NCCP 00525 · version 6

Ribociclib + endocrine therapy · metastatic

The usual metastatic starting dose is ribociclib 600 mg once daily on Days 1–21 followed by Days 22–28 off. Continue the prescribed AI daily or fulvestrant on its own injection schedule; add ovarian suppression when indicated. Continue while beneficial and tolerated.

Discussion aid: review with the patient and complete the approved local consent process.

Purpose and plan

□ Exact indication, treatment aim and uncertainty explained
□ Expected duration and review / switch points discussed
□ Alternatives and the option not to proceed discussed
□ Patient priorities, capacity and support needs explored

Practical safety

□ Medicine, route, schedule and missed-dose instructions
□ Menopause and ovarian-suppression requirements if relevant
□ Pregnancy, contraception / fertility and breastfeeding
□ Monitoring, symptom reporting and contact plan

Selected material risks

□ Low white cells and infection
□ Liver injury / abnormal blood tests
□ QT prolongation / heart-rhythm problems
□ Nausea, fatigue and hair thinning
□ Rare serious lung or skin reactions
□ Hot flushes, joint pain and fatigue
□ Bone loss with AI / ovarian suppression
□ Injection-site discomfort with fulvestrant
□ Drug-specific liver and other effects

Discuss the treatment aim, alternatives, benefit and uncertainty, important medicine-specific risks, reproductive precautions, symptom support and planned duration. Confirm the endocrine partner and any ovarian-suppression plan. The timeline does not authorise a restart or certify clinical review.

Individual benefit, alternatives and concerns

Agreed checks and next review

FBC, renal and liver profile, potassium, calcium, magnesium and phosphorus. ECG before initiation; QTcF must be below 450 ms. Correct electrolyte abnormalities and review QT/CYP3A interactions. Confirm endocrine partner, menopause/ovarian suppression, prior treatment and the NCCP indication/eligibility discrepancy. FBC, renal and liver profile every two weeks for cycles 1–2, then before cycles 3–6, then as clinically indicated. Electrolytes before each of the first six cycles, then as clinically indicated; correct abnormalities. Repeat ECG around Day 14 of cycle 1, then as clinically indicated. Increase liver monitoring for grade 2 or worse abnormalities. Review fever, jaundice, palpitations/fainting, pulmonary and severe skin symptoms; response imaging follows the advanced-disease plan.

Clinician / date: ____________________ Patient discussion documented: ____________________

Consent is an ongoing conversation and may be reconsidered. This aid is not treatment authorisation.