abrocitinib
Cibinqo · ATC code D11AH08
Also known as: Abrositinib
- Key facts
- Active substance
- abrocitinib
- ATC code
- D11AH08
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Cibinqo 50 mg film-coated tablets / Cibinqo 100 mg film-coated tablets / Cibinqo 200 mg film-coated tablets
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Information as of
- 2026-10-29
Key facts
Abrocitinib (Cibinqo) is an oral Janus kinase (JAK) inhibitor used to treat moderate-to-severe atopic dermatitis.
What it is used for
- Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Dosing
- Recommended starting dose 100 mg or 200 mg once daily based on individual patient characteristics; 100 mg for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy.
- If the response to 100 mg is inadequate, the dose can be increased to 200 mg; upon disease control, the dose should be decreased to 100 mg once daily. The lowest effective maintenance dose should be considered.
- Adolescents (12 to 17 years) weighing 25 kg to < 59 kg: starting dose 100 mg once daily; at least 59 kg: 100 mg or 200 mg.
- Patients 65 years and older: 100 mg once daily.
- Moderate renal impairment (eGFR 30 to < 60 mL/min): dose reduced by half to 100 mg or 50 mg; severe (eGFR < 30 mL/min): starting dose 50 mg, maximum daily dose 100 mg.
- With strong CYP2C19 inhibitors (e.g. fluvoxamine, fluconazole): dose reduced by half to 100 mg or 50 mg once daily.
- Discontinuation should be considered if there is no benefit after 24 weeks. Do not initiate with platelets < 150 × 10³/mm³, lymphocytes < 0.5 × 10³/mm³, neutrophils < 1.2 × 10³/mm³ or haemoglobin < 10 g/dL; blood counts before initiation and 4 weeks after.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Active serious systemic infections, including tuberculosis.
- Severe hepatic impairment.
- Pregnancy and breast-feeding.
Important warnings
- In patients 65 years and older, with atherosclerotic cardiovascular disease or other cardiovascular risk factors (e.g. smokers), or with malignancy risk factors, use only if no suitable treatment alternatives are available.
- Serious infections have been reported, most frequently herpes simplex, herpes zoster and pneumonia; caution in the elderly and in patients with diabetes.
- Deep venous thrombosis and pulmonary embolism have been reported; use with caution in patients with other VTE risk factors.
- Live, attenuated vaccines should be avoided during or immediately prior to treatment; immunisations should be brought up to date beforehand.
- Blood counts and lipid parameters require monitoring.
Side effects
- Most common: nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and upper abdominal pain (2.2%).
- The most frequent serious adverse reactions are infections (0.3%).
- Others include thrombocytopenia, lymphopenia, hyperlipidaemia and venous thromboembolism.
Interactions
- Metabolised mainly by CYP2C19 and CYP2C9: fluvoxamine and fluconazole increased exposure by 91% and 155%, respectively.
- Co-administration with moderate or strong CYP2C19/CYP2C9 inducers (e.g. rifampicin, phenytoin) is not recommended.
- With acid-reducing agents (e.g. proton pump inhibitors), a dose of 200 mg should be considered.
Pregnancy and breastfeeding
- Contraindicated during pregnancy and breast-feeding.
- Women of reproductive potential should use effective contraception during treatment and for 1 month after the final dose.
Summary of the official product information, written with AI on 2026-10-29. 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
This product has no separate US patient information.
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)
- CibinqoPfizer Europe MA EEIG · EMEA/H/C/005452
Source: European Medicines Agency (EMA), product information
Turkey
- CibinqoPFİZER PFE İLAÇLARI A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Cibinqo
- Liechtenstein
- Cibinqo
- Norway
- Cibinqo
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Cibinqo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/cibinqo-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-29 · 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.