Kryxana

Ribociclib

In combination w/ aromatase inhibitor as initial endocrine-based therapy for pre/peri- or postmenopausal women or men w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer. In combination w/ fulvestrant as initial endocrine-based or following disease progression therapy for postmenopausal women or men w/ HR +ve, HER2 -ve advanced or metastatic breast cancer.

Adult 600 mg once daily for 21 consecutive days followed by 7 days off-treatment to complete 28-day cycle. Concomitant use w/ strong CYP3A inhibitors Reduce dose to 400 mg once daily. Severe renal impairment Initially 200 mg once daily. Moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment Initially 400 mg once daily.

May be taken with or without food: Take at approx the same time each day, preferably in the morning. Swallow whole, do not chew/crush/split.

Hypersensitivity to ribociclib, peanut or soya.

Permanently discontinue use in recurrent symptomatic or severe ILD/pneumonitis; SJS, TEN or drug-induced hypersensitivity syndrome/DRESS is confirmed. Interrupt dose if new or worsening resp symptoms suspected due to ILD/pneumonitis; severe cutaneous reactions occur. Avoid use in patients w/ or at significant risk of developing Torsade de pointes including those w/ congenital long QT syndrome, uncontrolled or significant cardiac disease, recent MI, heart failure, unstable angina, bradyarrhythmias, uncontrolled HTN & hypothyroidism, high degree AV block, severe aortic stenosis & electrolyte abnormalities. Neutropenia. Monitor serum electrolytes eg, K, Ca, P & Mg prior to & beginning of 1st 6 cycles. Perform ECG prior to initiation & repeat at approx day 14 of 1st cycle; LFTs & CBC before initiation & monitor every 2 wk for 1st 2 cycles, beginning of each subsequent 4 cycles & as clinically indicated. Avoid drugs prolonging QT interval &/or strong CYP3A inhibitors. Avoid use w/ tamoxifen. Breast cancer patients w/ severe renal impairment. Drug-induced liver injury & increased transaminases. May impair male fertility. Women of childbearing potential should use effective contraception during & for at least 3 wk after last dose. Pregnancy. Not to be used during lactation & for at least 3 wk after last dose. Ped.

Decreased leukocytes, neutrophils, Hb, lymphocytes, platelets & serum glucose, increased AST, ALT, γ-glutamyl transferase & creatinine, infections, nausea, fatigue, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, backpain.

Increased exposure w/ strong CYP3A inhibitors. Decreased plasma exposure w/ strong CYP3A inducers. Increased exposure of sensitive CYP3A4 substrates. Prolonged QT interval w/ antiarrhythmics, QT interval-prolonging drugs.

Targeted Cancer Therapy

L01EF02 - ribociclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.

B