Drug Interaction Report
1 drug interaction and 27 additional warnings found for the following 2 drugs:
- ibrutinib
- Meridia (sibutramine)
Drug interactions
Moderate drug interactions
Moderate:sibutramine ibrutinib
Applies to: Meridia (sibutramine), ibrutinib
Using ibrutinib together with sibutramine may increase the risk of bleeding. The interaction may be more likely if you are elderly or have kidney or liver disease.
Talk to your doctor if you have any questions or concerns. Your doctor may already be aware of the risks, but has determined that this is the best course of treatment for you and has taken appropriate precautions and is monitoring you closely for any potential complications.
You should seek immediate medical attention if you experience any unusual bleeding or bruising, or have other signs and symptoms of bleeding such as:
- dizziness
- lightheadedness
- red or black, tarry stools
- coughing up or vomiting fresh or dried blood that looks like coffee grounds
- severe headache
- weakness
It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
Food/lifestyle interactions
Major food/lifestyle interactions
Major:Food/Lifestyle ibrutinib
Applies to: ibrutinib
Ibrutinib should be taken once daily at approximately the same time everyday.
Do not consume grapefruit, grapefruit juice, or Seville oranges unless directed otherwise by your doctor.
Grapefruit and Seville oranges may significantly increase the blood levels of ibrutinib.
This may increase the risk of side effects such as:
- nausea
- vomiting
- diarrhea
- abdominal pain
- constipation
- hemorrhage
- kidney problems
- impaired bone marrow function resulting in low numbers of different types of blood cells
You may also be more likely to develop anemia, bleeding problems, or infections due to low blood cell counts.
You should contact your doctor if you develop:
- paleness
- fatigue
- dizziness
- fainting
- unusual bruising or bleeding
- fever
- chills
- diarrhea
- sore throat
- muscle aches
- shortness of breath
- blood in phlegm
- weight loss
- red or inflamed skin
- body sores
- pain or burning during urination
Also seek immediate medical attention if you experience signs and symptoms that may suggest kidney damage such as:
- nausea
- vomiting
- loss of appetite
- increased or decreased urination
- sudden weight gain or weight loss
- fluid retention
- swelling
- shortness of breath
- muscle cramps
- tiredness
- weakness
- dizziness
- confusion
- irregular heart rhythm
It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
Moderate food/lifestyle interactions
Moderate:Food/Lifestyle sibutramine
Applies to: Meridia (sibutramine)
Using sibutramine with alcohol can increase the risk of cardiovascular side effects such as:
- increased heart rate
- chest pain
- blood pressure changes
In addition, you may also be more likely to experience nervous system side effects such as:
- dizziness
- drowsiness
- depression
- difficulty concentrating
You should avoid or limit the use of alcohol while being treated with sibutramine. Do not use more than the recommended dose of sibutramine, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you.
It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medication without first talking to your doctor.
Disease interactions
25 potential interactionsApplies to: 21 conditions, including High Blood Pressure, Type 2 Diabetes, Seizures, Heart Disease, and Diabetes Mellitus.
Alcoholism
Moderate:Meridia
The sibutramine in Meridia has a moderate potential interaction with Alcoholism.
Centrally-acting anorexiants are generally subject to habituation and abuse. While sibutramine does not appear to have a significant potential for abuse, clinical data are limited. Therapy with sibutramine should be administered cautiously in patients with a history of alcohol or substance abuse. Such patients should be observed carefully during therapy for signs of misuse of sibutramine.
Anorexia Nervosa
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Anorexia Nervosa.
The use of sibutramine is contraindicated in patients with anorexia nervosa. Sibutramine is an anorexiant used in the treatment of obesity.
Bleeding Associated with Coagulation Defect
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Bleeding Associated with Coagulation Defect.
