Elaprase Side Effects
Generic Name: idursulfase
Please note - some side effects for Elaprase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Elaprase - for the Consumer
Elaprase
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Elaprase:
Seek medical attention right away if any of these SEVERE side effects occur when using Elaprase:Anxiety; general unwell feeling; headache; irritability; pain, swelling, or redness at the injection site; stomach upset.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue/purple discoloration of lips, nails, or skin; chest pain; fever; hoarseness; irregular heartbeat; joint pain; seizures; severe headache or dizziness; shortness of breath; vision changes; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopElaprase Side Effects - for the Professional
Elaprase
The most serious infusion-related adverse reactions reported with Elaprase were anaphylactic and allergic reactions.
In clinical studies, the most frequent serious adverse events related to the use of Elaprase were hypoxic episodes. Other notable serious adverse reactions that occurred in the Elaprase treated patients but not in the placebo patients included one case each of: cardiac arrhythmia, pulmonary embolism, cyanosis, respiratory failure, infection, and arthralgia.
Adverse reactions were commonly reported in association with infusions. The most common infusion-related reactions were headache, fever, cutaneous reactions (rash, pruritus, erythema, and urticaria), and hypertension. The frequency of infusion-related reactions decreased over time with continued Elaprase treatment.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in practice.
Table 3 enumerates those adverse reactions that were reported during the 53-week, placebo-controlled study that occurred in at least 10% of patients treated with Elaprase weekly administration, and that occurred more frequently than in the placebo patients. The most common (>30%) adverse reactions were pyrexia, headache, and arthralgia.
| Adverse Event | Elaprase 0.5 mg/kg Weekly (n=32) |
Placebo (n=32) |
||
|---|---|---|---|---|
| Pyrexia | 20 | (63%) | 19 | (59%) |
| Headache | 19 | (59%) | 14 | (44%) |
| Arthralgia | 10 | (31%) | 9 | (28%) |
| Limb pain | 9 | (28%) | 8 | (25%) |
| Pruritus | 9 | (28%) | 5 | (16%) |
| Hypertension | 8 | (25%) | 7 | (22%) |
| Malaise | 7 | (22%) | 6 | (19%) |
| Visual disturbance | 7 | (22%) | 2 | (6%) |
| Wheezing | 6 | (19%) | 5 | (16%) |
| Abscess | 5 | (16%) | 0 | (0%) |
| Musculoskeletal dysfunction NOS | 5 | (16%) | 3 | (9%) |
| Chest wall musculoskeletal pain | 5 | (16%) | 0 | (0%) |
| Urticaria | 5 | (16%) | 0 | (0%) |
| Superficial injury | 4 | (13%) | 3 | (9%) |
| Anxiety, irritability | 4 | (13%) | 1 | (3%) |
| Atrial abnormality | 4 | (13%) | 3 | (9%) |
| Adverse events resulting from injury | 4 | (13%) | 2 | (6%) |
| Dyspepsia | 4 | (13%) | 0 | (0%) |
| Infusion site edema | 4 | (13%) | 3 | (9%) |
| Skin disorder NOS | 4 | (13%) | 1 | (3%) |
| Pruritic rash | 4 | (13%) | 0 | (0%) |
Immunogenicity
Fifty-one percent (32 of 63) of patients in the weekly Elaprase treatment arm in the clinical study (53-week placebo-controlled study with an open-label extension) developed anti-idursulfase IgG antibodies as assessed by ELISA or conformation specific antibody assay and confirmed by radioimmunoprecipitation assay (RIP). Sera from 4 out of 32 RIP confirmed anti-idursulfase antibody positive patients were found to neutralize idursulfase activity in vitro. The incidence of antibodies that inhibit cellular uptake of idursulfase into cells is currently unknown, and the incidence of IgE antibodies to idursulfase is not known. Patients who developed IgG antibodies at any time had an increased incidence of infusion reactions, including allergic reactions. The reduction of urinary GAG excretion was less in patients in whom circulating anti-idursulfase antibodies were detected. The relationship between the presence of anti-idursulfase antibodies and clinical efficacy outcomes is unknown.
The data reflect the percentage of patients whose test results were positive for antibodies to idursulfase in specific assays, and are highly dependent on the sensitivity and specificity of these assays. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to idursulfase with the incidence of antibodies to other products may be misleading.
TopSide Effects by Body System - for Healthcare Professionals
Hypersensitivity
Hypersensitivity side effects including anaphylactoid reactions have been observed in some patients during idursulfase infusions.
General
General side effects including pyrexia (63%), headache (59%), malaise (22%), and adverse events resulting from injury (13%) have been reported.
Immunologic
Immunologic side effects including anti-idursulfase IgG antibodies (51%) and abscess (16%) have been reported.
Musculoskeletal
Musculoskeletal side effects including arthralgia (31%), limb pain (28%), musculoskeletal dysfunction (16%), and chest wall musculoskeletal pain (16%) have been reported.
Dermatologic
Dermatologic side effects including pruritis (28%), urticaria (16%), superficial injury (13%), skin disorders (13%), and pruritic rash (13%) have been reported.
Cardiovascular
Cardiovascular side effects including hypertension (25%) and atrial abnormality (13%) have been reported.
Ocular
Ocular side effects including visual disturbances (22%) have been reported.
Respiratory
Respiratory side effects including wheezing (19%) have been reported.
Nervous system
Nervous system side effects including anxiety and irritability (13%) have been reported.
Gastrointestinal
Gastrointestinal side effects including dyspepsia (13%) have been reported.
Local
Local side effects including infusion site edema (13%) have been reported.
TopMore Elaprase resources
- Elaprase Prescribing Information (FDA)
- Elaprase Monograph (AHFS DI)
- Elaprase Advanced Consumer (Micromedex) - Includes Dosage Information
- Elaprase Consumer Overview
- Elaprase MedFacts Consumer Leaflet (Wolters Kluwer)
- Idursulfase Professional Patient Advice (Wolters Kluwer)
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