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apremilast

Otezla · ATC code L04AA32

Brand names: Otezla, Apremilast +pharma, Apremilast Devatis, Apremilast G.L., Apremilast Hcs, Apremilast Pelpharma, Apremilast Ratiopharm, Apremilast Stada, Apremilast Starterpackung, Apremilast Viatris, Apremilast Zentiva, Starterpackung, Tivlemaq, Apremia, Archi …

Key facts
Active substance
apremilast
Drug class
Immunosuppressive drug
ATC code
L04AA32
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Otezla 10 mg film-coated tablets / Otezla 20 mg film-coated tablets / Otezla 30 mg film-coated tablets
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-27

Key facts

Apremilast (Otezla) is an oral medicine used to treat psoriatic arthritis, plaque psoriasis in adults and children, and oral ulcers associated with Behçet's disease.

What it is used for

  • Active psoriatic arthritis in adults with inadequate response or intolerance to prior DMARD therapy, alone or with DMARDs
  • Moderate to severe chronic plaque psoriasis in adults who failed, cannot take or do not tolerate other systemic therapy (e.g. cyclosporine, methotrexate, PUVA)
  • Moderate to severe plaque psoriasis in children and adolescents from 6 years and at least 20 kg who are candidates for systemic therapy
  • Oral ulcers associated with Behçet's disease in adults

Dosing

  • Adults: 30 mg orally twice daily after an initial titration over the first days (starting at 10 mg)
  • Children 6 years and older: 20 kg to less than 50 kg 20 mg twice daily; 50 kg or more 30 mg twice daily, each after titration
  • Doses taken approximately 12 hours apart (morning and evening), with no food restrictions
  • Severe renal impairment (creatinine clearance less than 30 mL per minute): 30 mg once daily; titrate using only the morning doses
  • No dose adjustment in elderly patients or in mild to moderate renal impairment
  • Reconsider treatment if no benefit after 24 weeks (PsA, psoriasis) or 12 weeks (Behçet's disease)

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Pregnancy

Important warnings

  • Severe diarrhoea, nausea and vomiting, mostly in the first weeks, sometimes requiring hospitalisation; higher risk of complications at 65 years or older
  • Increased risk of psychiatric disorders (insomnia, anxiety, depression); suicidal ideation and suicide have been observed
  • Discontinuation is recommended if new or worsening psychiatric symptoms or suicidality occur
  • Severe renal impairment requires dose reduction

Side effects

  • PsA and psoriasis: diarrhoea (15.7%), nausea (13.9%), upper respiratory tract infections (8.4%), headache (7.9%), tension headache (7.2%)
  • Behçet's disease: diarrhoea (41.3%), nausea (19.2%), headache (14.4%), upper respiratory tract infection (11.5%)
  • GI reactions generally occur within the first 2 weeks and usually resolve within 4 weeks
  • Hypersensitivity reactions are uncommon

Interactions

  • Strong CYP3A4 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort) are not recommended: reduced apremilast exposure and possible loss of efficacy

Pregnancy and breastfeeding

  • Contraindicated in pregnancy; pregnancy must be excluded before starting, and women of childbearing potential should use effective contraception

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.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

