Advate recombinant

Name: Advate recombinant

What should I discuss with my health care provider before using recombinant antihemophilic factor?

You should not use this medicine if you have ever had a severe allergic reaction to antihemophilic factor, or if you are allergic to mouse, hamster, or beef proteins.

Before using recombinant antihemophilic factor, your specific blood clotting disorder must be diagnosed as factor VIII deficiency. Recombinant antihemophilic factor will not treat von Willebrand disease.

To make sure recombinant antihemophilic factor is safe for you, tell your doctor if you have heart disease.

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

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

How should I use recombinant antihemophilic factor?

Follow all directions on your prescription label. Do not use this medicine 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.

Recombinant antihemophilic factor 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.

Recombinant antihemophilic factor is usually given every 8 to 24 hours for 1 to 4 days, depending on the reason you are using the medicine.

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.

Recombinant antihemophilic factor must be mixed with a liquid (diluent) before injecting 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 recombinant antihemophilic factor 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.

While using recombinant antihemophilic factor, you may need frequent blood tests.

Your body may develop antibodies to antihemophilic factor, 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 recombinant antihemophilic factor 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 the medicine and diluent out 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.

What happens if I miss a dose?

Since recombinant antihemophilic factor is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while using Advate?

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

For Healthcare Professionals

Applies to antihemophilic factor: intravenous kit, intravenous powder for injection

Nervous system

Nervous system side effects have included headache, dizziness, somnolence, and asthenia.[Ref]

Respiratory

Respiratory side effects have included dyspnea and rhinitis.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia.[Ref]

Local

Local side effects have included injection site pain.[Ref]

General

General side effects have included pyrexia and chills.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, and vomiting.[Ref]

Dermatologic

Dermatologic side effects have include pruritus, rash, and urticaria.[Ref]

Cardiovascular

Cardiovascular side effects have included hemorrhage, hypotension, and vasodilatation.[Ref]

Some side effects of Advate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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