Drug Interactions between capivasertib and modafinil

Consumption of grapefruit, grapefruit juice, and supplements that contain grapefruit should be avoided during treatment with capivasertib as they may increase the blood levels of capivasertib. This may increase the risk of side effects such as high blood sugar levels, diarrhea, skin reactions, nausea, vomiting, tiredness, and changes in certain blood tests. Talk to your doctor if you have any questions or concerns. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Information for this minor interaction is available on the professional version.

The use of CNS stimulants can cause psychotic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder; CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders. All patients (particularly those with psychotic or bipolar disorders) should be monitored closely, especially during treatment initiation and at times of dose changes. Extreme caution should be exercised when CNS stimulants are given to patients with a history of psychosis, depression, mania, or bipolar disorder. Prior to initiating therapy, all patients should be screened for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or family history of suicide, bipolar disease, or depression). If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. Some CNS stimulants are contraindicated in patients with marked agitation or anxiety.

CNS stimulants increase blood pressure and heart rate; the use of some agents may be contraindicated in patients with severe/uncontrolled hypertension. Caution should be used when administering to patients with preexisting high blood pressure (even mild hypertension) and other cardiovascular conditions. All patients under treatment should be regularly monitored for potential tachycardia and hypertension.

The use of CNS stimulants can cause psychotic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder; CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders. All patients (particularly those with psychotic or bipolar disorders) should be monitored closely, especially during treatment initiation and at times of dose changes. Extreme caution should be exercised when CNS stimulants are given to patients with a history of psychosis, depression, mania, or bipolar disorder. Prior to initiating therapy, all patients should be screened for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or family history of suicide, bipolar disease, or depression). If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. Some CNS stimulants are contraindicated in patients with marked agitation or anxiety.

Patients with a history of drug and/or stimulant abuse should be closely followed during treatment with modafinil. Observe patients for signs of misuse and abuse. Clinical studies indicate modafinil produces psychoactive and euphoric effects/feelings consistent with other CNS stimulants.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, 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 as recommended by the manufacturer should be performed during treatment with capivasertib. Consider consultation with a specialist in the treatment of hyperglycemia and initiation of fasting glucose monitoring at home for patients who have risk factors for or who experience hyperglycemia. If hyperglycemia occurs during treatment, the dose of capivasertib may need to be withheld or reduced, or treatment permanently discontinued based on severity or if ketoacidosis is confirmed.

Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, 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 as recommended by the manufacturer should be performed during treatment with capivasertib. Consider consultation with a specialist in the treatment of hyperglycemia and initiation of fasting glucose monitoring at home for patients who have risk factors for or who experience hyperglycemia. If hyperglycemia occurs during treatment, the dose of capivasertib may need to be withheld or reduced, or treatment permanently discontinued based on severity or if ketoacidosis is confirmed.

Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, 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 as recommended by the manufacturer should be performed during treatment with capivasertib. Consider consultation with a specialist in the treatment of hyperglycemia and initiation of fasting glucose monitoring at home for patients who have risk factors for or who experience hyperglycemia. If hyperglycemia occurs during treatment, the dose of capivasertib may need to be withheld or reduced, or treatment permanently discontinued based on severity or if ketoacidosis is confirmed.

Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, 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 as recommended by the manufacturer should be performed during treatment with capivasertib. Consider consultation with a specialist in the treatment of hyperglycemia and initiation of fasting glucose monitoring at home for patients who have risk factors for or who experience hyperglycemia. If hyperglycemia occurs during treatment, the dose of capivasertib may need to be withheld or reduced, or treatment permanently discontinued based on severity or if ketoacidosis is confirmed.

Patients with a history of drug and/or stimulant abuse should be closely followed during treatment with modafinil. Observe patients for signs of misuse and abuse. Clinical studies indicate modafinil produces psychoactive and euphoric effects/feelings consistent with other CNS stimulants.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Exposure to modafinil is increased in patients with liver dysfunction. In patients with severe liver dysfunction, reduce the dose of modafinil to one-half the dose recommended dose.

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).