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ribociclib

Kisqali · ATC code L01EF02

Key facts
Active substance
ribociclib
ATC code
L01EF02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kisqali 200 mg film-coated tablets
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Ribociclib is a CDK4/6 inhibitor used in HR-positive, HER2-negative breast cancer, both early-stage at high risk of recurrence and advanced or metastatic.

What it is used for

  • Early HR+/HER2− breast cancer at high risk of recurrence: adjuvant, with an aromatase inhibitor
  • Locally advanced or metastatic HR+/HER2− breast cancer in women: with an aromatase inhibitor or fulvestrant
  • Pre-/perimenopausal women (and men in early breast cancer): add an LHRH agonist

Dosing

  • Early breast cancer: 400 mg once daily for 21 days, then 7 days off (28-day cycle), up to 3 years.
  • Advanced/metastatic: 600 mg once daily for 21 days, then 7 days off, as long as there is benefit.
  • Dose reductions: early disease to 200 mg/day; advanced to 400 mg then 200 mg/day; below that discontinue.
  • Avoid strong CYP3A4 inhibitors; if unavoidable, reduce 600 mg to 400 mg.
  • Start only in patients with QTcF less than 450 msec.

Contraindications

  • Hypersensitivity to the active substance, to peanut, soya or any excipient

Important warnings

  • Neutropenia: interrupt, reduce or discontinue by severity
  • Hepatobiliary toxicity: liver tests before and during treatment
  • QT prolongation: ECG before starting and at about day 14 of the first cycle; avoid in long QT syndrome, significant cardiac disease or electrolyte abnormalities
  • Severe cutaneous reactions (TEN) and interstitial lung disease/pneumonitis, which may be fatal
  • Not recommended in combination with tamoxifen

Side effects

  • Early disease (≥20%): neutropenia, infections, nausea, headache, fatigue, leukopenia, abnormal liver function tests
  • Advanced disease (≥20%): also diarrhoea, vomiting, constipation, alopecia, cough, rash, back pain, anaemia
  • Most common grade 3/4: neutropenia, abnormal liver function tests, leukopenia

Interactions

  • Strong CYP3A4 inhibitors (e.g. ritonavir) increase ribociclib exposure; avoid or reduce dose
  • Medicines affecting CYP3A4 activity alter ribociclib pharmacokinetics
  • Tamoxifen: combination not recommended

Pregnancy and breastfeeding

  • Can cause foetal harm; not recommended in pregnancy; effective contraception until at least 21 days after stopping.
  • Do not breast-feed for at least 21 days 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.

Full official text →

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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)

  • KisqaliNovartis Europharm Limited · EMEA/H/C/004213

Source: European Medicines Agency (EMA), product information

Turkey

  • ValamorFARMANOVA SAĞLIK HİZMETLERİ LTD. ŞTİ. · 1 register entry

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

Brand names in 3 more European countries
Iceland
Kisqali
Liechtenstein
Kisqali
Norway
Kisqali

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

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

  1. European Medicines Agency. Kisqali – 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/kisqali-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

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.