Interactions between Onglyza and Ribociclib

Ribociclib has a moderate potential interaction with Dermatitis, Drug-Induced.

Patients receiving ribociclib have developed severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms. This drug must not be reintroduced in patients who have experienced SCARs or other life-threatening cutaneous reactions during ribociclib treatment.

Ribociclib has a moderate potential interaction with Electrolyte Abnormalities.

Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. This drug should be avoided in patients who are at significant risk of developing torsade de pointes, including those with: congenital long QT syndrome; uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism; electrolyte abnormalities. ECG should be performed in all patients prior to initiation of treatment; ribociclib should be started only in patients with QTcF (QT corrected for heart rate using Fridericia's formula) values less than 450 milliseconds. ECG should be repeated at Day 14 of the first cycle, and as clinically indicated. Serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be monitored before the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated; any electrolyte abnormality should be corrected before starting this drug. Ribociclib may require dose interruption, dose reduction, or discontinuation according to observed QT prolongation during therapy.

Ribociclib has a moderate potential interaction with Heart Disease.

Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. This drug should be avoided in patients who are at significant risk of developing torsade de pointes, including those with: congenital long QT syndrome; uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism; electrolyte abnormalities. ECG should be performed in all patients prior to initiation of treatment; ribociclib should be started only in patients with QTcF (QT corrected for heart rate using Fridericia's formula) values less than 450 milliseconds. ECG should be repeated at Day 14 of the first cycle, and as clinically indicated. Serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be monitored before the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated; any electrolyte abnormality should be corrected before starting this drug. Ribociclib may require dose interruption, dose reduction, or discontinuation according to observed QT prolongation during therapy.

Ribociclib has a moderate potential interaction with High Blood Pressure.

Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. This drug should be avoided in patients who are at significant risk of developing torsade de pointes, including those with: congenital long QT syndrome; uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism; electrolyte abnormalities. ECG should be performed in all patients prior to initiation of treatment; ribociclib should be started only in patients with QTcF (QT corrected for heart rate using Fridericia's formula) values less than 450 milliseconds. ECG should be repeated at Day 14 of the first cycle, and as clinically indicated. Serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be monitored before the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated; any electrolyte abnormality should be corrected before starting this drug. Ribociclib may require dose interruption, dose reduction, or discontinuation according to observed QT prolongation during therapy.

Ribociclib has a moderate potential interaction with Interstitial Lung Disease.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with ribociclib. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis, which may include hypoxia, cough, and dyspnea. Ribociclib should be interrupted immediately and patients should be evaluated if new or worsening respiratory symptoms suspected to be due to ILD or pneumonitis develop. This drug should be permanently discontinued in patients with any recurrent symptomatic or severe ILD/pneumonitis.

Ribociclib has a moderate potential interaction with Liver Disease.

Ribociclib undergoes extensive hepatic metabolism mainly via CYP450 3A4 in humans. Increases in transaminases and drug-induced liver injury have occurred in clinical studies. The starting dose of ribociclib should be reduced to 400 mg in patients with advanced or metastatic breast cancer who have moderate or severe liver dysfunction (Child-Pugh B or C). Liver function tests (LFTs) should be performed before initiating therapy; LFTs should be monitored every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. Dose interruption, dose reduction, or drug discontinuation may be necessary based on the severity of transaminase elevations. No dose adjustment is necessary in patients with breast cancer who have mild liver dysfunction (Child-Pugh A).

The sAXagliptin in Onglyza has a moderate potential interaction with Pancreatitis.

There have been postmarketing reports of acute pancreatitis in patients taking DPP-4 inhibitors. These drugs should be used with caution in patients with a history of pancreatitis or pancreatic disease, although it is unknown if they are at increased risk. Patients should be observed for signs and symptoms of pancreatitis during treatment. If pancreatitis is suspected, treatment should be discontinued immediately and appropriate management should be initiated.

Ribociclib has a moderate potential interaction with Pulmonary Impairment.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with ribociclib. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis, which may include hypoxia, cough, and dyspnea. Ribociclib should be interrupted immediately and patients should be evaluated if new or worsening respiratory symptoms suspected to be due to ILD or pneumonitis develop. This drug should be permanently discontinued in patients with any recurrent symptomatic or severe ILD/pneumonitis.

The sAXagliptin in Onglyza has a moderate potential interaction with Renal Dysfunction.

It is recommended to assess renal function prior to initiating treatment with DPP-4 inhibitors and periodically thereafter. Patients with moderate to severe renal insufficiency and end stage renal dysfunction will require a dose adjustment. Linagliptin will not require a dose adjustment per manufacturer's information. Additionally, there have been postmarketing reports of worsening renal function in some patients with renal insufficiency taking sitagliptin at inappropriate doses.

Ribociclib has a moderate potential interaction with Renal Dysfunction.

The starting dose of ribociclib should be reduced to 200 mg in patients with severe renal dysfunction. No dose adjustment is necessary in patients with mild or moderate renal dysfunction (estimated GFR 30 to 89 mL/min/1.73 m2).

Ribociclib has a moderate potential interaction with Underactive Thyroid.

Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. This drug should be avoided in patients who are at significant risk of developing torsade de pointes, including those with: congenital long QT syndrome; uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism; electrolyte abnormalities. ECG should be performed in all patients prior to initiation of treatment; ribociclib should be started only in patients with QTcF (QT corrected for heart rate using Fridericia's formula) values less than 450 milliseconds. ECG should be repeated at Day 14 of the first cycle, and as clinically indicated. Serum electrolytes (including potassium, calcium, phosphorous, and magnesium) should be monitored before the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated; any electrolyte abnormality should be corrected before starting this drug. Ribociclib may require dose interruption, dose reduction, or discontinuation according to observed QT prolongation during therapy.