Medication Guide App

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 swallowing
  • dizziness
  • dry, red, hot, or irritated skin
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • headache
  • hives, itching, or skin rash
  • increased sweating
  • irregular, fast, slow, or shallow breathing
  • 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
  • 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
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
  • 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
  • tender, swollen glands in the neck
  • upper abdominal or stomach pain
  • voice changes
  • welts
  • 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 side effects were hypersensitivity reactions, fever, diarrhea, rash, vomiting, cough, pneumonia, otitis media, upper respiratory tract infection, gastroenteritis, and decreased oxygen saturation. The most serious side effects were anaphylactic reactions, acute cardiorespiratory failure, and cardiac arrest. The most common serious side effects were pneumonia, respiratory failure, respiratory distress, catheter-related infection, respiratory syncytial virus infection, gastroenteritis, and fever.[Ref]

Hypersensitivity

The most common side effects that required intervention in clinical trials in infantile-onset and juvenile-onset Pompe disease were hypersensitivity reactions (51%) and included rash, pyrexia, urticaria, flushing, decreased oxygen saturation, cough, tachypnea, tachycardia, hypertension/increased blood pressure, pallor, rigors, vomiting, cyanosis, agitation, and tremor. These side effects occurred more often with higher infusion rates. Hypersensitivity reactions were reported in some patients who were pretreated with antihistamines, antipyretics, and/or corticosteroids.

Delayed-onset hypersensitivity reactions (defined as side effects occurring 2 to 48 hours after infusion) included hyperhidrosis, fatigue, myalgia, and nausea.

Hypersensitivity reactions in infantile-onset Pompe disease patients included livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, and cold sweat.

Anaphylaxis and hypersensitivity reactions (included anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, hypoxia, dyspnea, wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, abdominal pain, apnea, muscle spasm, conjunctivitis) have been reported during postmarketing experience.[Ref]

Very common (10% or more): Hypersensitivity reactions (included anaphylaxis, headache, nausea, urticaria, dizziness, chest discomfort/pain, vomiting, hyperhidrosis, flushing/feeling hot, paresthesia, pyrexia, local swelling, diarrhea, pruritus, rash, throat tightness, fatigue, myalgia, cough, decreased oxygen saturation, tachycardia, tachypnea, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, livedo reticularis, irritability, retching, increased lacrimation, ventricular extrasystoles, nodal rhythm, rales, respiratory tract irritation, cold sweat, anaphylactic shock, respiratory failure, respiratory arrest, cardiac arrest, respiratory distress, hypoxia, dyspnea, bradycardia, bronchospasm, hypotension, angioedema [including tongue or lip swelling, periorbital edema, face edema], wheezing, convulsions, peripheral coldness, restlessness, nervousness, back pain, stridor, pharyngeal edema, abdominal pain, apnea, muscle spasm, conjunctivitis)
Common (1% to 10%): Anaphylaxis (presented as angioedema, throat tightness, chest pain/discomfort)
Postmarketing reports: Systemic and cutaneous immune-mediated reactions (including proteinuria and nephrotic syndrome secondary to membranous glomerulonephritis, ulcerative and necrotizing skin lesions)[Ref]

Cardiovascular

Supraventricular tachycardia was reported in a patient with history of Wolff-Parkinson-White syndrome.

Acute cardiorespiratory failure (possibly associated with fluid overload) was reported in infantile-onset Pompe disease patients with preexisting hypertrophic cardiomyopathy.[Ref]

Very common (10% or more): Tachycardia (up to 23%), flushing (up to 21%), bradycardia (up to 21%)
Common (1% to 10%): Hypertension, increased blood pressure, pallor, cyanosis
Frequency not reported: Supraventricular tachycardia, cardiac arrest, hypotension, vasoconstriction, increased heart rate, decreased blood pressure, decreased heart rate
Postmarketing reports: Acute cardiorespiratory failure[Ref]

Other

The most common side effects that required intervention in clinical trials in infantile-onset Pompe disease were infusion reactions (defined as side effects occurring during or within 2 hours after infusion; 51%) and included rash, fever, urticaria, flushing, decreased oxygen saturation, cough, tachypnea, tachycardia, hypertension, increased blood pressure, irritability, pallor, pruritus, retching, tremor, hypotension, rigors, vomiting, cyanosis, agitation, bronchospasm, erythema, face edema, feeling hot, headache, hyperhidrosis, increased lacrimation, livedo reticularis, nausea, periorbital edema, restlessness, wheezing, cardiac arrest, bradycardia, angioedema, pharyngeal edema, peripheral edema, chest pain, chest discomfort, dyspnea, muscle spasm, fatigue, respiratory distress, throat tightness, and conjunctivitis. Infusion reactions were reported more often in antibody-positive patients, especially those with high antibody titers.

