Afstyla recombinant

Name: Afstyla recombinant

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

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.

What should I avoid while using recombinant Afstyla (antihemophilic factor recombinant)?

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

Recombinant Afstyla (antihemophilic factor recombinant) side effects

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.

What other drugs will affect recombinant Afstyla (antihemophilic factor recombinant)?

Other drugs may interact with recombinant antihemophilic factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For the Consumer

Applies to antihemophilic factor: intravenous powder for solution

Along with its needed effects, antihemophilic factor (the active ingredient contained in Afstyla) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking antihemophilic factor:

More common
  • Fever
Less common or rare
  • Changes in facial skin color
  • chills
  • fast or irregular breathing
  • nausea
  • puffiness or swelling of the eyelids or around the eyes
  • sensation of burning, warmth, heat, numbness, tightness, or tingling
  • skin rash, hives, or itching
  • tightness in the chest
  • troubled breathing
  • unusual tiredness or weakness
Incidence not known
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • blurred vision
  • chest pain or discomfort
  • confusion
  • cough
  • deep or fast breathing with dizziness
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • noisy breathing
  • numbness of the feet, hands, and around the mouth
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • slow or irregular heartbeat
  • sweating
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness

Some side effects of antihemophilic factor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
Less common
  • Burning, stinging, or swelling at the injection site
  • diarrhea
  • dizziness or lightheadedness
  • dry mouth or bad taste in the mouth
  • lack or loss of strength
  • nosebleed
  • redness of the face
  • vomiting
Rare
  • Change in taste
  • loss of taste
Incidence not known
  • Abdominal or stomach pain
  • feeling of warmth
  • increased sweating
  • irritability
  • muscle or bone pain
  • redness of the eye
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • trouble seeing

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 Afstyla 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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