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Prescribing information

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KISQALI® (ribociclib) dosing and monitoring

Indications:1

Early breast cancer (eBC)

KISQALI, in combination with an aromatase inhibitor (AI), is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative eBC at high risk of recurrence (see section 5.1 of the SmPC for selection criteria).

  • In pre- or perimenopausal women, or in men, the AI should be combined with a luteinising hormone-releasing hormone (LHRH) agonist

Advanced or metastatic breast cancer (aBC) 

KISQALI is indicated for the treatment of women with HR+/HER2− aBC in combination with an AI or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (ET).

  • In pre- or perimenopausal women, the ET should be combined with a LHRH agonist

KISQALI is not recommended to be used in combination with tamoxifen.

KISQALI Summary of Product Characteristics (SmPC) can be found here.

Please consult your local SmPC for the full KISQALI safety and tolerability profile.

In eBC, KISQALI should be used in combination with an AI (AI should be taken orally once daily continuously throughout the 28-days cycle). In aBC, KISQALI should be used in combination with an AI (AI should be taken orally once daily continuously throughout the 28-days cycle) or fulvestrant (administered intramuscularly on Day 1, Day 15, Day 29 and once monthly thereafter).1

KISQALI should ...

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Be taken orally once daily with or without food1

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Be swallowed whole and should not be chewed, crushed or split prior to swallowing1

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NOT be ingested if the tablet is broken, cracked or otherwise not intact1

For eBC, the recommended dose is KISQALI 400 mg (two 200 mg film-coated tablets) once daily for 21 consecutive days, followed by 7 days off treatment, resulting in a complete cycle of 28 days.1

For aBC, the recommended dose is KISQALI 600 mg (three 200 mg film-coated tablets) once daily for 21 consecutive days, followed by 7 days off treatment, resulting in a complete cycle of 28 days.1

Please refer to the SmPC of the co-administered AI, fulvestrant or LHRH for dosing, dose modification guidelines and other relevant safety information in the event of toxicity.

Please refer to the KISQALI SmPC for full information on dosing and administration.

Dosing

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Recommended monitoring schedule:1

Recommended monitoring schedule graphic.

Adapted from KISQALI® (ribociclib) Summary of Product Characteristics.1

*Includes potassium, calcium, phosporus and magnesium.1
†After initiating treatment, assess every 2 weeks for the first 2 cycles.1
‡After initiating treatment, assess on Day 14 of cycle 1.1

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One ECG is required prior to treatment initiation, followed by another at approximately Day 14 of the cycle1

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During LFT assessment, more frequent monitoring is recommended if grade≥2 abnormalities are noted1

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Any electrolyte abnormalities must be corrected prior to and during treatment with KISQALI1

Icon of a heart rhythm as measured by an ECG.

KISQALI should only be initiated in patients with QTcF <450 msec. For patients with QTcF prolongation during therapy, more frequent monitoring is recommended1

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Any baseline assessments should be performed prior to treatment initiation1

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Any additional monitoring should be performed as clinically indicated1

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Post-hoc analysis showed that efficacy of KISQALI + ET§ was maintained regardless of dose modification in the Phase III trials across advanced and early HR+/HER2– breast cancer2–4

  • MONALEESA-2: At a median follow-up of 79.7 months, mOS and no dose reduction was 66.0 months (95% CI: 57.6–75.7) versus 60.6 (95% CI: 42.5–79.2) months, for patients treated with KISQALI + AI with 1 dose reduction and no dose reduction, respectively (HR=0.87; 95% CI: 0.65–1.18)2

  • MONALEESA-3: mOS was NR (95% CI: NR–43) and NR (95% CI: 41.4–NR) for patients treated with KISQALI + fulvestrant with ≥1 dose reduction and no dose reduction, respectively (HR=0.88; 95% CI: 0.64–1.21)3

  • MONALEESA-7: mOS was NR (95% CI: NR–NR) and NR (95% CI: NR–NR) for patients treated with KISQALI + non-steroidal aromatase inhibitor (NSAI) + LHRH with ≥1 dose reduction and no dose reduction, respectively (HR=0.79; 95% CI: 0.46–1.36)3

  • NATALEE: Invasive disease-free survival (iDFS) was similar irrespective of the relative dose intensity (RDI) of KISQALI; low (0 to <82.27%), medium (82.27% to <97.44%) and high (≥97.44%) RDI corresponded to similar iDFS (low vs high, HR=0.931; medium vs high, HR=0.985)4

§KISQALI is not recommended for use with tamoxifen.1
ET is defined as AI or fulvestrant and LHRH.2,3

Dose modification and management

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Guidance for drug-drug interactions

