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Generic Name: anti-inhibitor coagulant complex (koe-AG-ue-lant)
Brand Name: Feiba NF and Feiba VH Immuno
Serious blood clots, heart attack, and stroke have occurred in patients using Feiba NF. The risk of blood clots may be greater in patients who use high doses of Feiba NF. It may also be greater in the elderly, newborns, and in patients who have other risk factors of developing blood clots (eg, history of coronary heart disease, liver disease, disseminated intravascular coagulation [DIC]). Patients who are confined to a bed or chair for a period of time after surgery may also have a greater risk of developing blood clots. Discuss any questions or concerns with your doctor.
Feiba NF is used for:
Controlling bleeding episodes or bleeding during surgery in patients who have hemophilia A or B with inhibitors. It should not be used to treat patients with other bleeding disorders. It may also be used for other conditions as determined by your doctor.
Feiba NF is a clotting factor. It works by correcting the clotting defect, which allows blood clots to form.
Do NOT use Feiba NF if:
- you are allergic to any ingredient in Feiba NF
- you have normal blood clotting
- you have bleeding episodes caused by hemophilia A or B without inhibitors or bleeding episodes caused by other clotting factor deficiencies
- you have DIC or symptoms of DIC (eg, unusual bruising or bleeding; arm or leg pain, swelling, redness, or tenderness; shortness of breath; coughing up blood; chest pain)
- you are taking an antifibrinolytic (eg, aminocaproic acid, tranexamic acid)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Feiba NF:
Some medical conditions may interact with Feiba NF. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have certain blood conditions other than hemophilia (eg, acquired fibrinolytic bleeding; acquired inhibitors against clotting factors VIII, IX, or XII), have had a recent heart attack, blood clots, or if you are at risk of developing blood clots
- if you have an infection in the blood, a certain kind of injury (crush injury), or a history of coronary heart disease, hardening or narrowing of blood vessels, liver problems, blood infection, or DIC
Some MEDICINES MAY INTERACT with Feiba NF. Tell your heath care provider if you are taking any other medicines, especially any of the following:
- Antifibrinolytics (eg, aminocaproic acid, tranexamic acid) or recombinant factor VIIa because it may increase the risk of Feiba NF's side effects
How to use Feiba NF:
Use Feiba NF as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Feiba NF is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Feiba NF at home, carefully follow the injection procedures taught to you by your health care provider.
- If Feiba NF contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
- To use Feiba NF, allow both vials to reach room temperature.
- Do not shake Feiba NF. Swirl gently to mix.
- Do not use Feiba NF beyond the expiration date on the container.
- Any leftover medicine or supplies used with Feiba NF should be placed in a plastic bag and disposed of as instructed by your doctor or pharmacist.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials.
- If you miss a dose of Feiba NF, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Feiba NF.
Important safety information:
- Dizziness may occur while you are using Feiba NF. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Feiba NF. Using Feiba NF alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Feiba NF is made from human blood. There is a rare risk of getting a viral disease (eg, hepatitis, parvovirus B19) or a central nervous system disease called Creutzfeldt-Jakob disease from products made from human blood. Steps are taken by the manufacturer to decrease the risk of getting such a disease from Feiba NF; however, this may still rarely occur. Discuss any questions or concerns with your doctor.
- Contact your doctor if you develop symptoms of hepatitis A or parvovirus B19. Symptoms of hepatitis A may include loss of appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Symptoms of parvovirus B19 may include fever, drowsiness, chills, and runny nose followed about 2 weeks later by rash and joint pain.
- Lab tests, including blood pressure monitoring, fibrinogen counts, and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Feiba NF with caution in the ELDERLY; they may be more sensitive to its effects, especially blood clots.
- Use Feiba NF with extreme caution in NEWBORNS. Safety and effectiveness in this age group have not been confirmed. Newborns may be at higher risk of blood clots.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Feiba NF while you are pregnant. If you are or will be breast-feeding while you use Feiba NF, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Feiba NF:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; decreased sense of touch; decreased urination; difficulty swallowing; dizziness; fainting; flushing; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision problems); symptoms of serious blood clot (eg, arm or leg pain; swelling, redness, or tenderness; shortness of breath; coughing up blood; chest pain; change in pulse rate; dizziness; severe or persistent headache); symptoms of stroke (eg, confusion, one-sided weakness, vision problems, slurred speech); unusual bruising or bleeding; unusual, persistent, or severe headache; weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms of overdose may include symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision problems); symptoms of serious blood clot (eg, arm or leg pain, swelling, redness, or tenderness; shortness of breath; coughing up blood; chest pain; change in pulse rate; dizziness; severe or persistent headache); symptoms of stroke (eg, confusion, one-sided weakness, vision problems, slurred speech).Proper storage of Feiba NF:
Feiba NF is usually handled and stored by a health care provider. If you are using Feiba NF at home, store Feiba NF as directed by your pharmacist or health care provider. Keep Feiba NF out of the reach of children and away from pets.
- If you have any questions about Feiba NF, please talk with your doctor, pharmacist, or other health care provider.
- Feiba NF is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Feiba NF or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Feiba NF. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Feiba NF. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Feiba NF.