Select Safety Information About TRUQAP^® (capivasertib) tablets

TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.

Serious adverse reactions include hyperglycemia, including diabetic ketoacidosis and fatal outcomes; diarrhea; and cutaneous adverse reactions. Monitor fasting glucose and hemoglobin A1C levels regularly. May cause fetal harm when administered to a pregnant woman. Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%).

Indication and Usage

TRUQAP in combination with fulvestrant is indicated 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 alteration 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.

You may report side effects related to AstraZeneca products .

aBC=locally advanced breast cancer not amenable to resection or radiation therapy with curative intent; AKT1=serine/threonine protein kinase 1; APP=advanced practice provider; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; ET=endocrine therapy;
HER2–=human epidermal growth factor receptor 2 negative; HR+=hormone receptor positive; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PTEN=phosphatase and tensin homolog.

Reference: 1. TRUQAP^® (capivasertib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025.

This product information is intended for US healthcare professionals only.

TRUQAP is a registered trademark of the AstraZeneca group of companies.

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US-85251 Last Updated 5/25