Myozyme Side Effects

Generic name: alglucosidase alfa

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

Some side effects of Myozyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alglucosidase alfa: intravenous powder for injection

Some people receiving an injection of alglucosidase alfa (the active ingredient contained in Myozyme) have had a reaction to the infusion. This type of reaction can occur when the medicine is injected into the vein, or as long as 3 hours after the injection. Tell your caregivers or get emergency medical help right away if you have any of these signs of a severe allergic reaction:

• feeling like you might pass out, even while lying down;

• feeling restless, nervous, dizzy, or nauseated;

• pale skin, redness under your skin, sweating, feeling hot or cold;

• fast or slow heart rate;

• pain or tightness in your chest or throat;

• wheezing, trouble breathing;

• cold hands, blue lips;

• back pain;

• numbness, warmth, redness, or tingly feeling;

• seizure (convulsions);

• hives, severe skin rash; or

• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• pain or fullness in your ear, problems with hearing;

• skin ulcers;

• fast, slow, or uneven heartbeats;

• urinating less than usual or not at all;

• weak pulse, fainting, slow breathing (breathing may stop); or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling.

Less serious side effects of alglucosidase alfa may include:

• mild skin rash or itching;

• diarrhea, constipation, stomach pain or upset, vomiting;

• sore throat, neck pain;

• pain or swelling in your arms or legs; or

• pain, swelling, burning, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to alglucosidase alfa: intravenous powder for injection

General

Assessment of side effects is based on the exposure of 60 patients with late-onset Pompe disease to alglucosidase alfa (the active ingredient contained in Myozyme) Serious side effects included anaphylaxis, supraventricular tachycardia, coronary artery disease, intervertebral disc protrusion, pneumonia, gastroenteritis, and dehydration. The most common side effects reported were infusion reactions. During postmarketing experience, deaths, and serious adverse reactions have been reported, including anaphylaxis.

Hypersensitivity

Anaphylaxis and severe allergic reactions have been reported during and up to 3 hours after alglucosidase alfa (the active ingredient contained in Myozyme) infusion. Some reactions were life-threatening. At least one patient developed anaphylactic shock during alglucosidase alfa infusion that required life-support measures.

Hypersensitivity side effects have included anaphylaxis (6.7%) and severe allergic reactions. Some reactions were life-threatening and included anaphylactic shock, cardiac arrest, respiratory arrest, apnea, dyspnea, bradycardia, tachycardia, and hypotension. Other accompanying reactions included chest discomfort/pain, throat tightness, bronchospasm, wheezing, tachypnea, cyanosis, decreased oxygen saturation/hypoxia, convulsions, angioedema (including tongue or lip swelling, periorbital edema, and face edema), pruritus, rash, urticaria, hyperhidrosis, nausea, dizziness, hypertension, flushing/erythema, fever, pallor, peripheral coldness, feeling hot, restlessness, nervousness, headache, back pain, and paresthesia. Anaphylactic reactions included angioedema, throat tightness, and chest pain/discomfort.

Other

Infusion reactions are defined as side effects occurring during or within 2 hours after completion of the infusion. Delayed onset infusion reactions are defined as side effects occurring within 48 hours after completion of the infusion.

Infusion reactions were reported in twenty of thirty-nine patients treated with alglucosidase alfa (the active ingredient contained in Myozyme) in clinical studies and appear to be more common in antibody-positive patients. Eight of fifteen patients with high antibody titers experienced infusion reactions whereas none of the three antibody-negative patients experienced infusion reactions.

