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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 AND USE

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IMPORTANT SAFETY INFORMATION

Life-threatening hypersensitivity reactions, including anaphylaxis, may occur in patients treated with ELELYSO treatment. Anaphylaxis has occurred during the early hours of enzyme replacement therapy and after extended duration of therapy. Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions, including anaphylaxis and in a healthcare setting with appropriate medical monitoring and support. When treated with ELELYSO, your healthcare provider should closely monitor you for 3 hours after the start of each infusion for reactions.

If you show signs or symptoms of anaphylaxis during infusion, your healthcare provider should stop the infusion immediately and start appropriate medical treatment for the reactions. Signs and symptoms of anaphylaxis include hives (raised, red patches), low blood pressure, flushing, wheezing, chest tightness, nausea (feeling like you are going to be sick), vomiting, and dizziness. These reactions have occurred during ELELYSO infusion.

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 during ELELYSO infusion and up to 3 hours after the start of infusion.

Patients treated with ELELYSO who developed anti-drug antibodies (ADA) had a greater frequency of hypersensitivity reactions compared to those who did not have ADA. Your healthcare provider should closely watch for hypersensitivity reactions in patients who develop ADA.

Management of hypersensitivity reactions is based on the severity of the reaction. Your doctor may control 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 before infusion with ELELYSO may reduce the likelihood of hypersensitivity reactions. If serious hypersensitivity reactions including anaphylaxis happen, your doctor should immediately stop the infusion of ELELYSO and start appropriate medical treatment for the reactions.

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

The most common adverse reactions for ELELYSO are itching, flushing, headache, joint pain, pain in extremity, abdominal pain (stomach pain), vomiting, diarrhea, tiredness, 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.

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

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

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

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. Visit MedWatch or call 1-800-FDA-1088.

WHAT IS ELELYSO?

ELELYSO^® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.

Please click here for Full Prescribing Information, including BOXED WARNING.

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IMPORTANT SAFETY INFORMATION AND USE

Important Safety Information

Elelyso Patient Important Safety Information

IMPORTANT SAFETY INFORMATION

Life-threatening hypersensitivity reactions, including anaphylaxis, may occur in patients treated with ELELYSO treatment. Anaphylaxis has occurred during the early hours of enzyme replacement therapy and after extended duration of therapy. Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions, including anaphylaxis and in a healthcare setting with appropriate medical monitoring and support. When treated with ELELYSO, your healthcare provider should closely monitor you for 3 hours after the start of each infusion for reactions.

If you show signs or symptoms of anaphylaxis during infusion your healthcare provider should stop the infusion immediately and start appropriate medical treatment for the reactions. Signs and symptoms of anaphylaxis include hives (raised, red patches), low blood pressure, flushing, wheezing, chest tightness, nausea (feeling like you are going to be sick), vomiting, and dizziness. These reactions have occurred during ELELYSO infusion.

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 during ELELYSO infusion and up to 3 hours after the start of infusion.

Patients treated with ELELYSO who developed anti-drug antibodies (ADA) had a greater frequency of hypersensitivity reactions compared to those who did not have ADA. Your healthcare provider should closely watch for hypersensitivity reactions in patients who develop ADA.

Management of hypersensitivity reactions is based on the severity of the reaction. Your doctor may control 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 before infusion with ELELYSO may reduce the likelihood of hypersensitivity reactions. If serious hypersensitivity reactions including anaphylaxis happen, your doctor should immediately stop the infusion of ELELYSO and start appropriate medical treatment for the reactions.

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

The most common adverse reactions for ELELYSO are itching, flushing, headache, joint pain, pain in extremity, abdominal pain (stomach pain), vomiting, diarrhea, tiredness, 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.

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

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

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

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. Visit MedWatch or call 1-800-FDA-1088.

Elelyso Patient Important Safety Information

WHAT IS ELELYSO?

ELELYSO^® (taliglucerase alfa) for injection is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.

Please click here for Full Prescribing Information, including BOXED WARNING