FACTOR VIIA (Systemic)?

Some commonly used brand names are:

In the U.S.?

• NovoSeven

Other commonly used names are coagulationfactor VIIa (recombinant), eptacog alfa, factor 7, proconvertin, recombinant activated factor VIIa, recombinantcoagulation factor VIIa, recombinant factor VIIa, and rFVIIa.

? Not commercially available in Canada.

Category

• Antihemorrhagic

Description

FactorVIIa is a man-made protein produced to replicate the naturally occurring activatedfactor VII (factor VIIa) in the body. Factor VIIa is used to stop bleedingof injuries for patients with hemophilia by helping the blood to clot. Thisman-made protein, factor VIIa, is used in people who have Hemophilia A orHemophilia B, who have also formed antibodies against other clotting proteinsthat help bleeding to stop. Patients using factor VIIa are usually male.

Factor VIIa is to be administered only by or under the supervision of yourdoctor or other health care professional. It is available in the followingdosage form(s):

Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For factor VIIa, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to factor VIIa or to any products that contain mouse,hamster, or cow proteins. Also tell your doctor and pharmacist if you areallergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein humans.

Breast-feeding?It is not known whether factor VIIa passes intobreast milk. However, because this medicine may cause serious side effects,breast-feeding is generally not recommended while you are receiving it.

Children?This medicine has been tested in children and noside effects or problems were found that were different from those seen inadults.

Older adults?No information is available about the use of factorVIIa in older adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are taking factor VIIa, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

• Activated prothrombin complex concentrates (ie, FEIBA, Autoplex T)or
• Prothrombin complex concentrates (ie, AlphaNine, BeneFix)?Mayincrease the risk of side effects

Other medical problems?The presence of medical problemsmay affect the use of factor VIIa. Make sure to tell your doctor if you haveany medical problems, especially:

• Blood clots or a history of medical problems caused by blood clotsor
• Heart disease or
• Infection or
• Injury (crush)?These conditions may increase the risk of bleeding

Proper Use of This Medicine

This medicineis to be used in a medical setting under the direct supervision of a doctor.

Dosing?The dose of factor VIIa will be differentfor different patients. The dose you receive will be based on:

• Your body weight.
• How much, how often, and where in your body you are bleeding.

Precautions While Using This Medicine

If younotice early signs of a hypersensitivity reaction such as hives, skin rash,tightness of the chest or wheezing, lightheadedness or dizziness, notify yourphysician immediately.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctoras soon as possible if any of the following side effects occur:

More common

Bleeding problems; fever; high blood pressure; joint or musclepain and/or stiffness

Less common or rare

Bloating or swelling of face, hands, lower legs, and/or feet; bluish color hands or feet; blurred vision; changes in facial color; chest pain; chills; cold sweats; confusion; continuing thirst; cough; dizziness; excessive sweating; faintness; fast heartbeat; hives and/or itching; large flat blue or purplishpatches on the skin; lightheadedness when gettingup from a lying or sitting position; persistent bleedingor oozing from puncture sites or mucous membranes [bowel, mouth, nose, orurinary bladder]; puffiness or swelling of eyelidsor around the eyes; shakiness; slurred speech; shortness of breath; skin rash; slow or irregular heartbeat[less than 50 beats per minute]; sneezing; sore throat; sudden decrease in theamount urine; swelling of face, fingers, feet, and/orlower legs; troubled breathing, tightness in chest,and/or wheezing; unusual tiredness or weakness; weight gain (unusual).

Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

Less common or rare

Burning or stinging at the injection site; changes in blood pressure or pulse rate; drowsiness; flushing [redness of face]; headache; pinpoint red or purple spots on skin; nausea or vomiting

. Other side effects not listed above may also occurin some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has beenapproved for marketing for a certain use, experience may show that it is alsouseful for other medical problems. Although this use is not included in productlabeling, factor VIIa is used in certain patients with the following medicalconditions:

• Factor VII deficiency

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.