Healthcare Providers

Get Started on VPRIV

In order to help your patients begin treatment with VPRIV, you should work with your patient to complete, sign and submit a Start Form, available for download.

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If you have questions about the form, please contact us

Clinical Trial Program for VPRIV

See details on the most extensive Gaucher disease clinical trial program for an enzyme replacement therapy (ERT) to date.

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Dose Comparison Study—VPRIV 60 Units/kg and 45 Units/kg

Study 032

Multiple disease measures improved through 12 months of treatment with VPRIV 60 Units/kg.

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Switch-From-Imiglucerase Study

Study 034

Demonstrated that patients can safely transition from imiglucerase to VPRIV.

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Comparison of VPRIV and Imiglucerase

Study 039

A noninferiority study comparing VPRIV and imiglucerase.

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Data of VPRIV

VPRIV Has Been Extensively Studied

  • Clinical program—5 studies (025, 032, 034, 039, 044)
    • Multinational participation
    • 111 patients (25 pediatric patients)
  • In clinical studies:
    • VPRIV demonstrated clinically meaningful responses in therapeutic parameters (e.g. hemoglobin concentration, platelet count, spleen volume) 
    • VPRIV was at least as effective as imiglucerase in improving key therapeutic parameters ( hemaglobin concentration, platelet count)
    • Hemoglobin concentrations and platelet counts remained stable on average through 12 months of VPRIV treatment in patients switched from imiglucerase treatment.
  • FDA designated VPRIV for priority review; VPRIV received FDA approval in 6 months
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Indication

  • VPRIV® (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease.

Important Safety Information

  • The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions. Appropriate medical support should be available when VPRIV is administered. If a severe reaction occurs, medical standards for emergency treatment are to be followed.
  • Treatment with VPRIV should be used with caution in patients who have exhibited symptoms of hypersensitivity to the active ingredient, drug product excipients, or to other enzyme replacement therapies.
  • Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, asthenia/fatigue, and pyrexia. Generally the infusion-related reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
  • Management of infusion-related reactions should be based on severity of the reaction, such as slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
  • Other commonly observed adverse reactions in ≥10% of ERT-naïve or imiglucerase-switched patients were: headache, dizziness, abdominal pain, nausea, back pain, joint pain, upper respiratory tract infection, activated PTT prolonged, infusion-related reactions, pyrexia, and asthenia/fatigue.
  • All adult adverse reactions to VPRIV are considered relevant to pediatric patients (ages 4 to 17 years). Adverse reactions more common in pediatric patients (>10% difference) included upper respiratory tract infection, rash, aPTT prolonged, and pyrexia. The safety of VPRIV has not been established in pediatric patients younger than 4 years of age.
  • As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 treatment-naïve patients treated with VPRIV (who received a 45 Units/kg dose) developed IgG class antibodies (neutralizing in an in vitro assay). It is unknown if the presence of IgG 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.
  • For more information, please see the full prescribing information or call Shire at 1-866-888-0660
  • To report suspected adverse events, please contact Shire Human Genetic Therapies at 1-866-888-0660 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • For assistance with medical inquiries about VPRIV, please contact Medical Information at 1-866-888-0660 option 2 or US_ShireHGT_MedicalInformation@shire.com.