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Drug Interactions between gilteritinib and nintedanib

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

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Interactions between your drugs

Moderate

nintedanib gilteritinib

Applies to: nintedanib and gilteritinib

MONITOR: Coadministration with gilteritinib may increase the plasma concentrations and the risk of adverse effects of orally administered drugs that are substrates of the intestinal P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and/or organic cation transporter 1 (OCT1) transporters, such as dabigatran, digoxin, rosuvastatin, methotrexate, and metformin. The proposed mechanism, based on in vitro data, is decreased clearance due to gilteritinib-mediated inhibition of intestinal P-gp, BCRP, and/or OCT1 efflux transport proteins.

MANAGEMENT: Until more information is available, caution is advised if gilteritinib is used concomitantly with drugs that are substrates of the intestinal P-gp, BCRP, and/or OCT1 transport proteins, particularly those with a narrow therapeutic range. Dosage adjustments as well as clinical and laboratory monitoring should be considered whenever gilteritinib is added to or withdrawn from therapy with these drugs. Patients should be monitored for the development of adverse effects.

References (3)
  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Xospata (gilteritinib)." Astellas Pharma US, Inc

Drug and food interactions

Moderate

nintedanib food

Applies to: nintedanib

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of nintedanib. After food intake, nintedanib exposure increased by approximately 20% compared to administration under fasted conditions. Absorption was also delayed, as indicated by an increase in the median time to reach maximum plasma concentration (Tmax) from 2 hours in the fasted state to approximately 4 hours under fed conditions, irrespective of the type of food ingested. In an in vitro study, mixing nintedanib capsules with a small amount of apple sauce or chocolate pudding for up to 15 minutes did not have any impact on their pharmaceutical quality, but swelling and deformation of the capsules were observed with longer exposure time due to water uptake of the gelatin capsule shell. Therefore, administration with soft food would not be expected to alter the clinical effect of nintedanib when taken immediately.

GENERALLY AVOID: Grapefruit and grapefruit juice may increase the plasma concentrations of nintedanib, which has been shown to be a substrate of the P-glycoprotein (P-gp) efflux transporter and a minor substrate of the CYP450 3A4 isoenzyme. The proposed mechanism is inhibition of both P-gp-mediated efflux in the gut wall as well as CYP450 3A4-mediated first-pass metabolism in the intestinal tract by certain compounds present in grapefruit.

MANAGEMENT: Nintedanib should be administered with food to reduce the incidence of gastrointestinal effects. Nintedanib capsules may be taken with water or a small amount (teaspoonful) of cold or room temperature soft food, such as apple sauce or chocolate pudding, and must be swallowed whole (unchewed) immediately, to ensure the capsule stays intact. Food containing grapefruit, grapefruit juice, Seville orange (a citrus relative of the grapefruit), or Seville orange juice should be avoided during treatment with nintedanib.

References (5)
  1. (2024) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim
  2. (2024) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim (Canada) Ltd
  3. (2025) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Ltd
  4. (2024) "Product Information. Ofev (nintedanib)." Boehringer Ingelheim Pty Ltd, 2
  5. (2024) "Product Information. Vargatef (nintedanib)." Boehringer Ingelheim Ltd

Therapeutic duplication warnings

Therapeutic duplication is the use of more than one medicine from the same drug category or therapeutic class to treat the same condition. This can be intentional in cases where drugs with similar actions are used together for demonstrated therapeutic benefit. It can also be unintentional in cases where a patient has been treated by more than one doctor, or had prescriptions filled at more than one pharmacy, and can have potentially adverse consequences.

Duplication

Multikinase inhibitors

Therapeutic duplication

The recommended maximum number of medicines in the 'multikinase inhibitors' category to be taken concurrently is usually one. Your list includes two medicines belonging to the 'multikinase inhibitors' category:

  • gilteritinib
  • nintedanib

Note: In certain circumstances, the benefits of taking this combination of drugs may outweigh any risks. Always consult your healthcare provider before making changes to your medications or dosage.

See also

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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

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

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