Cases of bleeding (including bruising, petechia, intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and postprocedural hemorrhage), including fatal bleeding events, have been reported in patients treated with ibrutinib. Risk of major hemorrhage is increased in patients receiving antiplatelet or anticoagulant therapy; these patients should be monitored for signs/symptoms of bleeding. It is recommended to consider the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
Bone Marrow Depression/Low Blood Counts
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Bone Marrow Depression/Low Blood Counts.
Cytopenias (including neutropenia, thrombocytopenia, and anemia) have been reported with use of ibrutinib. Care should be taken with patients at risk, and complete blood counts should be monitored monthly.
Cardiovascular Conditions and Disorders
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Cardiovascular Conditions and Disorders.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce substantial increases in heart rate and blood pressure in some patients. Sibutramine therapy should not be initiated in patients with uncontrolled or poorly controlled hypertension and/or a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, or other severe cardiovascular or cerebrovascular disorders. All patients treated with sibutramine should have blood pressure and pulse measured prior to starting therapy and monitored at regular intervals thereafter. Sustained increases in blood pressure or pulse rate may require a dosage reduction or drug discontinuation.
Cerebral Vascular Disorder
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Cerebral Vascular Disorder.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce substantial increases in heart rate and blood pressure in some patients. Sibutramine therapy should not be initiated in patients with uncontrolled or poorly controlled hypertension and/or a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, or other severe cardiovascular or cerebrovascular disorders. All patients treated with sibutramine should have blood pressure and pulse measured prior to starting therapy and monitored at regular intervals thereafter. Sustained increases in blood pressure or pulse rate may require a dosage reduction or drug discontinuation.
Diabetes Mellitus
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Diabetes Mellitus.
Fatal and serious cardiac arrhythmias and cardiac failure have occurred with ibrutinib. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities; patients with cardiac comorbidities may be at greater risk of these events. Ventricular tachyarrhythmias, atrial fibrillation, and atrial flutter have occurred in patients treated with ibrutinib, especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmia). Cardiac history and function should be evaluated at baseline, and patients should be monitored for cardiac arrhythmias and cardiac function. Further evaluation (e.g., ECG, echocardiogram) should be obtained as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Cardiac arrhythmias and cardiac failure should be managed appropriately, dosage modification guidelines should be followed, and the risks and benefits of continued ibrutinib treatment should be considered.
Drug Dependence
Moderate:Meridia
The sibutramine in Meridia has a moderate potential interaction with Drug Dependence.
Centrally-acting anorexiants are generally subject to habituation and abuse. While sibutramine does not appear to have a significant potential for abuse, clinical data are limited. Therapy with sibutramine should be administered cautiously in patients with a history of alcohol or substance abuse. Such patients should be observed carefully during therapy for signs of misuse of sibutramine.
Glaucoma, Narrow Angle
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Glaucoma, Narrow Angle.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce mydriasis. In patients with narrow angles, pupillary dilation can provoke an acute attack of angle-closure glaucoma. Therapy with sibutramine should be administered cautiously in patients with narrow-angle glaucoma or anatomically narrow angles.
Heart Disease
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Heart Disease.
Fatal and serious cardiac arrhythmias and cardiac failure have occurred with ibrutinib. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities; patients with cardiac comorbidities may be at greater risk of these events. Ventricular tachyarrhythmias, atrial fibrillation, and atrial flutter have occurred in patients treated with ibrutinib, especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmia). Cardiac history and function should be evaluated at baseline, and patients should be monitored for cardiac arrhythmias and cardiac function. Further evaluation (e.g., ECG, echocardiogram) should be obtained as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Cardiac arrhythmias and cardiac failure should be managed appropriately, dosage modification guidelines should be followed, and the risks and benefits of continued ibrutinib treatment should be considered.
High Blood Pressure
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with High Blood Pressure.
