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Ribociclib (Kisqali)

Trade Name : KISQALI

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 200 mg/1

RIBOCICLIB Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ribociclib (Kisqali) which is also known as KISQALI and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 200 mg/1 per ml. Read more

Ribociclib (Kisqali) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • KISQALI is indicated in combination with:
  • KISQALI is a kinase inhibitor indicated in combination with:
  • an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy; or
  • fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. ()
  • KISQALI tablets are taken orally with or without food in combination with an aromatase inhibitor or fulvestrant. ()
  • Recommended starting dose: 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment. ()n
  • Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability. ()
  • Tablet: 200 mg ribociclib (equivalent to 254.40 mg ribociclib succinate)
  • Film coated, light greyish violet, round, curved with beveled edges, debossed with u201cRICu201d on one side and u201cNVRu201d on the other side.
  • Tablets: 200 mg ()
  • None.
  • None. ()
  • No data
  • Interstitial Lung Disease (ILD)/Pneumonitis: Patients treated with CDK 4/6 inhibitors should be monitored for pulmonary symptoms indicative of ILD/pneumonitis. Interrupt and evaluate patients with new or worsening respiratory symptoms suspected to be due to ILD/pneumonitis. Permanently discontinue KISQALI in patients with recurrent symptomatic or severe ILD/pneumonitis (, ).
  • QT Interval Prolongation: Monitor electrocardiograms (ECGs) and electrolytes prior to initiation of treatment with KISQALI. Repeat ECGs at approximately Day 14 of the first cycle and at the beginning of the second cycle, and as clinically indicated. Monitor electrolytes at the beginning of each cycle for 6 cycles, and as clinically indicated. Avoid using KISQALI with drugs known to prolong QT interval and/or strong CYP3A inhibitors. (, , , )nttttttttt
  • Increased QT Prolongation with Concomitant Use of Tamoxifen: KISQALI is not indicated for concomitant use with tamoxifen. ()nttttttttt
  • Hepatobiliary Toxicity: Increases in serum transaminase levels have been observed. Perform Liver Function Tests (LFTs) before initiating treatment with KISQALI. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. (, )nttttttttt
  • Neutropenia: Perform Complete Blood Count (CBC) before initiating therapy with KISQALI. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. (, )nttttttttt
  • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception during therapy. (, , )
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (incidence u2265 20%) are neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, rash, and cough. ()
  • No data
  • CYP3A4 Inhibitors: Avoid concomitant use of KISQALI with strong CYP3A inhibitors. If strong inhibitors cannot be avoided, reduce KISQALI dose. (, )u00a0
  • CYP3A4 Inducers: Avoid concomitant use of KISQALI with strong CYP3A inducers. ()n
  • CYP3A Substrates: The dose of sensitive CYP3A substrates with narrow therapeutic indices may need to be reduced when given concurrently with KISQALI. ()n
  • Drugs Known to Prolong QT Interval: Avoid concomitant use of drugs known to prolong QT interval, such as anti-arrhythmic medicines. ()
  • Lactation: Advise not to breastfeed. ()
  • There is limited experience with reported cases of overdose with KISQALI in humans. General symptomatic and supportive measures should be initiated in all cases of overdose where necessary.
  • KISQALI (ribociclib) is a kinase inhibitor.
  • The chemical name of ribociclib succinate is:u00a0Butanedioic acidu20147-cyclopentyl-,-dimethyl-2-{[5-(piperazin-1-yl)u00a0pyridin-2-yl]amino}-7-pyrrolo[2,3-]pyrimidine-6-carboxamide (1/1).
  • Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The molecular formula for ribociclib succinate is CHNOu00b7CHO and the molecular weight is 552.64 g/mol n
  • The chemical structure of ribociclib is shown below:
  • KISQALI film-coated tablets are supplied for oral use and contain 200 mg of ribociclib free base (equivalent to 254.40 mg ribociclib succinate). The tablets also contain colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, magnesium stearate and microcrystalline cellulose. The film-coating contains iron oxide black, iron oxide red, lecithin (soya), polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide, and xanthan gum as inactive ingredients.
  • No data
  • No data
  • MONALEESA-2: KISQALI in Combination with Letrozole
  • Postmenopausal Women with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer for Initial Endocrine-Based Therapy
