Ribociclib (Kisqali)
Pronunciation: rye-boe-SYE-klib.
- Generic name
- ribociclib
- Brand names
- Kisqali (all 6 markets reviewed)
- Drug class
- CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor, kinase inhibitor
- Form
- Film-coated tablet, 200 mg
- Route
- Oral
- Legal status
- Prescription-only, specialist (oncology) initiated
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Kisqali (5) · Full directory
What ribociclib is and how it works
Ribociclib is an oral cancer medicine that blocks two enzymes (CDK4 and CDK6) involved in cell division, helping to slow the growth of certain hormone-receptor-positive breast cancers. It is always combined with a hormonal breast cancer treatment. (1)
Ribociclib requires close monitoring throughout treatment, including regular blood tests (liver function and blood counts) and heart tracings (ECG), because it can affect the heart's electrical rhythm, the liver, and the bone marrow's ability to make white blood cells. Your oncology team will set your dose and monitoring schedule individually and adjust it based on your test results and how you tolerate treatment.
Mechanism of action: how ribociclib works
Ribociclib selectively inhibits cyclin-dependent kinases 4 and 6, which regulate cell-cycle progression through the G1 phase; inhibition blocks progression into S phase, arresting proliferation of breast cancer cells that depend on this pathway. (1)
What ribociclib is used for
Early breast cancer (adjuvant treatment)
Used together with an aromatase inhibitor for the adjuvant (after-surgery) treatment of hormone receptor (HR)-positive, HER2-negative early breast cancer at high risk of the cancer returning. (1)
Advanced or metastatic breast cancer
Used together with an aromatase inhibitor or with fulvestrant for HR-positive, HER2-negative locally advanced or metastatic breast cancer. (1)
Before taking ribociclib
Do not take / not appropriate for
- Ribociclib should not be combined with strong CYP3A inhibitor or inducer medicines, or with other medicines known to prolong the QT interval, without your oncology team's specific direction, because of serious interaction risk. (all countries) (1)
- Do not take ribociclib if you have had a serious allergic reaction to it or any of its ingredients. (all countries) (1)
Tell your clinician about
- Any personal or family history of a prolonged QT interval, irregular heartbeat, or other significant heart disease.
- Any liver problems or abnormal liver blood tests.
- Any history of lung problems or breathing symptoms.
- All other medicines and supplements you take, since many interact with ribociclib.
- Whether you are, or could become, pregnant, and your contraception plans.
- Whether you are breastfeeding.
How to take ribociclib
- Take ribociclib once daily, at about the same time each day, exactly as your oncology team prescribes.
- Swallow tablets whole; do not chew, crush, or split them.
- Can be taken with or without food.
- Ribociclib is taken for 21 consecutive days, followed by 7 days off, repeated in 28-day cycles -- always take it on this on/off schedule as directed.
- Your dose (early breast cancer typically 400 mg daily; advanced/metastatic typically 600 mg daily) and any dose reduction for side effects is individually set by your oncology team based on your test results and tolerance.
- Take ribociclib together with the hormonal breast cancer medicine (aromatase inhibitor or fulvestrant) your oncology team has prescribed alongside it.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
If you miss a dose or vomit after taking a dose, do not take an extra or make-up dose that day -- take your next dose at the regular scheduled time. Contact your oncology team if you are unsure.
Overdose
Contact your oncology team or seek urgent medical attention if an overdose is suspected, particularly if you develop symptoms such as severe nausea, vomiting, or an irregular heartbeat. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Low blood counts (white blood cells, red blood cells) shown on routine blood tests.
What to notice: Low blood counts (white blood cells, red blood cells) shown on routine blood tests.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Elevated liver enzymes on blood tests.
What to notice: Elevated liver enzymes on blood tests.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Nausea, fatigue, diarrhea, vomiting, and hair thinning or loss.
What to notice: Nausea, fatigue, diarrhea, vomiting, and hair thinning or loss.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Cough and increased risk of infections.
What to notice: Cough and increased risk of infections.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of an abnormal heart rhythm (QT prolongation) — high caution
Symptoms: Fainting, severe dizziness, palpitations, or an irregular heartbeat.
Action: Seek prompt medical attention -- ribociclib can prolong the heart's QT interval in a dose-related way, and this risk is why baseline and on-treatment ECGs are required. Report these symptoms to your oncology team immediately or seek emergency care for severe symptoms. (1)
Signs of liver injury — high caution
Symptoms: Yellowing of the skin or eyes, dark urine, severe fatigue, loss of appetite, or right-sided abdominal pain.
Action: Contact your oncology team promptly; this is why liver function tests are checked regularly during treatment. (1)
Signs of severe low white blood cell count (neutropenia) or infection — high caution
Symptoms: Fever, chills, or other signs of infection.
Action: Contact your oncology team promptly -- neutropenia is common with ribociclib and is monitored with regular blood counts; fever during low blood counts needs urgent evaluation. (1)
Signs of lung inflammation (interstitial lung disease/pneumonitis) — emergency
Symptoms: New or worsening shortness of breath, cough, or fatigue.
Action: Seek prompt medical evaluation -- severe, life-threatening, or fatal lung inflammation has been reported with ribociclib. (1)
Signs of a severe skin reaction — emergency
Symptoms: Widespread rash, blistering, peeling skin, or painful sores in the mouth, eyes, or genitals.
