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TREATMENT-EXPERIENCED* STUDIES

Treatment-experienced patients can switch to VPRIV at the same dose as their last imiglucerase dose administered 2 weeks prior while maintaining stability†1,2
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*Treatment-experienced: patients previously treated with imiglucerase for a minimum of 30 consecutive months prior to switching to VPRIV3


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 044 DESIGN (N=38)2

STUDY 034 OVERALL VPRIV (n=40)
VPRIV 15–60 U/KG EOW (N=38)

PRIMARY OBJECTIVE

To evaluate the long-term safety of VPRIV treatment.2

SECONDARY OBJECTIVES

To evaluate the effects of treatment on hemoglobin concentration, platelet count,
and liver and spleen volumes.2

Patients previously treated with imiglucerase maintained stability vs. baseline for up to 5 years after switching to VPRIV.1,2

MEAN INCREASE IN HEMOGLOBIN
CONCENTRATION2

24-month data – baseline: 13.82 g/dL; mean change from baseline:
–0.05 g/dL4

MEAN INCREASE IN PLATELET COUNT2

24-month data – baseline: 164.5 × 109/L; mean change from baseline:
+9.03 × 109/L4

MEAN DECREASE IN SPLEEN
VOLUME2

24-month data – baseline: 0.821% of body weight; mean change from baseline: –0.110% of body weight4

MEAN DECREASE IN LIVER VOLUME2

24-month data – baseline: 2.062% of body weight; mean change from baseline: –0.026% of body weight4

Baseline is defined as before the first dose of VPRIV in Study 034

CI, confidence interval; EOW, every other week; MN, multiples of normal

IMPORTANT SAFETY INFORMATION

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.