Note: This document contains side effect information about antihemophilic factor. Some dosage forms listed on this page may not apply to the brand name Adynovate.

Applies to antihemophilic factor: intravenous powder for solution.

Serious side effects of Adynovate

Along with its needed effects, antihemophilic factor (the active ingredient contained in Adynovate) 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
• trouble 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

Other side effects of Adynovate

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

• 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
• stomach pain
• trouble seeing

For Healthcare Professionals

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

Hematologic

Postmarketing reports: Factor VIII inhibition, hemolytic anemia, post-procedural hemorrhage^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity (including anaphylaxis, rash, pruritus)^[Ref]

Nervous system

Postmarketing reports: Generalized tonic-clonic seizure^[Ref]