Drug interactions
Apalutamide + Midazolam
Severity: Major
Apalutamide and Midazolam: major interaction.
Last updated Sources: US FDA label
For healthcare professionals — reference only. This page is a brief summary, not medical advice and not a substitute for official labeling or clinical judgement. Always verify before prescribing or dispensing.
Summary
Apalutamide substantially reduces midazolam exposure, particularly after oral dosing, because of intestinal and hepatic CYP3A4 induction. Sedation or anxiolysis may be inadequate.
What this interaction means in plain words
Apalutamide and Midazolam can interact in a way that may be serious. Using them together is sometimes necessary, but it needs a deliberate decision by the prescriber, a plan for monitoring, and clear advice on the warning signs to watch for.
Apalutamide belongs to Endocrine; Midazolam belongs to Central Nervous System.
Why it happens
Apalutamide induces intestinal and hepatic CYP3A4, increasing first-pass and systemic clearance of midazolam.
What to do
Avoid oral midazolam and use an alternative such as lorazepam or temazepam. If parenteral midazolam is needed, titrate to clinical effect with higher doses possible.
What to ask your pharmacist
- Does the benefit of taking both outweigh the risk in my case?
- Do I need any blood test, ECG or other check while on both?
- What early warning signs should I watch for, and what should I do if they appear?
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References
Other interactions of Midazolam
- Atazanavir + Midazolam Contraindicated
- Cobicistat + Midazolam Contraindicated
- Darunavir + Midazolam Contraindicated
- Elvitegravir / cobicistat / emtricitabine / tenofovir df + Midazolam Contraindicated
- Fosamprenavir + Midazolam Contraindicated
- Indinavir + Midazolam Contraindicated
Other interactions of Apalutamide
- Apalutamide + Cabotegravir Contraindicated
- Apalutamide + Cobicistat Contraindicated
- Apalutamide + Doravirine Contraindicated
- Apalutamide + Elbasvir / grazoprevir Contraindicated
- Apalutamide + Ensitrelvir Contraindicated
- Apalutamide + Fostemsavir Contraindicated
Frequently asked questions
Can I take Apalutamide with Midazolam?
MediHelp rates the interaction as major. Apalutamide and Midazolam can interact in a way that may be serious. Using them together is sometimes necessary, but it needs a deliberate decision by the prescriber, a plan for monitoring, and clear advice on the warning signs to watch for. Apalutamide substantially reduces midazolam exposure, particularly after oral dosing, because of intestinal and hepatic CYP3A4 induction. Sedation or anxiolysis may be inadequate.
How serious is the interaction between Apalutamide and Midazolam?
MediHelp rates it major, on a four-level scale (minor, moderate, major, contraindicated) based on published labels and references. What to do, in brief: Avoid oral midazolam and use an alternative such as lorazepam or temazepam. If parenteral midazolam is needed, titrate to clinical effect with higher doses possible.
What other medicines interact with Midazolam?
MediHelp also lists interactions of Midazolam with, for example, Atazanavir, Cobicistat, Darunavir. The full list is on the Midazolam page.
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