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Indications:1,2
- KISQALI® (ribociclib) is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy
- In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
KISQALI is not recommended to be used in combination with tamoxifen.
KISQALI should be used together with 2.5 mg letrozole or another aromatase inhibitor, or with 500 mg fulvestrant.1 Please refer to the Summary of Product Characteristics for the co-administered aromatase inhibitor, fulvestrant or LHRH agonist dose modification guidelines and other relevant safety information in the event of toxicity.
KISQALI offers adjustable dosing based on tolerability1,2
RECOMMENDED DOSE
TABLETS
(600 mg)
1ST REDUCTION
TABLETS
(400 mg)
2ND REDUCTION
TABLETS
(200 mg)
Each film-coated tablet contains 200 mg of ribociclib1,2
Dose modification of KISQALI is recommended based on individual safety and tolerability and made in a stepwise order by reducing the number of tablets taken1,2
If dose reduction below 200 mg/day is required, permanently discontinue treatment1,2
KISQALI should...
✓ Be taken orally once daily with or without food
✓ Be swallowed whole and should not be chewed, crushed or split prior to swallowing
✓ NOT be ingested if the tablet is broken, cracked or otherwise not intact
The recommended dose is 600 mg. Please refer to the Summary of Product Characteristics for full information on dose adjustment and additional modifications required in special populations and during co-administration of strong CYP3A4 inhibitors.1,2
OS benefit of KISQALI + ET* is not compromised in patients that require dose modification3
- At median follow-up of 79.7 months, median OS for patients with ≥1 dose reduction and no dose reduction was 66.0 months (95% CI: 57.6–75.7) versus 60.6 (42.5–79.2) months, respectively (HR 0.87 [95% CI: 0.65–1.18])3
Recommended monitoring schedule:1,2
TREATMENT
mid-cycle*
CYCLE 6 IS CLINICALLY INDICATED
Source: KISQALI® (ribociclib) Summary of Product Characteristics.1,2
One ECG prior to treatment initiation is required, followed by two within the first 30 days of treatment1,2
During LFT assessment, more frequent monitoring is recommended if grade ≥2 abnormalities are noted1,2
Any electrolyte abnormalities must be corrected prior to treatment1,2
KISQALI should only be initiated in patients with QTcF <450 msec. For patients with QTcF prolongation during therapy, more frequent monitoring is recommended1,2
Any baseline assessments should be performed prior to treatment initiation1,2
Any additional monitoring should be performed as clinically indicated1,2
KISQALI has a generally manageable safety profile, regardless of patient menopausal status4–12
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*KISQALI is not recommended to be used in combination with tamoxifen.1,2
†After initiating treatment, assess every 2 weeks for the first two cycles.1,2
‡After initiating treatment, assess on Day 14 of cycle 1.1,2
AE, adverse event; CBC, complete blood count; CI, confidence interval; ECG, electrocardiogram; ET, endocrine therapy; HER2−, human epidermal growth factor receptor-2 negative; HR, hazard ratio; HR+, hormone receptor-positive; LFT, liver function test; LHRH, luteinising hormone-releasing hormone; OS, overall survival; QTcF, QT interval corrected for Fridericia’s formula.
References
- KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
- KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
- Hart, L. et al. Poster 1017. ASCO Annual Meeting. 3–7 June 2022, Chicago USA and virtual.
- Hortobagyi GN, et al. N Engl J Med 2022;386(10):942–950 and supplementary appendix.
- Hortobagyi GN, et al. Oral presentation. ESMO Congress 2021, 16–21 September 2021, virtual.
- Im S-A, et al. N Engl J Med 2019;381(4):307–316.
- Tripathy D, et al. Lancet Oncol 2018;19(7):904–915.
- Slamon DJ, et al. J Clin Oncol 2018;36(24):2465–2472.
- Slamon DJ, et al. N Engl J Med 2020;382(6):514–524.
- Lu Y-S, et al. Clin Cancer Res 2022;2(5):851–859.
- Hortobagyi GN, et al. N Engl J Med 2016;375(18):1738–1748.
- Tripathy D, et al. Poster 166P. European Society for Medical Oncology. 2–4 May 2019, Berlin, Germany.