ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT-Fc - INJECTION

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ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT-Fc - INJECTION

PHONETIC PRONUNCIATION: (AN-tye-HEE-moe-FIL-ik FAK-tor)

COMMON BRAND NAME(S): Eloctate

GENERIC NAME(S): antihemophilic factor (FVIII) recombinant, Fc fusion protein

Uses

USES: This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.


How to use ANTIHEMOPHILIC FACTOR (FACTOR VIII), RECOMBINANT-Fc - 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 as directed by your doctor, usually no faster than 10 milliliters per minute. The injection time may be different, depending on your dose and how you respond to it. After first receiving this medication in a clinic or hospital, some people may be able to give this medication to themselves at home. If your doctor directs you to use this medication at home, read and learn all preparation and usage instructions in the product package. Learn how to store and discard medical supplies safely. If you have any questions, ask your health care professional. If the medication and the solution used to mix it are refrigerated, take them out of the refrigerator ahead of time and let them come to room temperature before mixing. After mixing, gently swirl to completely dissolve the powder. Do not shake. Before using this medication, check it visually for particles or discoloration. If either is present, do not use the liquid. Use the mixed medication as soon as possible, but no later than 3 hours after mixing. Do not refrigerate the mixed medication. The dosage is based on your medical condition, weight, blood test results, and response to treatment. Children younger than 6 years may need higher doses. Follow your doctor's instructions carefully. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: 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, 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, 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. 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. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). The manufacturers of some brands of this medication recommend that you check your pulse while giving yourself the injection. If your heart starts to beat faster, you may need to give this medication more slowly or 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 unknown if this medication passes into breast milk. 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.

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-Fc - INJECTION

Antihe-mophilic Factor (Factor VIII), Recombinant-Fc is a medication used to treat and control bleeding in patients with Hemophilia A, a rare genetic bleeding disorder caused by a deficiency in clotting factor VIII.

Antihe-mophilic Factor (Factor VIII), Recombinant-Fc works by replacing the missing or deficient factor VIII in patients with Hemophilia A. It helps blood to clot and control bleeding episodes.

Antihe-mophilic Factor (Factor VIII), Recombinant-Fc is administered through injection, either into a vein (intravenous) or into a port catheter.

The dosage of Antihe-mophilic Factor (Factor VIII), Recombinant-Fc varies depending on the patient's weight, severity of the bleeding episode, and response to treatment. It is important to follow the instructions provided by the healthcare provider.

Common side effects of Antihe-mophilic Factor (Factor VIII), Recombinant-Fc may include headache, nausea, vomiting, fever, injection site reactions, and allergic reactions. It is important to seek immediate medical attention if severe allergic reactions occur.

It is advisable to consult a healthcare provider before using Antihe-mophilic Factor (Factor VIII), Recombinant-Fc during pregnancy or breastfeeding. They can provide guidance based on individual circumstances and the potential risks and benefits.

Antihe-mophilic Factor (Factor VIII), Recombinant-Fc may interact with certain medications, such as anticoagulants. It is important to inform the healthcare provider about all medications being taken to avoid any potential interactions.

Antihe-mophilic Factor (Factor VIII), Recombinant-Fc should be stored in the refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze it. It should be protected from light.

If a dose of Antihe-mophilic Factor (Factor VIII), Recombinant-Fc is missed, it should be taken as soon as possible. However, if it is almost time for the next scheduled dose, the missed dose should be skipped and the regular dosing schedule should be followed.

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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.