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
*Treatment-naïve: patients who had not received disease-specific
treatment for at least 30 months prior to starting VPRIV3
12-MONTH PARALLEL-DOSE: STUDY 032
STUDY 032 DESIGN (N=25)3
R (N=25)
VPRIV 45 U/KG
EOW (n=13)
VPRIV 60 U/KG
EOW (n=12)
PRIMARY OBJECTIVE
Change in hemoglobin concentration from baseline to 12 months in
the 60 U/kg treatment group.3
SECONDARY OBJECTIVES
Included changes from baseline to 12 months in hemoglobin
concentration in the 45 U/kg treatment group; and changes from baseline to 12 months in platelet
count, and spleen and liver volumes, for both treatment groups.3
At 12 months, VPRIV improved hemoglobin concentration
with clinically relevant differences from baseline observed. Differences from baseline were observed for secondary
objectives.3
PRIMARY OBJECTIVE
HEMOGLOBIN CONCENTRATION
Mean hemoglobin concentration at baseline: 10.6 g/dL1
Mean change at 12 months: +2.4 g/dL ± 0.3 (SE)1,3
SECONDARY OBJECTIVES
PLATELET COUNT
Mean platelet count at baseline: 97 × 109/L1
Mean change at 12 months: +51 × 109/L ± 12 (SE)1,3
SPLEEN VOLUME
Mean spleen volume at baseline: 2.9% of body weight1
Mean change at 12 months: −1.9% ± 0.5 of body weight1
LIVER VOLUME
Mean liver volume at baseline: 3.6% of body weight1
Mean change at 12 months: −0.84% ± 0.33 of body weight1
Mean change (%) from baseline3
Increasing hemoglobin and platelet counts
Decreasing spleen and liver volumes
HEMOGLOBIN CONCENTRATION
PLATELET COUNT
SPLEEN VOLUME
LIVER VOLUME
+23%
n=12
+66%
n=12
−50%
n=12
−17%
n=12
†This decrease was not
statistically significant
after adjusting for
multiple tests
100
50
0
0
−50
−100
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.
IMPORTANT SAFETY INFORMATION
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
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.
If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.
Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies, including VPRIV. VPRIV-treated patients have had these reactions occur in clinical studies and postmarketing experience.
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.
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Administration of VPRIV should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Initiate VPRIV in a healthcare setting with appropriate medical monitoring and support measures including access to cardiopulmonary resuscitation equipment.
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. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue VPRIV and immediately initiate appropriate medical treatment, including use of epinephrine. 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. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.
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.
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.
Please click here
for Full Prescribing Information, including Boxed WARNING for Risk of Anaphylaxis.
For more information, contact Takeda at
1-877-TAKEDA-7 (1-877-825-3327), or by email at medinfous@takeda.com
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