Letrozole And Ribociclib (Kisqali Femara Co-Pack)

Trade Name : KISQALI FEMARA CO-PACK

Novartis Pharmaceuticals Corporation

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Letrozole And Ribociclib (Kisqali Femara Co-Pack) which is also known as KISQALI FEMARA CO-PACK and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of per ml. Read more

Letrozole And Ribociclib (Kisqali Femara Co-Pack) 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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The KISQALI FEMARA CO-PACK is indicated as initial endocrine-based therapy 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.
KISQALI FEMARA CO-PACK, a co-packaged product containing ribociclib, a kinase inhibitor, and letrozole, an aromatase inhibitor, is indicated as initial endocrine-based therapy 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. ()

KISQALI FEMARA CO-PACK tablets are taken in combination orally with or without food. ()

KISQALI recommended starting dose: 600 mg orally (three 200 mg tablets) taken once daily for 21 consecutive days followed by 7 days off KISQALI treatment. ()
KISQALI dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability. ()
FEMARA: 2.5 mg (one tablet) continuously for a 28-day cycle. ()

KISQALI FEMARA CO-PACK is KISQALI (ribociclib) tablets copackaged with FEMARA (letrozole) tablets.ntttttt
Tablets:ntttttttt

KISQALI: 200 mg ()
FEMARA: 2.5 mg ()

Known hypersensitivity to the active substance (letrozole), or to any of the excipients of FEMARA. Refer to FEMARA Prescribing Information.ntttttt
Known hypersensitivity to letrozole, or to any excipients of FEMARA. ()

No data

Interstitial Lung Disease (ILD)/pneumonitis:
QT Interval Prolongation
Hepatobiliary Toxicity
Neutropenia
Embryo-Fetal Toxicity

The following adverse reactions are discussed in greater detail in other sections of the labeling:ntttttt
Most common adverse reactions (incidence u2265 20%) are neutropenia, nausea, infections, fatigue, leukopenia, diarrhea, alopecia, vomiting, headache, constipation, back pain, rash, and anemia. ()ntttttttt

Ribociclib

CYP3A4 Inhibitors
CYP3A4 Inducers
CYP3A Substrates
Drugs Known to Prolong QT interval

Lactation: Advise not to breastfeed. () n

There is limited experience with reported cases of overdose with ribociclib and letrozole in MONALEESA-2 and MONALEESA-7. General symptomatic and supportive measures should be initiated in all cases of overdose where necessary.
Refer to the Full Prescribing Information of FEMARA for additional overdosage information.

KISQALI FEMARA CO-PACK consists of ribociclib 200 mg film coated tablets copackaged with letrozole 2.5 mg tablets.
Ribociclib:
KISQALI (ribociclib) is a kinase inhibitor.
Ribociclib succinate is a light yellow to yellowish brown crystalline powder. The chemical name of ribociclib succinate is: Butanedioic acidu20147-cyclopentyl-,-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7-pyrrolo[2,3-]pyrimidine-6-carboxamide (1/1).
The molecular formula for ribociclib succinate is CHNO.CHOand the molecular weight is 552.64 g/mol .ntttttt
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 hydrolyzed), talc, titanium dioxide, and xanthan gum as inactive ingredients.
Letrozole:
FEMARA (letrozole) is a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis).
Letrozole is a white to yellowish crystalline powder, practically odorless, freely soluble in dichloromethane, slightly soluble in ethanol, and practically insoluble in water. It has a molecular weight of 285.31 g/mol, empirical formula CHN, and a melting range of 184u00b0C to 185u00b0C.
The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene) dibenzonitrile, and its structural formula is
FEMARA is available as 2.5 mg tablets for oral administration.
Inactive Ingredients: Colloidal silicon dioxide, ferric oxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.

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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 (NCT01958021) was a randomized, double-blind, placebo-controlled, multicenter clinical study of KISQALI plus letrozole versus 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 and letrozole (n = 334) or placebo and 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 anti-hormonal therapy in the neoadjuvant or adjuvant setting. Thirty-four percent (34%) of patients had de novo metastatic disease, 21% had bone only disease, and 59% had visceral disease.
The efficacy results from MONALEESA-2 are summarized in Table 11 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 (NCT02278120) 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). Among 248 patients who received KISQALI plus NSAI plus goserelin, 211 (85%) received letrozole and 37 (15%) received anastrozole.
NSAI (letrozole 2.5 mg or anastrozole 1 mg) or tamoxifen 20 mg or 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 de novo 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 12, Figure 2, and Figure 3. Consistent results were observed in the stratification factor subgroups of disease site and prior chemotherapy for advanced disease.
Figure 2:tKaplan-Meier Progression Free Survival Curves u2013 MONALEESA-7 (NSAI, Investigator Assessment)
Figure 3tKaplan-Meier Overall Survival Curves- MONALEESA-7 (NSAI)

KISQALI FEMARA CO-PACK is dispensed in a carton for a total of 28 days of therapy.
Each carton contains individual ribociclib and letrozole drug products as follows:
KISQALI (ribociclib) Tablets:
200 mg tablets.
Light greyish violet, round, curved with beveled edge, debossed with u201cRICu201d on one side and u201cNVRu201d on the other side.
FEMARA (letrozole) Tablets:
2.5 mg tablets.
Dark yellow, round, slightly biconvex, with beveled edges, imprinted with the letters u201cFVu201d on one side and u201cCGu201d on the other side.
KISQALI FEMARA CO-PACK Cartons:
Store KISQALI FEMARA CO-PACK at 20u00b0C to 25u00b0C (68u00b0F-77u00b0F). Store in the original package.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
For additional information on KISQALI and FEMARA, refer to the full prescribing information for each product.
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 FEMARA CO-PACK 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 FEMARA CO-PACK n
Lactation
Advise women not to breastfeed during KISQALI FEMARA CO-PACK treatment and for at least 3 weeks after the last dose n
Drug Interactions
Dosing
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
u00a9 Novartis
T2020-06

No data

PRINCIPAL DISPLAY PANEL
KisqaliFemaraCO-PACK(ribociclib and letrozole) tablets
NDC 0078-0909-61
Rx only
28-Day supply
200 mg daily dose
(one 200 mg tablet)
21 Film-coated tablets
2.5 mg
per tablet
28 Film-coated tablets
Novartis

PRINCIPAL DISPLAY PANEL
KisqaliFemaraCO-PACK(ribociclib and letrozole) tablets
NDC 0078-0916-61
Rx only
28-Day supply
400 mg daily dose
(two 200 mg tablets)
42 Film-coated tablets
2.5 mg
per tablet
28 Film-coated tablets
Novartis

PRINCIPAL DISPLAY PANEL
KisqaliFemaraCO-PACK(ribociclib and letrozole) tablets
NDC 0078-0923-61
Rx only
28-Day supply
600 mg daily dose
(three 200 mg tablets)
63 Film-coated tablets
2.5 mg
per tablet
28 Film-coated tablets
Novartis

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Letrozole And Ribociclib (Kisqali Femara Co-Pack)

Trade Name : KISQALI FEMARA CO-PACK

KIT

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Letrozole And Ribociclib (Kisqali Femara Co-Pack)

Trade Name : KISQALI FEMARA CO-PACK

KIT

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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