VPRIV® (velaglucerase alfa for injection) logo
Long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Important Safety Information: Hypersensitivity reactions, including serious allergic reactions (anaphylaxis) have occurred. VPRIV should be administered under the supervision of a healthcare professional. Read more Important Safety Information

TREATING WITH VPRIV

What Happens Now?

 
 

Once your doctor has prescribed VPRIV, we're here for you. We can arrange to have a Patient Access Manager meet with you prior to your infusion, to make sure your questions are answered as you get started on treatment. But before then, here's a rundown on what VPRIV is, and how it works.

    Enzyme Replacement Therapy Enzyme Replacement Therapy

Enzyme Replacement Therapy

Enzyme replacement therapies (ERTs) are administered by infusion, which means that they are injected directly into your bloodstream. VPRIV is indicated for long-term enzyme replacement therapy for patients with type 1 Gaucher disease.

How VPRIV works

VPRIV is designed to replace the deficient enzyme (glucocerebrosidase) that patients with type 1 Gaucher lack. It has the same amino acid sequence as the naturally produced enzyme that occurs in your body. In clinical trials, some patients experienced hypersensitivity, or a serious allergic reaction. The most commonly observed symptoms of hypersensitivity reactions were headache, dizziness, low or high blood pressure, nausea, tiredness/weakness, or fever. That’s why working with a medical professional is important.

Read more Important Safety Information.

How VPRIV® treats Type 1 Gaucher Disease How VPRIV® treats Type 1 Gaucher Disease

How it may help*

 
   

At the end of a 12-month study, VPRIV improved several measures of type 1 Gaucher disease in 12 treatment-naïve patients who received 60 units per kilogram (U/kg) every other week.

VPRIV® increased hemoglobin concentrations in treatment-naïve patients

increase in hemoglobin concentrations

  • Mean hemoglobin concentration at start of trial: 10.6 g/dL
  • Mean change from start of trial for patients receiving the 60 U/kg dose: 2.4 g/dL ± 0.3 [SE]
VPRIV® increased platelet counts in treatment-naïve patients

increase in platelet count

  • Mean platelet count at start of trial: 97x109/L
  • Mean change from start of trial for patients receiving the 60 U/kg dose: 51x109/L ± 12 [SE]
VPRIV® decreased spleen size in treatment-naïve patients

decrease in spleen size

  • Mean spleen volume at start of trial: 2.9% of body weight
  • Mean change from start of trial for patients receiving the 60 U/kg dose: -1.9% ± 0.5 of body weight [SE]

SE = Standard error

*Individual results may vary, so talk to your doctor about the risks and benefits of treatment options that may be right for you.

IMPORTANT SAFETY INFORMATION

VPRIV may not be right for everyone and should be given under the supervision of a healthcare professional with appropriate medical support available. There is a possibility of developing antibodies to VPRIV. It is unknown if having antibodies to VPRIV is related to a higher risk of infusion reactions. Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be watched for antibodies to VPRIV.

Starting VPRIV

At first, VPRIV is taken at an infusion center, which is a site of care that focuses specifically on medications that are delivered intravenously. Your OnePath Patient Support Manager can help you find the one nearest to you.

Also, you may eventually be able to work with your doctor to arrange for your infusions to be taken at home.

Starting VPRIV® at an infusion center

“It took a while to get used to, but now infusions are just a part of my routine.”

- Amanda

living with type 1 Gaucher

VPRIV® is a 60-minute infusion taken once every other week VPRIV® is a 60-minute infusion taken once every other week

For patients 4 years and older who are new to treatment, VPRIV is a 60-minute infusion taken once every other week under the supervision of a healthcare professional.

Though the infusion is scheduled for 60 minutes, you may need to stay longer for post-treatment monitoring.

OnePath Patient Support Managers

Still have questions?

Our dedicated OnePath Patient Support Managers are here if you need information.

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INDICATION

VPRIV® (velaglucerase alfa for injection) is a prescription medication indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.

IMPORTANT SAFETY INFORMATION

  • Hypersensitivity reactions, including serious allergic reactions (anaphylaxis) have occurred. VPRIV should be administered under the supervision of a healthcare professional. VPRIV is given every other week by intravenous infusion that typically takes up to 60 minutes. Appropriate medical support should be available when VPRIV is administered. The most serious side effects in patients treated with VPRIV were hypersensitivity reactions.
  • Hypersensitivity reactions were the most commonly observed side effects in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, low blood pressure, high blood pressure, nausea, tiredness/weakness, and fever. Hypersensitivity reactions in the clinical trials include any event considered related to and occurring within up to 24 hours of VPRIV infusion, including one case of anaphylaxis. Generally the reactions were mild and, in patients not previously treated, occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
  • If anaphylactic or other acute reactions occur, immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment. A hypersensitivity reaction should be treated based on the severity of the reaction. Your healthcare provider may manage a reaction by slowing the infusion rate or treating with medicine such as antihistamines, fever-reducing agents and/or corticosteroids or possibly stopping the medication and then restarting with a longer infusion time. For patients who have had symptoms of hypersensitivity reaction to enzyme replacement therapy, the doctor may consider treating the patient with antihistamines and/or corticosteroids before an infusion to help prevent such a reaction from happening.
  • The most commonly reported side effects during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, increased time it takes for blood to clot, tiredness/weakness, and fever. In clinical studies, the overall frequency of side effects was generally higher in the patients not previously treated with ERT than in the patients who switched from imiglucerase to VPRIV.
  • VPRIV is classified as pregnancy category B which means that animal reproduction studies did not show a risk to the unborn and there are no adequate and well-controlled studies in pregnant women. Your doctor may prescribe VPRIV to you if you are pregnant, only if it is clearly necessary.
  • The safety and efficacy profiles were similar in pediatric (ages 4 to 17) and adult patients. The safety of VPRIV has not been established in patients under 4 years of age. Side effects more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, increased time it takes for blood to clot, and fever.
  • The side effect profile in elderly patients was generally similar to that seen in pediatric and other adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering other existing medical conditions.
  • As with all therapeutic proteins, there is a potential for developing antibodies to VPRIV. In clinical studies, 1 of 54 patients who had not previously been treated with ERT, who were then treated with VPRIV, developed antibodies. It is unknown if having antibodies to VPRIV is associated with a higher risk of infusion reactions. Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.
  • Please see full Prescribing Information.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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