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Active Pharma Ingredients / 18 Sep 2026

CULMERCICLIB

Generic Name: CULMERCICLIB

ABSTRACT -

Culmerciclib (SHR6390) is an oral inhibitor of CDK2, CDK4, and CDK6 kinases, targeting cell cycle progression in CDK-driven cancers. Its broader CDK inhibition profile compared to selective CDK4/6 inhibitors may overcome resistance mechanisms and extend anti-tumour activity. Phase I/II trials are evaluating it in HR+/HER2- breast cancer and other solid tumours.

DOSAGE -

Oral administration once or twice daily; dosing schedule defined in clinical protocol with standard rest periods to manage haematological toxicity.

SIDE EFFECTS-

  • Neutropenia
  • Thrombocytopenia
  • Nausea
  • Fatigue
  • Alopecia

ALLERGIC REACTIONS -

These symptoms may indicate an allergic reaction and require immediate medical attention.

  • Skin rash
  • Drug hypersensitivity
  • Urticaria
  • Anaphylaxis (rare)

DRUG INTERACTIONS-

  • CYP3A4 inhibitors elevate culmerciclib plasma levels
  • Avoid co-administration with potent CYP3A4 inducers
  • Monitor QTc when used with QT-prolonging drugs

PREAUTONS–

  • Haematological monitoring required before each cycle
  • Liver function tests at baseline and during treatment
  • Effective contraception required
  • Not studied in moderate-severe hepatic impairment

WARNINGS –

  • Myelosuppression including febrile neutropenia risk
  • Dose modifications critical to maintain safety
  • Embryo-foetal toxicity — avoid in pregnancy

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