Applies to imiglucerase: intravenous powder for solution.

Serious side effects of Imiglucerase

Along with its needed effects, imiglucerase 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 imiglucerase:

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• chest pain, discomfort, or tightness
• confusion
• cough
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever or chills
• headache
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms and occasionally, upper chest
• sneezing
• sore throat
• sweating
• trouble breathing
• unusual tiredness or weakness

Other side effects of Imiglucerase

Some side effects of imiglucerase 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:

Incidence not known

• Back pain
• diarrhea
• nausea
• stomach pain
• vomiting

For Healthcare Professionals

Applies to imiglucerase: intravenous powder for injection.

General

Experience in patients treated with this drug have revealed that about 13.8% of patients experienced adverse events which were judged to be related to administration and included discomfort, pruritus, burning, swelling, or sterile abscess at the site of venipuncture.^[Ref]

Local

Common (1% to 10%): Discomfort, burning, swelling, sterile abscess

Frequency not reported: Pruritus^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain, vomiting, diarrhea

Uncommon (0.1% to 1%): Abdominal cramping^[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia

Uncommon (0.1% to 1%): Flushing, hypotension, cyanosis^[Ref]

Immunologic

Common (1% to 10%): Hypersensitivity reaction

Rare (less than 0.1%): Anaphylactoid reaction^[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria, pruritus, angioedema^[Ref]

Musculoskeletal

Common (1% to 10%): Backache

Uncommon (0.1% to 1%): Arthralgia^[Ref]

Respiratory

Common (1% to 10%): Dyspnea, coughing^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Paresthesia^[Ref]

Other

Common (1% to 10%): Fatigue, fever, chills

Uncommon (0.1% to 1%): Rigors

Frequency not reported: Chest discomfort, peripheral edema^[Ref]