Ribociclib

Ribociclib was developed by Novartis AG in Switzerland. The drug specifications produced by Lucius are 200mg * 21pills.

After years of research and development, Ribociclib has shown significant efficacy and acceptable safety in clinical trials.

Ribociclib can be used in combination with other chemotherapy drugs or targeted drugs to enhance therapeutic efficacy.

1.Main components

Ribociclib

2.Adapt to the population

Adult patients with certain types of breast cancer.

3.Medication for special populations

3.1Pregnancy

Based on findings from animal studies and the mechanism of action, Ribociclib can cause fetal harm when administered to a  pregnant woman.

3.2Lactation

It is not known if ribociclib is present in human milk. There are no data on the effects of ribociclib on the breastfed infant or  on milk production. Ribociclib and its metabolites readily passed into the milk of lactating rats. Because of the potential for  serious adverse reactions in breastfed infants from Ribociclib, advise lactating women not to breastfeed while taking  Ribociclib and for at least 3 weeks after the last dose.

3.3Females and Males of Reproductive Potential

 Based on animal studies and mechanism of action, Ribociclib can cause fetal harm when administered to a pregnant woman.

Females

Advise females of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with Ribociclib and for at least 3 weeks after the last dose.  

Males

Based on animal studies, Ribociclib may impair fertility in males of reproductive potential.

3.4Pediatric Use

The safety and efficacy of Ribociclib in pediatric patients has not been established.

3.5Geriatric Use

Of the 2549 adults with early breast cancer who received Ribociclib in NATALEE, 407 patients (16%) were ≥ 65 years of age and 123 patients (2.4%) were > 75 years of age. No overall differences in safety or effectiveness of Ribociclib were  observed between older and younger adults with early breast cancer.

3.6Hepatic Impairment

No dose adjustment is necessary in patients with breast cancer who have mild hepatic impairment (Child-Pugh class A). A reduced starting dose of 400 mg is recommended in patients with advanced or metastatic  breast cancer who have moderate (Child-Pugh class B) and severe hepatic impairment (Child-Pugh class C).

3.7Renal Impairment

No dose adjustment is necessary in patients with breast cancer who have mild to moderate (30 mL/min to 89 mL/min/1.73  m2 ≤ estimated glomerular filtration rate (eGFR)) renal impairment. A reduced starting dose of 200 mg is recommended in patients with breast cancer who have severe renal impairment.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store refrigerated at 2°C to 8°C (36°F to 46°F). Excursions permitted between 2°C and 15°C (36°F and 59°F).

6.Pharmacokinetics

The Tmax following Ribociclib administration was between 1 and 4 hours. The mean absolute bioavailability of ribociclib  after a single oral dose of 600 mg was 65.8%.

from FDA，2024.09