Aldurazyme Side Effects

Generic name: laronidase

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

Some side effects of Aldurazyme 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 laronidase: intravenous solution

Some people receiving a laronidase (the active ingredient contained in Aldurazyme) have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, pale skin, or trouble breathing when laronidase is injected.

Get emergency medical help if you have any of these signs of an allergic reaction while taking laronidase: hives; wheezing, difficult breathing; slow heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• chest pain;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fever, chills, rapid heart rate; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heartbeats, seizure).

Less serious side effects of laronidase may include:

• mild skin rash;

• overactive reflexes;

• numbness or tingling;

• cold symptoms such as runny or stuffy nose, sneezing, sore throat; or

• pain, redness, swelling, or other irritation where the medicine was injected.

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 laronidase: intravenous solution

General

The most serious side effects reported with laronidase (the active ingredient contained in Aldurazyme) during clinical trials were anaphylactic and allergic reactions. The majority of side effects reported in clinical trials were considered disease-related and unrelated to study drug. The most common side effects were infusion reactions. Infusion reactions decreased in frequency over time with continued use of laronidase, and most were considered mild to moderate in severity. Most infusion reactions requiring intervention were ameliorated by slowing the infusion rate or temporarily stopping the infusion, with or without administering additional treatments (including antihistamines, antipyretics, or both).

During clinical trials, all patients were treated with antipyretics and antihistamines prior to the infusions.

Hypersensitivity

Some reactions were life-threatening and included respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, obstructive airways disorder, hypoxia, hypotension, bradycardia, and urticaria.

In patients with MPS I, preexisting upper airway obstruction may have contributed to the severity of some allergic reactions.

At least 1 patient had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both laronidase-specific IgE binding antibodies and complement activation.

About 1% of patients experienced severe or serious infusion allergic reactions and tested positive for IgE during postmarketing experience.

Frequency not reported: Anaphylactic reactions/anaphylaxis, allergic reactions
Postmarketing reports: Severe or serious infusion allergic reactions (some life-threatening), anaphylactic shock

Other

Patients with an acute febrile or respiratory illness at the time of laronidase (the active ingredient contained in Aldurazyme) infusion may be at greater risk for infusion reactions. One patient with acute bronchitis and hypoxia experienced increased tachypnea during the first laronidase infusion that resolved without intervention. The patient's respiratory symptoms returned within 30 minutes of completing the infusion and responded to bronchodilator therapy. Approximately 6 hours after the infusion, the patient experienced coughing, then respiratory arrest, and died.

Study 1 was a 26-week, double-blind, placebo-controlled clinical study of laronidase conducted in 45 patients with MPS I, ages 6 to 43 years old. The most commonly reported infusion reactions in Study 1 were flushing (23%), pyrexia, headache, and rash. Less common infusion reactions included angioedema (including face edema), hypotension, paresthesia, feeling hot, hyperhidrosis, tachycardia, vomiting, back pain, and cough.

All 45 patients who completed Study 1 continued treatment in Study 2, an open-label, uncontrolled extension study. The most commonly reported infusion reactions in Study 2 included rash (13%), flushing (11%), pyrexia (11%), headache (9%), abdominal pain or discomfort (9%), and injection site reaction (9%). Less commonly reported infusion reactions included nausea (7%), diarrhea (7%), feeling hot or cold (7%), vomiting (4%), pruritus (4%), arthralgia (4%), and urticaria (4%).

Study 3 was a 52-week, open-label, uncontrolled study of 20 MPS I patients, ages 6 months to 5 years old (at enrollment). Otitis media and central venous catheterization required for laronidase infusion were reported in Study 3. The most commonly reported infusion reactions in Study 3 included pyrexia (30%), chills (20%), increased blood pressure (10%), tachycardia (10%), and decreased oxygen saturation (10%). Other commonly reported infusion reactions (occurring in greater than or equal to 5% of patients) were pallor, tremor, respiratory distress, wheezing, pulmonary crepitations, pruritus, and rash.

Facial edema has occurred in a few patients who had MPS I-related upper airway and pulmonary involvement.

Very common (10% or more): Infusion reactions (up to 49%), pyrexia (up to 30%), flushing (up to 23%), chills (20%), otitis media (20%), central venous catheterization required for laronidase infusion (15%)
Common (1% to 10%): Chest pain (9%), face edema (9%), gravitational edema (9%), abscess (9%), feeling hot or cold (up to 7%), pallor (5% or greater)
Postmarketing reports: Extravasation

Dermatologic

Very common (10% or more): Rash (up to 36%)
Common (1% to 10%): Pruritus (up to 5% or greater), urticaria (up to 4%)
Frequency not reported: Angioedema (including face edema), hyperhidrosis, cold sweat, alopecia
Postmarketing reports: Erythema

Respiratory

Very common (10% or more): Respiratory tract infection (32%)
Common (1% to 10%): 5% or greater: Respiratory distress, wheezing, pulmonary crepitations
Frequency not reported: Bronchospasm, dyspnea, cough, stridor, tachypnea, obstructive airways disorder, hypoxia
Postmarketing reports: Cyanosis, cardiorespiratory arrest, respiratory failure, pneumonia

Side effects resulting in death during postmarketing experience have included cardiorespiratory arrest, respiratory failure, and pneumonia in MPS I patients with significant underlying disease.

Local

Very common (10% or more): Injection site reaction (up to 18%)
Common (1% to 10%): Injection site pain (9%)

Cardiovascular

Side effects resulting in death during postmarketing experience have included cardiac failure in MPS I patients with significant underlying disease.

Very common (10% or more): Poor venous access (14%), increased blood pressure (10%)
Common (1% to 10%): Tachycardia (up to 10%), hypotension (up to 9%)
Frequency not reported: Bradycardia
Postmarketing reports: Cardiac failure

Nervous system

Very common (10% or more): Hyperreflexia (14%), paresthesia (up to 14%)
Common (1% to 10%): Headache (up to 9%), tremor (5% or greater)
Frequency not reported: Dizziness

Immunologic

The clinical significance of antibodies to laronidase (the active ingredient contained in Aldurazyme) is unknown.

At least 1 patient had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both laronidase-specific IgE binding antibodies and complement activation.

About 1% of patients experienced severe or serious infusion allergic reactions and tested positive for IgE during postmarketing experience.

Very common (10% or more): Positive for IgG antibodies to laronidase (97%)
Rare (less than 0.1%): Complement activation (at least 1 case)
Postmarketing reports: Positive for IgE

Metabolic

Very common (10% or more): Decreased oxygen saturation (10%)

Hematologic

Common (1% to 10%): Thrombocytopenia (9%)

Hepatic

Common (1% to 10%): Hyperbilirubinemia (9%)

Ocular

Common (1% to 10%): Corneal opacity (9%)

Gastrointestinal

Common (1% to 10%): Abdominal pain or discomfort (9%), nausea (7%), diarrhea (7%), vomiting (up to 4%)

Musculoskeletal

Common (1% to 10%): Arthralgia (4%), back pain, musculoskeletal pain

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