COAGULATION FACTOR IX (RECOMBINANT) TAKEDA PHARMACEUTICALS AMERICA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RIXUBIS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RIXUBIS. RIXUBIS [COAGULATION FACTOR IX (RECOMBINANT)] FOR INTRAVENOUS INJECTION, LYOPHILIZED POWDER FOR SOLUTION INITIAL U.S. APPROVAL: 2013 INDICATIONS AND USAGE RIXUBIS (Coagulation Factor IX [Recombinant]) is an antihemophilic factor indicated in adults and children with hemophilia B for: On-demand treatment and control of bleeding episodes Perioperative management of bleeding Routine prophylaxis to reduce the frequency of bleeding episodes. RIXUBIS is not indicated for induction of immune tolerance in patients with Hemophilia B. (1) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY. (2) _On-demand treatment and control of bleeding episodes and perioperative management of bleeding:_ One international unit of RIXUBIS per kg of body weight increases the circulating activity of factor IX by 0.7 international units/dL for patients <12 years of age and 0.9 international units/dL for patients ≥12 years of age. (2.1) _Initial Dose:_ Required international units = body weight (kg) × desired factor IX increase (% of normal or IU/dL) × reciprocal of observed recovery (IU/kg per IU/dL). (2.1) The maintenance dose depends on the type of bleed or surgery, the intensity of the hemostatic challenge, and number of days until adequate wound healing is achieved. (2.2) _Routine prophylaxis:_ Patients <12 years of age: 60 to 80 international units per kg twice weekly. Patients ≥12 years of age: 40 to 60 international units per kg twice weekly. (2.1) DOSAGE FORMS AND STRENGTHS RIXUBIS is available as a lyophilized powder in single-dose vials containing nominally 250, 500, 1000, 2000 or 3000 international units. (3) CONTRAINDICATIONS Do not use in patients with: Known hypersensitivity to RIXUBIS or its excipients including hamster protein. (4 Llegiu el document complet