Hemofil-M (human)

Hemofil-M is a protein that naturally occurs in the blood and helps with blood clotting. A shortage of antihemophilic factor VIII causes hemophilia A. This medicine works by temporarily increasing the levels of factor VIII in the blood to help with clotting.

Human Hemofil-M is used to treat or prevent bleeding episodes in individuals with hemophilia A. It is also used to control bleeding during surgery or dental procedures in someone with hemophilia.

Human Hemofil-M is not for people with von Willebrand disease.

Human Hemofil-M may also be used for reasons not mentioned in this medication guide.

You should not use Hemofil-M if you have ever had a severe allergic reaction to Hemofil-M before.

Your body may create antibodies to Hemofil-M, which can make it less effective. Call your doctor if this medicine appears to be less effective in controlling your bleeding.

Make sure to follow all instructions on how to store this medicine. Each brand of human Hemofil-M may have specific guidelines about whether to keep the medicine in a refrigerator or at room temperature, and for how many months it can be stored.

You should not use this medicine if you have ever had a severe allergic reaction to Hemofil-M, or if you are allergic to mouse proteins.

Before using human Hemofil-M, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. This medicine will not treat von Willebrand disease.

Your doctor may want you to receive a hepatitis vaccination before you start using human Hemofil-M.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether human antihemophilic factor passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Some brands of human Hemofil-M are not approved for use by anyone younger than 18 years old. Ask your pharmacist if you have any questions about the specific brands of this medicine.

Human Hemofil-M is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Get emergency medical help if you notice signs of an allergic reaction: hives; chest tightness, wheezing, trouble breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Human Hemofil-M can cause serious side effects. Stop using human Hemofil-M and call your doctor right away if you experience:

• a tingling feeling in your face, ears, or arms;
• headache, blurred vision, feeling jittery;
• fever, chills, drowsiness, and a runny nose followed by a skin rash and joint pain 2 weeks later; or
• nausea, vomiting, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Hemofil-M may include:

• swelling, stinging, or irritation at the injection site;
• chills;
• mild nausea; or
• allergic reaction.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label. Do not use Hemofil-M in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Human Hemofil-M is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Always wash your hands before preparing and giving your injection.

Human Hemofil-M is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

After mixing the medicine and diluent, keep the mixture at room temperature and use it within 3 hours. Do not put mixed medicine into a refrigerator.

Prepare your dose in a syringe only when you are ready to give yourself an injection. A single-use vial is for one use only. After measuring your dose, throw this vial away, even if there is medicine left in it.

Do not use human Hemofil-M if it has changed colors or has particles in it. Call your pharmacist for new medication.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

You may need to check your pulse before and during your injection. If your pulse becomes rapid, slow down or stop the injection until your pulse rate returns to normal.

While using human Hemofil-M, you may need frequent blood tests.

Your body may develop antibodies to Hemofil-M, making it less effective. Call your doctor if this medicine seems to be less effective in controlling your bleeding.

Carefully follow all instructions about how to store this medicine. Each brand of human Hemofil-M may have specific storage instructions.

Store the medicine and the diluent in their original container in the refrigerator. Do not freeze. Before preparing your dose, take these items of the refrigerator and allow them to reach room temperature.

You may also store the medicine and diluent at room temperature until the expiration date on the label. Some brands of this medicine can be stored at room temperature for only a certain number of months, or until the expiration date (whichever comes first). Follow the storage directions on the medicine label.

If you store this medicine at room temperature, do not return it to the refrigerator.

Do not store this medicine in bright light. Throw away any leftover medicine and diluent if the expiration date has passed.

Wear a medical alert tag or carry an ID card stating that you have hemophilia. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Human Hemofil-M is sometimes used on an as-needed basis, so you might not have a regular dosing schedule. If you do have a schedule and miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to compensate for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with antihemophilic factor (human), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform all your health care providers about all medicines you are currently using and any medicine you begin or discontinue.