Gastrointestinal Stromal Tumor
Ayvakit (avapritinib) is a potent and highly selective KIT and PDGFR? inhibitor for the treatment of PDGFR? Exon 18 mutant gastrointestinal stromal tumors (GIST) and fourth-line GIST. AYVAKIT (avapritinib) tablets are supplied as follows:�100 mg, round, white film-coated tablet, printed with blue ink �BLU" on one side and �100" on the other side; available in bottles of 30 tablets (NDC 72064-110-30). �200 mg, capsule shaped, white film-coated tablet, printed with blue ink �BLU" on one side and �200" on the other side; available in bottles of 30 tablets (NDC 72064-120-30).�300 mg, capsule shaped, white film-coated tablet, printed with blue ink �BLU" on one side and �300" on the other side; available in bottles of 30 tablets (NDC 72064-130-30).Store at 20�C to 25�C (68�F to 77�F); excursions are permitted from 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature] HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 useInitial U.S. Approval:2020---------------------------INDICATIONS AND USAGE--------------------------- AYVAKIT is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. -----------------------DOSAGE AND ADMINISTRATION-----------------------�Select patients for treatment with AYVAKIT based on the presence of a PDGFRA exon 18 mutation. (2.1)�The recommended dosage is 300 mg orally once daily on an empty stomach, at least one hour before and two hours after a meal. (2.2)---------------------DOSAGE FORMS AND STRENGTHS--------------------- Tablets: 100 mg, 200 mg and 300 mg. (3)------------------------------CONTRAINDICATIONS------------------------------None. (4)-----------------------WARNINGS AND PRECAUTIONS----------------------- �Intracranial Hemorrhage: Withhold AYVAKIT for Grade 1 or 2 reactions until resolution and then resume at a reduced dose. Permanently discontinue for recurrent Grade 1 or 2 reactions or first occurrence of Grade 3 or 4 reactions. (2.3, 5.1)�Central Nervous System (CNS) Effects: CNS adverse reactions include cognitive impairment, dizziness, sleep disorders, mood disorders, speech disorders, and hallucinations. Depending on the severity, continue AYVAKIT at same dose, withhold and then resume at same or reduced dose upon improvement, or permanently discontinue. (2.3, 5.2)�Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.3, 8.1, 8.3)------------------------------ADVERSE REACTIONS------------------------------ The most common adverse reactions (incidence ? 20%) are edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash and dizziness. (6) To report SUSPECTED ADVERSE REACTIONS, contact Blueprint Medicines Corporation at 1-888-258-7768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------DRUG INTERACTIONS------------------------------ �Strong and Moderate CYP3A Inhibitors: Avoid coadministration of AYVAKIT with strong and moderate CYP3A inhibitors. If coadministration of AYVAKIT with a moderate inhibitor cannot be avoided, reduce dose of AYVAKIT. (2.4, 7.1)�Strong and Moderate CYP3A Inducers: Avoid coadministration of AYVAKIT with strong and moderate CYP3A inducers. (7.1) -----------------------USE IN SPECIFIC POPULATIONS----------------------- Lactation: Advise not to breastfeed. (8.2)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
