Novoseven (Intravenous)

Factor VIIa is used to treat and prevent bleeding episodes in patients with Hemophilia A or B who have developed antibodies against other clotting proteins (e.g., Factor VIII or Factor IX) that help stop bleeding. 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 caused by a blood abnormality) that has been treated with platelet transfusions but did not work well.

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

Factor VIIa must be given only by or under the direct supervision of your doctor.

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.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking it against the benefits it may provide. For this medicine, consider the following:

Allergies

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

Pediatric

Current studies have not shown any specific problems in children that would limit the use of Factor VIIa.

Geriatric

There have not been enough well-controlled studies to understand how age affects the use of Factor VIIa in older patients.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there could be an interaction. In such cases, your doctor may adjust the dose or take other precautions. It is important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions are noted for their potential significance but may not be all-inclusive.

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods because interactions may happen. Using alcohol or tobacco with some medicines can also lead to interactions. Discuss with your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Blood clots or a history of problems caused by blood clots
• Heart disease (e.g., coronary heart disease) or a history of it
• Infection
• Injury (crush)
• Liver disease—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, 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.

In the U.S.

• Novoseven
• NovoSeven RT
• Sevenfact

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Hemostatic

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.