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Velaglucerase alfa Side Effects

For the Consumer

Applies to velaglucerase alfa: intravenous powder for solution

Along with its needed effects, velaglucerase alfa 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 velaglucerase alfa:

More common
Less common
  • Blurred vision
  • bone pain
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • nervousness
  • pain, itching, burning, swelling, or a lump under your skin where the needle is placed
  • pounding in the ears
  • slow or fast heartbeat
  • sweating

Some side effects of velaglucerase alfa 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 Less common
  • Feeling of warmth
  • hives or welts
  • itching
  • redness of the skin
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to velaglucerase alfa: intravenous powder for injection

General

The most common side effects were hypersensitivity/infusion-related reactions. The most serious side effects reported were hypersensitivity reactions.[Ref]

Hypersensitivity

The term "hypersensitivity reaction" included any event related to and occurring within up to 24 hours of drug infusion, including at least 1 case of anaphylaxis.

The most common symptoms of hypersensitivity reactions were headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia; reactions were generally mild. In therapy-naive patients, onset was usually during the first 6 months of therapy and occurred less often over time.[Ref]

Very common (10% or more): Hypersensitivity reaction (up to 52%)
Frequency not reported: Anaphylaxis, anaphylactoid reaction[Ref]

Nervous system

Very common (10% or more): Headache (up to 35%), dizziness (up to 22%)
Frequency not reported: Paresthesia[Ref]

Other

Very common (10% or more): Pyrexia/increased body temperature (up to 22%), asthenia/fatigue (13%), infusion-related reaction
Common (1% to 10%): Flushing
Frequency not reported: Peripheral edema, influenza-like illness[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 19%)
Common (1% to 10%): Nausea, upper abdominal pain
Frequency not reported: Diarrhea, vomiting[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 18%), knee joint pain (up to 15%), arthralgia, bone pain
Frequency not reported: Muscle spasm, myalgia, neck pain[Ref]

Hematologic

Very common (10% or more): Prolonged activated partial thromboplastin time (up to 11%)[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia, hypertension, hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria
Frequency not reported: Allergic dermatitis, tinea versicolor, pruritus[Ref]

Immunologic

Common (1% to 10%): IgG antibodies to velaglucerase alfa, positive for neutralizing antibody[Ref]

Respiratory

Frequency not reported: Influenza, nasopharyngitis, rhinitis, bronchitis, cough, epistaxis

Genitourinary

Frequency not reported: Cystitis, urinary tract infection

References

1. "Product Information. VPRIV (velaglucerase alfa)." Shire US Inc, Florence, KY.

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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