Myozyme Side Effects

Generic Name: alglucosidase alfa

Note: This page contains information about the side effects of alglucosidase alfa. Some of the dosage forms included on this document may not apply to the brand name Myozyme.

Not all side effects for Myozyme may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to alglucosidase alfa: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by alglucosidase alfa (the active ingredient contained in Myozyme). 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 alglucosidase alfa, check with your doctor or nurse immediately:

More common
  • Blue lips, fingernails, or skin
  • body aches or pain
  • chest discomfort or pain
  • chills
  • cough
  • difficult or labored breathing
  • difficulty with breathing
  • difficulty with swallowing
  • dizziness
  • dry, red, hot, or irritated skin
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • hives
  • increased sweating
  • irregular, fast, slow, or shallow breathing
  • itching
  • lightheadedness, dizziness, or fainting
  • loss of voice
  • nasal congestion
  • pain
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness or pain at the catheter site
  • runny nose
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • skin rash
  • slow or irregular heartbeat
  • sneezing
  • sore throat
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • trembling or shaking of the hands or feet
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wheezing
Less common
  • Blood in the urine
  • convulsions
  • decreased urine
  • dry mouth
  • increased thirst
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pain in the groin or genitals
  • sharp back pain just below the ribs
Incidence not known
  • Blue-green to black skin discoloration
  • blurred vision
  • confusion
  • dilated neck veins
  • extreme fatigue
  • heart stops
  • inability to speak
  • no breathing
  • no pulse or blood pressure
  • pain, redness, swelling, or sloughing of the skin at the place of injection
  • seizures
  • severe or sudden headache
  • severe pain in the chest
  • slurred speech
  • sudden and severe weakness in the arm or leg on one side of the body
  • sudden onset of severe breathing difficulty
  • swelling of the face, fingers, feet, or lower legs
  • temporary blindness
  • unconscious
  • weight gain

Some of the side effects that can occur with alglucosidase alfa may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • acid or sour stomach
  • belching
  • body aches or pain
  • change in hearing
  • congestion
  • constipation
  • dryness or soreness of the throat
  • ear discomfort or pain
  • ear drainage
  • earache
  • feeling of constant movement of self or surroundings
  • general feeling of discomfort or illness
  • heartburn
  • hives or welts
  • hoarseness
  • indigestion
  • muscle or bone pain, stiffness, or tightness
  • muscle twitching
  • redness of the skin
  • redness or swelling in the ear
  • sensation of spinning
  • sore mouth or tongue
  • stomach discomfort, upset, or pain
  • stuffy nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • upper abdominal or stomach pain
  • voice changes
  • white patches in the mouth or on the tongue
Less common
  • Bloody nose
  • sleepiness or unusual drowsiness
Incidence not known
  • Burning, dry, or itching eyes
  • discharge, excessive tearing
  • muscle spasm
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to alglucosidase alfa: intravenous powder for injection

General

The most common adverse reactions included hypersensitivity reactions.

Hypersensitivity

Common (1% to 10%): Anaphylaxis
Frequency not reported: Hypersensitivity reactions included anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, hypoxia, dyspnea, wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, periorbital edema, abdominal pain, apnea, muscle spasm, and conjunctivitis. Hypersensitivity reactions in infantile-onset patients included livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, and cold sweat
Postmarketing reports: Severe and serious infusion reactions including cardiac arrest, respiratory arrest, apnea, stridor, pharyngeal edema, peripheral edema, chest pain, chest discomfort, muscle spasm, fatigue, and conjunctivitis

Immunologic

Very common (10% or more): Catheter-related infection (up to 28%)
Frequency not reported: Antibody development (alglucosidase alfa-specific IgE and IgG antibodies)
Postmarketing reports: Systemic and cutaneous immune-mediated reactions

Cardiovascular

Very common (10% or more): Tachycardia (up to 23%), flushing (up to 21%), bradycardia (up to 21%)
Common (1% to 10%): Hypertension, pallor, chest discomfort, peripheral edema
Postmarketing reports: Acute cardiorespiratory failure (possibly associated with fluid overload in infantile-onset Pompe disease patients with preexisting hypertrophic cardiomyopathy)

Respiratory

Very common (10% or more): Cough (up to 46%), pneumonia (up to 46%), upper respiratory infection (up to 44%), decreased oxygen saturation (up to 41%), pharyngitis (up to 36%), respiratory distress (up to 33%), respiratory failure (up to 31%), rhinorrhea (up to 28%), tachypnea (up to 23%), bronchiolitis (up to 23%)
Common (1% to 10%): Cyanosis, rhinitis

Dermatologic

Very common (10% or more): Rash (up to 54%), diaper dermatitis (up to 36%), urticaria (up to 21%)
Common (1% to 10%): Erythema, pruritus, hyperhidrosis
Postmarketing reports: Systemic and cutaneous immune-mediated reactions including ulcerative and necrotizing skin lesions

Renal

Postmarketing reports: Systemic immune-mediated reactions including proteinuria and nephrotic syndrome secondary to membranous glomerulonephritis

Other

Very common (10% or more): Pyrexia (up to 92%), otitis media (up to 77%), ear infection (up to 33%),
Common (1% to 10%): Malaise, rigors

Musculoskeletal

Common (1% to 10%): Muscle twitching, myalgia

Nervous system

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

Gastrointestinal

Very common (10% or more): Gastroenteritis (up to 41%), oral candidiasis (up to 31%), diarrhea (up to 62%), vomiting (up to 49%), gastroesophageal reflux disease (up to 26%), constipation (up to 23%), upper abdominal pain (up to 15%)

Hematologic

Very common (10% or more): Anemia (up to 31%)

Endocrine

Postmarketing reports: Hyperparathyroidism

Psychiatric

Common (1% to 10%): Agitation, insomnia, irritability
Postmarketing reports: Restlessness

Local

Postmarketing reports: Infusion site pain

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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