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U.S. Department of Health and Human Services

Safety

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Elaprase (idursulfase) injection, for intravenous use

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

BOXED WARNING

  • Life-threatening anaphylactic reactions, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have occurred in some patients during and up to 24 hours after Elaprase infusions. 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.
 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis
  • Serious hypersensitivity reactions, including anaphylaxis, have occurred during and up to 24 hours after infusion. Some of these reactions were life-threatening and included respiratory distress, hypoxia, hypotension, urticaria, and angioedema of the throat or tongue, regardless of duration of the course of treatment.
  • If anaphylactic or other acute reactions occur…
  • In postmarketing reports, patients receiving ELAPRASE experienced anaphylactic reactions up to several years after initiating treatment. Some patients were reported to have repeated anaphylactic events over a two- to four-month time period. Medical management included treatment with antihistamines, inhaled beta-adrenergic agonists, corticosteroids, oxygen, and vasopressors. Treatment was discontinued for some patients, while others continued treatment with premedication and a slower infusion rate.
Risk of Hypersensitivity, Serious Adverse Reactions, and Antibody Development in Hunter Syndrome Patients with Severe Genetic Mutations
  • In the clinical trial of Hunter syndrome patients aged 7 years and younger, patients with complete gene deletion, large gene rearrangement, nonsense, frameshift or splice site mutations experienced a higher incidence of hypersensitivity reactions, serious adverse…
Risk of Acute Cardiorespiratory Failure
  • Caution should be exercised when administering ELAPRASE to patients susceptible to fluid…
 

ADVERSE REACTIONS

  • entire section revised see label
 

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Teratogenicity studies have not been conducted with ELAPRASE. A pre- and postnatal development study in rats showed
Nursing Mothers
  • Elaprase was excreted in breast milk of lactating rats at a concentration higher (4 to 5-fold) than that of the plasma. It is not known whether Elaprase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Elaprase is administered to a nursing woman.
Pediatric Use
  • Clinical trials with ELAPRASE were conducted in 96 patients with Hunter syndrome, ages 5 to 31 years old, with the majority of the patients in the pediatric age group (median age 15 years old). In addition, an open-label, uncontrolled clinical trial was conducted in 28 patients with Hunter syndrome, ages 16 months to 7.5 years old. Patients 16 months to 5 years of age demonstrated reduction in spleen
Geriatric Use
  • Clinical studies of ELAPRASE did not include patients older than 31 years of age. It is not known whether older patients respond differently from younger patients.