VPRIV

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

This medication is given slowly, usually over 1 hour, into a vein as directed by your doctor, usually every 2 weeks. Your dose and how often it is given depends on your weight, medical condition, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. It may contain a few white particles. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Velaglucerase may rarely cause side effects (such as headache, dizziness, fainting, weakness/tiredness, nausea, high fever) while it is being given. Your doctor may decide to temporarily stop or slow down the medication infusion if this happens. Tell your healthcare professional right away if you have any of these symptoms during your treatment. Your doctor may direct you to take other medications (such as antihistamines, drugs for fever, or corticosteroids such as prednisone) before your treatment to prevent these reactions from happening again.

Tell your doctor if your condition persists or worsens. 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.

Fever, headache, nausea, dizziness, abdominal pain, back/joint pain, weakness, tiredness, or redness/pain/itching/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 velaglucerase, 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 breast-feeding.

Store in the refrigerator. Protect from light and freezing. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Laboratory and/or medical tests (such as IgG antibodies) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.