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KISQALI

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Overview

What is KISQALI?

KISQALI (ribociclib) is a kinase inhibitor.

The chemical name of ribociclib succinate is: Butanedioic acid—7-cyclopentyl-,-dimethyl-2-{[5-(piperazin-1-yl) pyridin-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 CHNO·CHO and the molecular weight is 552.64 g/mol

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.



What does KISQALI look like?



What are the available doses of KISQALI?

Tablet: 200 mg ribociclib (equivalent to 254.40 mg ribociclib succinate)

Film coated, light greyish violet, round, curved with beveled edges, debossed with “RIC” on one side and “NVR” on the other side.

What should I talk to my health care provider before I take KISQALI?

Lactation: Advise not to breastfeed. ()

How should I use KISQALI?

KISQALI is indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

The recommended dose of KISQALI is 600 mg (three 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 can be taken with or without food .

Coadminister KISQALI with letrozole 2.5 mg taken once daily throughout the 28-day cycle. Refer to the full prescribing information of letrozole. For dosing and administration with other aromatase inhibitors refer to the applicable full prescribing information.

Patients should take their dose of KISQALI and letrozole at approximately the same time each day, preferably in the morning.

If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. KISQALI tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.


What interacts with KISQALI?

Sorry No Records found


What are the warnings of KISQALI?

Sorry No Records found


What are the precautions of KISQALI?

Sorry No Records found


What are the side effects of KISQALI?

Sorry No records found


What should I look out for while using KISQALI?

None.


What might happen if I take too much KISQALI?

There are no known cases of overdose with KISQALI. General symptomatic and supportive measures should be initiated in all cases of overdose where necessary. 


How should I store and handle KISQALI?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP are cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP are cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Storage and HandlingStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. Capecitabine tablets, USP are cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package. KISQALI (ribociclib) Tablets Each film-coated tablet contains 200 mg of ribociclib free base.Light greyish violet, round, curved with beveled edge, debossed with “RIC” on one side and “NVR” on the other side; available in:Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (600 mg daily dose) Outer container - 3 Blister packs per outer container          NDC 0078-0874-63Blister pack (14 tablets) – each blister pack contains 14 tablets (200 mg per tablet) (400 mg daily dose) Outer container - 3 Blisters packs per outer container          NDC 0078-0867-42Blister pack (21 tablets) – each blister pack contains 21 tablets (200 mg per tablet) (200 mg daily dose) Outer container – 1 Blister pack per outer container          NDC 0078-0860-01 Store at 20°C to 25°C (68°F to 77°F). Store in the original package.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Ribociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. These kinases are activated upon binding to D-cyclins and play a crucial role in signaling pathways which lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the retinoblastoma protein (pRb).

In vitro

Non-Clinical Toxicology
None.

Patients using topical corticosteroids should receive the following information and instructions:

KISQALI has been shown to prolong the QT interval in a concentration-dependent manner, with estimated mean increase in QTc interval exceeding 20 ms (22.9 ms (90% CI: 21.6, 24.1)) at the mean steady-state C following administration at 600 mg once daily dose . In Study 1 (MONALEESA-2), one patient (0.3%) had >500 msec post-baseline QTcF value (average of triplicate), and nine patients out of 329 patients (3%) had a >60 msec increase from baseline in QTcF intervals (average of triplicate). These ECG changes occurred within the first four weeks of treatment and were reversible with dose interruption. There were no reported cases of Torsades de Pointes. Syncope occurred in 9 patients (2.7%) in the KISQALI plus letrozole arm versus 3 (0.9%) in placebo plus letrozole arm. On the KISQALI plus letrozole treatment arm, there was one (0.3%) sudden death in a patient with Grade 3 hypokalemia and Grade 2 QT prolongation .

Assess ECG prior to initiation of treatment. Initiate treatment with KISQALI only in patients with QTcF values less than 450 msec. Repeat ECG at approximately Day 14 of the first cycle and the beginning of the second cycle, and as clinically indicated.

Monitor serum electrolytes (including potassium, calcium, phosphorous and magnesium) prior to the initiation of treatment, at the beginning of the first 6 cycles, and as clinically indicated. Correct any abnormality before starting KISQALI therapy .

Avoid the use of KISQALI in patients who already have or who are at significant risk of developing QTc prolongation, including patients with:

Avoid using KISQALI with drugs known to prolong QTc interval and/or strong CYP3A inhibitors as this may lead to prolongation of the QTcF interval .

Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction or discontinuation as described in Table 4 .

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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