Sevenfact (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 created to mimic the naturally occurring activated factor VII (factor VIIa) in the body. It helps stop bleeding from injuries in patients with hemophilia by aiding the blood to clot.

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

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to ensure 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 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.

In deciding to use a medicine, you need to weigh the risks against the 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 you may have, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children 12 years of age and older that would limit the use of coagulation factor VIIa-jncw.

Geriatric

There have not been enough well-controlled studies on how age affects the use of coagulation factor VIIa-jncw in older adults.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while 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 want to adjust the dose or take other precautions. When you are receiving this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance but may not include all possible interactions.

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential 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

Having other medical issues may affect how you can use this medicine. Be sure to 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 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.