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TREATMENT-NAÏVE* STUDIES

VPRIV is a first-line option for your treatment-naïve patients1,2

The recommended starting dose for treatment-naïve patients 4 years of age and older is 60 U/kg once every other week as a 60-minute IV infusion.1 VPRIV should be administered under the supervision of a healthcare professional.1

male VPRIV patient hero blob

*Treatment-naïve: patients who had not received disease-specific treatment for at least 12 months prior to starting VPRIV3

STUDY 039 DESIGN (N=34)1,3

R
(N=34)

VPRIV 60 U/KG
EOW
(n=17)
IMIGLUCERASE
60 U/KG EOW
(n=17)

PRIMARY OBJECTIVE

Difference in the mean change from baseline to month 9 in hemoglobin concentration between the two groups.3

SECONDARY OBJECTIVES

Included differences in changes from baseline between treatment groups in mean platelet count, and spleen and liver volumes.3

VPRIV demonstrated non-inferiority to imiglucerase.3

PRIMARY OBJECTIVE

HEMOGLOBIN CONCENTRATION

  • Mean hemoglobin concentration at baseline: VPRIV, 11.5 g/dL; imiglucerase, 10.4 g/dL4
  • Mean treatment difference (VPRIV to imiglucerase) at 9 months: +0.1 g/dL ± 0.4 (SE)1,3
Hemoglobin

SECONDARY OBJECTIVES

PLATELET COUNT

  • Mean platelet count at baseline: VPRIV, 170 × 109/L; imiglucerase, 174 × 109/L4
  • Mean treatment difference (VPRIV to imiglucerase) at 9 months: −39 × 109/L3
Platelet

SPLEEN VOLUME

  • Mean spleen volume at baseline: VPRIV, 2.5% of body weight; imiglucerase, 4.2% of body weight4
  • Mean treatment difference (VPRIV to imiglucerase) at 9 months: +0.1% of body weight3
Spleen

LIVER VOLUME

  • Mean liver volume at baseline: VPRIV, 4.4% of body weight; imiglucerase, 4.2% of body weight4
  • Mean treatment difference (VPRIV to imiglucerase) at 9 months: −0.1% of body weight3
Liver

MEAN CHANGE (%) FROM BASELINE4

41 weeks imiglucerase 60 U/kg EOW

41 weeks VPRIV 60 U/kg EOW

Up arrow

Increasing hemoglobin and platelet counts

Down arrow

Decreasing spleen and liver volumes

HEMOGLOBIN
CONCENTRATION
PLATELET COUNT
SPLEEN VOLUME
LIVER VOLUME

+14%

n=17

+77%

n=17

−50%

n=7

−25%

n=17

100

50

0

0

−50

−100

Baseline values are for both treatment groups

EOW, every other week; R, randomized; SE, standard error

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.