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Novoseven

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Novoseven

NovoSeven®
Coagulation Factor VIIa Recombinant

Novoseven

DRUG DESCRIPTION

NovoSeven®is recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. 1 NovoSeven (coagulation factor viia recombinant) is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW 50 K Dalton). NovoSeven (coagulation factor viia recombinant) is structurally similar to human plasma-derived Factor VIIa.

The gene for human Factor VII is cloned and expressed in baby hamster kidney cells (BHK cells). Recombinant FVII is secreted into the culture media (containing newborn calf serum) in its single-chain form and then proteolytically converted by autocatalysis to the active two-chain form, rFVIIa, during a chromatographic purification process. The purification process has been demonstrated to remove exogenous viruses (MuLV, SV40, Pox virus, Reovirus, BEV, IBR virus). No human serum or other proteins are used in the production or formulation of NovoSeven.

NovoSeven is supplied as a sterile, white lyophilized powder of rFVIIa in single-use vials.

Each vial of lyophilized drug contains the following:

Contents 1.2 mg
(60 KIU) Vial
2.4 mg
(120 KIU) Vial
4.8 mg
(240 KIU) Vial
rFVIIa 1200 μg 2400 μg 4800 μg
sodium chloride* 5.84 mg 11.68 mg 23.36 mg
calcium chloride dihydrate* 2.94 mg 5.88 mg 11.76 mg
glycylglycine 2.64 mg 5.28 mg 10.56 mg
polysorbate 80 0.14 mg 0.28 mg 0.56 mg
mannitol 60.0 mg 120.0 mg 240.0 mg
*per mg of rFVIIa:0. 44 mEq sodium, 0. 06 mEq calcium

After reconstitution with the appropriate volume of Sterile Water for Injection, USP (not supplied), each vial contains approximately 0. 6 mg/mL NovoSeven (coagulation factor viia recombinant) (corresponding to 600 μg/mL). The reconstituted vials have a pH of approximately 5. 5 in sodium chloride (3 mg/mL), calcium chloride dihydrate (1. 5 mg/mL), glycylglycine (1. 3 mg/mL), polysorbate 80 (0. 1 mg/mL), and mannitol (30 mg/mL).

The reconstituted product is a clear colorless solution which contains no preservatives. NovoSeven (coagulation factor viia recombinant) contains trace amounts of proteins derived from the manufacturing and purification processes such as mouse IgG (maximum of 1. 2 ng/mg), bovine IgG (maximum of 30 ng/mg), and protein from BHK-cells and media (maximum of 19ng/mg).

What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • any bleeding that will not stop;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pain or...

Read All Potential Side Effects and See Pictures of Novoseven »

What are the precautions when taking coagulation factor viia (recombinant) (Novoseven)?

Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious infection in the blood, recent serious injury.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast...

Read All Potential Precautions of Novoseven »

REFERENCES

What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • any bleeding that will not stop;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pain or...

Read All Potential Side Effects and See Pictures of Novoseven »

What are the precautions when taking coagulation factor viia (recombinant) (Novoseven)?

Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious infection in the blood, recent serious injury.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast...

Read All Potential Precautions of Novoseven »

1. Roberts, H. R. : Thoughts on the mechanism of action of FVIIa, 2nd Symposium on New Aspects of Hemophilia Treatment, Copenhagen, Denmark, 1991, pgs. 153-156.

What are the possible side effects of coagulation factor VIIa (NovoSeven, NovoSeven RT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • any bleeding that will not stop;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance; or
  • pain or...

Read All Potential Side Effects and See Pictures of Novoseven »

What are the precautions when taking coagulation factor viia (recombinant) (Novoseven)?

Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other bleeding/clotting problems (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., atherosclerosis), recent serious infection in the blood, recent serious injury.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast...

Read All Potential Precautions of Novoseven »

Last reviewed on RxList: 1/12/2009
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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