mTOR inhibitor Pregnancy: Not recommended during pregnancy and in women of childbearing potential not using contraception; can cause fetal harm. Women of childbearing potential must use a highly effective non-oestrogen-containing method during treatment and for up to 8 weeks after ending treatment. Do not breastfeed during treatment and for 2 weeks after the last dose.

Everolimus

Brand names: Afinitor, Votubia, Certican

Everolimus is an oral mTOR inhibitor used as an immunosuppressant in transplantation and as an anticancer agent in certain renal, neuroendocrine and breast cancers, and in tuberous sclerosis-associated tumours.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 10 mg once daily

Route: oral

Frequency: once daily

Everolimus 10 mg Tablets (anticancer indication). Recommended dose is 10 mg once daily, taken at the same time each day, consistently with or without food; swallow tablets whole. Treatment should be initiated and supervised by a physician experienced in anticancer therapies and continued as long as clinical benefit is observed or until unacceptable toxicity. Dose reduction for adverse reactions is to 5 mg daily (not lower than 5 mg daily). Hepatic impairment: mild (Child-Pugh A) 7.5 mg daily; moderate (Child-Pugh B) 5 mg daily; severe (Child-Pugh C) only if benefit outweighs risk and dose must not exceed 2.5 mg daily. No dose adjustment for elderly (>=65 years) or renal impairment. NB: US labelling includes lower BSA-based dosing (4.5 mg/m2 or 5 mg/m2) for TSC-associated SEGA and partial-onset seizures using the oral suspension formulation.

Dose adjustments

Renal

No dose adjustment required for renal impairment (UK SPC). Note: monitor renal function; renal failure reported (US labelling).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients

Side effects

Stomatitis — very common
Rash — very common
Fatigue — very common
Diarrhoea — very common
Infections; non-infectious pneumonitis; anaemia; hyperglycaemia — very common

Interactions

P-gp and strong CYP3A4 inhibitors: avoid concomitant use
P-gp and moderate CYP3A4 inhibitors: reduce the dose as recommended
P-gp and strong CYP3A4 inducers: increase the dose as recommended
ACE inhibitors: increased risk of angioedema with concomitant use (US labelling advises avoiding)

Clinical monograph

How it works

It binds the intracellular protein FKBP-12 to inhibit the mammalian target of rapamycin (mTOR) signalling pathway, suppressing cell proliferation, growth and angiogenesis.

Prescribing in practice

It causes immunosuppression with increased infection risk and can produce non-infectious pneumonitis, which should be suspected with new respiratory symptoms and may require treatment interruption.
Initiate under specialist supervision with therapeutic drug monitoring in transplant settings and dose adjustment for hepatic impairment.
It is a substrate of CYP3A4 and P-glycoprotein, so concurrent strong inducers or inhibitors and grapefruit can markedly alter exposure.

Monitoring

Monitor blood glucose, lipids, full blood count, renal and hepatic function, and where applicable everolimus blood concentrations.

Counselling the patient

Report new or worsening cough or breathlessness, and any signs of infection.
Avoid grapefruit and grapefruit juice while taking this medicine.
Mouth ulcers are common; good oral hygiene and a non-alcoholic mouthwash can help.

Evidence & guidelines

NICE technology appraisal guidance supports everolimus in defined oncology indications, based on pivotal trials demonstrating progression-free survival benefit.

Reference: NICE TA432/TA421; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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