Elelyso is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in adults and children at least 4 years old with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Elelyso may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, Elelyso is not a cure for this condition.

Some people receiving a Elelyso injection have had a reaction when the medicine was injected, or up to 3 hours later. Tell your caregivers right away if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash.

Elelyso is not a cure for Gaucher disease.

Before taking this medicine

You should not use Elelyso if you are allergic to taliglucerase alfa.

Tell your doctor if you are pregnant. It is not known whether taliglucerase alfa will harm an unborn baby. However, having untreated or uncontrolled Type I Gaucher disease during pregnancy may cause new or worsening symptoms in the mother, or complications in the baby such as growth problems or bleeding. The benefit of treating your disease may outweigh any risks to the baby.

It may not be safe to breastfeed while using Elelyso . Ask your doctor about any risk.

Elelyso is injected into a vein through an IV. A healthcare provider will give you this injection.

You may be given other medications to help prevent an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.

You may be given other medications to prevent certain side effects of Elelyso.

Elelyso is usually given every other week. Follow your doctor's dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results.

Taliglucerase alfa doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Usual Adult Dose of Elelyso for Gaucher Disease:

Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

Use: For long-term enzyme replacement therapy (ERT) for patients with confirmed diagnosis of type 1 Gaucher disease

Usual Pediatric Dose of Elelyso for Gaucher Disease:

4 years or older:
Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

Use: For long-term enzyme ERT for patients with confirmed diagnosis of type 1 Gaucher disease

You should not use Elelyso if you are allergic to taliglucerase alfa.

Tell your doctor if you are pregnant. It is not known whether taliglucerase alfa will harm an unborn baby. However, having untreated or uncontrolled Type I Gaucher disease during pregnancy may cause new or worsening symptoms in the mother, or complications in the baby such as growth problems or bleeding. The benefit of treating your disease may outweigh any risks to the baby.

It may not be safe to breastfeed while using Elelyso . Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your Elelyso injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any signs of an allergic reaction to Elelyso: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a Elelyso injection have had a reaction when the medicine was injected, or up to 3 hours later. Tell your caregivers right away if you have:

• dizziness or feeling like you might pass out;

• chest tightness, wheezing;

• swelling in your face;

• cough, throat irritation;

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting; or

• skin rash, itching, or redness.

Common Elelyso side effects may include:

• headache;

• rash, itching, warmth or tingly feeling;

• dizziness or tired feeling;

• nausea, stomach pain, vomiting; or

• joint pain, back pain, pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.