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KISQALI is a brand name for Ribociclib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Early breast cancer KISQALI® (ribociclib tablets) is indicated: • In combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence. In pre- or…
Verbatim from this product's HC label. Tap a section to expand.
). KISQALI® ribociclib (as ribociclib succinate) Page 6 of 86 2 CONTRAINDICATIONS • Patients with hypersensitivity to this drug or to any ingredient in the formulation. For a complete listing, see
). Table 2 Dose modification and management for neutropenia Neutropenia Grade 1 or 2 (ANC1 1,000/mm3 – <LLN2) Grade 3 (ANC1 500- <1,000/mm3) Grade 3 febrile* neutropenia Grade 4 (ANC1 <500/mm3) No dose adjustment is required. Interrupt KISQALI until recovery to Grade ≤2.
Resume KISQALI at the same dose level. If toxicity recurs at Grade 3, interrupt KISQALI dose until recovery to Grade ≤2 , then resume KISQALI at the next lower dose level. Interrupt KISQALI until recovery of neutropenia to Grade ≤2. Resume KISQALI at the next lower dose level.
Interrupt KISQALI until recovery to Grade ≤2. Resume KISQALI at the next lower dose level. Perform Complete Blood Counts (CBC) before initiating treatment with KISQALI. After initiating treatment with KISQALI, monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and as clinically indicated.
03. 1: absolute neutrophil count 2: lower limit of normal Table 3 Dose modification and management for hepatobiliary toxicity AST and/or ALT elevations from baseline*, without increase in total bilirubin above 2 x ULN Grade 1 (>ULN – 3 x ULN) Grade 2 (>3 to 5 x ULN) Grade 3 (>5 to 20 x ULN) Grade 4 (>20 x ULN) No dose adjustment is required.
Baseline* at <Grade 2:
Interrupt KISQALI until recovery to ≤ baseline grade, then resume at next lower dose level. If Grade 3 recurs, discontinue KISQALI. Discontinue KISQALI KISQALI® ribociclib (as ribociclib succinate) Page 9 of 86 Interrupt KISQALI until recovery to ≤ baseline grade, then resume KISQALI at same dose level.
If Grade 2 recurs, resume KISQALI at next lower dose level. ------------------------------ Baseline* at Grade 2: No dose interruption. Combined elevations in AST and/or ALT together with total bilirubin increase, in the absence of cholestasis If patients develop ALT and/or AST >3 x ULN along with total bilirubin >2 x ULN irrespective of baseline grade, discontinue KISQALI.
3 Pharmacokinetics). Concomitant use of KISQALI should be avoided with strong CYP3A inhibitors. 3 Pharmacokinetics ). 5 Drug-Food Interactions). 2 Recommended Dose and Dosage Adjustment Treatment with KISQALI should only be prescribed by a physician experienced in the use of anticancer therapies.
6 mg as injectable subcutaneous implant on day 1 of each 28-day cycle. Early breast cancer The recommended dose of KISQALI is 400 mg (2 x 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days.
KISQALI should be continued until completion of 3 years of treatment or until disease recurrence or unacceptable toxicity occurs. 5 mg, taken once daily throughout the 28-day cycle or anastrozole at a dose of 1 mg taken once daily throughout the 28-day cycle.
For dosing and administration instructions of the co-administered endocrine therapy, refer to the applicable full prescribing information. Advanced or metastatic breast cancer The recommended dose of KISQALI is 600 mg (3 x 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days.
When co-administered with KISQALI, the recommended dose of fulvestrant is 500 mg administered intramuscularly on days 1, 15 and 29, and once monthly thereafter. Refer to the Product Monograph for fulvestrant for detailed conditions of use.
For dosing and co-administration of KISQALI with an aromatase inhibitor refer to the applicable Product Monograph for detailed conditions of use. Dose Adjustments for Adverse Drug Reactions Management of severe or intolerable adverse drug reactions (ADRs) may require temporary dose interruption, reduction, or permanent discontinuation of KISQALI.
If dose reduction is required, the recommended dose reduction guidelines for adverse drug reactions (ADRs) are listed in Table 1. Table 1 Recommended dose modification guidelines for adverse drug reaction KISQALI Dose Number of Tablets Early breast cancer Starting dose 400 mg/day 2 x 200 mg tablets Dose reduction 200 mg/day* 1 x 200 mg tablet Advanced or metastatic breast cancer Starting dose 600 mg/day 3 × 200 mg tablets First dose reduction 400 mg/day 2 × 200 mg tablets Second dose reduction 200 mg/day* 1 × 200 mg tablet *If further dose reduction below 200 mg/day is required, discontinue the treatment.
