WARNING: RISK OF ANAPHYLAXIS
Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions, and require additional monitoring.
The risk of anaphylaxis is not the only warning or precaution for Elaprase. Additional warnings and precautions are the risks of: hypersensitivity, serious adverse reactions, and antibody development in patients with severe genetic mutations; acute respiratory complications; and, acute cardiorespiratory failure. Please see the Important Safety Information below and the full Prescribing Information.
Clinical Trial in Patients ≥ 5 Years of Age
In clinical trials with 96 male patients age 5 and older with Hunter Syndrome, the most common adverse reactions (occurring in more than 10% of patients) following ELAPRASE treatment were hypersensitivity (allergic) reactions, and included rash, hives, itching, ﬂushing, fever, and headache. The most frequent serious adverse reactions were episodes of insuﬃcient oxygen supply, called hypoxia.
Adverse reactions that occurred in at least 9% of patients in the ELAPRASE 0.5 mg/kg once-weekly group and with a higher incidence than in the placebo group were:
|Adverse Reaction||ELAPRASE (0.5 mg/kg weekly) N=32 n (%)||Placebo N=32 n (%)|
|Headache||9 (28%)||8 (25%)|
|Itching (Pruritis)||8 (25%)||3 (9%)|
|Hives (Urticaria)||5 (16%)||0 (0%)|
|Musculoskeletal Pain||4 (13%)||1 (3%)|
|Cough||3 (9%)||1 (3%)|
|Diarrhea||3 (9%)||1 (3%)|
Hypersensitivity reactions were reported in 69% of patients who received once-weekly treatment with ELAPRASE.
Additional adverse reactions that occurred in at least 9% of patients (≥3 patients) in the ELAPRASE 0.5 mg/kg every other week group and with a higher incidence than in the placebo group included: rash (19%), ﬂushing (16%), fatigue (13%), rapid heart rate (9%), and chills (9%).
Adverse Reactions Reported Since Approval of ELAPRASE
Late-emergent symptoms and signs of anaphylactic reactions have occurred up to 24 hours after initial treatment and recovery from an initial anaphylactic reaction. In addition, patients experienced repeated anaphylaxis over a two- to four-month period, up to several years after initiating ELAPRASE treatment.
Serious adverse reactions that resulted in death included cardiorespiratory arrest, respiratory failure, respiratory distress, cardiac failure, and pneumonia.