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Drug Interactions between epirubicin and ozanimod

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

epiRUBicin ozanimod

Applies to: epirubicin and ozanimod

GENERALLY AVOID: Due to the risk of bradycardia and atrioventricular (AV) block, the risk of QT prolongation and torsade de pointes arrhythmia may be increased during initiation of ozanimod treatment in patients receiving drugs that prolong the QT interval. Ozanimod can cause a decrease in heart rate during initiation of therapy. In two studies, following an initial dose of 0.23 mg, the greatest mean decrease from baseline in heart rate of 1.2 bpm occurred at hour 5 on day 1 and returned to near baseline at hour 6. Following continued up-titration, the maximal heart rate effect of ozanimod occurred on day 8. Heart rates below 40 bpm were not observed. Initiation of ozanimod without dose titration may result in greater decreases in heart rate. Initiation of ozanimod treatment has also resulted in transient AV conduction delays. Reportedly, with the administration of ozanimod at doses higher than the recommended dosage and without dose titration, first- and second-degree AV block occurred in healthy subjects. However, in two studies which utilized dose titration, second- or third-degree AV block was not reported in patients receiving ozanimod. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

MANAGEMENT: Ozanimod has not been studied in patients receiving drugs that can prolong the QT interval. Because bradycardia and AV block are recognized risk factors for QT prolongation and torsade de pointes arrhythmia, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties. Advice from a cardiologist should be sought if treatment with ozanimod is considered in patients with significant QT prolongation (QTcF greater than 450 msec in males or 470 msec in females), patients on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes or drugs that slow heart rate or AV conduction, or in patients with arrhythmias requiring treatment with Class 1a or Class III antiarrhythmic agents.

MONITOR CLOSELY: Coadministration of ozanimod with antineoplastic, immunosuppressive, or other immune-modulating therapies may increase the risk of unintended additive immunosuppressive effects. Ozanimod causes reversible sequestration of lymphocytes in lymphoid tissues. When administered daily, ozanimod produced a mean reduction in peripheral blood lymphocyte count to 45% of baseline values, which may increase the risk of infections. Life-threatening and rare fatal infections have occurred in association with ozanimod. Decreased lymphocyte counts persist during chronic daily dosing and generally return to normal within 30 days after stopping the medication. Pharmacodynamic effects, such as decreased peripheral lymphocytes, may persist for up to 3 months after the last dose, and as a result, use of immunosuppressants during this time may also lead to additive immune effects. The safety and efficacy of ozanimod in combination with antineoplastic, immunosuppressive, or immune-modulating agents have not been evaluated.

MANAGEMENT: Concomitant use of ozanimod with antineoplastic, immunosuppressive, or immune-modulating agents should be avoided according to some authorities (UK); however, other authorities (AU, US) advise caution and close monitoring during coadministration and for up to 3 months after the last dose of ozanimod. When switching from drugs with prolonged immune effects to ozanimod, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2020) "Product Information. Zeposia (ozanimod)." Celgene Corporation

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Drug and food interactions

Moderate

ozanimod food

Applies to: ozanimod

GENERALLY AVOID: Foods that contain large amounts of tyramine may precipitate a hypertensive crisis in patients treated with ozanimod. The proposed mechanism involves potentiation of the tyramine pressor effect due to inhibition of monoamine oxidase (MAO) by the major active metabolites of ozanimod, CC112273 and CC1084037. Monoamine oxidase in the gastrointestinal tract and liver, primarily type A (MAO-A), is the enzyme responsible for metabolizing exogenous amines such as tyramine and preventing them from being absorbed intact. Once absorbed, tyramine is metabolized to octopamine, a substance that is believed to displace norepinephrine from storage granules causing a rise in blood pressure. In vitro, CC112273 and CC1084037 inhibited MAO-B (IC50 values of 5.72 nM and 58 nM, respectively) with more than 1000-fold selectivity over MAO-A (IC50 values >10000 nM). Because of this selectivity, as well as the fact that free plasma concentrations of CC112273 and CC1084037 are less than 8% of the in vitro IC50 values for MAO-B inhibition, ozanimod is expected to have a much lower propensity to cause hypertensive crises than nonselective MAO inhibitors. However, rare cases of hypertensive crisis have occurred during clinical trials for the treatment of multiple sclerosis (MS) and ulcerative colitis (UC) and in postmarketing use. In controlled clinical trials, hypertension and blood pressure increases were reported more frequently in patients treated with ozanimod (up to 4.6% in MS patients receiving ozanimod 0.92 mg/day) than in patients treated with interferon beta-1a (MS) or placebo (UC).

Administration of ozanimod with either a high-fat, high-calorie meal (1000 calories; 50% fat) or a low-fat, low-calorie meal (300 calories; 10% fat) had no effects on ozanimod peak plasma concentration (Cmax) and systemic exposure (AUC) compared to administration under fasted conditions.

MANAGEMENT: Dietary restriction is not ordinarily required during ozanimod treatment with respect to most foods and beverages that contain tyramine, which usually include aged, fermented, cured, smoked, or pickled foods (e.g., air-dried and fermented meats or fish, aged cheeses, most soybean products, yeast extracts, red wine, beer, sauerkraut). However, certain foods like some of the aged cheeses (e.g., Boursault, Liederkrantz, Mycella, Stilton) and pickled herring may contain very high amounts of tyramine and could potentially cause a hypertensive reaction in patients taking ozanimod, even at recommended dosages, due to increased sensitivity to tyramine. Patients should be advised to avoid the intake of very high levels of tyramine (e.g., greater than 150 mg) and to promptly seek medical attention if they experience potential signs and symptoms of a hypertensive crisis such as severe headache, visual disturbances, confusion, stupor, seizures, chest pain, unexplained nausea or vomiting, and stroke-like symptoms. Blood pressure should be regularly monitored and managed accordingly. Because of the long elimination half-lives of the major active metabolites, these precautions may need to be observed for up to 3 months following the last ozanimod dose. Ozanimod can be administered with or without food.

References

  1. (2022) "Product Information. Zeposia (ozanimod)." Celgene Pty Ltd
  2. (2023) "Product Information. Zeposia (ozanimod)." Bristol-Myers Squibb
  3. (2023) "Product Information. Zeposia (ozanimod)." Bristol-Myers Squibb Canada Inc
  4. (2023) "Product Information. Zeposia (ozanimod)." Bristol-Myers Squibb Pharmaceuticals Ltd
  5. Choi DK, Rubin DT, Puangampai A, Cleveland N (2022) "Hypertensive emergency after initiating ozanimod: a case report." Inflamm Bowel Dis, 28, e114-5
View all 5 references

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor 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.
Unknown No interaction information available.

Further information

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