Interactions between Finasteride / tadalafil and Ribociclib

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Alcoholism.

Alcohol consumption may intensify the pressure-lowering effects of mild vasodilators, such as phosphodiesterase 5 (PDE5) inhibitors. Therefore, patients that consume alcohol should be warned to limit alcohol intake while receiving these agents.

The tadalafil in finasteride / tadalafil has a major potential interaction with Cardiovascular Conditions and Disorders.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

The tadalafil in finasteride / tadalafil has a major potential interaction with Cerebral Vascular Disorder.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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 tadalafil in finasteride / tadalafil has a moderate potential interaction with Hearing Loss.

Use of phosphodiesterase-5 (PDE5) inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients with hearing problems should stop taking these agents and seek prompt medical care.

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.

The tadalafil in finasteride / tadalafil has a major potential interaction with History - Cerebrovascular Disease.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

The tadalafil in finasteride / tadalafil has a major potential interaction with History - Myocardial Infarction.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

The tadalafil in finasteride / tadalafil has a major potential interaction with Hypotension.

The use of phosphodiesterase-5 (PDE5) inhibitors is not recommended in patients with preexisting cardiovascular disease for whom sexual activity is inadvisable due to the potential cardiac risk. Physicians should also consider the vasodilatory effect of these drugs and whether they may adversely affect patients with underlying cardio- and/or cerebrovascular conditions, in particular those who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; those with resting hypotension (BP < 90/50) or hypertension (BP > 170/110); and those with unstable angina associated with cardiac failure or coronary artery disease. There are no controlled clinical data on the safety or efficacy in such patients. Other adverse cardiovascular effects reported include angina pectoris, myocardial infarction, AV block, ventricular arrhythmia, tachycardia, palpitation, hypotension, postural hypotension, syncope, cerebral thrombosis, cerebrovascular hemorrhage, transient ischemic attack, cardiac arrest, heart failure, and hypertension. Many of these events occurred in patients with cardiovascular risk factors and during or shortly after sexual activity.

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.

The finasteride in finasteride / tadalafil has a moderate potential interaction with Liver Disease.

Finasteride and dutasteride are extensively metabolized by the liver. Therapy with these drugs should be administered cautiously in patients with liver disease as exposure could be higher.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Liver Disease.

Phosphodiesterase 5 (PDE-5) inhibitors are cleared predominantly by hepatic metabolism. The pharmacokinetic disposition of these agents has not been assessed in patients with severe hepatic impairment. No dosage modification is recommended for patients with mild to moderate hepatic impairment, however, therapy with these agents should not be administered to patients with severe hepatic impairment. In patients with mild hepatic impairment a lower dose of these agents should be used as initial therapy.

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 tadalafil in finasteride / tadalafil has a moderate potential interaction with Myeloproliferative Disorders.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Optic Nerve Disorder.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Penis Disorders.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Peyronie Disease.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

The tadalafil in finasteride / tadalafil has a major potential interaction with Pulmonary Edema.

Tadalafil tablet for the treatment of pulmonary arterial hypertension (PAH) should not be used in patients with pulmonary veno-occlusive disease (PVOD) as it may significantly worsen the cardiovascular status of these patients. If signs of pulmonary edema develop during therapy, the possibility of associated PVOD should be considered.

The tadalafil in finasteride / tadalafil has a major potential interaction with Pulmonary Heart or Vascular Disease.

Tadalafil tablet for the treatment of pulmonary arterial hypertension (PAH) should not be used in patients with pulmonary veno-occlusive disease (PVOD) as it may significantly worsen the cardiovascular status of these patients. If signs of pulmonary edema develop during therapy, the possibility of associated PVOD should be considered.

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 tadalafil in finasteride / tadalafil has a major potential interaction with Renal Dysfunction.

The plasma clearance of phosphodiesterase-5 (PDE5) inhibitors may be decreased in patients with severe renal impairment, resulting in drug accumulation. Therapy with these agents should be avoided in patients with severe renal disease or on renal dialysis. Dose adjustments might be needed based on individual renal assessment and tolerability if used in these patients.

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 tadalafil in finasteride / tadalafil has a moderate potential interaction with Retinitis Pigmentosa.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Retinitis Pigmentosa.

Phosphodiesterase-5 (PDE5) inhibitors have been associated with transient impairment of color discrimination (blue/green) and blue- or color-tinged vision. These agents also inhibit phosphodiesterase-6 (PDE6), to a much lesser extent, which is involved in phototransduction in the retina. There are no controlled clinical data on the safety in patients with retinitis pigmentosa, a minority of whom may have genetic disorders of retinal phosphodiesterases. Therapy with these agents should be avoided in such patients.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Seizures.

The use of phosphodiesterase 5 (PDE-5) inhibitors has been associated with seizures. Therapy with these agents should be administered cautiously in patients with preexisting seizure disorders.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Sickle Cell Anemia.

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours) have been reported during treatment with phosphodiesterase-5 (PDE 5) inhibitors. Priapism may result in penile tissue damage and permanent loss of potency if not treated promptly. These agents should be used cautiously in patients with conditions that may predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia, and those with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease). If an erection persists longer than 4 hours, the patient should seek immediate medical assistance.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Tinnitus.

Use of phosphodiesterase-5 (PDE5) inhibitors has been associated with sudden decrease or loss of hearing, which may be accompanied by tinnitus or dizziness. Patients with hearing problems should stop taking these agents and seek prompt medical care.

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.

The finasteride in finasteride / tadalafil has a moderate potential interaction with Urinary Tract Obstruction.

Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for finasteride therapy.

The tadalafil in finasteride / tadalafil has a moderate potential interaction with Visual Defect/Disturbance.

Tadalafil for the treatment of erectile dysfunction (ED) should be used with caution and only if the benefit outweighs the risk in patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) or with retinitis pigmentosa. Use of tadalafil for the treatment of pulmonary arterial hypertension is not recommended in patients with retinitis pigmentosa. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil; patients taking tadalafil for ED should immediately stop treatment. Most patients who developed NAION during therapy with tadalafil had underlying anatomic or vascular risk factors, including low cup to disc ratio ("crowded disc").