Ribociclib

The Basics

What is Ribociclib?

Used along with an aromatase inhibitor to treat women with advanced hormone receptor-positive breast cancer.

Brand names for Ribociclib

Kisqali

How Ribociclib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors

Ribociclib During Pregnancy

Ribociclib pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ribociclib while pregnant

Based on findings from animal studies and the mechanism of action, KISQALI can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no available human data informing the drug-associated risk. In animal reproduction studies, administration of ribociclib to pregnant animals during organogenesis resulted in increased incidences of postimplantation loss and reduced fetal weights in rats and increased incidences of fetal abnormalities in rabbits at exposures 0.6 or 1.5 times the exposure in humans, respectively, at the highest recommended dose of 600 mg/day based on AUC (see Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies in the U.S. general population.

Taking Ribociclib While Breastfeeding

What are recommendations for lactation if you're taking Ribociclib?

No information is available on the clinical use of ribociclib during breastfeeding. Because protein binding of ribociclib is 70%, clinically important amounts of the drug might pass into breastmilk. The manufacturer recommends that breastfeeding be discontinued during ribociclib therapy and for at least 3 weeks after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of ribociclib during breastfeeding. Because protein binding of ribociclib is 70%, clinically important amounts of the drug might pass into breastmilk. The manufacturer recommends that breastfeeding be discontinued during ribociclib therapy and for at least 3 weeks after the final dose.

Possible effects of Ribociclib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ribociclib

None listed