Recurrent reactions consisting of influenza-like illness or a combination of events (e.g., pyrexia, chills, myalgia, arthralgia, pain, fatigue) after infusion generally lasted for 1 to 3 days.

Severe and serious infusion reactions (including cardiac arrest, respiratory arrest, apnea, stridor, pharyngeal edema, peripheral edema, chest pain, chest discomfort, muscle spasm, fatigue, conjunctivitis) have been reported during postmarketing experience.[Ref]

Very common (10% or more): Pyrexia (up to 92%), infusion reactions, otitis media (up to 44%), ear infection (up to 33%), catheter-related infection (up to 28%), postprocedural pain (up to 26%)
Common (1% to 10%): Malaise, rigors, chest discomfort, flushing/feeling hot, peripheral edema, chills, fatigue, increased body temperature
Frequency not reported: Chest pain, face edema, peripheral coldness, enzyme activity inhibited, enzyme uptake inhibited, lethargy, hypothermia
Postmarketing reports: Recurrent reactions (consisting of influenza-like illness or combination of events [e.g., pyrexia, chills, myalgia, arthralgia, pain, fatigue]) after infusion[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 62%), vomiting (up to 49%), gastroenteritis (up to 41%), oral candidiasis (up to 31%), gastroesophageal reflux disease (up to 26%), constipation (up to 23%), upper abdominal pain (up to 15%)
Common (1% to 10%): Retching, nausea
Frequency not reported: Abdominal pain[Ref]

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, papular rash, macular rash, maculopapular rash
Frequency not reported: Erythematous rash, livedo reticularis, palmar erythema
Postmarketing reports: Ulcerative and necrotizing skin lesions[Ref]

Respiratory

Very common (10% or more): Cough (up to 46%), pneumonia (up to 46%), upper respiratory infection (up to 44%), 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%), nasopharyngitis (up to 23%)
Common (1% to 10%): Rhinitis, throat tightness
Frequency not reported: Respiratory arrest, apnea, bronchospasm, wheezing, pharyngeal edema, dyspnea, stridor, respiratory syncytial virus infection, increased respiratory rate, rales[Ref]

Metabolic

Very common (10% or more): Decreased oxygen saturation (up to 41%)
Frequency not reported: Increased blood calcium[Ref]

Immunologic

Very common (10% or more): IgG antibodies to alglucosidase alfa (the active ingredient contained in Myozyme) (up to 100%)
Frequency not reported: Development of alglucosidase alfa-specific IgE antibodies, development of neutralizing antibodies[Ref]

Hematologic

Very common (10% or more): Anemia (up to 31%)
Frequency not reported: Decreased hemoglobin, decreased platelet count[Ref]

Musculoskeletal

Common (1% to 10%): Muscle twitching, myalgia, muscle spasms, increased blood creatine phosphokinase MB
Frequency not reported: Arthralgia, increased blood creatine phosphokinase[Ref]

Nervous system

Common (1% to 10%): Headache, tremor, paresthesia, dizziness[Ref]

Psychiatric

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

Local

Common (1% to 10%): Local swelling
Frequency not reported: Infusion site pain, infusion site reaction[Ref]

Renal

Frequency not reported: Increased blood urea
Postmarketing reports: Nephrotic syndrome (secondary to membranous glomerulonephritis)[Ref]

Genitourinary

Postmarketing reports: Proteinuria

Endocrine

Postmarketing reports: Hyperparathyroidism[Ref]

Hepatic

Frequency not reported: Increased ALT, increased AST

Ocular

Frequency not reported: Conjunctivitis, periorbital edema, increased lacrimation

References

1. "Product Information. Lumizyme (alglucosidase alfa)." Genzyme Corporation, Cambridge, MA.

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

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

4. "Product Information. Myozyme (alglucosidase alfa)." Genzyme Corporation, Cambridge, MA.

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