Fatal and serious cardiac arrhythmias and cardiac failure have occurred with ibrutinib. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities; patients with cardiac comorbidities may be at greater risk of these events. Ventricular tachyarrhythmias, atrial fibrillation, and atrial flutter have occurred in patients treated with ibrutinib, especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmia). Cardiac history and function should be evaluated at baseline, and patients should be monitored for cardiac arrhythmias and cardiac function. Further evaluation (e.g., ECG, echocardiogram) should be obtained as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Cardiac arrhythmias and cardiac failure should be managed appropriately, dosage modification guidelines should be followed, and the risks and benefits of continued ibrutinib treatment should be considered.
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with High Blood Pressure.
The use of ibrutinib may cause hypertension. Blood pressure should be monitored in patients treated with this drug. Antihypertensive medication should be started or adjusted throughout ibrutinib treatment as appropriate, and the dosage modification guidelines should be followed for grade 3 or higher hypertension.
History, Thrombotic/Thromboembolic Disorder
Major:Meridia
The sibutramine in Meridia has a major potential interaction with History, Thrombotic/Thromboembolic Disorder.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce substantial increases in heart rate and blood pressure in some patients. Sibutramine therapy should not be initiated in patients with uncontrolled or poorly controlled hypertension and/or a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, or other severe cardiovascular or cerebrovascular disorders. All patients treated with sibutramine should have blood pressure and pulse measured prior to starting therapy and monitored at regular intervals thereafter. Sustained increases in blood pressure or pulse rate may require a dosage reduction or drug discontinuation.
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with History, Thrombotic/Thromboembolic Disorder.
Cases of bleeding (including bruising, petechia, intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and postprocedural hemorrhage), including fatal bleeding events, have been reported in patients treated with ibrutinib. Risk of major hemorrhage is increased in patients receiving antiplatelet or anticoagulant therapy; these patients should be monitored for signs/symptoms of bleeding. It is recommended to consider the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.
History - Cerebrovascular Disease
Major:Meridia
The sibutramine in Meridia has a major potential interaction with History - Cerebrovascular Disease.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce substantial increases in heart rate and blood pressure in some patients. Sibutramine therapy should not be initiated in patients with uncontrolled or poorly controlled hypertension and/or a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, or other severe cardiovascular or cerebrovascular disorders. All patients treated with sibutramine should have blood pressure and pulse measured prior to starting therapy and monitored at regular intervals thereafter. Sustained increases in blood pressure or pulse rate may require a dosage reduction or drug discontinuation.
History - Myocardial Infarction
Major:Meridia
The sibutramine in Meridia has a major potential interaction with History - Myocardial Infarction.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine and can induce substantial increases in heart rate and blood pressure in some patients. Sibutramine therapy should not be initiated in patients with uncontrolled or poorly controlled hypertension and/or a history of coronary artery disease, arrhythmias, congestive heart failure, stroke, or other severe cardiovascular or cerebrovascular disorders. All patients treated with sibutramine should have blood pressure and pulse measured prior to starting therapy and monitored at regular intervals thereafter. Sustained increases in blood pressure or pulse rate may require a dosage reduction or drug discontinuation.
Infection
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Infection.
Fatal and nonfatal infections (including bacterial, viral, or fungal) have occurred with ibrutinib therapy. Cases of progressive multifocal leukoencephalopathy (PML) and Pneumocystis jirovecii pneumonia (PJP) have been reported in patients treated with ibrutinib. Prophylaxis (according to standard of care) should be considered in patients at increased risk for opportunistic infections. Patients should be monitored and evaluated for fever and infections and treated appropriately.
Liver Disease
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Liver Disease.
Sibutramine is converted by the liver to two active metabolites, which are further metabolized to inactive substances and subsequently eliminated by the kidney. Due to a lack of clinical data, the manufacturer does not recommend the use of sibutramine in patients with severe renal and/or hepatic impairment. Based on limited pharmacokinetic data, sibutramine may be administered in mild or moderate hepatic insufficiency at normally recommended dosages.
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Liver Disease.
