FACTOR VIII/VON WILLEBRAND FACTOR, HUMAN - INJECTION

FACTOR VIII/VON WILLEBRAND FACTOR, HUMAN - INJECTION

PHONETIC PRONUNCIATION: (AN-tee-he-mow-FILL-ick factor/von wil-LE-brand factor)

COMMON BRAND NAME(S): Alphanate, Humate-P

GENERIC NAME(S): antihemophilic factor, human/von Willebrand factor,human

Uses

USES: This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. Factors are proteins normally found in the blood that help the blood to thicken (clot) and stop any bleeding. People with low levels of factor VIII and von Willebrand factor are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product is used to temporarily replace the missing factors and reduce bleeding. Different brands of this product have different amounts of these factors, and therefore different uses. These products are not interchangeable. Do not change brands of this medication without the approval of your doctor. Some products are used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Some products are used to treat bleeding episodes in people with low levels of von Willebrand factor (von Willebrand disease) who do not respond to or cannot tolerate desmopressin. Some products are used to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.


How to use FACTOR VIII/VON WILLEBRAND FACTOR, HUMAN - INJECTION

HOW TO USE: This medication is given by slow injection into a vein as directed by your doctor. How fast you receive this medication depends on your dose and how you respond to it. See Side Effects section. This medication is given in a hemophilia treatment center or hospital. In some cases, 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 product information 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. 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 vial to completely dissolve the powder. Do not shake the vial. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. After the medication is mixed, use right away. The dosage is based on your medical condition, weight, blood test results, and response to treatment. Follow your doctor's instructions closely. Ask your doctor or pharmacist if you have any questions. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

SIDE EFFECTS: Flushing of the face, nausea, vomiting, and fast heartbeat may sometimes occur and can be lessened by giving this medication more slowly. Burning/redness/irritation at the injection site, fever, chills, and numbness/tingling of the hands/feet 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. Tell your doctor right away if any of these unlikely but serious side effects occur: signs of anemia (e.g., tiredness, low energy, pale skin color, shortness of breath), new or worsening bleeding/bruising. This medication may rarely cause serious blood clots. Seek immediate medical attention if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, coughing up blood, chest/jaw/left arm pain, sudden vision changes, confusion, slurred speech, weakness on one side of the body, sudden severe headache, fainting. This medication is made from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor right away if you develop any signs of hepatitis or other infection, including fever, persistent sore throat, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine. 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. 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 clotting factor 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. Manufacturers of some factor VIII products 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. Since this medication is made from human blood, there is a very small chance that you may get infections from it (e.g., viral infections such as hepatitis). It is recommended that you get the appropriate vaccinations (e.g., for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. 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 FACTOR VIII/VON WILLEBRAND FACTOR, HUMAN - INJECTION

Factor VIII/Von Willebrand Factor, Human injection is used to treat and prevent bleeding episodes in patients with hemophilia A (a genetic blood clotting disorder) or von Willebrand disease (a bleeding disorder).

Factor VIII/Von Willebrand Factor, Human is a protein that helps in blood clotting. In people with hemophilia A or von Willebrand disease, their bodies do not produce enough or do not produce functional Factor VIII/Von Willebrand Factor. The injection replaces or supplements this factor, allowing the blood to clot properly.

Factor VIII/Von Willebrand Factor, Human injection is administered intravenously (into a vein) by a healthcare professional. It should not be injected directly into a muscle or under the skin.

Common side effects include headache, nausea, diarrhea, fever, localized swelling or redness at the injection site, and dizziness. Serious side effects include allergic reactions, blood clots, and the development of inhibitors (antibodies) that may reduce the effectiveness of the medication.

Patients should inform their healthcare provider about any allergies, medical conditions, or medications they are taking. They should also inform their doctor if they have a history of developing inhibitors to Factor VIII medications. Regular monitoring of blood clotting factors and platelet function may be necessary.

The frequency of administration depends on the individual's condition and their doctor's instructions. It may be needed on demand to treat bleeding episodes, or it may be prescribed as prophylaxis to prevent bleeding in certain patients.

Yes, some patients are trained to self-administer the injection at home. However, proper training and guidance from a healthcare professional are essential before starting self-administration.

The use of Factor VIII/Von Willebrand Factor, Human injection during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential risks and benefits need to be considered on an individual basis.

Yes, Factor VIII/Von Willebrand Factor, Human injection requires a prescription from a healthcare professional.



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.