Treatment-Experienced Switch Study | VPRIV® (velaglucerase alfa) for injection

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TREATMENT-EXPERIENCED* STUDIES

VPRIVʼs safety and efficacy have been demonstrated in patients switching from imiglucerase^†1,2

*Treatment-experienced: patients previously treated with imiglucerase for a minimum of 30 consecutive months prior to switching to VPRIV²

^†Patients aged ≥4 years currently being treated on a stable dose of imiglucerase for type 1 Gaucher disease may be switched to VPRIV at the last imiglucerase dose administered 2 weeks prior¹

STUDY 034 DESIGN (N=41)²

PATIENTS TREATED WITH IMIGLUCERASE FOR ≥30 MONTHS

SWITCH

(no washout)

VPRIV
15–60 U/KG EOW (n=40)

PRIMARY OBJECTIVE

To evaluate the safety of every-other-week dosing of VPRIV in patients with type 1 Gaucher disease who were previously treated with imiglucerase.²

SECONDARY OBJECTIVES

Absolute change from baseline to 12 months in hemoglobin concentration; and percentage change from baseline to 12 months in platelet count, and spleen and liver volumes normalized by body weight.²

Over 12 months, stability vs. baseline was maintained in all four clinical parameters.²

HEMOGLOBIN CONCENTRATION

Median hemoglobin concentration at baseline: 13.8 g/dL²
Mean change at 12 months: −0.1 g/dL (within the pre-defined efficacy criterion of ±1 g/dL)²

PLATELET COUNT

Median platelet count at baseline: 162 × 10⁹/L²
Mean change at 12 months: +7.0% (within the pre-defined efficacy criterion of ±20%)²

SPLEEN VOLUME

Median spleen volume at baseline: 2.5 MN²
Mean change at 12 months: −5.6% (within the pre-defined efficacy criterion of ±15%)²

LIVER VOLUME

Median liver volume at baseline: 0.8 MN²
Mean change at 12 months: 0.0% (within the pre-defined efficacy criterion of ±15%)²

MEAN CHANGE FROM BASELINE IN
HEMOGLOBIN CONCENTRATION²

12 months VPRIV 15–60 U/kg EOW

12-month data – median baseline: 13.8 g/dL; mean change from baseline: −0.1 g/dL (within the pre-defined efficacy criterion of ±1 g/dL)²

MEAN % CHANGE FROM BASELINE IN
PLATELET COUNT²

12 months VPRIV 15–60 U/kg EOW

12-month data – median baseline: 162 × 10⁹/L; mean change from baseline: +7.0% (within the pre-defined efficacy criterion of ±20%)²

MEAN % CHANGE FROM BASELINE IN
SPLEEN VOLUME²

12 months VPRIV 15–60 U/kg EOW

12-month data – median baseline: 2.5 MN; mean change from baseline: –5.6% (within the pre-defined efficacy criterion of ±15%)²

MEAN % CHANGE FROM BASELINE IN
LIVER VOLUME²

12 months VPRIV 15–60 U/kg EOW

12-month data – median baseline: 0.8 MN; mean change from baseline: 0.0% (within the pre-defined efficacy criterion of ±15%)²

EOW, every other week; MN, multiples of normal

IMPORTANT SAFETY INFORMATION

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.

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 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. Additional hypersensitivity reactions of chest discomfort, dyspnea, pruritus and vomiting have been reported in post-marketing experience. In some cases vomiting can be serious, requiring hospitalization and/or drug discontinuation.

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 velaglucerase alfa 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 partial thromboplastin time (aPTT), fatigue/asthenia, and pyrexia. In clinical studies, the overall frequency of adverse events was generally higher in the population naïve to enzyme replacement therapy (ERT) than in the population switched from imiglucerase to VPRIV.

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, prolonged aPTT, 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 (2%) enzyme treatment-naïve patients treated with VPRIV developed IgG class antibodies (neutralizing in an in vitro assay). One additional patient developed IgG antibodies to VPRIV during an extension study. 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 ERTs who are switching to VPRIV should continue to be monitored for antibodies to VPRIV.

Please click here for Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact 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 Takeda at 1-877-TAKEDA-7 (1-877-825-3327), or email medinfous@takeda.com.

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TREATMENT-EXPERIENCED* STUDIES

12-MONTH SWITCH: STUDY 034