Coagulation factor viia-jncw (Intravenous)

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 that mimics the naturally occurring activated factor VII (factor VIIa) in the body. It is used to stop bleeding from injuries in patients with hemophilia by helping the blood to clot.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important that your doctor closely monitors you or your child's progress while receiving this medicine to ensure it is effective. Blood tests might be necessary to check for unwanted effects.

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

This medicine may increase your risk of blood clotting issues. The risk is higher if you have had medical conditions such as intravascular coagulation, or arterial or venous thromboembolic disease, or if you are taking certain blood clotting medicines. Inform your doctor immediately if you have a sudden or severe headache, problems with vision or speech, chest pain, shortness of breath, or numbness or weakness while receiving this medicine.

In deciding to use a medicine, you need to think about the risks and benefits. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not found specific problems that would limit the use of coagulation factor viia-jncw in children aged 12 years and older.

Geriatric

There have not been enough well-controlled studies to understand how age affects the use of coagulation factor viia-jncw in older patients.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while you are receiving this medicine. The following interactions have been highlighted because they may be significant, but this list may not cover all possible interactions.

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, 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 issues caused by blood clots (e.g., atherosclerotic disease, cerebrovascular disease, coronary artery disease, thromboembolism) or
• Infection (septicemia) or
• Injury (crush)—These conditions may increase the risk of developing blood clots.

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.

In the U.S.

• Sevenfact

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

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.