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These highlights do not include all the information needed to use AYVAKIT safely and effectively. See full prescribing information for AYVAKIT. AYVAKIT® (avapritinib) tablets, for oral use Initial U.S. Approval: 2020
Medication labelWhy this: Advisory · dailymed-prescription
AYVAKIT® is indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations [see Dosage and Administration (2.2)]. AYVAKIT is indicated for the treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Limitations of Use: AYVAKIT is not recommended for the treatment of patients with AdvSM with platelet counts of less than 50 × 109/L [see Warnings and Precautions (5.1)]. AYVAKIT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM). Limitations of Use: AYVAKIT is not recommended for the treatment of patients with ISM with platelet counts of less than 50 × 109/L [see Warnings and Precautions (5.1)].
- generic_name
- avapritinib
- product_names
- avapritinib
- ndc
- 72064-110, 72064-110-30, 72064-120, 72064-120-30, 72064-130, 72064-130-30, 72064-125, 72064-125-30, 72064-150, 72064-150-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en