Interactions between Ozanimod and Pralatrexate

Ozanimod has a moderate potential interaction with Arrhythmia.

The use of ozanimod may result in a transient decrease in heart rate and atrioventricular conduction delays upon starting treatment. It is recommended to follow an up-titration scheme to reach the maintenance dosage. Initiation of ozanimod without titration may result in greater decreases in heart rate. If treatment with ozanimod is considered, advice from a cardiologist should be sought for those individuals at risk of cardiovascular effects, particularly conduction delays.

Ozanimod has a major potential interaction with Cardiovascular Conditions and Disorders.

Ozanimod is contraindicated in patients who have had a recent myocardial infarction, those with unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure, a presence of Mobitz Type II 2nd degree or 3rd degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a pacemaker, severe untreated sleep apnea or those patients being treated with monoamine oxidase inhibitor drugs.

Ozanimod has a moderate potential interaction with Cardiovascular Conditions and Disorders.

The use of ozanimod may result in a transient decrease in heart rate and atrioventricular conduction delays upon starting treatment. It is recommended to follow an up-titration scheme to reach the maintenance dosage. Initiation of ozanimod without titration may result in greater decreases in heart rate. If treatment with ozanimod is considered, advice from a cardiologist should be sought for those individuals at risk of cardiovascular effects, particularly conduction delays.

Ozanimod has a moderate potential interaction with Central Nervous System Disorders.

Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving a sphingosine 1-phosphate receptor modulator. It is recommended to promptly schedule a complete physical and neurological examination and should consider an MRI, if a patient develops any unexpected neurological or psychiatric symptoms/signs, any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration. Delay in diagnosis and treatment may lead to permanent neurological sequelae. Exercise care when using this agent in patients with a history of ischemic stroke or cerebral hemorrhage. Treatment should be discontinued if PRES is suspected.

Ozanimod has a moderate potential interaction with Diabetes Mellitus.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

Ozanimod has a major potential interaction with Heart Disease.

Ozanimod is contraindicated in patients who have had a recent myocardial infarction, those with unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure, a presence of Mobitz Type II 2nd degree or 3rd degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a pacemaker, severe untreated sleep apnea or those patients being treated with monoamine oxidase inhibitor drugs.

Ozanimod has a moderate potential interaction with High Blood Pressure.

The use of ozanimod may result in increased blood pressure. Care should be exercised when using this drug in hypertensive patients and those at risk for hypertension. It is recommended to monitor blood pressure during treatment and manage it according to clinical practices.

Ozanimod has a moderate potential interaction with Infection.

Ozanimod may increase the risk of infections and some serious infections with opportunistic pathogens including viruses have been reported. Because of reversible sequestration of lymphocytes in lymphoid tissues, this drug causes a mean reduction in peripheral blood lymphocyte count to approximately 45% of baseline values. Prior to treatment, a recent CBC (i.e., within 6 months or after discontinuation of prior therapy), including lymphocyte count must be available. It is recommended to delay treatment initiation in patients with an active infection until complete resolution. Consider withholding or discontinuing treatment if a patient develops a serious infection, and reassess the benefits and risks prior to reinitiating therapy.

Ozanimod has a moderate potential interaction with Liver Disease.

The use of ozanimod may result in elevations of aminotransferases. The use of ozanimod in patients with hepatic impairment is not recommended. While on treatment with this drug, if a patient develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine, should have hepatic enzymes checked, and ozanimod should be discontinued if significant liver injury is confirmed.

PRALAtrexate has a moderate potential interaction with Liver Disease.

The safety, efficacy and pharmacokinetics of pralatrexate have not been evaluated in patients with hepatic impairment. Additionally, this drug can cause hepatotoxicity and liver function test abnormalities, which might require dose modification or discontinuation. Caution and monitoring is advised.

Ozanimod has a moderate potential interaction with Macular Edema.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

Ozanimod has a moderate potential interaction with Multiple Sclerosis.

Rare cases of severe exacerbation of multiple sclerosis (MS), including disease rebound, have been reported after discontinuation of sphingosine 1-phosphate receptor modulator in MS treated patients. The possibility of severe exacerbation of disease should be considered after stopping treatment with these agents. Patients should be observed for a severe increase in disability upon discontinuation and appropriate treatment should be instituted, as required.

Ozanimod has a moderate potential interaction with Pulmonary Impairment.

The use of ozanimod may result in a dose-dependent reduction in absolute forced expiratory volume over 1 second (FEV1) and may manifest as early as 3 months after treatment initiation. Care should be exercised when using this drug in patients with respiratory complications. It is recommended to perform spirometric evaluation of respiratory function during therapy if clinically appropriate.

PRALAtrexate has a moderate potential interaction with Renal Dysfunction.

Patients with moderate to severe renal function impairment may be at greater risk of toxicity due to increased exposure. Patients should be monitored for renal function and toxicity and dosage should be adjusted accordingly. For patients with severe renal impairment (GFR 15 to <30), the recommended dose of pralatrexate is 15 mg/m2. Avoid the use of pralatrexate in patients with ESRD undergoing dialysis, unless the potential effect justifies the potential risk.

Ozanimod has a major potential interaction with Sleep Apnea.

Ozanimod is contraindicated in patients who have had a recent myocardial infarction, those with unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure, a presence of Mobitz Type II 2nd degree or 3rd degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a pacemaker, severe untreated sleep apnea or those patients being treated with monoamine oxidase inhibitor drugs.

Ozanimod has a moderate potential interaction with Uveitis.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

Ozanimod has a moderate potential interaction with Vaccination.

Vaccinations may be less effective if administered during ozanimod treatment. Patients without a clinical confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating treatment. It is recommended to obtain a full course of vaccination for antibody-negative patients with varicella vaccine prior to starting treatment with ozanimod and to postpone treatment for 4 weeks to allow the full effect of vaccination. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ozanimod. Avoid the use of live attenuated vaccines during and for 3 months after treatment with ozanimod.