All the Active Ingredient Drugs
Protein Kinase Inhibitor. Ribociclib Succinate 200 mg. F.C.TABS.: 21,42, 63.
The recomm. dose is 600 mg (3 tabs. ×1/d) for 21 consecut. days follow. by 7 days off tmt., result. in a complete cycle of 28 d. The tmt. should be cont. as long as the pt. is deriving clinic. benefit from ther. or until unacceptab. toxicity occurs.
The drug should be used together with 2.5 mg letrozole or another non steroidal aromatase inhib. The non steroid. aromatase inhib. should be taken oral. once dly. contin. throughout the 28-d. cycle.
In comb with fulvestrant: fulvestrant is admin. IM on 1st , 15th and 29th day , and once mnthly. thereafter.
Tmt. of pre- and perimenopaus. women with the approved Ribociclib comb. should also includ. an LHRH agon. in accordance with local clin. practice.
Pts. should be encouraged to take their dose at approx. the same time each day, prefer. in the morn. If the pt. vomits after taking the dose/ misses a dose, an addit. dose should not be taken that day. The next prescrib. dose should be taken at the usual time. See lit.
ECG should be assessed before initiating tmt. with this drug.
Tmt. should be initiated only in pts. with QTcF values less than 450 msec.
After initiating tmt., ECG should be repeated at approx. day 14 of the first cycle, then as clinically indicated. In case of QTcF prolong. during tmt. more frequent ECG monitoring is recommended.
In comb. with a non steroidal aromatase inhib. for the tmt. of postmenopaus. women with hormone receptor (HR)-posit. ,human epiderm. growth factor receptor 2 (HER2)-negative local. advanc. or metastat. breast cancer as initial endocr.-based ther.
Also in comb. with fulvestrant for the tmt. of men and postmenopaus. women with HR-posit., HER2-neg., advanc./ metastat. breast cancer, as initial endocrine-based ther. or follow. dis. progress. on endocrine ther.
C/I:Hypersens.
