Can you take Ribociclib with Sodium phenylbutyrate / taurursodiol?

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Biliary Obstruction.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Central Nervous System Disorders.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

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.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Fluid Retention.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Gallbladder Disease.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

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.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Heart Failure.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Liver Disease.

Sodium phenylbutyrate is primarily metabolized in the liver and kidney. Therapy with sodium phenylbutyrate should be administered cautiously in patients with liver disease. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Malabsorption Syndrome.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Myoneural Disorder.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Peripheral Neuropathy.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Renal Dysfunction.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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).

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Renal Dysfunction.

Sodium phenylbutyrate is primarily metabolized in the liver and kidney. Therapy with sodium phenylbutyrate should be administered cautiously in patients with liver disease. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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.