Drug-drug interactions1

KISQALI is primarily metabolised by CYP3A4. Certain medicines can interact with CYP3A4 enzyme activity and may alter the pharmacokinetics of KISQALI. Additionally, KISQALI is a strong CYP3A4 inhibitor at the 600 mg dose and a moderate CYP3A4 inhibitor at the 400 mg dose. Thus, KISQALI may interact with medicinal products which are metabolised via CYP3A4, which may lead to increased serum concentrations of CYP3A4 substrates.1

When KISQALI is co-administered with other medicinal products, the SmPC of the other medicinal products must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors. Caution is recommended in case of concomitant use with sensitive CYP3A4 substrates with a narrow therapeutic index and the SmPC of the other product should be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors.1

Category1

Examples (including, but not limited to)1

Strong CYP3A4 inhibitors
Should be avoided

  • If coadministration with KISQALI cannot be avoided, the daily dose of KISQALI should be reduced to the next lower dose

  • If the CYP3A4 inhibitor is discontinued, resume the dose of KISQALI used prior to the initiation of the CYP3A4 inhibitor, after waiting at least 5 half-lives of the CYP3A4 inhibitor

No clinical data with this dose adjustment are available. If dose reduction below 200 mg/day is required, KISQALI treatment should be interrupted. Due to inter-patient variability, the recommended dose adjustments may not be optimal in all patients, therefore close monitoring for KISQALI-related adverse reactions is recommended. In the event of KISQALI-related toxicity, the dose should be modified or treatment should be interrupted until toxicity is resolved. 

Clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, posaconazole, voriconazole, verapamil, grapefruit, grapefruit juice, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir

Moderate CYP3A4 inhibitors
No dose adjustments of KISQALI are required at initiation of treatment with mild or moderate CYP3A4 inhibitors; however, monitoring of KISQALI-related adverse reactions is recommended.

 

Strong CYP3A4 inducers
Should be avoided

  • An alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered

Rifampicin, carbamazepine, phenytoin, St. John’s Wort (Hypericum perforatum)

Moderate CYP3A4 inducers
Concomitant use of moderate CYP3A4 inducers may lead to decreased KISQALI exposure and consequently a risk of impaired efficacy, in particular in patients treated with KISQALI at 400 mg or 200 mg once daily.

 

CYP3A4 substrates
Caution is recommended with sensitive CYP3A4 substrates with a narrow therapeutic index.

Ciclosporin, sirolimus, tacrolimus, everolimus, alfentanil, fentanyl

Concomitant administration of KISQALI with certain CYP3A4 substrates should be avoided

  • The SmPC of the other medicinal product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors

Alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam and triazolam

Antiarrhythmics and medicines known to prolong QT interval
Should be avoided.

Amiodarone, disopyramide, procainamide, quinidine, sotalol; azithromycin, ciprofloxacin, clarithromycin, levofloxacin, moxifloxacin, chloroquine, halofantrine, haloperidol, pimozide, bepridil, methadone, ondansetron (IV)
KISQALI is not recommended to be used in combination with tamoxifen

Drug transporters
Caution and monitoring for toxicity are advised with concomitant administration with sensitive substrates of transporters which exhibit a narrow therapeutic index.

Digoxin, pravastatin, rosuvastatin, pitavastatin, metformin

 

Patients should be instructed to avoid grapefruit or grapefruit juice. These are known to inhibit cytochrome CYP3A4 enzymes and may increase the exposure to KISQALI.1

Drug-drug interaction studies between KISQALI and oral contraceptives have not been conducted.1

Co-administration of KISQALI with medicinal products that elevate the gastric pH has not been evaluated in a clinical study.1

For a list of medications and components that are known to interact with CYP3A4 enzyme activity and basic heart function, please see the SmPC.

Please refer to the SmPC for important safety information.1

Find out more about the safety profile of KISQALI in aBC

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aBC, advanced or metastatic breast cancer; AE, adverse event; AI, aromatase inhibitor; CBC, complete blood count; Cl, confidence interval; CYP3A4, cytochrome P450 3A4; eBC, early breast cancer; ECG, electrocardiogram; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; iDFS, invasive disease-free survival; IV, intravenous; LFT, liver function test; LHRH, luteinising hormone-releasing hormone; mOS, median overall survival; NR, not reported; NSAI, non-steroidal aromatase inhbitor; OS, overall survival; QTcF, corrected QT interval by Fridericia's formula; RDI, relative dose intensity; SmPC, summary of product characteristics.

References

  1. KISQALI® (ribociclib) Summary of Product Characteristics. Available at: www.medicines.ie.

  2. Hart L, et al. J Clin Oncol 2022;40(suppl 16; abstr 1017).

  3. De Laurentiis, M et al. Poster 311P. European Society for Medical Oncology Virtual Congress. 19–21 September 2020.

  4. Hamilton E, et al. Poster P1-11-16. San Antonio Breast Cancer Symposium. 10–13 December 2024; San Antonio, TX, US.

IE11636722 | May 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.