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.

pink callout button

If you have questions about the form, please contact us

The Chemical Structure of VPRIV

Glycan

Find out details about the glycan structure and cellular uptake of VPRIV.

LEARN MORE

Clinical Trial Program for VPRIV

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

LEARN MORE

Data of VPRIV

Learn more about the efficacy and safety of VPRIV in treating type 1 Gaucher disease.

VPRIV data

See how improvement of multiple disease measures is brought together in one treatment.

LEARN MORE

About ERT

An Effective Treatment Option for Type 1 Gaucher Disease

Lysosomal storage diseases (LSDs) are a group of inherited disorders, including type 1 Gaucher disease, that have been transformed by innovative treatments.

Multiple organ systems are affected by type 1 Gaucher disease, including the spleen and liver. Treatment for type 1 Gaucher disease is lifelong.

With enzyme replacement therapy (ERT)—the most common treatment for type 1 Gaucher disease—patients have an effective choice to treat their condition. ERT is not a cure, but it can modify or attenuate the phenotype by replacing or supplementing the malfunctioning glucocerebrosidase enzyme and thus diminish the effects of lysosomal storage buildup.1,2

Early diagnosis and treatment of type 1 Gaucher disease is essential for optimal treatment.2

find out how onepath can assis your patients who have type 1 gaucher disease

References:
1. Jmoudiak M, Futerman AH. Gaucher disease: pathological mechanisms and modern management. Br J Haematol. 2005;129(2):178-188.
2. Heese BA. Current strategies in the management of lysosomal storage diseases. Semin Pediatr Neurol. 2008;15(3):119-126.

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.