everolimus
Afinitor, Votubia · ATC code L01XE10
Brand names: Afinitor, Votubia, Certican, Everolimus Ethypharm, Everolimus Hcs, Everolimus Ratiopharm, Everofin, Everolimus Accord, Everolimus Al, Everolimus Ascend, Everolimus Beta, Everolimus Biocon, Everolimus Genthon, Everolimus Heumann, Everolimus Mylan …
- Key facts
- Active substance
- everolimus
- Drug class
- ALK inhibitor
- ATC code
- L01XE10
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Afinitor 2.5 mg tablets / Afinitor 5 mg tablets / Afinitor 10 mg tablets · Votubia 2.5 mg tablets / Votubia 5 mg tablets / Votubia 10 mg tablets · Votubia 1 mg dispersible tablets / Votubia 2 mg dispersible tablets / Votubia 3 mg dispersible tablets
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-27
Key facts
Everolimus is an mTOR inhibitor (rapamycin derivative). It is used as Afinitor for certain cancers and as Votubia for manifestations of tuberous sclerosis complex (TSC).
What it is used for
- Afinitor: hormone receptor-positive, HER2-negative advanced breast cancer in postmenopausal women, with exemestane
- Afinitor: neuroendocrine tumours of pancreatic, gastrointestinal or lung origin (unresectable or metastatic, progressive)
- Afinitor: advanced renal cell carcinoma after VEGF-targeted therapy
- Votubia: renal angiomyolipoma with TSC; subependymal giant cell astrocytoma (SEGA) with TSC
- Votubia dispersible tablets: adjunctive treatment of refractory partial-onset seizures with TSC from 2 years
Dosing
- Afinitor and Votubia for renal angiomyolipoma: 10 mg once daily
- Afinitor for adverse reactions: reduce to 5 mg daily, not lower
- Afinitor in hepatic impairment: Child-Pugh A 7.5 mg, Child-Pugh B 5 mg daily; Child-Pugh C not more than 2.5 mg daily
- Votubia for SEGA: starting dose 4.5 mg/m2 (1 to less than 3 years: 7 mg/m2); trough 5 to 15 ng/ml
- Votubia for seizures: starting dose by age and CYP3A4/PgP inducers (5 to 9 mg/m2); titrate to trough level
- Do not take an extra dose if one is missed
Contraindications
- Hypersensitivity to the active substance, other rapamycin derivatives or any excipient
Important warnings
- Non-infectious pneumonitis (class effect), sometimes severe, rarely fatal; rule out PJP/PCP
- Infections, including opportunistic infections
- Stomatitis, mostly within the first 8 weeks
- Avoid live vaccines during treatment
- Increased exposure in hepatic impairment
Side effects
- Afinitor very common: stomatitis, rash, fatigue, diarrhoea, infections, nausea, decreased appetite, anaemia, dysgeusia, pneumonitis, peripheral oedema, hyperglycaemia
- Votubia very common: stomatitis, pyrexia, nasopharyngitis, diarrhoea, upper respiratory tract infection, vomiting, cough, rash, amenorrhoea, acne
- Grade 3-4 include stomatitis, anaemia, hyperglycaemia, infections, pneumonitis, pneumonia
Interactions
- Everolimus is a substrate of CYP3A4 and PgP
- CYP3A4/PgP inhibitors increase and CYP3A4/PgP inducers decrease everolimus blood concentrations
- Votubia: when starting or stopping strong CYP3A4 inducers, check trough levels and adjust the dose
Pregnancy and breastfeeding
- Not recommended in pregnancy; women of childbearing potential use highly effective contraception during and up to 8 weeks after treatment
- Do not breast-feed during treatment and for 2 weeks after the last dose
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- AfinitorNovartis Europharm Limited · EMEA/H/C/001038
- VotubiaNovartis Europharm Limited · EMEA/H/C/002311
Source: European Medicines Agency (EMA), product information
Austria
- CerticanNovartis Pharma Gmbh · 1 register entry
- Everolimus EthypharmEthypharm · 1 register entry
- Everolimus HcsHcs Bvba · 1 register entry
- Everolimus RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- CerticanNovartis Pharma Gmbh · 1 register entry
- EverofinTad Pharma Gmbh · 1 register entry
- Everolimus AccordAccord Healthcare B.V. · 1 register entry
- Everolimus AlAliud Pharma Gmbh · 1 register entry
- Everolimus AscendAscend Gmbh · 1 register entry
