Formulary
Everolimus: Indications, Dosing, Side Effects and Interactions
Everolimus is a protein kinase inhibitor.
MedNext Academy | 4 min read
Everolimus: Indications, Dosing, Side Effects and Interactions
Everolimus is a protein kinase inhibitor.
Drug action
Everolimus is a protein kinase inhibitor.
Indications and dose
**Neuroendocrine tumours of pancreatic origin (specialist use only),Neuroendocrine tumours of gastro-intestinal origin (specialist use only)**
- **Adult** (By Mouth): Specialist indication - access specialist resources for dosing information.
**Neuroendocrine tumours of pancreatic origin (specialist use only),Neuroendocrine tumours of lung origin (specialist use only),Neuroendocrine tumours of gastro-intestinal origin (specialist use only),Renal cell carcinoma (specialist use only),Breast cancer (specialist use only)**
- **Adult** (By Mouth): Specialist indication - access specialist resources for dosing information.
**Liver transplantation (under expert supervision)**
- **Adult** (By Mouth): Initially 1 mg twice daily, to be started approximately 4 weeks after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4-5 days.
**Renal transplantation (under expert supervision),Heart transplantation (under expert supervision)**
- **Adult** (By Mouth): Initially 750 micrograms twice daily, to be started as soon as possible after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments can be made every 4-5 days.
**Subependymal giant cell astrocytoma associated with tuberous sclerosis complex (initiated by a specialist)**
- **Adult** (By Mouth Using Tablets): (consult product literature).
**Adjunctive treatment of refractory partial-onset seizures, with or without secondary generalisation, associated with tuberous sclerosis complex (initiated by a specialist)**
- **Adult** (By Mouth Using Dispersible Tablets): (consult product literature).
**Renal angiomyolipoma associated with tuberous sclerosis complex (initiated by a specialist)**
- **Adult** (By Mouth Using Tablets): (consult product literature).
**Subependymal giant cell astrocytoma associated with tuberous sclerosis complex (initiated by a specialist) for Votubia dispersible tablets**
- **Child 1-17 years** (By mouth using dispersible tablets): (consult product literature).
**Adjunctive treatment of refractory partial-onset seizures, with or without secondary generalisation, associated with tuberous sclerosis complex (initiated by a specialist) for Votubia dispersible tablets**
- **Child 2-17 years** (By mouth using dispersible tablets): (consult product literature).
**Subependymal giant cell astrocytoma associated with tuberous sclerosis complex (initiated by a specialist) for Votubia tablets**
- **Child 1-17 years** (By mouth using tablets): (consult product literature).
Cautions
History of bleeding disorders; peri-surgical period (impaired wound healing)
Side effects
Common or very common Alopecia; anaemia; appetite decreased; arthralgia; asthenia; cough; decreased leucocytes; dehydration; diabetes mellitus; diarrhoea; dry mouth; dyslipidaemia; dysphagia; dyspnoea; electrolyte imbalance; eye inflammation; fever; gastrointestinal discomfort; haemorrhage; headache; hyperglycaemia; hypertension; increased risk of infection; insomnia; interstitial lung disease; menstrual cycle irregularities; mucositis; nail disorders; nausea; neutropenia; oral disorders; peripheral oedema; proteinuria; renal impairment; respiratory disorders; skin reactions; taste altered; thrombocytopenia; vomiting; weight decreased Uncommon Congestive heart failure; embolism and thrombosis; flushing; healing impaired; hepatitis B; musculoskeletal chest pain; pancytopenia; rhabdomyolysis; sepsis; urinary frequency increased Rare or very rare Pure red cell aplasia Frequency not known Hepatitis B reactivation; suicidal behaviours Side-effects, further information Reduce dose or discontinue if severe side-effects occur-consult product literature.
Interactions
**Severe interactions:**
- A clinically significant effect on the efficacy response to everolimus in patients with advanced neuroendocrine tumours could not be established.
**Other interactions (25):**
- Everolimus is a substrate of CYP3A4, and also a substrate and moderate inhibitor of PgP.
- Therefore, absorption and subsequent elimination of everolimus may be influenced by products that affect CYP3A4 and/or PgP.
- In vitro , everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6.
- CYP3A4 and PgP inhibitors increasing everolimus concentrations Substances that are inhibitors of CYP3A4 or PgP may increase everolimus blood concentrations by decreasing metabolism or the efflux of...
- CYP3A4 and PgP inducers decreasing everolimus concentrations Substances that are inducers of CYP3A4 or PgP may decrease everolimus blood concentrations by increasing metabolism or the efflux of...
- Table 2 Effects of other active substances on everolimus Active substance by interaction Interaction - Change in Everolimus AUC/C max Geometric mean ratio (observed range) Recommendations concerning...
Pregnancy
Important safety information For everolimus Risks of incorrect dosing of oral anti-cancer medicines See Cytotoxic drugs . MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Manufacturer advises avoid.
Hepatic impairment
Consult product literature.
Medicinal forms
Tablet,Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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