SevenFact 5 mg (5,000 mcg) intravenous solution

Generic name:
Factor viia, recombinant - injection

Pronunciation
(factor VIIA,ree-KOM-bin-unt)

Brand name(s)
Novoseven

This medication has caused serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, liver disease, or if you are immobile (such as being bedridden after surgery). Talk with your doctor about the risks and benefits of this medication. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, sudden vision changes, weakness on one side of the body, trouble speaking, or confusion.

This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and stop bleeding.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually every 2 to 6 hours until no longer needed. The dosage is based on your medical condition, weight, and response to treatment.

Do not inject the mixing solution directly into the medication powder because this may cause the medication to become ineffective. Aim the syringe so that the water flows gently down the side of the vial. Do not shake the vial. Gently swirl the mixture until all the powder has dissolved. Do not mix this medication with any other drugs.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning Section.

Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• swelling ankles/feet
• new or worsening bleeding/bruising
• new or worsening joint pain/swelling
• fast/slow heartbeat
• signs of kidney problems (such as change in the amount of urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other bleeding/clotting problems (such as disseminated intravascular coagulation-DIC)
• blood vessel problems (such as atherosclerosis)
• recent serious infection in the blood
• recent serious injury

Newborns may be at greater risk for blood clots while using this drug.

Older adults may be at greater risk for blood clots while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This product should not be given at the same time as certain other clotting factor products (activated and non-activated prothrombin complex concentrates).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as clotting time tests, factor VII activity) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.