ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION

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ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION

PHONETIC PRONUNCIATION: (AN-tye-HEE-moe-FIL-ik FAK-tor, ree-KOM-bi-nant)

COMMON BRAND NAME(S): Advate, Adynovate, Kogenate, Obizur, Recombinate

GENERIC NAME(S): antihemophilic factor VIII, human recombinant

Uses

USES: This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels 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 VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.


How to use ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION

HOW TO USE: This medication is given by injection into a vein as directed by your doctor. The medication may need to be given more slowly over a longer time depending on your dose and how you respond to it. After first receiving this medication in a hemophilia treatment center or hospital, some patients may be able to give this medication to themselves at home. If your doctor directs you to give this medication at home, read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If you have any questions, ask your health care professional. If the medication and the solution used to mix it were refrigerated, bring both to room temperature before combining. After adding the solution to the powder, gently swirl the mixture to completely dissolve the powder. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. Use right away according to the product instructions. The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Flushing of the face, headache, nausea, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, and chills may also 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. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/tightness. 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 this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or if you have any other allergies. Some brands may also contain animal proteins (such as mouse, hamster) or inactive ingredients (such as natural rubber/latex), 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. Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal. Consult your doctor for more details. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT - INJECTION

Antihemophilic factor (Factor VIII), recombinant is a medication used to treat and prevent bleeding episodes in patients with hemophilia A, a genetic disorder that impairs the blood's clotting ability. It works by replacing or increasing the levels of Factor VIII in the blood, which is necessary for proper blood clotting.

Common side effects of this medication include headache, fever, chills, nausea, vomiting, rash, itching, injection site reactions, and joint pain.

Antihemophilic factor (Factor VIII), recombinant is given by intravenous (IV) injection into a vein. It is usually administered in a healthcare setting under the supervision of a healthcare professional. Dosage and frequency of administration depend on individual patient needs and the severity of hemophilia A.

Before using this medication, inform your healthcare provider about any allergies, medical conditions, and all other medications you are currently taking. It is important to disclose if you have a history of blood clots or inhibitors to Factor VIII. This medication should not be used during pregnancy unless necessary, as the safety for unborn babies is not well-established.

Yes, this medication can be used in children with hemophilia A, following appropriate dosing guidelines and under the supervision of a healthcare professional. However, the use of antihemophilic factor (Factor VIII), recombinant in infants less than 6 months old should be done with caution due to a higher risk of developing inhibitors.

If you miss a dose, contact your healthcare provider or hemophilia treatment center for instructions. It is important to adhere to the prescribed dosing schedule to maintain adequate Factor VIII levels in the blood.

Drug interactions are not well-documented for this medication. However, it is always important to inform your healthcare provider about all the medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements, to avoid any potential interactions.

This medication should be stored in the refrigerator at a temperature between 2-8 degrees Celsius (36-46 degrees Fahrenheit). It should not be frozen. Always check the manufacturer's instructions for specific storage requirements and expiration dates.

In case of an overdose, seek immediate medical attention. Overdosing on antihemophilic factor (Factor VIII), recombinant may potentially increase the risk of blood clot formation.

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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.