Ribokis is identified on this website as a product containing 200 mg of ribociclib. The specific manufacturer, authorization holder and regulatory registration of the Ribokis-branded product require verification.
Ribociclib is a selective CDK4/6 inhibitor. By inhibiting these cell-cycle regulatory enzymes, ribociclib interferes with signaling required for progression of susceptible cells through the cell cycle.
Product identity
| Attribute | Information |
|---|---|
| Product | Ribokis |
| Generic name | Ribociclib |
| Active substance | Ribociclib |
| Stated strength | 200 mg |
| Dosage form | [Information requires verification] |
| Drug class | CDK4/6 inhibitor |
| Therapeutic category | Antineoplastic |
| Reference product | KISQALI |
| Reference-product developer | Novartis under collaboration with Astex Pharmaceuticals |
| Ribokis manufacturer | – |
The U.S. reference product KISQALI is supplied as 200 mg film-coated tablets.
Ribociclib and KISQALI
KISQALI is a branded ribociclib product developed by Novartis under a research collaboration with Astex Pharmaceuticals. The FDA records an initial U.S. approval in 2017.
The existence of a common active ingredient does not by itself establish that Ribokis and KISQALI are the same product. Product-specific formulation, manufacturer, authorization and packaging information should be verified independently.
What does 200 mg mean?
The 200 mg designation describes the strength of the tablet. Current U.S. labeling uses 200 mg tablets as building blocks for the approved ribociclib regimens.
Professional supervision
Ribociclib can cause neutropenia, liver toxicity and QT prolongation and requires laboratory and cardiac monitoring under the applicable prescribing information.