  • MONALEESA-2 was a randomized, double-blind, placebo-controlled, multicenter clinical study of KISQALI plus letrozole vs. placebo plus letrozole conducted in postmenopausal women with HR-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease.
  • A total of 668 patients were randomized to receive either KISQALI plus letrozole (n = 334) or placebo plus letrozole (n = 334), stratified according to the presence of liver and/or lung metastases. Letrozole 2.5 mg was given orally once daily for 28 days, with either KISQALI 600 mg or placebo orally once daily for 21 consecutive days followed by 7 days off until disease progression or unacceptable toxicity. The major efficacy outcome measure for the study was investigator-assessed progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients enrolled in MONALEESA-2 had a median age of 62 years (range, 23 to 91) and 45% of patients were older than 65. The majority of patients were White (82%), and all patients had an ECOG performance status of 0 or 1. A total of 47% of patients had received chemotherapy and 51% had received antihormonal therapy in the neoadjuvant or adjuvant setting. Thirty-four percent (34%) of patients had metastatic disease, 21% had bone only disease, and 59% had visceral disease.
  • The efficacy results from MONALEESA-2 are summarized in Table 13 and Figure 1. The results shown are from a pre-planned interim efficacy analysis of PFS. Results were consistent across patient subgroups of prior adjuvant or neoadjuvant chemotherapy or hormonal therapies, liver and/or lung involvement, and bone-only metastatic disease. The PFS assessment based on a blinded independent central radiological review was consistent with investigator assessment. At the time of the PFS analysis, 6.5% of patients had died, and overall survival data were immature.
  • Figure 1 Kaplan-Meier Progression Free Survival Curves u2013 MONALEESA-2 (Intent-to-Treat Population)
  • MONALEESA-7: KISQALI in Combination with an Aromatase Inhibitor
  • Pre/perimenopausal Patients with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer for Initial Endocrine-Based Therapy
  • MONALEESA-7 was a randomized, double-blind, placebo-controlled study of KISQALI plus either a non-steroidal aromatase inhibitor (NSAI) or tamoxifen and goserelin vs. placebo plus either a NSAI or tamoxifen and goserelin conducted in pre/perimenopausal women with HR-positive, HER2-negative, advanced breast cancer who received no prior endocrine therapy for advanced disease.
  • A total of 672 patients were randomized to receive KISQALI plus NSAI or tamoxifen plus goserelin (n = 335) or placebo plus NSAI or tamoxifen plus goserelin (n = 337), stratified according to the presence of liver and/or lung metastases, prior chemotherapy for advanced disease and endocrine combination partner (tamoxifen and goserelin vs. NSAI and goserelin). NSAI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen 20 mg were given orally once daily on a continuous daily schedule, goserelin was administered as a sub-cutaneous injection on Day 1 of each 28 day cycle, with either KISQALI 600 mg or placebo orally once daily for 21 consecutive days followed by 7 days off until disease progression or unacceptable toxicity. The major efficacy outcome measure for the study was investigator-assessed progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients enrolled in MONALEESA-7 had a median age of 44 years (range, 25 to 58) and were primarily Caucasian (58%), Asian (29%), or Black (3%). Nearly all patients (99%) had an ECOG performance status of 0 or 1. Of the 672 patients, 33% had received chemotherapy in the adjuvant vs. 18% in the neoadjuvant setting and 40% had received endocrine therapy in the adjuvant vs. 0.7% in the neoadjuvant setting prior to study entry. Forty percent (40%) of patients had metastatic disease, 24% had bone only disease, and 57% had visceral disease. Demographics and baseline disease characteristics were balanced and comparable between study arms, and endocrine combination partner.
  • The efficacy results from a pre-specified subgroup analysis of 495 patients who had received KISQALI or placebo with NSAI plus goserelin are summarized in Table 14, Figure 2, and Figure 3. Consistent results were observed in stratification factor subgroups of disease site and prior chemotherapy for advanced disease.
  • Figure 2tKaplan-Meier Progression Free Survival Curves u2013 MONALEESA-7 (NSAI, Investigator Assessment)
  • Figure 3tKaplan-Meier Overall Survival Curves- MONALEESA-7 (NSAI)
  • MONALEESA-3: KISQALI in Combination with Fulvestrant
  • Postmenopausal women with HR-positive, HER2-negative advanced or Metastatic Breast Cancer for Initial Endocrine-Based Therapy or After Disease Progression on Endocrine Therapy
  • MONALEESA-3 was a randomized double-blind, placebo-controlled study of ribociclib in combination with fulvestrant for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received no or only one line of prior endocrine treatment.
