Pronunciation:

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

Brand Names:

• Novoseven
• NovoSeven RT
• Sevenfact

Dosage Forms:

• Powder for Solution

Warnings:

Serious arterial and venous thrombotic events are associated with the use of coagulation factor VIIa. Patients should be advised of the risks and know the signs and symptoms of thrombotic and thromboembolic events. Monitor for signs/symptoms of thrombosis and of activation of the coagulation cascade .

ThrombosisSerious arterial and venous thrombotic events may occur following administration of coagulation factor VIIa recombinant-jncw.Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive coagulation factor VIIa (recombinant)-jncw.Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis .

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 (eg, Factor VIII or Factor IX) that help bleeding to stop. It is also used to treat or prevent bleeding in patients with acquired hemophilia, congenital Factor VII deficiency, or Glanzmann's thrombasthenia (a bleeding disorder that is caused by a blood abnormality) that has been treated with platelet transfusions but did not work well.

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 given only by or under the direct supervision of your doctor.

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.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anti-Inhibitor Coagulant Complex
• Factor XIII
• Prothrombin Complex

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 (eg, coronary heart disease), history of or
• Infection or
• Injury (crush) or
• Liver disease—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.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may increase your chance of having blood clotting problems. The risk is higher if you have a medical condition such as disseminated intravascular coagulation (DIC) or severe artery disease, or if you are taking certain blood clotting medicines. 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 or stiffness

Less common or rare

Bloating or swelling of the face, hands, lower legs, 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, itching, or skin rash

large flat blue or purplish patches on the skin

lightheadedness when getting up suddenly from a lying or sitting position

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

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, or lower legs

troubled breathing, tightness in the chest

unusual tiredness or weakness

unusual weight gain

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

drowsiness

feeling of warmth

headache

nausea or vomiting

pinpoint red or purple spots on the skin

redness of the face, neck, arms and occasionally, upper chest

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.