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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.
Applies to laronidase: intravenous solution
Intravenous route (Solution)
Life-threatening anaphylactic reactions have been reported in some patients during laronidase infusions. Therefore, when laronidase is administered, appropriate medical support should be readily available. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory condition due to infusion reactions and need additional monitoring.
Along with its needed effects, laronidase (the active ingredient contained in Aldurazyme) 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 laronidase:
Some side effects of laronidase 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:
Applies to laronidase: intravenous solution
The most frequently reported infusion reactions included pyrexia, chills, blood pressure, increased, tachycardia, and oxygen saturation decreased.
The most frequently reported adverse reactions included rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.
Common (1% to 10%): Anaphylactic reaction
Very common (10% or more): Infusion reactions (up to 49%), pyrexia (up to 30%), otitis media (20%), chills (up to 20%), central venous catheterization required for infusion (15%), oxygen saturation decreased (up to 10%)
Common (1% to 10%): Chest pain, face edema, gravitational/dependent edema, abscess, feeling hot, feeling cold, influenza-like illness, body temperature increased
Frequency not reported: Laryngeal edema, extravasation
Postmarketing reports: Fatigue
The most common adverse reactions were infusion reactions; the frequency decreased over time with continued use, and most were classified as mild to moderate in severity. The majority of infusion reactions requiring intervention were ameliorated with slowing of the infusion rate, temporarily stopping the infusion, with or without administering additional antihistamines and/or antipyretics.
Very common (10% or more): Nausea, abdominal pain/discomfort
Common (1% to 10%): Vomiting, diarrhea
In clinical trials, 99 of 102 patients developed IgG antidrug antibodies. No correlation was demonstrated between presence of antidrug antibodies and therapeutic response or the occurrence of allergic reactions. There was also no consistent association between presence of antibodies that neutralize enzymatic activity and therapeutic response. The potential for antibody neutralization of cellular uptake has not been evaluated. There were 9 patients collectively in clinical studies who experienced severe infusion reactions and were subsequently tested for drug specific IgE antibodies and complement activation. Following testing, 1 of the 9 patients had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both drug specific IgE binding antibodies and complement activation. In a separate open-label study of patients 5 years and younger, none tested positive for IgE. The clinical significance of IgE antibodies has not been established.
Very common (10% or more): Antidrug antibody development (97%)
Postmarketing reports: Anaphylactic shock, IgE antibody development, compliment activation
Very common (10% or more): Rash (up to 36%)
Common (1% to 10%): Angioedema, urticaria, pruritus, hyperhidrosis, alopecia, cold sweat
Frequency not reported: Erythema
Very common (10% or more): Injection site reaction (up to 18%)
Common (1% to 10%): Injection site pain
Very common (10% or more): Upper respiratory tract infection (32%)
Common (1% to 10%): Respiratory distress, dyspnea, cough, wheezing, pulmonary crepitation
Frequency not reported: Bronchospasm, hypoxia, tachypnea, respiratory arrest
Postmarketing reports: Respiratory failure, pneumonia
Very common (10% or more): Flushing (up to 23%), poor venous access/vein disorder (14%), blood pressure increased (up to 10%), tachycardia (up to 10%)
Common (1% to 10%): Hypotension, pallor, peripheral coldness
Frequency not reported: Cyanosis
Postmarketing reports: Cardiorespiratory arrest, cardiac failure
Very common (10% or more): Hyperreflexia (14%), paresthesia (14%), headache
Common (1% to 10%): Dizziness, tremor
Common (1% to 10%): Thrombocytopenia
Common (1% to 10%): Hyperbilirubinemia, bilirubinemia
Common (1% to 10%): Corneal opacity
Very common (10% or more): Arthropathy, arthralgia, back pain, pain in extremity
Common (1% to 10%): Musculoskeletal pain
Common (1% to 10%): Restlessness