Kisqali Tablets / Film-coated
Ribociclib
200mg
NOVARTIS PHARMACEUTICALS CORPORATION
| Pack size | 63's (21's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 25634.50 AED |
Indications
Kisqali Tablets / Film-coated is used for:
Hormone receptor positive, HER2-negative locally advanced carcinoma of breast, Hormone receptor positive, HER2-negative metastatic carcinoma of breast
Adult Dose
Oral
Hormone receptor positive, HER2-negative locally advanced carcinoma of breast, Hormone receptor positive, HER2-negative metastatic carcinoma of breast
Adult: In combination with an aromatase inhibitor, or in combination with fulvestrant in postmenopausal women: 600 mg once daily preferably in the morning for 21 days followed by 7-days off to complete 28 days cycle.
Pre/perimenopausal women should be treated with luteinising hormone-releasing hormone (LHRH) agonist. Dose reduction, dosing interruption, or discontinuation may be required according to individual safety or tolerability.
Management of adverse reactions adjustment:1st reduction: 400 mg once daily; 2nd dose: 200 mg once daily; discontinue if dose reduction below 200 mg once daily is required.
Hepatic impairment
Mild (Child-Pugh A): No dose adjustment required
Moderate-to-severe (Child-Pugh B or C): Reduce starting dose to 400 mg/day
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl ?30 mL/min): No dose adjustment necessary
Severe (CrCl 15-30 mL/min): Decrease starting dose to 200 mg/day
Only studied healthy subjects and noncancer subjects with severe renal impairment
Administration
May be taken with or without food.
Contra Indications
Pregnancy and lactation.
Precautions
Severe renal and hepatic impairment.
Pregnancy-Lactation
Pregnancy
There are no available human data informing the drug-associated risk
Based on findings from animal studies and the mechanism of action, can cause fetal harm when administered to a pregnant woman
In animal reproduction studies, administration 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
Infertility: Based on animal studies, may impair fertility in males
Contraception
Females of reproductive potential should have a pregnancy test prior to starting treatment
Females: Advise females of reproductive potential to use effective contraception (methods that result in <1% pregnancy rates) during treatment and for at least 3 weeks after the last dose
Lactation
Unknown if distributed in human breast milk
Because of the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed while taking ribociclib and for at least 3 weeks after the last dose
In lactating rats administered a single dose of 50 mg/kg, exposure to ribociclib was 3.56-fold higher in milk compared to maternal plasma
Interactions
Increased risk of QT prolongation with antiarrhythmic drugs (e.g. amiodarone, disopyramide) and other drugs which are known to prolong QT interval (e.g. chloroquine, bepridil, pimozide, moxifloxacin, tamoxifen). May increase the plasma concentration and risk of toxicity with strong CYP3A4 inhibitors (e.g. clarithromycin, indinavir, itraconazole, nefazodone) and increase plasma concentration of CYP3A4 substrates (e.g. ergotamine, quinidine, cisapride). May decrease efficacy with CYP3A4 inducers (e.g. phenytoin, rifampicin, carbamazepine).
Adverse Effects
Side effects of Ribociclib :
>10%
Neutropenia (75%)
Nausea (52%)
Neutropenia, grade 3 (50%)
Fatigue (37%)
Diarrhea (35%)
Leukopenia (33%)
Alopecia (33%)
Vomiting (29%)
Constipation (25%)
Headache (22%)
Leukopenia, grade 3 (20%)
Back pain (20%)
Decreased appetite (19%)
Anemia (18%)
Abnormal LFTs (18%)
Rash (17%)
Pruritus (14%)
Pyrexia (13%)
Peripheral edema (12%)
Stomatitis (12%)
Insomnia (12%)
Dyspnea (12%)
Lymphopenia (11%)
Urinary tract infection (11%)
Abdominal pain (11%)
1-10%
Neutropenia, grade 2 (10%)
Mechanism of Action
Ribociclib selectively inhibits cyclin-dependent kinases (CDK) 4 and 6 which are involved in cell proliferation. The interaction between cyclin D and CDK 4 and 6 is blocked, preventing the phosphorylation of tumour suppressor protein retinoblastoma and the progression of cell cycle from G1 into S phase thereby inhibiting cancer cell growth.
Note
Kisqali 200mg Tablets / Film-coated manufactured by NOVARTIS PHARMACEUTICALS CORPORATION. Its generic name is Ribociclib. Kisqali is availble in United Arab Emirates.
Farmaco UAE drug index information on Kisqali Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.