Velaglucerase alfa

Velaglucerase alfa contains an enzyme that is normally found in healthy people. Some individuals do not have this enzyme due to a genetic disorder. Velaglucerase alfa helps to replace this missing enzyme in people with Type I Gaucher disease.

Gaucher disease is a genetic condition where the body does not produce the enzyme needed to break down certain fatty materials (lipids). When lipids build up in the body, they can cause symptoms like easy bruising or bleeding, weakness, anemia, bone or joint pain, an enlarged liver or spleen, or weakened bones that may fracture easily.

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

Velaglucerase may also be used for purposes not listed in this medication guide.

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

Velaglucerase alfa is usually given every other week. Follow your doctor's dosing instructions.

Velaglucerase alfa must be given slowly, and the infusion can take at least 1 hour to complete.

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

An allergic reaction may happen during or soon after receiving this medicine. Inform your caregivers or seek emergency medical help immediately if you experience any signs of a severe allergic reaction, including headache, dizziness, fever, nausea, feeling weak or tired, and feeling faint.

Tell your doctor if you are pregnant or breastfeeding.

It is not known if velaglucerase alfa can harm an unborn baby. However, not treating Type I Gaucher disease during pregnancy may lead to complications like miscarriage or stillbirth. Type I Gaucher disease can also worsen during pregnancy and may cause health issues for both mother and baby. The benefits of treating this disease with velaglucerase alfa may be more important than any risks to the baby.

Velaglucerase alfa is not approved for use by anyone younger than 4 years old.

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

An allergic reaction may happen during or shortly after the infusion of velaglucerase alfa. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as headache, dizziness, fever, nausea, feeling weak or tired, and feeling like you might pass out.

Common side effects of velaglucerase alfa may include:

• headache;
• dizziness;
• feeling weak or tired;
• nausea, stomach pain;
• joint pain, back pain; or
• fever.

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:

Starting dose for patients naive to enzyme replacement therapy (ERT): 60 units/kg IV every other weekSwitching from imiglucerase to velaglucerase alfa: Patients currently being treated with stable doses of imiglucerase may switch by starting this drug at the previous imiglucerase dose 2 weeks after the last imiglucerase dose.Comments:-This drug should be administered as a 60-minute IV infusion under the supervision of a healthcare professional.Use: For long-term ERT for patients with type 1 Gaucher disease

Usual Pediatric Dose for Gaucher Disease:

4 years or older:-Starting dose for patients naive to ERT: 60 units/kg IV every other week-Switching from imiglucerase to velaglucerase alfa: Patients currently being treated with stable doses of imiglucerase may switch by starting this drug at the previous imiglucerase dose 2 weeks after the last imiglucerase dose.Comments:-This drug should be administered as a 60-minute IV infusion under the supervision of a healthcare professional.Use: For long-term ERT for patients with type 1 Gaucher disease

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

Since velaglucerase alfa is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

Other drugs may affect velaglucerase 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.