• Patients with hypersensitivity to this drug or to any ingredient in the formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING. • Patients with untreated congenital long QT syndrome, a QTcF interval of ≥450 msec at baseline, and those who are at significant risk of developing QTc prolongation (see 7 WARNINGS and PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Perform LFTs before initiating treatment with KISQALI. After initiating treatment with KISQALI, monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each of the subsequent 4 cycles, and monitor periodically as clinically indicated.
If Grade ≥2 abnormalities are observed, more frequent monitoring, for example, twice weekly, is recommended. AST= aspartate aminotransferase - ALT= alanine aminotransferase *Baseline = prior to treatment initiation. 03. Table 4 Dose modification and management for QT prolongation QTcF* prolongation Early breast cancer Advanced or metastatic breast cancer >480 ms and ≤500 ms Interrupt KISQALI treatment and wait until QTcF resolves to ≤480ms Resume at the same dose Reduce to the next lower level dose If QTcF >480ms recurs, interrupt KISQALI treatment and wait until QTcF resolves to ≤480ms, then resume at next lower level dose.
>500 ms Interrupt KISQALI treatment and wait until QTcF resolves to ≤480ms, then resume at next lower level dose. If QTcF > 500ms recurs, discontinue KISQALI. Permanently discontinue KISQALI if QTcF interval is greater than 500 ms or shows a greater than 60 ms change from baseline and is associated with Torsade de Pointes or polymorphic ventricular tachycardia, unexplained syncope or signs/symptoms of serious arrhythmia.
Note:
If further dose reductions are required at the 200 mg dose, KISQALI should be discontinued. Electrocardiograms (ECGs) should be assessed prior to initiation of treatment in all patients. KISQALI® ribociclib (as ribociclib succinate) Page 10 of 86 Repeat ECGs at approximately Day 14 of the first cycle and as clinically indicated.
In case of QTcF prolongation at any given time during treatment, more frequent ECG monitoring is recommended as clinically indicated. *QTcF = QT interval corrected by Fridericia’s formula. Table 5 Dose modification and management for ILD/Pneumonitis ILD/pneumonitis Grade 1 (asymptomatic) Grade 2 (symptomatic) Grade 3 or 4 (severe) No dose adjustment is required.
Initiate appropriate medical therapy and monitor as clinically indicated. Interrupt KISQALI until recovery to Grade ≤1, then resume KISQALI at the next lower dose level*. 03. * An individualized benefit-risk assessment should be performed when considering resuming KISQALI ILD = Interstitial Lung Disease Table 6 Dose modification and management for other toxicities* Other toxicities Grade 1 or 2 Grade 3 Grade 4 No dose adjustment is required.
Initiate appropriate medical therapy and monitor as clinically indicated. Interrupt KISQALI dose until recovery to Grade ≤1, then resume KISQALI at the same dose level. If Grade 3 recurs, resume KISQALI at the next lower dose level. Discontinue KISQALI.
*Excluding neutropenia, hepatobiliary toxicity, QT interval prolongation and ILD/Pneumonitis. 03. Refer to the Product Monograph for the co-administered aromatase inhibitor, fulvestrant or LHRH agonist for dose modification guidelines in the event of toxicity and other relevant safety information.
Dose modification for use of KISQALI with strong CYP3A inhibitors Concomitant use of KISQALI with strong CYP3A inhibitors should be avoided and an alternative concomitant medication should be considered with low potential for CYP3A inhibition.
If a strong CYP3A inhibitor must be co-administered, reduce the dose of KISQALI according to Table 7.
KISQALI® ribociclib (as ribociclib succinate) Page 11 of 86 Table 7:
Dose modifications for concomitant use with strong CYP3A inhibitors Indication Co-administration with Strong CYP3A Inhibitors Early breast cancer Monitor for adverse reactions and, if necessary, […]
Tables 2, 3, 4, 5 and 6 summarize recommendations for dose interruption, reduction, or discontinuation of KISQALI in the management of specific ADRs. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk KISQALI® ribociclib (as ribociclib succinate) Page 8 of 86 assessment (see 7 WARNINGS AND PRECAUTIONS and