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palbociclib

Ibrance · ATC code L01EF01

Brand names: Ibrance, Ibrammaclib, Palbopol, Paldibo, Reampla, Repalbo

Key facts
Active substance
palbociclib
ATC code
L01EF01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
IBRANCE 75 mg hard capsules / IBRANCE 100 mg hard capsules / IBRANCE 125 mg hard capsules · IBRANCE 75 mg film-coated tablets / IBRANCE 100 mg film-coated tablets / IBRANCE 125 mg film-coated tablets
Marketing authorisation holder
Pfizer Europe MA EEIG
Information as of
2026-10-27

Key facts

Palbociclib is a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. It is used with endocrine therapy for HR-positive, HER2-negative advanced or metastatic breast cancer.

What it is used for

  • HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor
  • Same indication in combination with fulvestrant after prior endocrine therapy
  • Pre- or perimenopausal women also receive an LHRH agonist

Dosing

  • 125 mg once daily for 21 consecutive days followed by 7 days off (28-day cycle)
  • Dose reductions for adverse reactions: first 100 mg/day, then 75 mg/day; discontinue if lower is needed
  • Blood counts before starting, at the start of each cycle and on Day 15 of the first 2 cycles
  • Severe hepatic impairment (Child-Pugh C): 75 mg once daily
  • If a strong CYP3A inhibitor is unavoidable: 75 mg once daily
  • Fulvestrant 500 mg intramuscularly on Days 1, 15, 29 and monthly thereafter

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Preparations containing St. John's Wort

Important warnings

  • Neutropenia: Grade 3 or 4 requires interruption, dose reduction or cycle delay
  • Interstitial lung disease/pneumonitis, which can be severe or fatal; monitor respiratory symptoms
  • Ovarian suppression with an LHRH agonist is mandatory in pre/perimenopausal women given an aromatase inhibitor
  • Not studied in critical visceral disease

Side effects

  • Most common (≥20%): neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anaemia, diarrhoea, alopecia, thrombocytopenia
  • Most common Grade ≥3: neutropenia, leukopenia, infections, anaemia, AST and ALT increased, fatigue

Interactions

  • Avoid strong CYP3A inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, voriconazole) and grapefruit
  • St. John's Wort contraindicated; strong CYP3A inducers affect exposure
  • Palbociclib is a weak CYP3A inhibitor

Pregnancy and breastfeeding

  • Not recommended in pregnancy; contraception during and for at least 3 weeks (females) or 14 weeks (males) after therapy
  • Should not breast-feed during treatment

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)

Source: European Medicines Agency (EMA), product information

Austria

  • IbrammaclibG.L. Pharma Gmbh · 1 register entry

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

Turkey

  • PalbopolPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PaldiboABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ReamplaPFİZER PFE İLAÇLARI A.Ş. · 12 register entries
  • RepalboSABA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

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

Brand names in 14 more European countries
Bulgaria
Palbociclib
Croatia
Palbociclib, Palbociklib Corapharm Corapharm
Denmark
Palbociclib Newbury
Estonia
Palbociclib
Finland
Palbociclib Avansor
Greece
Palbociclib Faran, Palbociclib Innovis, Palbociclib Win Medica
Hungary
Palbociclib
Iceland
Ibrance, Palbociclib Viatris
Liechtenstein
Ibrance, Palbociclib Viatris
Malta
Palbociclib
Netherlands
Ibaclib, Palbociclib Elpen, Palbociclib Synthon
Norway
Ibrance, Palbociclib Newbury, Palbociclib Viatris
Poland
Palbociclib Polpharma
Sweden
Brancen, Brical, Ibneyo, Ibrammaclib, Palbociclib, Palsiva, Valocyra

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

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Sources

  1. European Medicines Agency. Ibrance – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ibrance-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. 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.