Indication
VPRIVTM (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-naive 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-naive and 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-naive 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 reptherapies who are switching to VPRIV should continue to be monitored for anitbodies.
- For more information, please see the full prescribing information or call Shire at 1866-888-0660. To report suspected adverse events contact Shire Human Genetic Therapies, at the OnePathSM phone number 1-866-888-0660 or MedInfoGlobal@shire.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
