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Coagulation factor viia (Intravenous route)

Pronunciation:

koh-a-gyoo-LAY-shun FAK-tor SEV-en A

Brand Names:

  • Novoseven
  • NovoSeven RT

Dosage Forms:

  • Powder for Solution

Warnings:

Intravenous route(Powder for Solution)

Serious arterial and venous thrombotic and thromboembolic adverse events, including fatalities, are associated with the use of coagulation factor VIIa when used outside labeling indications. Patients should be advised and monitored on the signs/symptoms of thrombotic and thromboembolic events .

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Factor VIIa is used to treat and prevent bleeding episodes in patients with Hemophilia A or B who have formed antibodies against other clotting proteins (e.g., Factor VIII or Factor IX) that help bleeding to stop. It is also used to treat or prevent bleeding in patients with acquired hemophilia or congenital Factor VII deficiency.

Factor VIIa is a man-made protein produced to replicate the naturally occurring activated factor VII (factor VIIa) in the body. It is used to stop bleeding of injuries for patients with hemophilia by helping the blood to clot.

Factor VIIa is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Factor VIIa in children.

Older adults—

Adequate and well-controlled studies have not been done on the relationship of age to the effects of Factor VIIa in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for unwanted effects.

If you notice early signs of a hypersensitivity reaction such as hives, skin rash, tightness of the chest or wheezing, lightheadedness or dizziness, notify your physician immediately.

This medicine may increase your chance of having blood clotting problems. Tell your doctor right away if you have sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while you are receiving this medicine.

Side Effects of This Medicine:

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
Bleeding problems
fever
high blood pressure
joint or muscle pain and/or stiffness
Less common or rare
Bloating or swelling of the face, hands, lower legs, and/or feet
bluish color of the 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 purplish patches on the skin
lightheadedness when getting up from a lying or sitting position suddenly
persistent bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder)
puffiness or swelling of the eyelids or around the eyes
shakiness
shortness of breath
skin rash
slow or irregular heartbeat (less than 50 beats per minute)
slurred speech
sneezing
sore throat
sudden decrease in the amount of urine
swelling of the face, fingers, feet, and/or lower legs
troubled breathing, tightness in the chest, and/or wheezing
unusual tiredness or weakness
weight gain (unusual)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare
Burning or stinging at the injection site
changes in the blood pressure or pulse rate
drowsiness
flushing (redness of the face)
headache
nausea or vomiting
pinpoint red or purple spots on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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