Source: European Medicines Agency (EMA), product information

Austria

  • Apremilast +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Apremilast DevatisDevatis Gmbh · 1 register entry
  • Apremilast G.L.G.L. Pharma Gmbh · 1 register entry
  • Apremilast HcsHcs Bvba · 1 register entry
  • Apremilast PelpharmaPelpharma Handels Gmbh · 1 register entry
  • Apremilast RatiopharmRatiopharm Gmbh · 1 register entry
  • Apremilast StadaStadapharm Gmbh · 1 register entry
  • Apremilast StarterpackungPelpharma Handels Gmbh, +pharma Arzneimittel Gmbh, Stadapharm Gmbh, Hcs Bvba · 4 register entries
  • Apremilast ViatrisViatris Limited · 2 register entries
  • Apremilast ZentivaZentiva, K.S. · 1 register entry
  • StarterpackungZentiva, K.S. · 1 register entry
  • TivlemaqSandoz Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • ApremilastDermapharm Ag, 089pharm Gmbh, 123 Acurae Pharma Gmbh, Viatris Germany Gmbh, Ratiopharm Gmbh, Glenmark Arzneimittel Gmbh, Macleods Pharma España, S.L.U, Devatis Gmbh, Torrent Pharma (Malta) Ltd, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Biomo Pharma Gmbh, Elpen Pharmaceutical Co. Inc., Galenpharma Gmbh, Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Nio Health Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 22 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ApremiaADEKA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • ArchiSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • AripemilBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • LedezlaSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MilastoFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MipralisHUMANİS SAĞLIK A.Ş. · 2 register entries
  • OprelastEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 2 register entries
  • OtemilastDEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Apremilast Eg, Apremilast Hcs, Apremilast Sandoz, Apremilast Teva
Bulgaria
Апремиласт Devatis, Тивлемак
Croatia
Aperzyx, Apremilast Belupo, Apremilast Sandoz, Apremilast Stada, Jaelitho, Tivlemaq
Cyprus
Apremilast Ebewe, Apremilast Sandoz, Apremilast Stada, Astizia
Czechia
Apremilast +pharma, Apremilast Belupo, Apremilast Krka, Apremilast Sandoz, Apremilast Teva, Apremilast Zentiva, Atrimil, Bratiti Adalvo
Denmark
Apremilast Devatis, Apremilast Stada, Apremilast Teva, Apremilast Viatris
Estonia
Apremilast Krka, Apremilast Stada, Imaplix
Finland
Apremilast Avansor, Apremilast Bioglan, Apremilast Devatis, Apremilast Hexal, Apremilast Krka, Apremilast Ratiopharm, Apremilast Sandoz, Apremilast Stada
France
Apremilast Arrow, Apremilast Biogaran, Apremilast Gnr, Apremilast Hcs, Apremilast Medgen, Apremilast Sandoz, Apremilast Stada, Apremilast Teva, Apremilast Viatris, Apremilast Zentiva, Apremilast Zydus
Greece
Afimax, Apremilast Anabiosis, Apremilast Ebewe, Apremilast Sandoz, Apremilast Stada, Apremilast Teva, Apremilast Win Medica, Apremo, Astizia, Jaelitho, Mestla
Hungary
Apremilast Kezdőcsomag Stada, Apremilast Krka, Apremilast Stada, Bratiti
Iceland
Apremilast Accord, Apremilast Aristo, Apremilast G.L., Apremilast Rafarm, Apremilast Stada, Bratiti Adalvo, Imaplix, Otezla, Phomilot Adalvo, Supota Adalvo, Voyflen Adalvo
Ireland
Apremilast
Italy
Apremilast Day Zero, Apremilast Dr. Reddy’s, Apremilast Eg, Apremilast G.L., Apremilast Glenmark, Apremilast Krka, Apremilast Macleods, Apremilast Medac, Apremilast Mylan, Apremilast Noucor, Apremilast Reig Jofre, Apremilast Sandoz, Apremilast Teva, Apremilast Zentiva, Phomilot
Latvia
Apremilast Krka, Apremilast Stada, Imaplix
Liechtenstein
Apremilast Accord
Lithuania
Apremilast Krka, Apremilast Stada, Imaplix
Luxembourg
Apremilast Eg
Malta
Apremilast
Netherlands
Apremilast Amarox, Apremilast Devatis, Apremilast Hcs, Apremilast Medgen, Apremilast Sandoz, Apremilast Stada, Apremilast Teva, Tivlemaq
Norway
Apremilast Accord, Apremilast Devatis, Apremilast Stada, Otezla
Poland
Apremilast Aristo, Apremilast Farmaprojects, Apremilast Krka, Bratiti Adalvo, Ozlam, Tivlemaq
Portugal
Apremilaste Humanis
Romania
Apremilast Stada
Slovakia
Apremilast Belupo, Apremilast Hcs, Apremilast Krka, Apremilast Sandoz, Apremilast Stada, Apremilast Teva, Atrimil, Tivlemaq
Slovenia
Apremilast Belupo, Apremilast Elpen, Apremilast Krka, Apremilast Stada, Apremilast Win Medica, Astizia, Tivlemaq
Spain
Apremilast
Sweden
Apremilast Anabiosis, Apremilast Avansor, Apremilast Bioglan, Apremilast Devatis, Apremilast Hexal, Apremilast Krka, Apremilast Sandoz, Apremilast Stada, Apremilast Teva, Apremilast Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Otezla – 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/otezla-epar-product-information_en.pdf
  2. 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
  3. 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
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L04AA.

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.