Indications & Dose:

Indicated in combination with: · an aromatase inhibitor for the treatment of pre/ perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer, as initial endocrine-based therapy or · fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

DOSAGE AND ADMINISTRATION l

• BY MOUTH

with or without food in combination with an aromatase inhibitor or fulvestrant. · Recommended starting dose: 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment. · Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability

Contraindications:

None

Cautions:

Precautions:

QT interval prolongation: Monitor electrocardiograms (ECGs) and electrolytes prior to initiation of treatment with Ribocicilib. Repeat ECGs at approximately Day 14 of the first cycle and at the beginning of the second cycle, and as clinically indicated. Monitor electrolytes at the beginning of each cycle for 6 cycles, and as clinically indicated. Avoid using ibocicilib with drugs known to prolong QT interval and/or strong CYP3A inhibitors. · Increased QT Prolongation with Concomitant Use of Tamoxifen: Ribocicilib is not indicated for concomitant use with tamoxifen. · Hepatobiliary Toxicity: Increases in serum transaminase levels have been observed. Perform Liver Function Tests (LFTs) before initiating treatment with ibocicilib. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. · Neutropenia: Perform Complete Blood Count (CBC) before initiating therapy with Ribocicilib. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated. · Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception during therapy. 

Interaction:

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Most common adverse reactions : neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, rash and cough

Patient And Carer Advice: