Ayvakit FDA Approval History
Last updated by Judith Stewart, BPharm on June 28, 2021.
FDA Approved: Yes (First approved January 9, 2020)
Brand name: Ayvakit
Generic name: avapritinib
Dosage form: Tablets
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor, Systemic Mastocytosis
Ayvakit (avapritinib) is a kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST), and advanced systemic mastocytosis (AdvSM).
- Ayvakit is an oral tablet administered once daily on an empty stomach, at least 1 hour before or 2 hours after a meal.
- Ayvakit can cause serious side effects including intracranial hemorrhage, cognitive symptoms, and harm to a newborn baby. Common adverse reactions in patients with GIST include edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash, and dizziness. Common adverse reactions in patients with AdvSM include edema, diarrhea, nausea, and fatigue/asthenia.
Development Timeline for Ayvakit
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