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Dried Factor VIII Fraction Type 8Y Side Effects

Generic Name: antihemophilic factor / von willebrand factor

Note: This page contains information about the side effects of antihemophilic factor / von willebrand factor. Some of the dosage forms included on this document may not apply to the brand name Dried Factor VIII Fraction Type 8Y.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by antihemophilic factor / von willebrand factor. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking antihemophilic factor / von willebrand factor, check with your doctor or nurse immediately:

More common:
  • Difficulty with breathing or swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives or welts
  • itching
  • nausea
  • reddening of the skin, especially around the ears
  • shortness of breath
  • skin rash
  • swelling of the face, throat, or tongue
  • unusual tiredness or weakness
Incidence not known:
  • Cough
  • tightness in the chest
  • vomiting
  • wheezing

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Alphanate (antihemophilic factor-von Willebrand factor)." Alpha Therapeutic Corporation, Los Angeles, CA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. "Product Information. Humate-P (antihemophilic factor-von Willebrand factor)." CSL Behring, King of Prussia, PA.

5. "Product Information. Wilate (antihemophilic factor-von Willebrand factor)." Octapharma USA, Centreville, VA.

Not all side effects for Dried Factor VIII Fraction Type 8Y may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

More about Dried Factor VIII Fraction Type 8Y (antihemophilic factor / von willebrand factor)

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