coagulation factor VIIa


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Related to coagulation factor VIIa: BeneFix, Novoseven

coagulation factor VIIa (recombinant)

NovoSeven RT

Pharmacologic class: Coagulation factor VIIa

Therapeutic class: Antihemophilic agent

Pregnancy risk category C

FDA Box Warning

• Arterial and venous thrombotic and thromboembolic events following administration of NovoSeven RT have been reported during postmarketing surveillance. Clinical studies have shown an increased risk of arterial thromboembolic adverse events with NovoSeven RT when administered outside the current approved indications. Fatal and nonfatal thrombotic events have been reported.

• Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven RT.

• Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis.

• Safety and efficacy of NovoSeven RT haven't been established outside the approved indications.

Action

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

Availability

Lyophilized powder for injection: 1 mg/vial, 2 mg/vial, 5 mg/vial

Indications and dosages

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

Adults: For hemostatic dosing, 90 mcg/kg I.V. bolus q 2 hours until hemostasis occurs or therapy is deemed ineffective. For posthemostatic dosing, appropriate dosing duration hasn't been determined. For severe bleeds, continue dosing at 3- to 6-hour intervals after hemostasis is achieved, to maintain hemostatic plug.

Prevention of bleeding in surgical interventions or invasive procedures in patients with hemophilia A or B who have inhibitors to factor VIII or IX and in patients with acquired hemophilia

Adults: Initially, 90 mcg/kg I.V. immediately before intervention and repeated at 2-hour intervals for duration of surgery. For minor surgery, administer postsurgical doses by I.V. bolus injection at 2-hour intervals for first 48 hours and then at 2- to 6-hour intervals until healing has occurred. For major surgery, administer postsurgical doses by I.V. injection at 2-hour intervals for 5 days, followed by 4-hour intervals until healing has occurred. Administer additional bolus doses, if required.

Bleeding episodes or prevention of bleeding in surgical intervention or invasive procedures in patients with congenital factor VII deficiency

Adults: 15 to 30 mcg/kg I.V. q 4 to 6 hours until hemostasis is achieved. Effective treatment has been achieved with dosages as low as 10 mcg/kg.

Bleeding episodes or surgery in patients with acquired hemophilia

Adults: 70 to 90 mcg/kg I.V., repeated q 2 to 3 hours until hemostasis is achieved

Contraindications

None

Precautions

Use cautiously in:
• hypersensitivity to drug, its components, or mouse, hamster, or bovine products
• prolonged use of drug
• concomitant use of activated or non-activated prothrombin complex concentrates (avoid use)
• patients with increased risk of thromboembolic complications (including advanced atherosclerotic disease, crush injury, septicemia, history of coronary heart disease, liver disease, disseminated intravascular coagulation, postoperative immobilization, elderly patients and neonates)
• pregnant or breastfeeding patients
• children.

Administration

• Monitor factor VII-deficient patients for prothrombin time and factor VII coagulant activity before administering drug.

Give by I.V. bolus only over 2 to 5 minutes, depending on dosage.
• Reconstitute only with specified volume of diluent supplied.

Don't mix with sterile water for injection or infusion solutions.

Don't inject diluent directly on the powder.
• Administer within 3 hours of reconstituting. If line needs to be flushed before or after administering drug, use normal saline solution.

Adverse reactions

CNS: headache,

cerebral artery occlusion, cerebrovascular accident

CV: hypertension, hypotension, bradycardia, angina, superficial thrombophlebitis, thrombophlebitis, deep vein thrombosis, coagulation disorder, disseminated intravascular coagulation (DIC), increased fibrinolysis, purpura

GI: nausea, vomiting

GU: renal dysfunction

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

Musculoskeletal: arthrosis, arthralgia

Respiratory: pneumonia, pulmonary embolism

Skin: pruritus, rash, urticaria

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. If DIC or thrombosis is confirmed, reduce dosage or discontinue drug, depending on patient's symptoms.
• Monitor factor VII-deficient patients for prothrombin time and factor VII coagulant activity before and after administering drug. If factor VIIa activity fails to reach expected level, prothrombin time isn't corrected, or bleeding isn't controlled after treatment with recommended dosages, antibody formation may be suspected and analysis for antibodies should be performed.
• 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.
• Monitor renal function tests.

Patient teaching

Instruct patient to immediately report signs and symptoms of hypersensitivity reactions (including hives, urticaria, chest tightness, or wheezing) and thrombosis (including new-onset swelling and pain in limbs or abdomen, new-onset chest pain, shortness of breath, loss of sensation, or altered consciousness or speech).
• 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.

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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References in periodicals archive ?
About the recombinant fusion protein linking coagulation factor VIIa with recombinant albumin (rVIIa-FP) Preclinical studies have confirmed that CSL Behring's rVIIa-FP has favorable pharmacokinetic properties compared with the existing recombinant FVIIa product.
About the recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) Preclinical studies have confirmed that CSL Behring's rVIIa-FP has favorable pharmacokinetic properties compared with the existing recombinant FVIIa product.
a pioneer in the discovery and development of engineered proteases known as Alterase(TM) therapeutics, announced that it has selected CB 813, an improved, second-generation variant of human coagulation factor VIIa, as a development candidate for the treatment of acute bleeding in hemophilia patients.
com/cgi-bin/prnh/20020404/NVOLOGO ) * Reported sales increased by 16% in the first nine months of 2006 - Sales of insulin analogs increased by 52% - Sales of NovoSeven(R) Coagulation Factor VIIa (Recombinant) increased by 13% - Sales of Norditropin(R) (somatropin [rDNA origin] injection) increased by 21% - Sales in North America increased by 29% - Sales in International Operations increased by 22% * Gross profit increased by 20% reflecting a continued improvement in the production economy, thereby expanding the gross margin by 2.
These proteins include recombinant forms of human coagulation factor VIIa, factor VIII, alpha-1 antitrypsin and ATryn([R]), GTC's recombinant form of human antithrombin, which has been approved for use in Europe and is nearing completion of a comparative clinical study in the United States.
FDA Approves Supplemental Use of NovoSeven(R) Coagulation Factor VIIa (Recombinant) for Treatment of Acquired Hemophilia ~
Reported sales increased by 20% in the first six months of 2006 -- Sales of insulin analogs increased by 59% -- Sales of NovoSeven(R) Coagulation Factor VIIa (Recombinant) increased by 19% -- Sales in North America increased by 31% -- Sales in International Operations increased by 41% -- Operating profit increased by 17% to USD 742 million.

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