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ELELYSO (taliglucerase alfa)

ELELYSO

 

For full prescribing information, please click here.

 

CAUTION: This page is intended for residents of the United States.

 

ELELYSO, which is branded as UPLYSOTM (alphataliglicerase) in Latin America, is a plant cell-expressed form of the glucocerebrosidase (GCD) enzyme. The U.S. Food and Drug Administration granted approval for ELELYSO for injection in May 2012 as a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease. The Israeli Ministry of Health granted marketing authorization for ELELYSO in September 2012. UPLYSO was approved by the Brazilian National Health Surveillance Agency (ANVISA) in March 2013.  Approvals have also been granted by the applicable regulatory authorities in Uruguay, Mexico, Australia, Canada, Chile and other countries.  Our commercialization partner, Pfizer, is currently pursuing marketing approvals elsewhere throughout the world.

 

Learn more at ELELYSO.com

 

Important Safety Information for ELELYSO

 

As with any intravenous protein medicine, like enzyme replacement therapy (ERT), severe allergic reactions (including anaphylaxis) have been observed in patients treated with ELELYSO. If this occurs, ELELYSO should be immediately discontinued, and appropriate medical treatment should be initiated. Patients who have experienced anaphylaxis to ELELYSO or another ERT should proceed with caution upon retreatment.

 

In addition, infusion reactions (including allergic reactions) – defined as a reaction occurring within 24 hours of the infusion -- were the most commonly observed reactions to ELELYSO. The most commonly observed infusion reactions were headache, chest pain or discomfort, weakness, fatigue, hives, abnormal redness of the skin, increased blood pressure, back or joint pain, and flushing.  Other infusion or allergic reactions included swelling of the face, mouth, and/or throat; wheezing; shortness of breath; skin color turning blue; coughing; and low blood pressure.  Most of these reactions were mild and did not require treatment.

 

Management of infusion reactions is based on the type and severity of the reaction. Your doctor may manage infusion reactions by temporarily stopping the infusion, slowing the infusion rate, or treating with medications such as an antihistamine and/or a fever reducer. Treatment with antihistamines and/or corticosteroids prior to infusion with ELELYSO may prevent these reactions.

 

Other common adverse reactions observed were upper respiratory tract infections, throat infection, flu, urinary tract infection, and pain in extremities.

 

As with all therapeutic proteins, including ERTs, there is a possibility of developing antibodies to ELELYSO. However, it is unknown if the presence of ADA to taliglucerase alfa is associated with a higher risk of infusion reactions.  Patients with an immune response to other ERTs who are switching to ELELYSO should continue to be monitored for antibodies. Patients who have developed infusion or immune reactions with ELELYSO or patients with an immune reaction to other enzyme replacement therapies who are switching to ELELYSO should be monitored for ADA to ELELYSO.

 

Comparison of the frequency of antibodies across ERTs may be misleading. 

 

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

 

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.

 

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.