Action: Seek emergency medical attention immediately -- severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. (1)
Interactions
- Strong CYP3A inhibitors (such as certain antifungal or HIV medicines) can significantly increase ribociclib levels and side-effect risk; these are generally avoided or require a dose adjustment directed by your oncology team. (1)
- Strong CYP3A inducers (such as rifampicin) can significantly reduce ribociclib's effectiveness and are generally avoided. (1)
- Other QT-prolonging medicines increase the risk of heart rhythm problems when combined with ribociclib; tamoxifen is not recommended in combination. (1)
- Ribociclib can raise blood levels of other medicines processed by the same liver pathway (CYP3A), such as midazolam -- tell your oncology team about all your medicines. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Ribociclib can cause fetal harm. Pregnancy status is verified before starting treatment, and effective contraception is required during treatment and for at least 3 weeks after the last dose for anyone who can become pregnant. (1) (2) (3) (4) (5) (6)
Breastfeeding
It is not known whether ribociclib passes into human milk. Breastfeeding is generally advised against during treatment and for at least 3 weeks after the last dose because of the potential for serious effects in a breastfed infant. (1) (2) (3) (4) (5) (6)
Children
Ribociclib is used in adults; safety and effectiveness in children have not been established in the sources reviewed. (1) (2) (3) (4) (5) (6)
Elderly
No specific dose adjustment based on age alone is described in the source reviewed; monitoring is individualised regardless of age. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Liver problems can affect ribociclib dosing and are monitored closely with regular liver function tests during treatment. (1) (2) (3) (4) (5) (6)
Renal_impairment
Tell your oncology team about any kidney problems; dosing is individualised accordingly. (1) (2) (3) (4) (5) (6)
Source_ids
Monitoring
Before starting
- Baseline ECG (QTcF must be under 450 ms to start)
- Baseline liver function tests
- Baseline complete blood count
- Baseline electrolytes, corrected if abnormal
- Pregnancy test where relevant
During treatment
- Repeat ECG at approximately day 14 of the first treatment cycle and as clinically indicated.
- Liver function tests every 2 weeks for the first 2 cycles, then at the start of each of the next 4 cycles, and as clinically indicated.
- Complete blood count on the same schedule as liver function tests.
- Electrolyte checks at baseline and the start of the first 6 cycles.
- Ongoing monitoring for cough, shortness of breath, or other lung symptoms.
Storage
Store at room temperature as directed on the product label, out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.
United States
Indication: Early breast cancer (adjuvant)
Dose summary: 400 mg orally once daily, 21 days on/7 days off in 28-day cycles, combined with an aromatase inhibitor. Individualised dose reduction for toxicity.
Renal context: Not specifically established as a major adjustment factor in the source reviewed; individualised regardless. (1)
United States
Indication: Advanced/metastatic breast cancer
Dose summary: 600 mg orally once daily, 21 days on/7 days off in 28-day cycles, combined with an aromatase inhibitor or fulvestrant. Individualised dose reduction for toxicity.
Renal context: Not specifically established as a major adjustment factor in the source reviewed; individualised regardless. (1)
Hepatic guidance
Drug-induced liver injury and transaminase elevation are recognised risks; scheduled LFT monitoring and dose modification/discontinuation criteria apply per label.
Overdose note
Manage suspected overdose supportively with cardiac (ECG) monitoring given the QT-prolongation risk; contact a poison control service for guidance. (1)
Frequently asked questions
Is Kisqali (ribociclib) available in the US, UK, Europe, Canada, Australia, and New Zealand?
Yes, it is approved and available in all of these regions, always used together with a hormonal breast cancer treatment. (1) (2) (3) (4) (5) (6)
Why do I need so many ECGs and blood tests while taking ribociclib?
Ribociclib can affect the heart's electrical rhythm (QT interval), the liver, and the bone marrow's ability to make white blood cells. Regular ECGs and blood tests let your oncology team catch and manage these effects early, and are a required part of safe treatment, not an optional extra. (1)
What symptoms during ribociclib treatment need urgent medical attention?
Seek prompt medical attention for a fast or irregular heartbeat, fainting, yellowing of the skin or eyes, dark urine, unusual tiredness, new or worsening cough, shortness of breath, or a severe skin rash with blistering or peeling -- these can signal QT prolongation, liver injury, lung inflammation, or a serious skin reaction, all of which need timely assessment. (1)
What is the mechanism of action of ribociclib?
Ribociclib selectively inhibits cyclin-dependent kinases 4 and 6, which regulate cell-cycle progression through the G1 phase; inhibition blocks progression into S phase, arresting proliferation of breast cancer cells that depend on this pathway. (1)
What is the generic name of Ribociclib (Kisqali)?
The generic name is ribociclib. It is sold under brand names including Kisqali (all 6 markets reviewed). (1)
What class of drug is ribociclib?
Ribociclib (Kisqali) is classed as: CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor, kinase inhibitor. (1)
References
- KISQALI (ribociclib) tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Novartis Pharmaceuticals Corporation · United States · accessed 2026-07-29 · source 1
- Kisqali European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 2
- Kisqali 200 mg film-coated tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Novartis · United Kingdom · accessed 2026-07-29 · source 3
- KISQALI (ribociclib, as ribociclib succinate) -- Product MonographHealth Canada product monograph · Canada · accessed 2026-07-29 · source 4
- KISQALI ribociclib 200 mg (as succinate) film coated tablet -- ARTG registrationTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
- KISQALI Film coated tablet -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · accessed 2026-07-29 · source 6
Brand names by country
Single-ingredient ribociclib names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- KISQALI200 mg · novartis pharmaceuticals corporation
United Kingdom
- Kisqali (3)MHRA licensed emc smpc confirmed · 200 mg · Novartis
Canada
- Kisqali (4)Health Canada approved confirmed · 200 mg · Novartis Pharmaceuticals Canada Inc.
Australia
- Kisqali (5)TGA ARTG registered 2017-10-23 confirmed · 200 mg · Novartis Pharmaceuticals Australia Pty Ltd
New Zealand
- Kisqali (6)Medsafe approved confirmed · 200 mg · Novartis New Zealand Limited
View brands in additional countries.
European Union
Kisqali (2)