Elelyso

What is ELELYSO?

(ELELYSO) Taliglucerase is used to treat a certain rare genetic problem (Gaucher disease). Taliglucerase replaces a certain natural substance (an enzyme called glucocerebrosidase) that is missing in people with Gaucher disease. This medication improves blood, bone, liver, and spleen problems caused by Gaucher disease. Taliglucerase does not correct the genetic problem, and treatment must be continued for life.

How should I use ELELYSO?

This medication is given slowly over 1 to 2 hours into a vein as directed by your doctor, usually every 2 weeks. The dosage is based on your weight, medical condition, and response to treatment. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake while mixing the solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Discard any unused prepared medication. Do not save for later use. Learn how to store and discard medical supplies safely. Infusion reactions may happen during the infusion of this drug and for some time afterward. Your doctor may prescribe other medications before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as headache, nausea/vomiting, dizziness, increased blood pressure, weakness/tiredness, back/joint pain, flushing, coughing. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time. Tell your doctor if your condition lasts or gets worse. Blood, liver, and spleen problems usually improve in the first year of treatment. It may take 2 to 3 years of treatment to see the full benefit to your bones.

What should I tell my health care provider before I take ELELYSO?

Before using taliglucerase, tell your doctor or pharmacist if you are allergic to it; or to alglucerase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

What may interact with ELELYSO?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What should I watch for while using ELELYSO?

Taliglucerase may sometimes cause a serious (sometimes fatal) allergic reaction. This reaction can happen at any time during treatment. Your doctor may prescribe other medications (such as antihistamines, fever reducers, corticosteroids) before each treatment to help prevent these side effects. Get medical help right away if you have any symptoms of a serious allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

What if I miss a dose of ELELYSO?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

What side effects may I notice from receiving ELELYSO?

See also Warning and How to Use section. Redness, pain, itching, or swelling at the injection site may occur. Runny nose, sore throat, or flu-like symptoms (such as fever, chills, muscle aches, tiredness) may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep ELELYSO?

Store unmixed vial in the refrigerator away from light. Do not freeze. Once mixed, consult the product instructions and your pharmacist for storage details. Discard any unused portion. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.