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Elaprase Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Elaprase in Detail - Patient Information: Side Effects
Some people receiving a idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.
It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.
Call your doctor at once if you have any of these serious side effects:
- worsened asthma;
- uneven heartbeats;
- blue lips or fingernails;
- vision problems; or
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
- joint pain;
- pain in your arms or legs;
- itching, mild skin rash; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Elaprase (Idursulfase Solution) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Elaprase FDA Prescribing Information: Side Effects
In clinical studies, the most frequent serious adverse events related to the use of ELAPRASE (idursulfase solution) were hypoxic episodes. Other notable serious adverse reactions that occurred in the ELAPRASE (idursulfase solution) 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 (idursulfase solution) 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 (idursulfase solution) weekly administration, and that occurred more frequently than in the placebo patients. The most common ( > 30%) adverse reactions were pyrexia, headache, and arthralgia.
Table 3 Summary of Adverse Reactions Occurring in at Least 10% of Patients Treated with ELAPRASE (idursulfase solution) Weekly in the 53-week Controlled Trial and Occurring More Frequently than in the Placebo Group
|Adverse Event|| ELAPRASE (idursulfase solution)
0.5 mg/kg Weekly
|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%)|
Fifty-one percent (32 of 63) of patients in the weekly ELAPRASE (idursulfase solution) 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.
Read the entire FDA prescribing information for Elaprase (Idursulfase Solution) »
Additional Elaprase Information
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