Xyntha recombinant

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.

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

Stop using recombinant antihemophilic factor and call your doctor at once if you have:

• chest pain;

• easy bruising, increased bleeding episodes; or

• bleeding from a wound or where the medicine was injected.

Common side effects may include:

• nausea, vomiting, diarrhea;

• headache, dizziness;

• joint pain;

• rash;

• sore throat, cough, stuffy nose;

• weakness, feeling tired;

• fever; or

• pain, swelling, itching, or irritation where the injection was given.

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

You should not use Xyntha if you have ever had a severe allergic reaction to antihemophilic factor in the past.

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 instructions about keeping the medicine in a refrigerator or at room temperature, and for only a certain number of months.

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

To be sure Xyntha is helping your condition and is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

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.

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.

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