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Drug Interaction Report

3 potential interactions and/or warnings found for the following 2 drugs:

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Interactions between your drugs

Moderate

lefamulin xanomeline

Applies to: lefamulin, trospium / xanomeline

MONITOR: Xanomeline may increase the concentration of sensitive oral CYP450 3A4 substrates and/or narrow therapeutic index (NTI) oral P-glycoprotein (P-gp) substrates. In vitro data suggest that xanomeline may transiently inhibit CYP450 3A4 and P-gp locally in the intestine after dosing. Xanomeline does not appear to inhibit CYP450 3A4 and/or P-gp systemically. Clinical data evaluating this interaction are not available.

MANAGEMENT: Caution and clinical monitoring are advised if xanomeline is used in combination with an orally administered CYP450 3A4 sensitive substrate and/or NTI P-gp substrate for which a small change in substrate plasma concentration could lead to serious toxicities. The labeling of the substrate may be consulted for specific monitoring and dose adjustment recommendations should adverse reactions result from this combination.

References (1)
  1. (2024) "Product Information. Cobenfy (trospium-xanomeline)." Bristol-Myers Squibb

Drug and food interactions

Moderate

trospium food

Applies to: trospium / xanomeline

ADJUST DOSING INTERVAL: Food may reduce the oral absorption and bioavailability of trospium chloride. According to the product labeling, administration of trospium chloride with a high fat meal reduced the peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) by 70% to 80% compared to administration while fasting.

MANAGEMENT: To ensure maximal oral absorption, trospium chloride should be administered at least 1 hour before meals or on an empty stomach. If trospium chloride is administered as a combination with xanomeline, the manufacturer recommends administering the capsules at least 1 hour before a meal or at least 2 hours after a meal. Capsules should be taken whole.

References (5)
  1. (2012) "Product Information. Sanctura (trospium)." Odyssey Pharmaceuticals
  2. (2024) "Product Information. Cobenfy (trospium-xanomeline)." Bristol-Myers Squibb
  3. (2019) "Product Information. Trosec (trospium)." Oryx Pharmaceuticals Inc
  4. (2022) "Product Information. Regurin (trospium)." Mylan Healthcare Sdn. Bhd.
  5. (2023) "Product Information. Trospium Chloride (trospium)." Padagis
Moderate

lefamulin food

Applies to: lefamulin

ADJUST DOSING INTERVAL: Food may reduce the oral bioavailability of lefamulin. When a single 600 mg oral dose of lefamulin was administered with a high-calorie, high-fat breakfast (800 to 1000 calories; approximately 50% from fat), lefamulin peak plasma concentration (Cmax) and systemic exposure (AUC) decreased by approximately 23% and 18%, respectively.

GENERALLY AVOID: Grapefruit juice may increase the oral bioavailability of lefamulin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. Inhibition of hepatic CYP450 3A4 may also contribute. The interaction has not been studied with grapefruit juice, but pharmacokinetic data are available for the potent CYP450 3A4 inhibitor, ketoconazole. When oral lefamulin was administered with oral ketoconazole, mean lefamulin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 58% and 165%, respectively. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased exposure to lefamulin may increase the risk of QT interval prolongation, which has been associated with ventricular arrhythmias including torsade de pointes and sudden death.

MANAGEMENT: Lefamulin tablets should be taken at least one hour before or two hours after a meal. Patients should preferably avoid or limit the consumption of grapefruit and grapefruit juice during treatment with lefamulin.

References (1)
  1. (2019) "Product Information. Xenleta (lefamulin)." Nabriva Therapeutics US, Inc.

Therapeutic duplication warnings

No duplication 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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.