Vonjo
PACRITINIB
Manufacturer: Sobi, Inc.
FDA-Approved Indications (3)
indicated for the treatment of adults with intermediate or high-risk secondary (post-polycythemia vera) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L
Population: adults
indicated for the treatment of adults with intermediate or high-risk primary myelofibrosis (MF) with a platelet count below 50 × 10 9 /L
Population: adults
indicated for the treatment of adults with intermediate or high-risk secondary (post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L
Population: adults
Indications & Usage
1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies (14.2)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L ( 1 ). This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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