Taliglucerase alfa

Taliglucerase is used as an enzyme replacement for people with Type I Gaucher disease who are adults or children at least 4 years old.

Gaucher disease is a genetic disorder where the body does not have the enzyme needed to break down certain fatty materials (lipids). These lipids can accumulate in the body, leading to symptoms like easy bruising or bleeding, weakness, anemia, bone or joint pain, an enlarged liver or spleen, or fragile bones that can break easily.

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

Taliglucerase may also be used for purposes not mentioned in this medication guide.

Taliglucerase alfa is given as an infusion into a vein. A healthcare provider will give you this injection.

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

You may also receive other medications to prevent certain side effects of taliglucerase alfa.

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

Your doctor may occasionally change your dose to ensure 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.

Some people who get a taliglucerase alfa injection have experienced a reaction either during the injection or within 3 hours afterward. Inform your caregivers immediately if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash.

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 this medicine. Ask your doctor about any risk.

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

Some people receiving a taliglucerase alfa 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;
• skin rash, itching, or redness.

Common side effects of taliglucerase alfa may include:

• headache;
• rash, itching, warmth or tingly feeling;
• dizziness or feeling tired;
• 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.

Usual Adult Dose for Gaucher Disease:

Treatment-naive: -Initial dose: 60 units/kg IV every other weekConversion from imiglucerase: -For patients on a stable dose of imiglucerase: Begin at same units/kg dose IV every other week Dose adjustments should be based on individual's therapeutic goals Comments: -Administer as an IV infusion over 60 to 120 minutes every other week; in adult patients, an initial infusion rate of 1.2 mL/minute should be used.-After tolerability to infusion is established, the infusion rate may be increased, but should not exceed the maximum recommended infusion rate of 2.2 mL/minute; infusion should be delivered over a minimum or 60 minutes. Use: For long-term enzyme replacement therapy (ERT) for patients with confirmed diagnosis of type 1 Gaucher disease

Usual Pediatric Dose for Gaucher Disease:

4 years or older:Treatment-naive: Initial dose: 60 units/kg IV every other weekConversion from imiglucerase: -For patients on a stable dose of imiglucerase: Begin with same units/kg dose IV every other week Dose adjustments should be based on individual's therapeutic goals Comments: -Administer as an IV infusion over 60 to 120 minutes every other week; in adult patients, an initial infusion rate of 1.2 mL/minute should be used.-After tolerability to infusion is established, the infusion rate may be increased, but should not exceed the maximum recommended infusion rate of 2.2 mL/minute; infusion should be delivered over a minimum or 60 minutes. Use: For the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease.

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.

Other drugs may affect taliglucerase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.