Ribociclib (KISQALI)

Breast Cancer advanced or metastatic hormone-receptor positive

Breast Cancer advanced or metastatic hormone-receptor positive

• Oral: 600 mg once daily on days 1 to 21 out of every 28 days until disease progression or unacceptable toxicity
• Given in combination with fulvestrant or a non-steroidal aromatase inhibitor

Available as 200 mg film-coated tablets as ribociclib succinate. Tablets should NOT be crushed or broken. Store at room temperature.

Cyclin-Dependent Kinase (CDK) 4/6 inhibitor

Take with or without food

If a dose is missed, patients should be instructed not to take the missed dose but to resume with the next scheduled dose.

Common: Anemia, Leukopenia, Neutropenia, ALT increase, QT prolongation.

Less Common: Febrile neutropenia, Hepatotoxicity, AST increase , Pulmonary embolism.

The adverse effects listed above are not exhaustive. Please refer to the relevant product monograph for full details.

Baseline before treatment: CBC & differential, platelets, creatinine, albumin, ALT, alkaline phosphatase, total bilirubin, sodium, potassium, calcium, magnesium, phosphorus, GGT, LDH, ECG.

During treatment: CBC & differential, platelets, creatinine, albumin, ALT, alkaline phosphatase, total bilirubin.

• Note: For first two cycles, also monitor sodium, potassium, calcium, magnesium, phosphorus, ECG, and check CBC & differential, platelets on day 15.

After cycle 7: Can reduce to monitoring CBC & differential, platelets, creatinine and extend to repeating every third cycle if no previous concerns with neutropenia.

If clinically indicated: albumin, ALT, alkaline phosphatase, total bilirubin, GGT, LDH, sodium, potassium, calcium, magnesium, phosphorus, CA15-3, ECG, serum cholesterol, triglycerides, CEA, CA125.

• May increase the risk for QT interval prolongation. Avoid concurrent therapy with drugs associated with QTc prolongation and/or Torsades de pointes, if possible. If unavoidable, monitor for QT prolongation or cardiac arrhythmias.
• This drug can impact or be impacted by metabolic enzymes for absorption and excretion. Many drugs can also affect or be affected by these enzymes, so please consult with pharmacy to assess for interactions.
• Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
• Current drug interaction databases should be consulted for more information.

• Avoid in pregnancy and lactation.
• Neutropenia is a common toxicity. The median duration of ≥ grade 3 neutropenia was 7 days. Febrile neutropenia and neutropenic sepsis have also been reported. Neutropenia is quickly reversible with cessation of ribociclib.

• Due to QT prolongation risk, correct electrolyte abnormalities prior to ribociclib treatment initiation
• Patients should administer dose preferably in the morning.
• Ribociclib treatment requires patients to be postmenopausal. Patients can be chemically induced into menopause with LHRH agonists.

BC Cancer. BC Cancer Drug Manual. Ribociclib. Vancouver, British Columbia: BC Cancer Agency. Available at:  http://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Ribociclib_monograph.pdf. Updated September 1, 2022. Accessed January 22, 2024.

Lexicomp. Ribociclib Monograph. In: Lexi-Drugs. Hudson, Ohio: Lexi-Comp, Inc. Available at: https://online-lexi-com.qe2a-proxy.mun.ca/lco/action/doc/retrieve/docid/patch_f/6447134?cesid=1Yt91gpH4WV&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Dribociclib%26t%3Dname%26acs%3Dtrue%26acq%3Dribociclib. Updated January 24, 2024. Accessed January 28, 2024.

Cancer Care Ontario. Ribociclib Monograph. Drug Formulary. Toronto, Ontario: Cancer Care Ontario. Available at: https://www.cancercareontario.ca/en/drugformulary/drugs/monograph/54136. Updated April 2021. Accessed January 22, 2024.

Novartis Pharmaceuticals Canada Inc. KISQALI® Product monograph. Dorval, Quebec. Updated February 10, 2023