May 25, 2017
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Kisqali FeMara Co-Pack

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Kisqali FeMara Co-Pack

KISQALI®
(ribociclib) Tablets

FEMARA®
(letrozole) Tablets

DRUG DESCRIPTION

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 acid—7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl) pyridin-2-yl]amino}-7H-pyrrolo[2,3d]pyrimidine-6-carboxamide (1/1).

The molecular formula for ribociclib succinate is C23H30N8O.C4H6O4 and the molecular weight is 552.64 g/mole [Free base: 434.55 g/mol].

The chemical structure of ribociclib is shown below:

KISQALI® (ribociclib) Structural Formula Illustration

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, empirical formula C17H11N5, and a melting range of 184°C to 185°C.

The chemical name of letrozole is 4,4'-(1H-1,2,4-Triazol-1ylmethylene)dibenzonitrile, and its structural formula is

FEMARA® (letrozole) Structural Formula Illustration

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.

Last reviewed on RxList: 5/10/2017
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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