SEVENFACT- coagulation factor viia recombinant human kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COAGULATION FACTOR VIIA RECOMBINANT HUMAN (UNII: AC71R787OV) (COAGULATION FACTOR VIIA RECOMBINANT HUMAN - UNII:AC71R787OV)

Available from:

Laboratoire Français du Fractionnement et des Biotechnologies Société Anonyme (LFB S.A.)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SEVENFACT  [coagulation factor VIIa (recombinant)-jncw] 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 of Use: SEVENFACT is not indicated for the treatment of patients with congenital Factor VII deficiency. SEVENFACT is contraindicated in - known allergy to rabbits or rabbit proteins. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction.  - patients with severe hypersensitivity reaction to SEVENFACT or any of its components. Exposure to SEVENFACT in these patients can result in severe hypersensitivity reaction.  Risk Summary There are no adequate and well-controlled studies using SEVENFACT in pregnant women to determine whether there is a drug-associated risk. Animal studies evaluating the embryo-fetal teratogenic potential of SEVENFACT have not been conducted. It is unknown whether SEVENFACT can cause fetal harm when administered to a pregnant

Product summary:

How Supplied Storage and Handling

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

SEVENFACT- COAGULATION FACTOR VIIA RECOMBINANT HUMAN
LABORATOIRE FRANÇAIS DU FRACTIONNEMENT ET DES BIOTECHNOLOGIES
SOCIÉTÉ
ANONYME (LFB S.A.)
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEVENFACT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEVENFACT .
SEVENFACT [COAGULATION FACTOR VIIA (RECOMBINANT)-JNCW]
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
WARNING: THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
● SERIOUS ARTERIAL AND VENOUS THROMBOTIC EVENTS MAY OCCUR FOLLOWING
ADMINISTRATION OF
SEVENFACT (5.1).
● DISCUSS THE RISKS AND EXPLAIN THE SIGNS AND SYMPTOMS OF THROMBOTIC
AND
THROMBOEMBOLIC EVENTS TO PATIENTS WHO WILL RECEIVE SEVENFACT .
● MONITOR PATIENTS FOR SIGNS OR SYMPTOMS OF ACTIVATION OF THE
COAGULATION SYSTEM AND
FOR THROMBOSIS.
INDICATIONS AND USAGE
SEVENFACT [coagulation factor VIIa (recombinant)-jncw] 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 of Use: SEVENFACT is not indicated for treatment of
congenital factor VII deficiency.
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE AFTER RECONSTITUTION ONLY.
Bleeding Episodes in Congenital Hemophilia A or B with inhibitors
(2.1).
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
DOSAGE FORMS AND STRENGTHS
SEVENFACT is available as a lyophilized powder in single-use vials
containing 1 or 5 mg of coagulation
factor VIIa (recombinant)-jncw. After reconstitution with a specified
volume o