1 PIK3CA/AKT1/PTEN-alteration following progression on
1 endocrine-based regimen in the metastatic setting or recurrence on or within 12 mo of completing adjuvant therapy (in combination with fulvestrant).Contraindicated in:
Use Cautiously in:
Derm: dermatitis, dry skin, eczema, pruritus, rash, skin discoloration, urticaria, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), ERYTHEMA MULTIFORME, palmar-plantar erythrodysesthesia.
Endo: hyperglycemia.
F and E: hypocalcemia, hypokalemia, dehydration, ketoacidosis.
GI: ↑liver enzymes, diarrhea, nausea, stomatitis, vomiting.
GU: ↑serum creatinine, urinary tract infection.
Hemat: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia.
Metab: ↓appetite, hypertriglyceridemia.
Drug-Drug:
Absorption: 29% absorbed following oral administration.
Distribution: Extensively distributed to extravascular tissues.
Metabolism/Excretion: Primarily metabolized in the liver via the CYP3A4 and UGT2B7. 45% excreted in the urine, 50% in the feces.
Half-life: 8.3 hr.