Sevenfact
Generic: COAGULATION FACTOR VIIA RECOMBINANT HUMAN
Basic Information
Manufacturer
Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
b23ad666-8ce0-4e0b-9eff-c6983ac5f7e6
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.
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.
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, infusion-related reaction, and fever.
Adverse reactions reported in the two clinical studies are shown in Table 2.
Table 2 Adverse Reactions Occurring in Clinical Studies Preferred Terms Number of Patient Adverse Reactions (% Incidence Rate) Study 2 (N=15) Number of A dverse R eactions * Study 2 Number of Patient Adverse Reactions (% Incidence Rate) Study 1 (N=27) Number of A dverse R eactions * Study 1 Infusion site discomfort - - 1 (4) 4 Infusion site hematoma - - 1 (4) 2 Dizziness 1 (7) 2 - - Headache 1 (7) 1 - - Body temperature increase - - 1 (4) 1 Infusion related reaction** 1 (7) 1 - - * Three patients experienced adverse reactions in Study 2 and two patients experienced adverse reactions in Study 1.
** Symptoms resolved without any intervention and did not recur with subsequent administration.
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, infusion-related reaction, and fever.
Adverse reactions reported in the two clinical studies are shown in Table 2.
Table 2 Adverse Reactions Occurring in Clinical Studies Preferred Terms Number of Patient Adverse Reactions (% Incidence Rate) Study 2 (N=15) Number of A dverse R eactions * Study 2 Number of Patient Adverse Reactions (% Incidence Rate) Study 1 (N=27) Number of A dverse R eactions * Study 1 Infusion site discomfort - - 1 (4) 4 Infusion site hematoma - - 1 (4) 2 Dizziness 1 (7) 2 - - Headache 1 (7) 1 - - Body temperature increase - - 1 (4) 1 Infusion related reaction** 1 (7) 1 - - * Three patients experienced adverse reactions in Study 2 and two patients experienced adverse reactions in Study 1.
** Symptoms resolved without any intervention and did not recur with subsequent administration.