  • A total of 726 patients were randomized in a 2:1 ratio to receive KISQALI 600 mg and fulvestrant (n = 484) or placebo and fulvestrant (n = 242), stratified according to the presence of liver and/or lung metastases and prior endocrine therapy for advanced or metastatic disease. Fulvestrant 500 mg was administered intramuscularly on Days 1, 15, 29, and once monthly thereafter, with either KISQALI 600 mg or placebo given orally once daily for 21 consecutive days followed by 7 days off until disease progression or unacceptable toxicity. The major efficacy outcome measure for the study was investigator-assessed progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients enrolled in this study had a median age of 63 years (range, 31 to 89). Of the patients enrolled, 47% were 65 years and older, including 14% age 75 years and older. The patients enrolled were primarily Caucasian (85%), Asian (9%), and Black (0.7%). Nearly all patients (99.7%) had an ECOG performance status of 0 or 1. First and second line patients were enrolled in this study (of which 19% had metastatic disease). Forty-three percent (43%) of patients had received chemotherapy in the adjuvant vs. 13% in the neoadjuvant setting and 59% had received endocrine therapy in the adjuvant vs. 1% in the neoadjuvant setting prior to study entry. Twenty-one percent (21%) of patients had bone only disease and 61% had visceral disease. Demographics and baseline disease characteristics were balanced and comparable between study arms.
  • The efficacy results from MONALEESA-3 are summarized in Table 15 and Figure 3. Consistent results were observed in stratification factor subgroups of disease site and prior endocrine treatment for advanced disease. At the time of the PFS analysis, 17% of patients had died, and overall survival data were immature.
  • Figure 4tKaplan-Meier Progression Free Survival Curves u2013 MONALEESA-3 (Investigator assessment)
  • KISQALI (ribociclib) Tablets
  • Each film-coated tablet contains 200 mg of ribociclib free base.
  • Light greyish violet, round, curved with beveled edge, debossed with u201cRICu201d on one side and u201cNVRu201d on the other side; available in:
  • Blister pack (21 tablets) u2013 each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer containeru00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0078-0874-63
  • Blister pack (14 tablets) u2013 each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer containeru00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0078-0867-42
  • Blister pack (21 tablets) u2013 each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container u2013 1 Blister pack per outer containeru00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0078-0860-01
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). Store in the original package.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Interstitial Lung Disease/Pneumonitis
  • Advise patients to immediately report new or worsening respiratory symptoms .
  • QT Prolongation
  • Inform patients of the signs and symptoms of QT prolongation. Advise patients to contact their healthcare provider immediately for signs or symptoms of QT prolongation .
  • Hepatobiliary Toxicity
  • Inform patients of the signs and symptoms of hepatobiliary toxicity. Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatobiliary toxicity .
  • Neutropenia
  • Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any suggestion of infection .
  • Embryo-Fetal Toxicity
  • Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during KISQALI therapy and for at least 3 weeks after the last dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with KISQALI .
  • Lactation
  • Advise lactating women not to breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose .
  • Drug Interactions
  • Dosing
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2020-04
  • No data
  • PRINCIPAL DISPLAY PANEL
  • Kisqalin (ribociclib)tablets
  • NDC 0078-0860-01
  • Rx only
  • 200 mg daily dose
  • (one 200 mg tablet)
  • 21 Film-coated tablets
  • Contents: 1 individual monthly blister pack. Blister pack contains 21 tablets (200 mg per tablet).
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • Kisqalin (ribociclib)tablets
  • NDC 0078-0867-42
  • Rx only
  • 400 mg daily dose
  • (two 200 mg tablet)
  • 42 Film-coated tablets
  • Contents: 3 individual weekly blister pack. Blister pack contains 14 tablets (200 mg per tablet).
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • Kisqalin (ribociclib)tablets
  • NDC 0078-0874-63
  • Rx only
  • 600 mg daily dose
  • (three 200 mg tablet)
  • 63 Film-coated tablets
  • Contents: 3 individual weekly blister pack. Blister pack contains 21 tablets (200 mg per tablet).
  • Novartis

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