Coagulation Factor VIIa (Recombinant)

Trade Names:
NovoSeven RT
- Injection, lyophilized powder for solution 1 mg
- Injection, lyophilized powder for solution 2 mg
- Injection, lyophilized powder for solution 5 mg

Pharmacology

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Coagulation factor VIIa, when complexed with tissue factor, can activate coagulation factor X to Xa. Factor Xa, in complex with other factors, converts prothrombin to thrombin, leading to formation of a hemostatic plug by converting fibrinogen to fibrin, thereby inducing local hemostasis.

Pharmacokinetics

Distribution

Vd at steady state is 103 mL/kg.

Elimination

Median Cl is 33 mL/kg/h. Median half-life is 2.3 h. Median plasma recovery is 44%.

Indications and Usage

Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to factors VIII or IX, and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to factors VIII or IX, and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital factor VII deficiency; prevention of bleeding in surgical interventions or invasive procedures in patents with congenital factor VII deficiency.

Contraindications

None.

Dosage and Administration

Use evaluation of hemostasis to determine the effectiveness of recombinant coagulation factor VIIa and to provide a basis for modification of the treatment schedule. Coagulation parameters do not necessarily correlate with or predict efficacy of coagulation factor VIIa.

IV Recommended dose range is 70 to 90 mcg/kg repeated every 2 to 3 h until hemostasis is achieved.

IV Recommended dose range is 15 to 30 mcg/kg every 4 to 6 h until hemostasis is achieved.

IV

Recommended dosage is 90 mcg/kg every 2 h by bolus infusion until hemostasis is achieved or until treatment is judged to be inadequate.

For severe bleeds, continue dosing at 3- to 6-h intervals after hemostasis is achieved to maintain the hemostatic plug.

Start with 90 mcg/kg administered immediately prior to the intervention and repeat at 2-h intervals for the duration of surgery. For minor surgery, postsurgical dosing by bolus infusion should occur at 2-h intervals for the first 48 h, and then at 2- to 6-h intervals until healing has occurred. For major surgery, postsurgical dosing by bolus infusion should occur at 2-h intervals for 5 days, followed by 4-h intervals until healing occurs. Administer additional bolus doses if needed.

General Advice

• For IV use only.
• Before reconstitution, bring coagulation factor VIIa to room temperature, but not above 98.6°F.
• When reconstituting, gently swirl the vial until all material is dissolved. The reconstituted solution is a clear, colorless solution.
• Visually inspect reconstituted solution for particulate matter and discoloration prior to administration. Do not administer if particulate matter or discoloration is observed.
• Do not mix with infusion solutions.
• Administer within 3 h after reconstitution.
• Discard any unused solution.
• Do not store reconstituted solution in a syringe.

Storage/Stability

Prior to reconstitution, store under refrigeration at 36° to 46°F. Avoid exposure to direct sunlight. After reconstitution, may be stored at room temperature or refrigerated for up to 3 h. Do not freeze reconstituted product or store in syringes.

Drug Interactions

Avoid simultaneous use with coagulation factor VIIa.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (9%); bradycardia, hypotension (1%); deep vein thrombosis; MI; myocardial ischemia; pulmonary embolism; thromboembolic events, including arterial thrombosis, cerebral infarction, and/or ischemia; thrombophlebitis (postmarketing).

CNS

Headache (1%); cerebral infarction, cerebral ischemia, intracranial hemorrhage.

Dermatologic

Pruritus, purpura, rash (1%).

GI

Vomiting (1%).

Genitourinary

Abnormal renal function (1%).

Hematologic-Lymphatic

Hemorrhage (15%); decreased fibrinogen plasma (10%); coagulation disorder, decreased prothrombin, DIC, increased fibrinolysis (1%); acute postoperative hemarthrosis; high D-dimer levels and consumptive coagulopathy; internal jugular thrombosis (postmarketing).

Respiratory

Pneumonia (1%).

Miscellaneous

Fever (16%); hemarthrosis (14%); allergic reaction, arthrosis, decreased therapeutic response, edema, injection-site reaction, pain (1%); hypersensitivity reactions, including anaphylactic reactions; pneumonia; renal failure complicating a retroperitoneal bleed; ruptured abscess leading to sepsis and DIC; shock; splenic hematoma and GI bleeding; trauma; worsening of chronic renal failure (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy were not determined to be different in various age groups (infants to adolescents). Clinical trials were conducted by dosing according to body weight and not age.

Elderly

Clinical studies did not include sufficient numbers of subjects 65 yr of age and older to determine whether they respond differently from younger subjects.

Hypersensitivity

Use with caution in patients with known hypersensitivity to any component of the product, or in patients with known hypersensitivity to bovine, hamster, or mouse proteins.

Antibody formation

If factor VIIa activity fails to reach the expected level, PT is not corrected, or bleeding is not controlled after treatment, suspect antibody formation and perform analysis for antibodies.

Prolonged dosing

Because of limited data, use with caution for prolonged administration.

Thrombotic events

The risk of developing thrombotic events may be increased in patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates.

Overdosage

Symptoms

Dose-limiting toxicities have not been investigated. Antibodies against recombinant factor VIIa and occipital stroke have been reported with accidental overdosages.

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