Uses of Eloctate:

• It is used to treat hemophilia.
• It is used to treat or prevent bleeding.

What do I need to tell my doctor BEFORE I take Eloctate?

• If you are allergic to Eloctate (antihemophilic factor (recombinant [fc fusion protein])); any part of Eloctate (antihemophilic factor (recombinant [fc fusion protein])); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Eloctate (antihemophilic factor (recombinant [fc fusion protein])) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Eloctate?

• Tell all of your health care providers that you take Eloctate (antihemophilic factor (recombinant [fc fusion protein])). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Call the doctor right away if the normal dose does not work as well.
• Talk with the doctor before you travel. You will need to bring enough of Eloctate (antihemophilic factor (recombinant [fc fusion protein])) for use during travel.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Eloctate) best taken?

Use Eloctate (antihemophilic factor (recombinant [fc fusion protein])) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• If stored in a refrigerator, let Eloctate (antihemophilic factor (recombinant [fc fusion protein])) come to room temperature before mixing. Do not heat Eloctate (antihemophilic factor (recombinant [fc fusion protein])).
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not shake.
• Use within 3 hours of making.
• After mixing, do not refrigerate. Protect from direct sunlight.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away any part of opened vial not used after use.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Eloctate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Headache.
• Muscle or joint pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Eloctate?

• Store unopened containers in a refrigerator. Do not freeze.
• Store in the original container to protect from light.
• If needed, you may store at room temperature for up to 6 months. Write down the date you take Eloctate (antihemophilic factor (recombinant [fc fusion protein])) out of the refrigerator. If stored at room temperature and not used within 6 months, throw Eloctate (antihemophilic factor (recombinant [fc fusion protein])) away.
• Do not put Eloctate (antihemophilic factor (recombinant [fc fusion protein])) back in the refrigerator after it has been stored at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Eloctate (antihemophilic factor (recombinant [fc fusion protein])), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.