Elelyso (taliglucerase) is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people 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.
Important information
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.
FDA pregnancy category B. Elelyso is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether taliglucerase alfa passes into breast milk or if it could harm a nursing baby. Do not use Elelyso without telling your doctor if you are breast-feeding a baby.
How is Elelyso given?
Elelyso is injected into a vein through an IV. A healthcare provider will give you this injection.
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.
Elelyso dosing information
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
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Elelyso injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Elelyso?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Elelyso side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Elelyso: hives; difficult breathing; blue lips or fingernails; 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:
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dizziness, anxiety, weakness, tired feeling;
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sudden headache, or light-headed feeling (like you might pass out);
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flushing (warmth, redness, or tingly feeling);
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fast or uneven heartbeats, chest pain or tightness, wheezing;
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nausea, vomiting; or
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red skin rash.
Common Elelyso side effects may include:
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headache;
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rash, itching, warmth or tingly feeling;
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dizziness or tired feeling;
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nausea, stomach pain, vomiting; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Elelyso?
Other drugs may interact with taliglucerase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
