Applies to velaglucerase alfa: intravenous powder for solution.
Serious side effects of Velaglucerase alfa
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
- Body aches or pain
- cough
- difficulty with breathing
- dizziness
- ear congestion
- facial swelling
- fever or chills
- headache
- loss of voice
- nasal congestion
- nausea or vomiting
- runny nose
- shortness of breath
- skin rash
- sneezing
- sore throat
- unusual tiredness or weakness
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
Other side effects of Velaglucerase alfa
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
- Abdominal or stomach pain
- back pain
- joint pain
- lack or loss of strength
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
Very common (10% or more): Hypersensitivity reaction (up to 52%)
Frequency not reported: Anaphylaxis, anaphylactoid reaction[Ref]
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]
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
