Elelyso 200 unit intravenous solution

Generic name:
Taliglucerase alfa - injection

Pronunciation
(TAL-i-GLOO-ser-ase AL-fa)

Brand name(s)
Elelyso

Taliglucerase alfa may cause serious (sometimes fatal) allergic reactions. 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, chest tightness, low blood pressure, nausea, vomiting, flushing, or coughing.

Taliglucerase alfa is used to treat a certain rare genetic problem (Gaucher disease). Taliglucerase alfa 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 alfa does not correct the genetic problem, and treatment must be continued for life.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 2 weeks. It is injected slowly into a vein over 1 to 2 hours. The dosage is based on your weight, medical condition, and response to treatment.

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.

See also Warning section.

Redness, pain, itching, or swelling at the injection site may occur. Headache, joint pain, 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.

Before using taliglucerase alfa, 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.

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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as IgG antibodies) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.