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Aldurazyme (Laronidase) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most serious adverse reaction reported with ALDURAZYME was an anaphylactic reaction consisting of urticaria and airway obstruction, which occurred in one patient. Pre-existing upper airway obstruction may have contributed to the severity of the reaction (see WARNINGS: Hypersensitivity Reactions).

The most common adverse reactions associated with ALDURAZYME treatment in the clinical studies were upper respiratory tract infection, rash, and injection site reaction.

The most common adverse reactions requiring intervention were infusion-related reactions, particularly flushing. Most infusion-related reactions requiring intervention were ameliorated with slowing of the infusion rate, temporarily stopping the infusion, and/or administering additional antipyretics and/or antihistamines.

The data described below reflect exposure to 0.58 mg/kg of ALDURAZYME for 26 weeks in a placebo-controlled double-blind study in 45 patients with MPS I (N=22 ALDURAZYME, and N=23 placebo). All 45 patients continued into an open-label study of ALDURAZYME treatment for an additional 36 weeks. An additional 10 patients participated in a Phase 1 open-label study with continued infusions for up to 3 years. The population in the placebo-controlled study was evenly distributed for gender (N=23 females and 22 males) and ranged in ages from 6 to 43 years. Of the 45 patients in the placebo-controlled study, 1 was clinically assessed as having Hurler form, 37 Hurler-Scheie, and 7 Scheie. All patients were treated with antipyretics and antihistamines prior to the infusions.

Because clinical trials are conducted under widely varying and controlled conditions, the observed adverse reaction rates may not predict the rates observed in patients in clinical practice.

Table 2 enumerates adverse events and selected laboratory abnormalities that occurred during the placebo-controlled trial in at least 2 patients more in the ALDURAZYME group than was observed in the placebo group. Reported adverse events have been classified using standard WHOART terms. Observed adverse events in the Phase 1 study and the open-label treatment period following the controlled study were not different in nature or severity.

Table 2: Number and (%) of Patients with Adverse Events and Selected Laboratory Abnormalities
in the Placebo-Controlled Study
Adverse Event Placebo
(N = 23)
ALDURAZYME
(N = 22)
Respiratory System
   Upper respiratory tract infection 4 (17) 7 (32)
Body as a Whole
   Chest pain 0 2 (9)
Nervous System
   Hyperreflexia 0 3 (14)
   Paresthesia 1 (4) 3 (14)
Skin and Appendages
   Rash 5 (22) 8 (36)
Resistance Mechanism
   Abscess 0 2 (9)
Liver and Biliary System
   Bilirubinemia 0 2 (9)
Vascular
   Vein disorder 1 (4) 3 (14)
Urinary System
   Facial edema02 (9)Cardiovascular, General
   Hypotension 0 2 (9)
   Dependent edema 0 2 (9)
Vision
   Corneal opacity 0 2 (9)
Application Site
   Injection site pain 0 2 (9)
   Injection site reaction 2 (9) 4 (18)
Platelet, Bleeding and Clotting
   Thrombocytopenia 0 2 (9)

INFUSION-RELATED REACTIONS

Infusion-related reactions were reported in 7 of 22 patients treated with ALDURAZYME. Infusion-related reactions were not significantly different between the ALDURAZYME treatment group and the placebo group who received infusions of diluent and all components of ALDURAZYME except the laronidase enzyme. The most common infusion-related reactions included flushing, fever, headache and rash. Flushing occurred in 5 patients (23%) receiving ALDURAZYME; the other reactions were less frequent. All reactions were mild to moderate in severity. The frequency of infusion-related reactions decreased with continued use during the open-label extended use period. There was one case of anaphylaxis during the open-label extension period (see WARNINGS and ADVERSE REACTIONS: Immunogenicity). Less common infusion-related reactions include cough, bronchospasm, dyspnea, urticaria, angioedema and pruritus.

IMMUNOGENICITY

Fifty of 55 patients (91%) treated with ALDURAZYME were positive for antibodies to laronidase. The clinical significance of antibodies to ALDURAZYME is not known, including the potential for product neutralization.

The data reflect the percentage of patients whose test results were considered positive for antibodies to ALDURAZYME using an enzyme-linked immunosorbent assay (ELISA) for laronidase-specific IgG binding antibodies, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ALDURAZYME with the incidence of antibodies to other products may be misleading.

Four patients in the controlled study who experienced severe infusion-related reactions were tested for ALDURAZYME specific IgE antibodies and complement activation. IgE testing was performed by ELISA and complement activation was measured by the Quidel Enzyme Immunoassay. One of the four patients had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both ALDURAZYME specific IgE binding antibodies and complement activation (see WARNINGS:Hypersensitivity Reactions).

Other hypersensitivity reactions were also seen in patients receiving ALDURAZYME (see ADVERSE REACTIONS: Infusion-Related Reactions).



REPORTS OF SUSPECTED ALDURAZYME SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Aldurazyme. The information is not vetted and should not be considered as verified clinical evidence.

Possible Aldurazyme side effects / adverse reactions in 12 year old female

Reported by a individual with unspecified qualification from Netherlands on 2011-10-06

Patient: 12 year old female weighing 25.0 kg (55.0 pounds)

Reactions: Mucopolysaccharidosis I, Sleep Apnoea Syndrome, Cardiac Disorder, Disease Progression

Adverse event resulted in: death

Suspect drug(s):
Aldurazyme



Possible Aldurazyme side effects / adverse reactions in 13 year old male

Reported by a individual with unspecified qualification from Argentina on 2011-10-06

Patient: 13 year old male

Reactions: Cardiac Arrest, Infusion Related Reaction

Adverse event resulted in: death

Suspect drug(s):
Aldurazyme



Possible Aldurazyme side effects / adverse reactions in 19 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-18

Patient: 19 year old male weighing 34.7 kg (76.3 pounds)

Reactions: Poor Venous Access, Device Related Infection

Suspect drug(s):
Aldurazyme



See index of all Aldurazyme side effect reports >>

Drug label data at the top of this Page last updated: 2006-06-26

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