51/12. Capivaserib- (TRUQAB)- (Nov 2023)- to treat breast cancer that meets certain disease criteria
Drug Name:
51/12. Capivaserib- (TRUQAB)- (Nov 2023)- to treat breast cancer that meets certain disease criteria
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Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRUQAP safely and effectively. See full prescribing information for TRUQAP. TRUQAP™ (capivasertib) tablets, for oral use Initial U.S. Approval: 2023 --------------------------- INDICATIONS AND USAGE -------------------------- TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. (1) ---------------------- DOSAGE AND ADMINISTRATION ---------------------- • Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with TRUQAP based on the presence of one or more of the following genetic alterations in tumor tissue: PIK3CA/AKT1/PTEN. (2.1) • Recommended Dosage: 400 mg orally twice daily, with or without food, for 4 days followed by 3 days off. (2.3) --------------------- DOSAGE FORMS AND STRENGTHS -------------------- Tablets: 160 mg and 200 mg (3) ------------------------------ CONTRAINDICATIONS ----------------------------- Severe hypersensitivity to TRUQAP or any of its components. (4) ----------------------- WARNINGS AND PRECAUTIONS ---------------------- • Hyperglycemia: Evaluate blood glucose levels prior to starting and at regular intervals during treatment. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity. (2.2, 2.4, 5.1)
