VPRIV® (Velaglucerase Alfa for Injection)

VPRIV®

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Important Safety Information

VPRIV® (velaglucerase alfa for injection) is a form of enzyme replacement therapy (ERT) that’s used for long-term treatment of pediatric and adult patients with Type 1 Gaucher disease — a gene mutation that causes a lack of glucocerebrosidase. When you don’t have enough of such enzymes, bones can erode, the liver and spleen can become enlarged, and the patient may experience muscle weakness and seizures.

VPRIV® effectively replaces glucocerebrosidase. However, some patients have experienced serious allergic reactions and/or hypersensitivity. Tell your doctor immediately if you experience dizziness, headaches, nausea, fever, breathing difficulties, chest discomfort, itching, and/or feel weak. These reactions could occur up to 24 hours after an infusion therapy session.

What is the most important information I should know about VPRIV®?

It has not been researched whether VPRIV® would be effective in patients who are under four years of age. For other patients, VPRIV® could result in developing antibodies. This could lower your immune response to infections.

In the case of anaphylaxis, treatment should be immediately discontinued. Once the patient has been stabilized, the medical provider may decide to either continue treatment with a slower infusion rate or ceasing ERT with VPRIV® altogether. Healthcare professionals may also choose to treat the patient with corticosteroids or antihistamines prior to resuming ERT.

Caution is recommended if you’re pregnant. VPRIV® carries an increased risk of abortion — especially in women with uncontrolled Type 1 Gaucher disease prior to conception and pregnancy. It is unknown whether the medication could be passed on to a child through breastfeeding. Talk with your doctor about your options if you’re currently lactating or planning on doing so.

Side Effects of VPRIV®

As with any prescription medication, VPRIV® carries the risk of side effects. They are more likely to occur in patients who have never received ERT prior to commencing treatment. The most common ones include:

  • Headaches
  • Dizziness
  • Joint pain
  • Fever
  • Abdominal pain
  • Back pain
  • Nausea

Certain side effects are more common in pediatric patients (four to 17 years of age). These include:

  • Skin rash
  • Fever
  • Increased time for blood to clot

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

VPRIV® is administered bi-weekly. Each infusion therapy takes approximately 60 minutes and should be thoroughly monitored by a healthcare professional. Dosage for elderly patients should be modified taking into account the patient’s age and medical history.

Please refer to the full prescribing information.