- Everolimus BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Everolimus BioconBiocon Pharma Malta I Limited · 1 register entry
- Everolimus EthypharmEthypharm · 1 register entry
- Everolimus GenthonGenthon Bv · 1 register entry
- Everolimus HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Everolimus MylanViatris Germany Gmbh · 1 register entry
- Everolimus PurenEugia Pharma (Malta) Limited · 1 register entry
Show all 16 brand names
- Everolimus RatiopharmRatiopharm Gmbh · 1 register entry
- Everolimus TamTamarang, S.A. · 1 register entry
- Everolimus TamarangTamarang, S.A. · 1 register entry
- Everolimus ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AfinitorNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 6 register entries
- EvaxmusTEVA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Certican, Everolimus Eg, Everolimus Krka
- Bulgaria
- Еверолимус Крка, Еверолимус Майлан, Еверолимус Сандоз, Еверолимус Тева, Сертикан, Сирлено
- Croatia
- Certican, Everolimus Krka, Everolimus Pliva, Everolimus Stada, Everolimus Viatris, Syrleno
- Cyprus
- Certican, Everolimus Pharmazac
- Czechia
- Certican, Everolimus Accord, Everolimus Krka, Everolimus Pharmagen, Everolimus Sandoz, Everolimus Teva, Everolimus Vipharm, Verimmus
- Denmark
- Certican, Everolimus Eql Pharma, Everolimus Krka, Everolimus Sandoz, Everolimus Stada, Everolimus Teva, Everolimus Viatris
- Estonia
- Certican, Everolimus Krka, Everolimus Norameda
- Finland
- Aderolio, Certican, Everolimus Avansor, Everolimus Krka, Everolimus Sandoz, Everolimus Stada, Everolimus Viatris
- France
- Certican, Everolimus Arrow, Everolimus Biogaran, Everolimus Cristers, Everolimus Eg, Everolimus Hcs, Everolimus Sandoz, Everolimus Teva, Everolimus Viatris, Everolimus Zentiva
- Greece
- Certican, Everolimus Faran, Everolimus Pharmazac, Everolimus Sandoz, Everolimus Teva, N
- Hungary
- Certican, Everolimus Accord, Everolimus Krka, Everolimus Onkogen, Everolimus Vipharm, Verimmus
- Iceland
- Afinitor, Certican, Everolimus Wh, Votubia
- Ireland
- Certican, Everolimus Tad
- Italy
- Certican, Everolimus Accord, Everolimus Ethypharm, Everolimus Medac, Everolimus Sandoz Gmbh, Everolimus Tam
- Latvia
- Certican, Everolimus Norameda, Everolimus Teva
- Liechtenstein
- Afinitor, Votubia
- Lithuania
- Certican, Everolimus Norameda
- Luxembourg
- Certican, Everolimus Eg
- Malta
- Certican, Everolimus Ascend, Everolimus Dr. Reddy's, Everolimus Genthon
- Netherlands
- Certican, Everofin, Everolimus Accord, Everolimus Biocon, Everolimus Cf, Everolimus Ethypharm, Everolimus Genthon, Everolimus Krka, Everolimus Mylan, Everolimus Sandoz, Everolimus Synthon, Everolimus Teva, Everolimus Zentiva, Syrleno, Verimmus
- Norway
- Afinitor, Certican, Everolimus Eql Pharma, Everolimus Krka, Everolimus Sandoz, Everolimus Teva, Everolimus Viatris, Votubia
- Poland
- Aderolio, Certican, Everolimus Accord, Everolimus Stada, Everolimus Synthon, Everolimus Vipharm
- Portugal
- Certican, Everolimus Ethypharm, Everolimus Teva, Everolímus Mylan, Everolímus Sandoz, Everolímus Tad
- Romania
- Certican, Everolimus Accord, Everolimus Pharmazac, Syrleno, Verimmus
- Slovakia
- Certican, Everolimus Accord, Everolimus Krka, Everolimus Pharmagen, Everolimus Sandoz, Everolimus Stada, Everolimus Teva, Everolimus Vipharm, Verimmus
- Slovenia
- Certican, Everolimus Krka, Syrleno
- Spain
- Certican, Everolimus Accord, Everolimus Avalon, Everolimus Biocon, Everolimus Dr. Reddys, Everolimus Ethypharm, Everolimus Stada, Everolimus Tad, Everolimus Tamarang, Everolimus Tillomed, Everolimus Viatris
- Sweden
- Certican, Everolimus Avansor, Everolimus Eql Pharma, Everolimus Ethypharm, Everolimus Krka, Everolimus Sandoz, Everolimus Stada, Everolimus Teva, Everolimus Viatris, Everolimus Zentiva
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Afinitor – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf
- European Medicines Agency. Votubia – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/votubia-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC L01XE.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.