FACTOR VIIA, RECOMBINANT - INJECTION

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FACTOR VIIA, RECOMBINANT - INJECTION

PHONETIC PRONUNCIATION: (factor VIIA,ree-KOM-bin-unt)

COMMON BRAND NAME(S): Novoseven

GENERIC NAME(S): coagulation factor VIIa (recombinant)

Uses

USES: 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 therefore stop bleeding.


How to use FACTOR VIIA, RECOMBINANT - INJECTION

HOW TO USE: 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 usually over several minutes. The dose is usually repeated every 2 to 6 hours or as directed by your doctor. 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 visually 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 improve or if it worsens.

Side Effects

SIDE EFFECTS: See also Warning Section. Fever, headache, pain/redness/irritation at the injection site, dizziness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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.

Precautions

PRECAUTIONS: Before using factor VIIa, tell your doctor or pharmacist if you are allergic to it; or to animal proteins (e.g., mouse, hamster, cow); 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 (e.g., disseminated intravascular coagulation-DIC), blood vessel problems (e.g., 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. Because of the possible risk to the infant, consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: 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).

Overdose

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for FACTOR VIIA, RECOMBINANT - INJECTION

Factor VIIa, Recombinant - Injection is used to treat and prevent bleeding episodes in patients with hemophilia A or B with inhibitors or congenital Factor VII deficiency.

Factor VIIa, Recombinant works by helping the blood to clot. It activates certain clotting factors in the blood, leading to the formation of a clot and stopping bleeding.

Factor VIIa, Recombinant is administered through an injection directly into a vein or as a continuous infusion.

Common side effects may include headache, injection site reactions, fever, and nausea. Serious side effects include blood clots, allergic reactions, and an increased risk of heart attack or stroke.

Factor VIIa, Recombinant works quickly and should start to stop bleeding within 10-30 minutes after the injection.

The safety of Factor VIIa, Recombinant - Injection during pregnancy or breastfeeding has not been established. It should only be used if the benefits outweigh the potential risks.

The dosing and frequency of Factor VIIa, Recombinant - Injection will depend on the individual's specific condition and the severity of their bleeding episodes. It is important to follow the dosing instructions provided by the healthcare provider.

Factor VIIa, Recombinant - Injection is typically administered under the supervision of a healthcare professional. However, in certain cases, patients may receive training to self-administer the medication at home.

Factor VIIa, Recombinant - Injection is not a cure for hemophilia. It is used to manage and prevent bleeding episodes in patients with hemophilia A or B with inhibitors or congenital Factor VII deficiency.

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Warning

WARNING: This medication has caused very serious blood clots (such as heart attack, stroke, pulmonary embolus-PE, deep vein thrombosis-DVT). 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 you develop symptoms of a blood clot, such as pain/swelling/redness/weakness of the arms or legs, calf pain/swelling that is warm to the touch, shortness of breath, coughing up blood, chest/jaw/left arm pain, sudden vision changes, weakness on one side of the body, slurred speech, or confusion.


Disclaimer

IMPORTANT: 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.