Hemofil-M

Hemofil-M is a prescription medication used to prevent bleeding episodes in children and adults with hemophilia A (cogenital factor VIII deficiency). 

Hemofil-M belongs to a group of drugs called clotting factors. It works by replacing a protein in the blood that is needed to control bleeding that people with hemophilia A are missing.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include fever, headache, and changes in taste.

Hemofil-M can also cause dizziness. Do not drive or operate heavy machinery until you know how Hemofil-M affects you.

Hemofil-M is a prescription medication used to prevent and control bleeding in adults and children with hemophilia A, a genetic disorder that increases bleeding and is caused by a missing or defective protein called factor VIII clotting factor. Advate may also be used to prevent bleeding during surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Baxter Healthcare Bioscience Division

• Baxter Healthcare Corporation

Serious side effects have been reported with Hemofil-M. See the "Hemofil-M Precautions" section.

Common side effects of Hemofil-M include the following:

• headache
• changes in taste
• fever
• swelling at the injection site
• dizziness

This is not a complete list of Hemofil-M side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Hemofil-M including the following:

Hypersensitivity Reactions. Hemofil-M can cause serious allergic reactions. Tell your healthcare provider immediately about any signs or symptoms of an allergic reaction, which include the following:

• dizziness
• numbness or tingling
• rash
• flushing
• swelling in the face
• hives
• itching
• trouble breathing
• vomiting

Neutralizing antibodies. Your body may form inhibitors to factor VIII, known as antibodies. Antibodies are proteins made by the body as a natural part of the immune system in response to something it recognizes as foreign. If your form these inhibitors, Hemofil-M may not work properly. Your healthcare provider will monitor you for development of these inhibitors with blood tests.

Infections. Because Hemofil-M is made from human blood, there is a chance that Hemofil-M may contain infectious agents, such as viruses, that can cause disease. Immediately tell your doctor if you develop any signs or symptoms of an infection, including the following:

• fever
• chills
• nausea or vomiting
• stomach pain
• dark urine
• yellowing of the skin or the white part of the eyes
• fatigue

Do not take Hemofil-M if you:

• are allergic to Hemofil-M or to any of its ingredients
• are allergic to mice or hamsters

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Hemofil-M, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Hemofil-M, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Hemofil-M or to any of its ingredients
• have or have had any medical problems
• are allergic to mice or hamsters
• have been told that you have inhibitors to factor VIII
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Hemofil-M falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Hemofil-M should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Hemofil-M comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

If you miss an appointment to receive a dose of Hemofil-M, contact your healthcare provider for instructions on when to receive your next dose.

The dose and duration of treatment of Hemofil-M your doctor recommends will be based on the following:

• your weight
• the severity of factor VIII deficiency
• the location of the bleeding
• your overall clinical condition
• how you respond to this medication

The recommended dose of Hemofil-M when being used for control and prevention of a bleeding episode depends on the severity and location of the bleed. Your doctor will determine how much your factor VIII needs to increase and determine your dose based on this information. This dose may be given every 8 to 24 hours as determined by your doctor until the bleeding is resolved.

The recommended dose of Hemofil-M when being given during surgery to prevent bleeding is one dose (determined by your doctor based on your factor VIII level) one hour prior to surgery. The dose may be repeated every 8 to 24 hours until bleeding is resolved or you are healed as determined by your doctor.

Your doctor will perform blood tests to measure your level of factor VIII and may adjust your dose or frequency based on the results.

If Hemofil-M is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and laboratory. Your doctor will order lab tests to check your levels of factor VIII to determine your dose and frequency of Hemofil-M.