IMPORTANT SAFETY INFORMATION AND INDICATION
Serious hypersensitivity reactions, including anaphylaxis, have occurred in some patients treated with ELELYSO® (taliglucerase alfa) for injection. Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment.
In clinical trials, 2 of 72 (3.0%) patients treated with ELELYSO experienced signs and symptoms of anaphylaxis. This included urticaria, hypotension, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness. These reactions have occurred during ELELYSO infusion.
In clinical trials with ELELYSO, 21 of 72 (29%) patients experienced hypersensitivity reactions, including anaphylaxis. This 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.
Base the management of hypersensitivity reactions 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.
The most common adverse reactions with ELELYSO, either as initial therapy or as therapy following a switch from imiglucerase (≥5%) reported during clinical trials with ELELYSO were pruritus, flushing, headache, arthralgia, pain in extremity, abdominal pain, vomiting, diarrhea, fatigue, back pain, dizziness, nausea, and rash.
The most common adverse reaction (≥10%) for treatment-naïve pediatric patients was vomiting. Pediatric patients experienced a higher frequency of vomiting than adults and this may be a symptom of hypersensitivity reaction. The frequencies of other adverse reactions were similar between pediatric and adult patients.
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other taliglucerase alfa products may be misleading.
In a clinical trial of treatment-naïve adult patients, 17 of 32 (53%) patients who were administered ELELYSO developed anti-drug antibodies (ADA) during treatment.
In a clinical trial of treatment-naïve pediatric patients, 2 of 9 (22%) patients developed ADA during treatment with ELELYSO.
In another clinical trial of 26 adults and 5 pediatric patients switched from imiglucerase treatment to ELELYSO treatment, 5 (16%) adults developed ADA after the switch.
The relationship between ADA and hypersensitivity reactions is not fully understood. Monitoring for ADA to ELELYSO may be useful in ADA-positive patients or in patients who have experienced hypersensitivity to other enzyme replacement therapies.
The recommended dosage for treatment-naïve adult and pediatric patients 4 years of age and older is 60 Units per kg of body weight administered once every 2 weeks as a 60- to 120-minute intravenous infusion.
Patients switching from a stable dose of imiglucerase are recommended to begin treatment with ELELYSO at that same dosage. Dose adjustments can be made based on achievement and maintenance of each patient’s therapeutic goals.
ELELYSO is supplied as 200 Units per vial and is available by prescription only.
ELELYSO® (taliglucerase alfa) for injection is indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.
Please see Full Prescribing Information.