Adynovate

Antihemophilic Factor (Recombinant [Pegylated]) Injection

(an tee hee moe FIL ik FAK tor ree KOM be nant PEG i late ed)

Adynovate

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

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have an allergy to hamster or mouse protein. This drug 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 this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. 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 this drug 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.

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. Chest pain. Dizziness or passing out. Very upset stomach or throwing up.

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: Headache. Cough. Upset stomach. Mild fever. Irritation where this drug is given. 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.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as a shot into a vein. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot. Wash hands before and after use. If stored in a refrigerator, let this drug come to room temperature before mixing. Do not heat this drug. You can bring this drug to room temperature by holding it in your hands until it feels as warm as your hands. This drug needs to be mixed before use. Follow how to mix as you were told by the doctor. Do not shake. After mixing, do not refrigerate. Use within 3 hours of making. 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.

Call your doctor to find out what to do.

Store unopened vials in a refrigerator. Do not freeze. Store in the original container to protect from light. If needed, you may store unopened containers at room temperature for up to 3 months. If stored at room temperature and not used within 3 months, throw this drug away. If stored at room temperature, make a note of the date it was placed at room temperature. Do not put this drug 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.

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 this drug, 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.