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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... SAFETY INFORMATION CONTINUED BELOW

About VPRIV
(velaglucerase alfa for injection)

VPRIV (velaglucerase alfa for injection) is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease (GD1).

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VPRIV has up to 5 years of data from the largest clinical trial program of an ERT for GD11-4*

*Study 044 was a long-term, open-label extension study (up to 5 years) of 93 patients (aged 4 years and older) with GD1 who completed 1 of 3 pivotal studies that were included in the clinical development program. The primary objective of Study 044 was to evaluate the long-term safety of VPRIV.1,3,4

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: http://pi.shirecontent.com/PI/PDFs/Vpriv_USA_ENG.pdf

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

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Important Safety Information

Hypersensitivity Reactions Including Anaphylaxis

  • Hypersensitivity reactions, including anaphylaxis, have occurred. The most serious adverse reactions in patients treated with VPRIV 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.

Management of Hypersensitivity Reactions

  • 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.
adverse-new
  • 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.

Pediatric Patients

  • The safety and effectiveness of VPRIV have been established for enzyme replacement therapy (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. The safety and efficacy profiles were similar between pediatric and adult patients.
  • The safety and efficacy of VPRIV has not been established in pediatric patients younger than 4 years of age.

Geriatric Patients

  • In clinical studies of VPRIV in Gaucher’s 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 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.

Immunogenicity

  • As with all therapeutic proteins, there is a potential for immunogenicity.
  • In clinical studies, 1 of 54 treatment-naïve patients treated with VPRIV developed IgG class antibodies to VPRIV.
  • In this patient, the antibodies were determined to be neutralizing in an in vitro assay. No infusion-related 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.
  • Patients with an immune response to other enzyme replacement therapies who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.
  • 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.

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

INDICATION

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

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