NovoSeven RT
Coagulation Factor VIIa (Recombinant) · KIT · Novo Nordisk
NovoSeven RT is a kit containing coagulation factor viia (recombinant). Manufactured by Novo Nordisk.
Key Facts
- Brand Name
- NovoSeven RT
- Generic Name
- Coagulation Factor VIIa (Recombinant)
- NDC Code (Product)
0169-7050- Manufacturer
- Novo Nordisk
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA103665
- Marketing Start
- 04/30/2008
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 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 (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 Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B. 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 Limitations of Use : REBINYN is not indicated for immune tolerance induction in patients with hemophilia B ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous infusion after reconstitution only. For intravenous infusion after reconstitution only ( 2 ). • Each carton and vial label for REBINYN states the actual Factor IX potency in international units (IU) ( 2.1 ). 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 ). 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 ). Routine prophylaxis : • 40 IU/kg body weight once weekly ( 2.1 ). 2.1 Dosing Guidelines • Dose and duration of treatment depend on the location and extent of bleeding, and the patient’s clinical condition. • If monitoring of Factor IX activity is performed, use a chromogenic assay or selected one-stage clotting a…
Contraindications
4 CONTRAINDICATIONS REBINYN is contraindicated in patients who have known hypersensitivity to REBINYN or its components (including hamster proteins) [ see Warnings and Precautions ( 5.1 ) and Description ( 11 ) ] Do not use in patients who have known hypersensitivity to REBINYN or its components, including hamster proteins ( 4 ).
Adverse Reactions
6 ADVERSE REACTIONS 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. The most frequently reported adverse reactions (≥ 1%) in previously treated patients (PTPs) and previously untreated patients (PUPs) were itching and injection site reactions ( 6 ). Additional frequently reported adverse reactions (≥ 1%) in PUPs included rash, Factor IX inhibition, hypersensitivity, and anaphylactic reaction ( 6 ). In animals administered repeat doses of REBINYN, accumulation of polyethylene-glycol (PEG) was observed in the choroid plexus, pituitary, circumventricular organs, and cranial motor neurons ( 8.4 and 13.2 ). 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying cond…
Frequently Asked Questions
What is NovoSeven RT used for?
NovoSeven RT contains Coagulation Factor VIIa (Recombinant). It is a kit taken as directed. Consult your doctor for specific uses.
Is NovoSeven RT a controlled substance?
NovoSeven RT is not classified as a controlled substance by the DEA.
What is the generic name for NovoSeven RT?
The generic name for NovoSeven RT is Coagulation Factor VIIa (Recombinant). There are no other listed brand versions of Coagulation Factor VIIa (Recombinant).
What is the NDC code for NovoSeven RT ?
The NDC (National Drug Code) for NovoSeven RT is 0169-7050, listed by Novo Nordisk.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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