Ribociclib 200mg tablets
Requires a prescription from a doctor or prescriber
Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6).
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Ribociclib
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Ribociclib
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2 branded products available
MHRA licensed products
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Kisqali 200mg tablets
WHO defined daily dose (DDD)
450 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Ribociclib
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(10)
Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy (TA687)
Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (TA496)
Ribociclib with an aromatase inhibitor for adjuvant treatment of hormone receptor-positive HER2-negative early breast cancer at high risk of recurrence (TA1086)
Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy (TA836)
Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (TA563)
Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy (TA725)
Alpelisib with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer (TA816)
Talazoparib for treating HER2-negative advanced breast cancer with germline BRCA mutations (TA952)
Elacestrant for treating oestrogen receptor-positive HER2-negative advanced breast cancer with an ESR1 mutation after endocrine treatment (TA1036)
Early and locally advanced breast cancer: diagnosis and management (NG101)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
1 found
Half-life
32 hours
Mechanism
Ribociclib is a selective inhibitor of cyclin-dependent kinases (CDK) 4 and 6.
Food interactions
4 warnings
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
600 mg
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Half-life
32 hours
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Protein binding
70%
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Volume of distribution
1090 L
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Metabolism
9%
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Elimination
17%
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Clearance
600 mg
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Ribociclib was approved by the FDA in March 2017 under the brand name Kisqali.
[L51529]
It is also indicated, in combination with an aromatase inhibitor or [fulvestrant], in adults with HR-positive, HER2-negative advanced or metastatic breast cancer.
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Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1182 interactions
How the body processes this drug — absorption, distribution, metabolism, and elimination
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Following repeated 600 mg once daily administration, steady-state was generally achieved after 8 days and the mean steady-state Cmax and AUC were 1820 ng/mL and 23800 ng*h/mL, respectively.
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The Tmax of ribociclib at steady-state generally occurs between 1 and 4 hours following administration.
[L51529]
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In healthy adults receiving the 600 mg dose, the mean apparent plasma terminal half-life of ribociclib ranged from 29.7 to 54.7 hours and mean apparent oral clearance of ribociclib ranged from 39.9 to 77.5 L/h.
[L51529]
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Major circulating metabolites following oral administration include metabolite M13 (CCI284, N-hydroxylation), M4 (LEQ803, N-demethylation), and M1 (secondary glucuronide), each representing an estimated 9%, 9%, and 8% of total radioactivity, and 22%, 20%, and 18% of ribociclib exposure.
[L51529]
Parent drug is the major circulating entity in plasma, accounting for 44% of total exposure.
[L51529]
[L51529]
Metabolite M4 (LEQ803) represented approximately 14% and 4% of the administered dose in feces and urine, respectively.
[L51529]
[L51529]
At steady-state in patients with early breast cancer administered receiving the 400 mg dose, the mean apparent oral clearance of ribociclib was 38.4 L/h.
[L51529]
Proteins and enzymes this drug interacts with in the body
Cyclin D-CDK4 complexes are major integrators of various mitogenenic and antimitogenic signals. Also phosphorylates SMAD3 in a cell-cycle-dependent manner and represses its transcriptional activity. Component of the ternary complex, cyclin D/CDK4/CDKN1B, required for nuclear translocation and activity of the cyclin D-CDK4 complex
Involved in initiation and maintenance of cell cycle exit during cell differentiation; prevents cell proliferation and negatively regulates cell differentiation, but is required for the proliferation of specific cell types (e.g. erythroid and hematopoietic cells). Essential for cell proliferation within the dentate gyrus of the hippocampus and the subventricular zone of the lateral ventricles. Required during thymocyte development.
Promotes the production of newborn neurons, probably by modulating G1 length. Promotes, at least in astrocytes, changes in patterns of gene expression, changes in the actin cytoskeleton including loss of stress fibers, and enhanced motility during cell differentiation. Prevents myeloid differentiation by interfering with RUNX1 and reducing its transcription transactivation activity, but promotes proliferation of normal myeloid progenitors.
Delays senescence. Promotes the proliferation of beta-cells in pancreatic islets of Langerhans. May play a role in the centrosome organization during the cell cycle phases PMID:23918663
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC L01EF02
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Ribociclib
Additional database identifiers
Drugs Product Database (DPD)
22938
ChemSpider
30798107
BindingDB
148264
PDB
6ZZ
ZINC
ZINC000072316335
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1773
GenAtlas
CDK4
GeneCards
CDK4
GenBank Gene Database
M14505
GenBank Protein Database
456427
Guide to Pharmacology
1976
UniProt Accession
CDK4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1777
GenAtlas
CDK6
GeneCards
CDK6
GenBank Gene Database
X66365
GenBank Protein Database
36623
Guide to Pharmacology
1978
UniProt Accession
CDK6_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
Patent information
10 active patents
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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