Sevenfact
Coagulation Factor VIIa Recombinant Human · KIT · Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)
Sevenfact is a kit containing coagulation factor viia recombinant human, taken intravenous. Manufactured by Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.).
Key Facts
- Brand Name
- Sevenfact
- Generic Name
- Coagulation Factor VIIa Recombinant Human
- NDC Code (Product)
71127-1000- Manufacturer
- Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)
- Dosage Form
- KIT
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125641
- Marketing Start
- 12/10/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors. Limitation s of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency. SEVENFACT is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors ( 1 ). Limitation s of Use: SEVENFACT is not indicated for treatment of congenital factor VII deficiency.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For i ntravenous u se after reconstitution only . Type of Bleeding Dosing Regimen Recommendation For Mild or Moderate bleeds 75 mcg/kg repeated every 3 hours until hemostasis is achieved or Initial dose of 225 mcg/kg. If hemostasis is not achieved within 9 hours, additional 75 mcg/kg doses may be administered every 3 hours as needed to achieve hemostasis For Severe bleeds 225 mcg/kg, followed if necessary 6 hours later with 75 mcg/kg every 2 hours Consider alternative treatments if successful control of bleeding does not occur within 24 hours of the first administration of SEVENFACT. The vial includes a rubber stopper under the plastic cap. The syringe plunger rod has a wide top end and threaded end. The pre-filled syringe with Water for Injection diluent has a plastic backstop, rubber stopper, syringe tip (luer lock top under syringe cap), and syringe cap. The SEVENFACT 1 mg and 2 mg vial adapter and SEVENFACT 5 mg vial adapter each contain a plastic cover, paper protective cover, and spike (under protective paper). 2.1 Dose For intravenous use after reconstitution only. Dose and duration of SEVENFACT depend on the location and severity of the bleeding,…
Contraindications
4 CONTRAINDICATIONS SEVENFACT is contraindicated in patients with: known allergy to rabbits or rabbit proteins. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction. severe hypersensitivity reaction to SEVENFACT or any of its components. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction. Known allergy to rabbits or rabbit proteins. Severe hypersensitivity reaction to SEVENFACT or any of its components ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Clinical experience with pharmacologic use of FVIIa-containing products indicates an elevated risk of serious thrombotic events when used simultaneously with activated prothrombin complex concentrates. Clinical experience with pharmacologic use of FVIIa-containing products indicates an elevated risk of serious thrombotic events when used simultaneously with activated prothrombin complex concentrates ( 7 ).
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥1%) were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact HEMA Biologics at 855-718-HEMA (4362) or FDA at 1-800-FDA-1088 or https://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 database described in this section reflect exposure to SEVENFACT in two clinical studies, Study 1 and Study 2. A total of 42 patients with Hemophilia A or B with or without inhibitors received SEVENFACT: 27 patients in Study 1 at doses 75 mcg/kg and 225 mcg/kg and 15 patients in Study 2 at three escalating dose levels 25 mcg/kg, 75 mcg/kg and 225 mcg/kg [see Clinical Studies ( 14 )] . The most common adverse reactions (incidence ≥1%) reported in clinical trials for SEVENFACT were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infus…
Frequently Asked Questions
What is Sevenfact used for?
Sevenfact contains Coagulation Factor VIIa Recombinant Human. It is a kit taken intravenous. Consult your doctor for specific uses.
Is Sevenfact a controlled substance?
Sevenfact is not classified as a controlled substance by the DEA.
What is the generic name for Sevenfact?
The generic name for Sevenfact is Coagulation Factor VIIa Recombinant Human. There are no other listed brand versions of Coagulation Factor VIIa Recombinant Human.
What is the NDC code for Sevenfact ?
The NDC (National Drug Code) for Sevenfact is 71127-1000, listed by Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.).
Other Sevenfact Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)