Drug Interactions between ixazomib and modafinil

Food may interfere with the absorption of ixazomib, which may lead to lower blood levels of the medication and possibly reduced effectiveness. You should take ixazomib at least 1 hour before or 2 hours after eating. On days when you take both ixazomib and dexamethasone, make sure you do not take them at the same time, since ixazomib should be taken on an empty stomach while dexamethasone should be taken with food to prevent irritation and injury to the stomach.

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.

Ixazomib may cause diarrhea, constipation, nausea, and vomiting. Care should be taken when using this agent in patients experiencing gastrointestinal complications. Dosing should be adjusted for Grade 3 or 4 symptoms. The use of antidiarrheal and antiemetic medications and supportive care may be necessary.

Ixazomib may cause diarrhea, constipation, nausea, and vomiting. Care should be taken when using this agent in patients experiencing gastrointestinal complications. Dosing should be adjusted for Grade 3 or 4 symptoms. The use of antidiarrheal and antiemetic medications and supportive care may be necessary.

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.

In pharmacokinetic (PK) studies of ixazomib, dose-normalized mean AUC was 20% higher in patients with moderate (total bilirubin greater than 1.5 to 3 times the upper limit of normal [1.5 to 3 x ULN]) or severe (total bilirubin greater than 3 x ULN) liver dysfunction as compared to patients with normal liver function. The PKs of ixazomib were similar in patients with normal liver function and in patients with mild liver dysfunction (total bilirubin up to ULN and AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN and any AST) based on population PK analysis. The starting dose of ixazomib should be reduced in patients with moderate or severe liver dysfunction; caution should be exercised in these patients. Drug-induced liver injury, hepatocellular injury, hepatic steatosis, cholestatic hepatitis, and hepatotoxicity have been reported with ixazomib; hepatic enzymes should be monitored regularly and dosing should be adjusted for Grade 3 or 4 symptoms.

Peripheral neuropathy has been reported with the use of ixazomib. Patients should be monitored for symptoms of neuropathy, and those experiencing new or worsening peripheral neuropathy may require dose modification.

In pharmacokinetic (PK) studies of ixazomib, mean AUC was 39% higher in patients with severe renal dysfunction (CrCl less than 30 mL/min) or ESRD requiring dialysis as compared to patients with normal renal function (CrCl at least 90 mL/min). The PKs of ixazomib were similar in patients with normal renal function and in patients with mild or moderate renal dysfunction (CrCl at least 30 mL/min) based on population PK analysis. The starting dose should be reduced in patients with severe renal dysfunction or ESRD requiring dialysis; caution should be exercised in these patients. Ixazomib is not dialyzable and therefore can be administered without regard to the timing of dialysis.

Thrombocytopenia has been reported with the use of ixazomib. Before starting a new cycle of therapy, platelet count should be at least 75,000/mm3. Platelet counts should be monitored at least monthly during treatment; more frequent monitoring should be considered during the first 3 cycles. Thrombocytopenia should be managed with dose modifications and platelet transfusions as per standard medical guidelines.

Ixazomib may cause diarrhea, constipation, nausea, and vomiting. Care should be taken when using this agent in patients experiencing gastrointestinal complications. Dosing should be adjusted for Grade 3 or 4 symptoms. The use of antidiarrheal and antiemetic medications and supportive care may be necessary.