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Prescribing Information
Important Safety Information
Indication
Indication
ELELYSO^® (taliglucerase alfa) for injection is indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.
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Important Safety Information

Important Safety Information & Indication ＋

Important Safety Information & Indication－

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IMPORTANT SAFETY INFORMATION

Serious hypersensitivity reactions including anaphylaxis have occurred in some patients treated with ELELYSO^® (taliglucerase alfa) for injection. When treated with ELELYSO your doctor should monitor you before and after infusion for reactions.

Medical support should be readily available when ELELYSO is given. Discontinue ELELYSO immediately if you show signs or symptoms of anaphylaxis during infusion and get immediate medical care. Signs and symptoms of anaphylaxis include hives, low blood pressure, flushing, wheezing, chest tightness, nausea, vomiting, and dizziness.

Signs and symptoms of hypersensitivity include itching, swelling under the skin, flushing, redness, rash, nausea, vomiting, cough, chest tightness, and throat irritation. These reactions occurred up to 3 hours after the start of infusion.

Management of hypersensitivity reactions is based on the severity of the reaction. Your doctor may manage the reactions by slowing or temporarily stopping the infusion, and/or treating with medications such as an antihistamine, a fever reducer, and/or corticosteroids for mild reactions. Treatment with antihistamines and/or corticosteroids prior to infusion with ELELYSO may prevent these reactions from reoccurring. If severe hypersensitivity reactions occur, immediately stop the infusion of ELELYSO and get immediate medical care.

You should be carefully re-evaluated for treatment with ELELYSO if serious or hypersensitivity reactions including anaphylaxis occur.

The most common adverse reactions for ELELYSO are itching, flushing, headache, joint pain, pain in extremity, abdominal pain, vomiting, diarrhea, fatigue, back pain, dizziness, nausea, and rash. Vomiting occurred more often in children than adults and this may be due to a hypersensitivity reaction. The occurrence of other adverse reactions was similar between children and adults.

The recommended dosage of ELELYSO for adults and children who are 4 years of age and older and not taking another enzyme replacement therapy (ERT) is 60 Units per kg of body weight given every other week as a 60- to 120-minute intravenous infusion.

As with all therapeutic proteins, including ERTs, there is a possibility of developing antibodies to ELELYSO. The relationship between developing antibodies and hypersensitivity reactions is not clear. Your doctor should monitor you for antibodies to ELELYSO if you have developed antibodies or if you have experienced hypersensitivity reactions to ELELYSO or other ERTs.

If you are pregnant, or plan to become pregnant, you should talk to your doctor about potential benefits and risks.

ELELYSO is supplied as 200 Units per vial and is available by prescription only.

INDICATION

ELELYSO^® (taliglucerase alfa) for injection is indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.

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Patients should always ask their doctors for medical advice about adverse events.

You are encouraged to report an adverse event related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch where health care professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.

Need help paying for ELELYSO? Call Pfizer Gaucher Personal Support (GPS) toll-free at 1-855-ELELYSO (1-855-353-5976).

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