KISQALI (Ribociclib)

What is this medication?

KISQALI (Ribociclib)
Antineoplastic Agent, Cyclin-Dependent Kinase Inhibitor

KISQALI (Ribociclib) is indicated for the treatment of advanced or metastatic breast cancer.

How does this medication work? 

KISQALI (Ribociclib) is a small molecule selective cyclin-dependent kinase (CDK) inhibitor for CDK 4 and 6.   It blocks phosphorylation of retinoblastoma protein and prevents cell cycle progression, resulting in arrest at the G1 phase.

How should I take this medication?

Oral: Take 600 mg once daily for 21 days, followed by a 7-day rest period to complete a 28-day treatment cycle.  Continue until disease progression or unacceptable toxicity.

How to Take: May be administered with or without food. Administer at approximately the same time each day, preferably in the morning. Ribociclib is associated with a moderate to high emetic potential, so antiemetics are recommended to prevent nausea and vomiting. Swallow tablets whole. Do not crush, chew, or split tablets (do not ingest broken or cracked tablets). Avoid grapefruit and grapefruit juice.

What should I watch for while using this medication? 

Before starting KISQALI (Ribociclib) make sure your physician is aware of any allergies or medications you currently take, if you have renal impairment, hepatic impairment, are pregnant, or breastfeeding. Ribociclib use has been associated with rare but serious adverse events such as bone marrow suppression, dermatologic toxicity, GI toxicity, hepatobiliary toxicity, pulmonary toxicity, and QT prolongation.  Monitor electrocardiograms (ECGs) and electrolytes prior to initiation of treatment with KISQALI. 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.  Check for hepatobiliary toxicity by performing Liver Function Tests (LFTs) before initiating treatment with Ribociclib. Monitor LFTs every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated.  Perform Complete Blood Count (CBC) before initiating therapy with Ribociclib. Monitor CBC every 2 weeks for the first 2 cycles, at the beginning of each subsequent 4 cycles, and as clinically indicated.

What if I miss a dose?

If a dose is missed or vomited, do not administer an additional dose that day. Resume usual dosing with the next scheduled dose.

How should I store this medication?

Keep out of the reach of children at all times.  Store at room temperature, 59 to 86° F (15 to 30° C).  Protect from light.  Keep the container tightly closed.  Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

Peripheral edema, alopecia, pruritus, skin rash, decreased serum albumin, decreased serum glucose, decreased serum phosphate, decreased serum potassium, increased gamma-glutamyl transferase, abdominal pain, constipation, decreased appetite, diarrhea, gastroenteritis, nausea, stomatitis, vomiting, urinary tract infection, anemia, leukopenia, lymphocytopenia, neutropenia, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum bilirubin, infection, dizziness, fatigue, headache, insomnia, arthralgia, asthenia, back pain, increased serum creatinine, cough, dyspnea, respiratory tract infection, fever.

Note this is not a complete list of side effects for KISQALI (Ribociclib), only common ones.