RECOMBINATE
antihemophilic factor recombinant · KIT · Takeda Pharmaceuticals America, Inc.
RECOMBINATE is a kit containing antihemophilic factor recombinant. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- RECOMBINATE
- Generic Name
- antihemophilic factor recombinant
- NDC Code (Product)
0944-2843- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA103375
- Marketing Start
- 04/10/2009
Recall History
Cardinal Health Inc.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment & control of bleeding episodes Perioperative management of bleeding ( 1 ) Limitation of Use: ALTUVIIIO is not indicated for the treatment of von Willebrand disease. ( 1 ) Limitation of Use ALTUVIIIO is not indicated for the treatment of von Willebrand disease.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only. For intravenous use only. Each ALTUVIIIO vial label states Factor VIII activity in international units (IU or unit). ( 2.1 ) For routine prophylaxis: 50 IU/kg once weekly. ( 2.1 ) For on-demand treatment and control of bleeding episodes and perioperative management: 50 IU/kg ( 2.1 ) Estimated Increment of Factor VIII (IU/dL or % of normal) = 50 IU/kg × 2 (IU/dL per IU/kg) ( 2.1 ) To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5 (IU/kg per IU/dL). ( 2.1 ) 2.1 Dose Each ALTUVIIIO vial label states the Factor VIII potency in international units (IU). One IU corresponds to the Factor VIII activity contained in one milliliter of normal human plasma, as defined by the current World Health Organization (WHO) international standard for Factor VIII concentrate. Potency assignment for ALTUVIIIO is determined using an activated partial thromboplastin time (aPTT)-based one-stage clotting assay. It is recommended to use a validated one-stage clotting assay to measure ALTUVIIIO Factor VIII activity in…
Contraindications
4 CONTRAINDICATIONS ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients [see Description (11) ] . Do not use in patients who have had severe hypersensitivity reactions, including anaphylaxis, to ALTUVIIIO or excipients of ALTUVIIIO. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence >10%) are headache and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bioverativ Therapeutics Inc. (A SANOFI COMPANY) at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ALTUVIIIO in two clinical studies, Study 1 and Study 2 and are pooled for analysis. In Study 1, a total of 159 previously treated patients (PTPs) (134 adults and 25 adolescents) with severe Hemophilia A) received at least one dose of ALTUVIIIO for either routine prophylaxis, on-demand treatment of bleeding episodes or perioperative management. A total of 152 (96%) patients achieved at least 25 exposure days and 115 (72%) patients achieved at least 50 exposure days with a median of 53.0 (range 2–63) for both exposure days and injections per patient. Overall exposure was…
Frequently Asked Questions
What is RECOMBINATE used for?
RECOMBINATE contains antihemophilic factor recombinant. It is a kit taken as directed. Consult your doctor for specific uses.
Is RECOMBINATE a controlled substance?
RECOMBINATE is not classified as a controlled substance by the DEA.
What is the generic name for RECOMBINATE?
The generic name for RECOMBINATE is antihemophilic factor recombinant. There are 6 other brand versions of antihemophilic factor recombinant.
What is the NDC code for RECOMBINATE ?
The NDC (National Drug Code) for RECOMBINATE is 0944-2843, listed by Takeda Pharmaceuticals America, Inc..