Starting Treatment

Get Started on VPRIV

In order to begin treatment with VPRIV, you should work with your physician 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

About VPRIV

Learn more about an effective treatment option for type 1 Gaucher disease

Enzyme replacement therapy has an important treatment choice in type 1 Gaucher disease management.

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Learn About Key VPRIV Dosing Details

Dosing

Download this brochure and learn more about what to expect at the first infusion.

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OnePath® Services

Learn about the many support services that OnePath® can offer you

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OnePath® is a comprehensive and personalized support program for eligible patients, families, and healthcare providers needing assistance with approved Shire Human Genetic Therapies, Inc. products.

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Dosing and Administration

Key Dosing and Administration Details About VPRIV

  • The recommended dose of VPRIV is 60 Units/kilogram every other week given as a 60 minute intravenous infusion
  • How much VPRIV your doctor prescribes is based on your body weight i.e., units per kilogram
  • Patients who were previously treated with a stable dose of imiglucerase are recommended to begin VPRIV with the same dose as prescribed for imiglucerase
  • Patients did not have to take any special medications before receiving infusions of VPRIV in clinical trials. You might be given an antihistamine and/or corticosteroid before your infusion to help prevent an allergic reaction from occurring. Pre-treatment medications for patients were not routinely required, however, in clinical studies.
  • Dosage adjustments may be made based on achievement and maintenance of individual therapeutic goals
    • These goals should be discussed between you and your doctor at the start of therapy

Tools Used for Enzyme Replacement Infusion With VPRIV

The following items are some of the tools that are used to administer your infusion of VPRIV:

  • Saline bag (normal saline) 100 mL, 0.9% Sodium Chloride Injection, USP
  • Syringes, which are used to prepare the medication
  • Intraveous (IV) infusion pump, a device that controls the rate of infusion
  • In-line low protein-binding filter, used to filter out substances that may have gotten into the IV line
  • Angiocatheter, a soft, tube-like device that’s inserted into a blood vessel for infusion

VPRIV infusions are always done under the supervision of a healthcare professional (HCP).

If You Experience a Reaction During an Infusion

If you experience an infusion-related reaction, your HCP will manage it by doing one or more of the following:

  • Slowing the infusion rate
  • Giving medications such as antihistamines, fever-reducing agents, and/or corticosteroids
  • Stopping infusion and resuming treatment with increased infusion time

Be sure to speak with your doctor or healthcare professional if you have further questions about VPRIV infusions.

VPRIV is available by prescription only.

Indication

VPRIV 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 side effects seen in patients in clinical trials with VPRIV were allergic reactions. Patients who have experienced allergic reactions to VPRIV or to other enzyme replacement therapy should proceed with caution.
  • The most common side effects observed in clinical trials in patients treated with VPRIV were infusion-related and included: headache, dizziness, low blood pressure, high blood pressure, nausea, weakness/fatigue, and fever. Generally, infusion-related reactions were mild and, in newly treated patients, occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
  • Management of infusion-related reactions is based on severity and may include slowing the infusion rate, treatment with medications such as antihistamines, fever-reducing agents and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. Side effects and any treatment concerns should be discussed with your physician.
  • The most commonly reported side effects (occurring in ≥10% of patients) that were considered related to VPRIV included: headache, dizziness, abdominal pain, nausea, back pain, joint pain, upper respiratory tract infection, aPTT prolonged (eg, blood clotting difficulty), infusion-related reactions, fever, and weakness/fatigue.
  • All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.
  • As with all therapeutic proteins, there is the potential of developing antibodies. It is unknown if the presence of 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.
  • Your doctor may prescribe VPRIV to you if you are pregnant, only if it is clearly necessary.
  • Tell your healthcare provider if you experience any side effects. For more information about VPRIV, ask your healthcare provider, read the Full Prescribing Information, visit www.VPRIV.com, or call Shire at 1-866-888-0660.
  • 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.