Note: This document contains side effect information about antihemophilic factor/von willebrand factor. Some dosage forms listed on this page may not apply to the brand name Humate-P.

Applies to antihemophilic factor/von willebrand factor: intravenous powder for solution.

Serious side effects of Humate-P

Along with its needed effects, antihemophilic factor/von willebrand factor 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 or nurse immediately if any of the following side effects occur while taking antihemophilic factor/von willebrand factor:

More common

• Difficulty with breathing or swallowing
• dizziness
• fast heartbeat
• fever
• hives or welts, itching, rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the face, throat, or tongue
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain
• blurred vision
• cough
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• tightness in the chest
• vomiting

For Healthcare Professionals

Applies to antihemophilic factor/von willebrand factor: intravenous powder for injection.

General

The most serious side effects were anaphylaxis/hypersensitivity reactions.^[Ref]

Immunologic

Common (1% to 10%): Allergy, infection, hypersensitivity

Uncommon (0.1% to 1%): Factor VIII inhibition

Very rare (less than 0.01%): Von Willebrand factor inhibition, anaphylactic shock

Frequency not reported: Allergic-anaphylactic reactions, sepsis^[Ref]

Other

Very common (10% or more): Pain (up to 17.5%)

Common (1% to 10%): Fever, surgery, facial edema, chest pain, peripheral edema, rigors

Frequency not reported: Chills, pseudothrombocytopenia, postoperative pain

Postmarketing reports: Fatigue, malaise^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 23.8%), constipation (11.1%)

Common (1% to 10%): Gastrointestinal bleeding, abdominal pain, vomiting

Frequency not reported: Postoperative nausea^[Ref]

Hematologic

Common (1% to 10%): Groin bleed, ear bleed, shoulder bleed, anemia/hemoglobin decreased, thromboembolic event

Frequency not reported: Hemorrhage, hematocrit decreased, postoperative hemorrhage, postoperative wound bleeding

Postmarketing reports: Hemolysis^[Ref]

Nervous system

Common (1% to 10%): Cerebral hemorrhage/subdural hematoma, dizziness, headache, dysgeusia, somnolence

Frequency not reported: Headache, paresthesia, drowsiness^[Ref]

Respiratory

Common (1% to 10%): Epistaxis, hemoptysis, pulmonary embolus, sore throat

Frequency not reported: Respiratory distress

Postmarketing reports: Dyspnea, cough, sneezing, throat irritation^[Ref]

Dermatologic

Common (1% to 10%): Sweating increased, pruritus, rash, urticaria^[Ref]

Genitourinary

Common (1% to 10%): Menorrhagia, hematuria, urinary retention, urinary tract infection^[Ref]

Hepatic

Common (1% to 10%): ALT increased, liver function test abnormal^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle and joint stiffness

Frequency not reported: Extremity pain

Postmarketing reports: Joint pain^[Ref]

Cardiovascular

Common (1% to 10%): Thrombophlebitis

Frequency not reported: Orthostatic hypotension, phlebitis, vasodilation, bradycardia, palpitations^[Ref]

Local

Common (1% to 10%): Infusion site erythema or rash or pain

Frequency not reported: Injection site bleeding

Postmarketing reports: Infusion site pain^[Ref]

Psychiatric

Common (1% to 10%): Insomnia^[Ref]

Ocular

Frequency not reported: Blurred vision^[Ref]

Renal

Frequency not reported: Pyelonephritis^[Ref]

Metabolic

Postmarketing reports: Hypervolemia^[Ref]