coagulation factor VIIa

coagulation factor VIIa, recombinant,

an antihemophilic.

indications This drug is prescribed to prevent the bleeding associated with hemophilia A or B when inhibitors to Factor VIII or IX are present.

contraindications Factors that prohibit its use include known hypersensitivity to this product or to mouse-, hamster-, or bovine-derived products.

adverse effects Life-threatening side effects include hemorrhage, hemarthrosis, decreased fibrinogen plasma, diffuse intravascular coagulation, coagulation disorder, and thrombosis. Other adverse effects include fever, headache, hypertension, bradycardia, pain, redness at the injection site, pruritus, purpura, and rash.

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coagulation factor VIIa (recombinant)

NovoSeven

Pharmacologic class: Coagulation factor VIIa

Therapeutic class: Antihemophilic agent

Pregnancy risk category C

Action

Promotes hemostasis by activating intrinsic pathway of coagulation cascade to form fibrin

Availability

Lyophilized powder for injection: 1.2 mg/vial, 2.4 mg/vial, 4.8 mg/vial

⊘Indications and dosages

➣ Bleeding episodes in patients with hemophilia A or B who have inhibitors to factor VIII or IX

Adults: 90 mcg/kg I.V. bolus q 2 hours until hemostasis occurs or therapy is deemed ineffective

Contraindications

• Hypersensitivity to drug or to mouse, hamster, or bovine products

Precautions

Use cautiously in:
• pregnant or breastfeeding patients
• children.

Administration

☞ Give by I.V. bolus only over 2 to 5 minutes, depending on dosage.
• Reconstitute only with specified volume of sterile water for injection.
☞ Don't mix with infusion solutions.
• Administer within 3 hours of reconstituting.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: headache

CV: hypertension, hypotension, bradycardia

GU: renal dysfunction

Hematologic: purpura, hemorrhage, hemarthrosis, disseminated intravascular coagulation, coagulation disorders, decreased fibrinogen plasma, thrombosis

Musculoskeletal: arthrosis

Skin: pruritus, rash

Other: fever, edema, pain, redness or reaction at injection site, hypersensitivity reaction

Interactions

Drug-drug. Activated prothrombin complex concentrates, prothrombin complex concentrates: risk of potential interaction (though not evaluated)

Patient monitoring

• Monitor for signs and symptoms of coagulation activation or thrombosis.
• Be aware that laboratory coagulation parameters may be used as adjunct to clinical evaluation of hemostasis to monitor drug efficacy and treatment schedule. However, these parameters lack direct correlation with achievement of hemostasis.

Patient teaching

• Instruct patient to report swelling, pain, burning, or itching at infusion site.
• Tell patient to inform prescriber if she's pregnant or intends to become pregnant.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.