For: Hemophilia B
Rebinyn (coagulation factor IX (recombinant), glycopegylated is an extended-half-life recombinant DNA-derived coagulation factor IX concentrate for the treatment and control of bleeding episodes in patients with hemophilia B. These highlights do not include all the information needed to use REBINYN safely and effectively. See full prescribing information for REBINYN.
REBINYN� (Coagulation Factor IX (Recombinant), GlycoPEGylated)
Lyophilized Powder for solution for intravenous injection
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
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 for:
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On-demand treatment and control of bleeding episodes
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Perioperative management of bleeding
Limitations of Use: REBINYN is not indicated for routine prophylaxis in the treatment of patients with hemophilia B. REBINYN is not indicated for immune tolerance induction in patients with hemophilia B (1).
DOSAGE AND ADMINISTRATION
For intravenous infusion after reconstitution only (2).
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Each carton and vial label for REBINYN states the actual Factor IX potency in international units (IU) (2.1).
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Recommended dose for 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. Additional doses of 40 IU/kg can be given (2.1).
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Recommended dose for perioperative management: Pre-operative dose of 40 IU/kg body weight for minor surgery, and 80 IU/kg body weight for major surgery. As clinically needed for the perioperative management of bleeding, repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after major surgery may be administered. Frequency may be extended to once weekly after the first week until bleeding stops and healing is achieved (2.1).
DOSAGE FORMS AND STRENGTHS
REBINYN is available as a lyophilized powder in single-use vials of 500, 1000, and 2000 IU (3).
CONTRAINDICATIONS
Do not use in patients who have known hypersensitivity to REBINYN or its components, including hamster proteins (4).
WARNINGS AND PRECAUTIONS
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Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue REBINYN and administer appropriate treatment (5.1).
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Development of neutralizing antibodies (inhibitors) may occur. Perform an assay that measures Factor IX inhibitor concentration if bleeding is not controlled with the recommended dose of REBINYN or if the expected plasma Factor IX activity levels are not attained (5.2, 5.5).
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The use of Factor IX-containing products has been associated with the development of thrombotic complications (5.3).
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Factor IX activity assay results may vary with the type of activated partial thromboplastin time reagent used (5.5).
ADVERSE REACTIONS
The most frequently reported adverse reactions (? 1%) were itching and injection site reactions (6).
Animals administered repeat doses of REBINYN showed accumulation of PEG in the choroid plexus. The potential clinical implications of these animal findings are unknown (6.3).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-877-668-6777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pediatric Use: No dose adjustment is needed (8.4).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2017 How Supplied
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REBINYN is supplied in packages comprised of a single-use vial containing nominally 500, 1000, or 2000 IU of Factor IX potency; a MixPro� pre-filled diluent syringe containing 10 mM histidine solution (1.6 mg/mL), and a sterile vial adapter with 25 micrometer filter, which serves as a needleless reconstitution device.
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The actual Factor IX potency in IU is stated on each REBINYN carton and vial.
Table 10: REBINYN Presentations
Presentation (Nominal Product Strength; IU)
Cap Color Indicator
Carton NDC Number
Components
500
Red
NDC 0169 7905 01
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REBINYN in single-use vial [NDC 0169 7955 11]
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Pre-filled histidine diluent in syringe, 4 mL [NDC 0169 7009 98]
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Vial adapter
1000
Green
NDC 0169 7901 01
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REBINYN in single-use vial [NDC 0169 7911 11]
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Pre-filled histidine diluent in syringe, 4 mL [NDC 0169 7009 98]
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Vial adapter
2000
Yellow
NDC 0169 7902 01
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REBINYN in single-use vial [NDC 0169 7922 11]
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Pre-filled histidine diluent in syringe, 4 mL [NDC 0169 7009 98]
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Vial adapter
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The REBINYN vials are made of glass, closed with a chlorobutyl rubber stopper (not made with natural rubber latex), and sealed with an aluminum cap.
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The pre-filled diluent syringes are made of glass, with a siliconised bromobutyl rubber plunger (not made with rubber latex).
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The closed vials and pre-filled diluent syringes are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Storage and Handling
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Store REBINYN in the original package in order to protect from light.
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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.
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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. Record the date when the product was removed from the refrigerator in the space provided on the outer carton. The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator.
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Do not use REBINYN after the end of the 6-month period at room temperature storage, or after the expiration date stated on the vial, whichever occurs earlier.
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Do not freeze REBINYN.
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Use REBINYN within 4 hours after reconstitution when stored at room temperature. Store the reconstituted product in the vial.
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Discard any unused reconstituted product stored at room temperature for more than 4 hours.
