Capivasertib Disease Interactions

Severe hyperglycemia (associated with ketoacidosis) has occurred in patients treated with capivasertib. The safety of capivasertib in patients with Type 1 diabetes or with diabetes requiring insulin has not been established; these patients were excluded from clinical studies. Fasting blood glucose and hemoglobin A1C should be evaluated and optimized before starting treatment. Regular monitoring of fasting blood glucose is recommended during treatment with capivasertib. More frequent monitoring of fasting blood glucose is recommended in patients with a medical history of diabetes mellitus and in patients with risk factors for hyperglycemia such as obesity, elevated fasting blood glucose, hemoglobin A1C at or above the upper limit of normal, use of concomitant systemic corticosteroids, or intercurrent infections. If hyperglycemia occurs during treatment, the dose of capivasertib may need to be withheld or reduced, or treatment permanently discontinued based on severity.

Capivasertib has not been studied in patients with severe hepatic impairment (bilirubin greater than 3 times ULN and any AST). In patients with moderate hepatic impairment (bilirubin greater than 1.5 to 3 times ULN and any AST), additional monitoring for adverse side effects is recommended due to the potential for increased exposure. No dose adjustment is recommended in patients with mild hepatic impairment.

Capivasertib has not been studied in patients with severe renal dysfunction (CrCl 15 to 29 mL/min). No dose adjustment is recommended in patients with mild to moderate renal dysfunction (CrCl 30 to 89 mL/min).