Ibrutinib is metabolized in the liver. In patients with B-cell malignancies, ibrutinib should be avoided in those with severe liver dysfunction (Child-Pugh C). The recommended dosage should be reduced when administering ibrutinib to patients with mild or moderate liver dysfunction (Child-Pugh A and B); more frequent monitoring for ibrutinib adverse reactions is recommended for these patients.
In patients with chronic graft-versus-host disease, ibrutinib should be avoided in those with total bilirubin level greater than 3 times the upper limit of normal (3 x ULN), unless of nonhepatic origin or due to Gilbert's syndrome. The recommended dosage should be reduced when administering ibrutinib to patients with total bilirubin level greater than 1.5 to 3 x ULN, unless of nonhepatic origin or due to Gilbert's syndrome.
Renal Dysfunction
Major:Meridia
The sibutramine in Meridia has a major potential interaction with Renal Dysfunction.
Sibutramine is converted by the liver to two active metabolites, which are further metabolized to inactive substances and subsequently eliminated by the kidney. Due to a lack of clinical data, the manufacturer does not recommend the use of sibutramine in patients with severe renal and/or hepatic impairment. Based on limited pharmacokinetic data, sibutramine may be administered in mild or moderate hepatic insufficiency at normally recommended dosages.
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Renal Dysfunction.
The use of ibrutinib in patients with mild to moderate renal dysfunction (CrCl greater than 25 mL/min [as estimated by Cockcroft-Gault equation]) is not expected to influence on the exposure to ibrutinib. Caution and close monitoring are recommended in patients with severe renal dysfunction and in patients on dialysis as no data are available for these patients.
Seizures
Moderate:Meridia
The sibutramine in Meridia has a moderate potential interaction with Seizures.
Sibutramine and its metabolites inhibit the reuptake of norepinephrine, serotonin, and dopamine. In clinical trials, seizures were reported in < 0.1% of patients treated with sibutramine. Therapy with sibutramine should be administered cautiously in patients with or predisposed to seizures.
Smoking
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Smoking.
Fatal and serious cardiac arrhythmias and cardiac failure have occurred with ibrutinib. These adverse reactions occurred in patients with and without preexisting hypertension or cardiac comorbidities; patients with cardiac comorbidities may be at greater risk of these events. Ventricular tachyarrhythmias, atrial fibrillation, and atrial flutter have occurred in patients treated with ibrutinib, especially in patients with acute infections or cardiac risk factors (including hypertension, diabetes mellitus, history of cardiac arrhythmia). Cardiac history and function should be evaluated at baseline, and patients should be monitored for cardiac arrhythmias and cardiac function. Further evaluation (e.g., ECG, echocardiogram) should be obtained as indicated for patients who develop symptoms of arrhythmia (e.g., palpitations, lightheadedness, syncope, chest pain), new onset dyspnea, or other cardiovascular concerns. Cardiac arrhythmias and cardiac failure should be managed appropriately, dosage modification guidelines should be followed, and the risks and benefits of continued ibrutinib treatment should be considered.
Tumor Lysis Syndrome
Moderate:ibrutinib
Ibrutinib has a moderate potential interaction with Tumor Lysis Syndrome.
Tumor lysis syndrome has been reported with ibrutinib therapy infrequently. The baseline risk (e.g., high tumor burden) should be assessed and appropriate precautions should be taken. Patients should be monitored closely and treated as appropriate.
Type 2 Diabetes
Moderate:Meridia
The sibutramine in Meridia has a moderate potential interaction with Type 2 Diabetes.
Obese, type 2 diabetic patients who achieve weight loss may demonstrate improved metabolic control of their disease as a result of their reduced weight. Therefore, patients with type 2 diabetes mellitus should be monitored during weight-reduction therapy (or therapy that may be expected to induce significant weight loss as a secondary effect) for hypoglycemia and reduced need for oral hypoglycemic medication or insulin, and the dosages of these agents adjusted accordingly. Patients should be apprised of the risk of hypoglycemia and be alert to potential signs and symptoms such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, and palpitation.
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
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