Pronunciation:

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

Brand Names:

• Sevenfact

Dosage Forms:

• Powder for Solution

Warnings:

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—

Antihemophilic Agent

Uses of This Medicine:

Coagulation factor VIIa-jncw is used to treat and prevent bleeding episodes in patients with Hemophilia A or B. Factor VIIa-jncw 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.

This medicine 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 coagulation factor VIIa-jncw in children 12 years of age and older.

Older adults—

Adequate and well-controlled studies have not been done on the relationship of age to the effects of coagulation factor VIIa-jncw 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:

• Allergic reaction to rabbits or rabbit proteins, history of—Should not be used in patients with this condition.

• Blood clots or a history of medical problems caused by blood clots (eg, atherosclerotic disease, cerebrovascular disease, coronary artery disease, thromboembolism) or
• Infection (septicemia) 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 or your child 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 or your child's 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 had medical conditions such as intravascular coagulation, or arterial or venous thromboembolic 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:

Less common

Back pain

chest tightness

chills

dizziness

fever

flushing

headache

nausea and vomiting

redness, pain, or swelling at the injection site

trouble breathing

weakness

Incidence not known

Blood in the stools or urine

bruising

confusion

coughing or vomiting blood

difficulty swallowing

fast heartbeat

hives, itching, or rash

persistent bleeding or oozing from puncture sites, mouth, or nose

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness in the chest

unusual tiredness or weakness

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.