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 ?g 2400 ?g 4800 ?g
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 ?g/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,...

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 »

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,...

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 »

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,...

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 »


Novoseven Consumer (continued)

SIDE EFFECTS: Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling ankles/feet, new or worsening bleeding/bruising, new or worsening joint pain/swelling.

Get medical help right away if any of these rare but very serious side effects occur: pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, fast/slow heartbeat, sudden vision changes, weakness on one side of the body, slurred speech, confusion, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 milk. Because of the possible risk to the infant, consult your doctor before breast-feeding.


Novoseven Patient Information Including Side Effects

Brand Names: NovoSeven, NovoSeven RT

Generic Name: coagulation factor VIIa (injection) (Pronunciation: koe AG yoo LAY shun FAK tor )

  • What is coagulation factor VIIa (Novoseven)?
  • What are the possible side effects of coagulation factor VIIa (Novoseven)?
  • What is the most important information I should know about coagulation factor VIIa (Novoseven)?
  • What should I discuss with my healthcare provider before using coagulation factor VIIa (Novoseven)?
  • How should I use coagulation factor VIIa (Novoseven)?
  • What happens if I miss a dose (Novoseven)?
  • What happens if I overdose (Novoseven)?
  • What should I avoid while using coagulation factor VIIa (Novoseven)?
  • What other drugs will affect coagulation factor VIIa (Novoseven)?
  • Where can I get more information?

What is coagulation factor VIIa (Novoseven)?

Coagulation factor VIIa is a man-made protein that is similar to a natural protein in the body that helps the blood to clot.

Coagulation factor VIIa is used to treat or prevent bleeding in people with hemophilia A or hemophilia B, or factor VII deficiency.

Coagulation factor VIIa may also be used for other purposes not listed in this medication guide.

What are the possible side effects of coagulation factor VIIa (Novoseven)?

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 swelling in one or both legs.

Less serious side effects may include:

  • headache;
  • joint pain;
  • nausea, vomiting;
  • swelling;
  • mild itching or rash; or
  • pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about coagulation factor VIIa (Novoseven)?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have coronary artery disease (hardening of the arteries), a history of stroke or heart attack, a severe injury or infection, or if you are allergic to mouse, hamster, or pork proteins.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Carry an ID card or wear a medical alert bracelet stating that you have a bleeding disorder in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know about your condition.

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