Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- (updated paragraph) In a clinical trial of treatment-naïve pediatric patients, 2 (22%) of 9 patients developed ADA during treatment with ELELYSO, and one of 9 patients was ADA-positive prior to initiation of ELELYSO. Two of these 3 patients experienced hypersensitivity reactions (1 who developed ADA during treatment and became negative after Week 12 and 1 who was ADA-positive at baseline and became ADA negative after Week 8) and continued treatment with ELELYSO. The third patient who developed ADA during treatment and continued to be ADA-positive until study completion at Week 52 did not experience a hypersensitivity reaction.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Anaphylaxis
- Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with Elelyso. In clinical trials, 2 of 72 (2.8%) patients treated with Elelyso experienced signs and symptoms consistent with anaphylaxis. Signs and symptoms of these patients included urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions occurred during Elelyso infusion.
- In clinical trials with Elelyso, 21 of 72 (29%) patients experienced hypersensitivity reactions, including anaphylaxis. Signs and symptoms of hypersensitivity reactions included pruritus, angioedema, flushing, erythema, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions have occurred up to 3 hours after the start of infusion.
- Due to the potential for anaphylaxis, appropriate medical support should be readily available when Elelyso is administered. Observe patients closely for an appropriate period of time after administration of Elelyso, taking into account the time to onset of anaphylaxis seen in clinical trials. Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs and symptoms occur. If anaphylaxis occurs, Elelyso should be immediately discontinued, and appropriate medical treatment should be initiated.
- Management of hypersensitivity reactions should be based on the severity of the reaction and include slowing or temporary interruption of the infusion and/or administration of antihistamines, antipyretics, and/or corticosteroids for mild reactions. Pretreatment with antihistamines and/or corticosteroids may prevent subsequent hypersensitivity reactions. Patients were not routinely premedicated prior to infusion of Elelyso during clinical studies. If severe hypersensitivity reactions occur, immediately stop the infusion of Elelyso and initiate appropriate treatment.
- Consider the risks and benefits of re-administering Elelyso in patients who have experienced a severe reaction associated with Elelyso. Caution should be exercised upon rechallenge, and appropriate medical support should be readily available.
- *revised to reflect the addition of text related to the occurrence of anaphylaxis related events as a postmarketing event*