Other side effects have included infusion reactions, delayed onset infusion reactions, chest discomfort or pain (16.7%), peripheral edema (16.7%), procedural pain (15%), infusion site reactions (13.3%), ear discomfort or pain (11.7%), pain (8.3%), and malaise (5%). Infusion reactions (greater than or equal to 5%) have included anaphylaxis, urticaria, diarrhea, vomiting, dyspnea, pruritus, rash/erythema, pharyngolaryngeal pain, neck pain, hypoacusis, flushing/feeling hot, pain in extremity, fall, and chest discomfort. Additional infusion reactions have included respiratory distress, cough, livedo reticularis, agitation, irritability, retching, rigors, tremor, and increased lacrimation. Delayed onset infusion reactions (greater than or equal to 3%) have included urticaria, dizziness, procedural pain, pharyngolaryngeal pain, malaise, muscle spasms, musculoskeletal pain, musculoskeletal weakness, musculoskeletal stiffness, neck pain, insomnia, and epistaxis. Adverse events resulting in death during postmarketing experience have included sepsis. Infusion reactions reported in at least 2 patients during postmarketing experience included dyspnea, respiratory failure, bronchospasm, stridor, decreased oxygen saturation/hypoxia, pharyngeal edema, chest discomfort, chest pain, hypotension, hypertension, erythema, flushing, lung infection, tachycardia, cyanosis, and hypersensitivity.

Immunologic

Immunologic side effects have included the presence of IgG antibodies to alglucosidase alfa (the active ingredient contained in Myozyme) Systemic immune mediated reactions (including nephrotic syndrome secondary to membranous glomerulonephritis and possible type III immune complex-mediated reactions) have been reported during postmarketing experience.

During one study, all 59 patients with available samples treated with alglucosidase alfa developed antibodies to alglucosidase alfa. All patients who developed IgG antibodies did so within the first 3 months of exposure. There was no apparent association between mean or peak IgG antibody titers and the occurrence of side effects.

Testing was performed in patients who experienced moderate to severe or recurrent infusion reactions, for which mast cell activation was suspected. Two of 10 patients evaluated tested positive for alglucosidase alfa specific IgE binding antibodies, both of whom experienced anaphylactic reactions.

Patients who develop IgE antibodies to alglucosidase alfa appear to be at greater risk for anaphylaxis and severe allergic reactions.

Cardiovascular

Cardiovascular side effects have included coronary artery disease. Supraventricular tachycardia was reported in a patient with a history of Wolff-Parkinson-White syndrome. Acute cardiorespiratory failure has been reported in a few infantile-onset Pompe disease patients with underlying cardiac hypertrophy, possibly associated with fluid overload with intravenous administration of alglucosidase alfa (the active ingredient contained in Myozyme) Cardiac arrhythmia, including ventricular fibrillation, ventricular tachycardia, and bradycardia, resulting in cardiac arrest or death, or requiring cardiac resuscitation or defibrillation have been reported in infantile-onset Pompe disease patients with cardiac hypertrophy (associated with the use of general anesthesia for the placement of a central venous catheter intended for alglucosidase alfa infusion). Adverse events resulting in death during postmarketing experience have included cardiorespiratory arrest, cardiac failure, and aortic dissection.

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal pain (36.7%), musculoskeletal stiffness or tightness (15%), muscle twitching (8.3%), and intervertebral disc protrusion.

Nervous system

Nervous system side effects have included hypoacusis (33.3%), vertigo (6.7%), tremor (6.7%), and somnolence (5%). Adverse events resulting in death during postmarketing experience have included cerebrovascular accident.

Gastrointestinal

Gastrointestinal side effects have included vomiting (21.7%), constipation (10%), gastroenteritis (10%), and dyspepsia (8.3%). Abdominal pain has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included upper respiratory tract infection (18.3%), exertional dyspnea (6.7%), epistaxis (5%), respiratory tract infection (5%), and pneumonia. Adverse events resulting in death during postmarketing experience have included respiratory failure, hemothorax, and pneumothorax.

Dermatologic

Dermatologic side effects have included urticaria (10%), pruritus (10%), and hyperhidrosis (8.3%). Severe cutaneous reactions (including necrotizing skin lesions) have been reported during postmarketing experience. Adverse events resulting in death during postmarketing experience have included skin necrosis.

Hematologic

Hematologic side effects have included lymphadenopathy (8.3%).

Metabolic

Metabolic side effects have included hypokalemia (5%) and dehydration.

Ocular

Ocular side effects have included blurred vision (5%).

Renal

Renal side effects have included nephrolithiasis (5%). Nephrotic syndrome has been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included proteinuria during postmarketing experience.

Endocrine

Endocrine side effects have included at least 1 case of hyperparathyroidism during postmarketing experience.

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