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Important Safety InformationPrescribing InformationContact Us

Important Safety Information: Hypersensitivity reactions, including anaphylaxis have occurred. The most serious adverse reactions in patients treated with VPRIV (velaglucerase alfa for injection) were hypersensitivity reactions. Read more Important Safety Information

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VPRIV Safety Profile

The safety profile of VPRIV was similar between pediatric (ages 4-17) and adult patients.1  

The most serious, and most commonly observed, adverse reactions in 94 patients treated with VPRIV in clinical studies were hypersensitivity reactions. The most commonly observed symptoms of hypersensitivity reactions were1:

  • Headache
  • Dizziness
  • Hypotension
  • Hypertension
  • Nausea
  • Fatigue/asthenia
  • Pyrexia

The most common adverse reactions during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, pyrexia, abdominal pain, back pain, joint pain (knee), asthenia/fatigue, aPTT prolonged, and nausea.1

The safety profile of VPRIV was similar between pediatric patients and adult patients. Adverse reactions more commonly seen in pediatric patients compared with adult patients include (>10% difference): rash, aPTT prolonged, and pyrexia.1

As with any intravenous protein product, hypersensitivity reactions are possible. Therefore appropriate medical support, including personnel adequately trained in cardiopulmonary resuscitative measures and access to emergency measures, should be readily available when VPRIV is administered.1

The safety of VPRIV remained consistent when further assessed in a long-term, open-label extension study (044).2,3

Management of Hypersensitivity Reactions

If anaphylactic or other acute reactions occur, immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment.1

Management of hypersensitivity reactions, 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, should be based on the severity of the reaction.1

In cases where patients have exhibited symptoms of hypersensitivity to the active ingredient or excipients in the drug product or to other ERT, pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions.1

Less common adverse reactions affecting more than one patient (>2% in the treatment-naïve group and >3% in patients switched from imiglucerase to VPRIV) were bone pain, tachycardia, rash, urticaria, flushing, hypertension, and hypotension.1

VPRIV for Pediatric Use

The safety and effectiveness of VPRIV have been established for ERT in patients between 4 and 17 years of age with type 1 Gaucher disease. Use of VPRIV in this age group is supported by evidence from adequate and well-controlled studies of VPRIV in 74 adult patients and 20 pediatric patients.1

The safety and efficacy profiles were similar between pediatric and adult patients.1

The safety and efficacy of VPRIV have not been established in pediatric patients younger than 4 years of age.1

VPRIV for Geriatric Use

In clinical studies of VPRIV in Gaucher disease, a total of 56 VPRIV-treated patients were 65 years of age or older, including 10 patients who were 75 years of age or older. Among 205 patients who switched from imiglucerase to VPRIV, 52 patients were 65 years of age or older of which 10 were 75 years of age and older. The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be approached cautiously, considering potential comorbid conditions.1

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 out of 54 treatment-naïve patients treated with VPRIV developed IgG class antibodies to VPRIV.1

In this patient, the antibodies were determined to be neutralizing in an in vitro assay. No hypersensitivity reactions were reported for this patient. It is unknown if the presence of IgG antibodies to VPRIV is associated with a higher risk of infusion reactions.1

Patients with an immune response to other ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.1

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to VPRIV with the incidence of antibodies to other products may be misleading.1

For more information, please see the Full Prescribing Information or call Shire Medical Information at 1-866-888-0660, option 2.

To report suspected adverse events, contact Shire Medical Information at 1-866-888-0660 or the FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.

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Important Safety Information

Hypersensitivity reactions, including anaphylaxis have occurred. The most serious adverse reactions in patients treated with VPRIV (velaglucerase alfa for injection) were hypersensitivity reactions.

Hypersensitivity reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. Patients were not routinely pre-medicated prior to infusion of VPRIV. The most commonly observed symptoms of hypersensitivity reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. 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 treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.

As with any intravenous protein product, hypersensitivity reactions are possible, therefore appropriate medical support, including personnel adequately trained in cardiopulmonary resuscitative measures and access to emergency measures should be readily available when VPRIV is administered. If anaphylactic or other acute reactions occur, immediately discontinue the infusion of VPRIV and initiate the appropriate medical treatment.

Management of hypersensitivity 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. In cases where patients have exhibited symptoms of hypersensitivity to the active ingredient or excipients in the drug product or to other enzyme replacement therapy, pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions.

The most common adverse reactions during clinical studies (in ≥10% of patients) were hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia. In clinical studies, the overall frequency of adverse events was generally higher in the population naïve to ERT (enzyme replacement therapy) than in the population switched from imiglucerase to VPRIV.

VPRIV is classified as pregnancy category B.

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. Adverse reactions more commonly seen in pediatric patients compared to adult patients include (>10% difference): rash, aPTT prolonged, and pyrexia.

The adverse reaction profile in elderly patients was consistent with that previously observed across pediatric and adult patients. In general, dose selection for an elderly patient should be approached cautiously, considering comorbid conditions.

As with all therapeutic proteins, there is a potential for immunogenicity. In clinical studies, 1 of 54 enzyme treatment-naïve patients treated with VPRIV 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 to VPRIV.

Please see Full Prescribing Information.

To report suspected adverse reactions, contact Shire Medical Information at 1-866-888-0660, option 2 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 email
US_ShireHGT_MedicalInformation@shire.com.

Indication

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

References

  1. VPRIV [prescribing information]. Lexington, MA: Shire.
  2. Data on file. Clinical Study Report: HGT-GCB-044. Shire, 2013; Lexington, MA.
  3. Smith L, Rhead W, Charrow J, et al. Long-term velaglucerase alfa treatment in children with Gaucher disease type 1 naïve to enzyme replacement therapy or previously treated with imiglucerase. Mol Genet Metab. 2016;117(2):164-171.