Can you take Sodium phenylbutyrate / taurursodiol with Sunitinib?

SUNItinib has a moderate potential interaction with Adrenal Insufficiency.

Caution should be exercised when prescribing sunitinib in patients that elicit a stress response due to the hormonal and metabolic changes resulting from an injury, trauma, or a severe infection.

SUNItinib has a moderate potential interaction with Arrhythmia.

Sunitinib can cause QT prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. This agent should be administered with caution in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Serum electrolytes should be corrected before initiating therapy with this agent. Periodic monitoring of ECGs and electrolytes is recommended in these patients.

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.

SUNItinib has a moderate potential interaction with Bleeding Disorder.

The use of sunitinib has been associated with hemorrhagic events, some of which have been fatal. Caution should be exercised in patients with or predisposed to bleeding complications. Clinical assessment of these patients should include serial complete blood counts and physical examinations.

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.

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

Cutaneous reactions, in some cases severe, have been reported with the use of sunitinib. Monitor patients who develop dermatologic or soft tissue toxicities while receiving this agent. It is recommended to withhold treatment, and appropriate measures should be instituted as appropriate or discontinue the use of this agent for dermatologic or soft tissue toxicity associated with severe or life-threatening complications. If a diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected treatment with sunitinib must not be re-started.

SUNItinib has a moderate potential interaction with Diabetes Mellitus.

The use of sunitinib has been associated with symptomatic hypoglycemia, resulting in loss of consciousness or hospitalization. Patients with diabetes mellitus should be monitored more closely during and after discontinuation of treatment with sunitinib, and their antidiabetic regimen should be adjusted accordingly.

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.

SUNItinib has a moderate potential interaction with Heart Disease.

The use of sunitinib has been associated with adverse cardiovascular events, including heart failure, cardiomyopathy, myocardial ischemia, and myocardial infarction, some of which were fatal. Because of these risks, physicians are advised to weigh this risk against the potential benefits of the drug when prescribing this drug to patients with cardiovascular dysfunction. These patients should be carefully monitored and baseline and periodic evaluations of cardiovascular function should be considered while these patients are receiving sunitinib, especial caution is recommended in patients who are at risk for, or who have a history of cardiovascular events. In patients without cardiac risk factors, a baseline evaluation of ejection fraction should be considered.

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.

SUNItinib has a moderate potential interaction with High Blood Pressure.

The use of sunitinib has been associated with hypertension and it should be used with caution in patients with elevated blood pressure. Therapy with sunitinib should be withheld in case of severe hypertension and appropriate measures should be taken to correct the blood pressure to acceptable readings. Close monitoring of blood pressure is recommended.

SUNItinib has a moderate potential interaction with Infection.

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking sunitinib. Patients with risk factors, such as those taking bisphosphonate medications or that have a dental disease could be at an increased risk of developing ONJ. Close monitoring should be exercise when prescribing sunitinib to these patients.

SUNItinib has a moderate potential interaction with Infection.

Caution should be exercised when prescribing sunitinib in patients that elicit a stress response due to the hormonal and metabolic changes resulting from an injury, trauma, or a severe infection.

SUNItinib has a moderate potential interaction with Interstitial Lung Disease.

The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.

SUNItinib has a major potential interaction with Liver Disease.

The use of sunitinib has been associated with hepatotoxicity, including hepatic failure and in some cases with fatal outcomes. Patients with hepatic impairment (total bilirubin > upper limit of normal (ULN) or Child-Pugh A, B and C) should be closely monitored during therapy with sunitinib. Safety in patients with ALT or AST >2.5 × ULN or, if due to liver metastases, >5.0 × ULN has not been established. Clinical monitoring of hepatic function (transaminases, bilirubin, and alkaline phosphatase) is recommended during treatment and increase frequency of monitoring is required for patients with preexisting or existing hepatic impairment. Obtain periodic liver function testing and withhold for Grade 3 or 4 drug-related hepatic adverse events. Discontinued if symptoms of pancreatitis or hepatic failure are present. Do not restart sunitinib if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

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.

SUNItinib has a moderate potential interaction with Proteinuria.

Therapy with sunitinib should be administered cautiously in patients with renal dysfunction. Monitoring for proteinuria and hematuria is recommended and perform baseline and periodic urinalyses during treatment, with follow up measurement as clinically indicated. Patients with nephrotic syndrome or repeat episodes of urine protein >=3 grams despite dose reductions should be instructed to withhold the dose of sunitinib and take appropriate actions according to clinical standards.

SUNItinib has a moderate potential interaction with Pulmonary Impairment.

The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.

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.

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.

SUNItinib has a moderate potential interaction with Renal Dysfunction.

No dosage adjustment of sunitinib is necessary in patients with renal impairment. However, when sunitinib therapy was given to patients with end-stage renal disease (ESRD) or on hemodialysis, the systemic exposure was 47% lower in subjects with ESRD on hemodialysis compared to subjects with normal renal function. Therefore, the subsequent doses may be increased gradually up to 2 fold based on safety and tolerability.

SUNItinib has a moderate potential interaction with Thyroid Disease.

Thyroid abnormalities, hypothyroidism or hyperthyroidism, have been reported in patients taking sunitinib. Therapy with sunitinib should be administered cautiously to patients with thyroid dysfunction. Baseline laboratory measurement of thyroid function is recommended and if appropriate, treatment per standard medical practice should be given prior to initiation of therapy. Clinical monitoring of thyroid function is recommended during therapy.

SUNItinib has a moderate potential interaction with Ventricular Arrhythmia.

Sunitinib can cause QT prolongation in a dose-dependent manner, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. This agent should be administered with caution in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Serum electrolytes should be corrected before initiating therapy with this agent. Periodic monitoring of ECGs and electrolytes is recommended in these patients.