Ribociclib tablets 200mg/tablet, 21 tablets/box

Medication Safety Tips

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Contraindications

Warnings and Precautions
• Interstitial lung disease (ILD)/pneumonia: Patients treated with CDK 4/6 inhibitors should be monitored for lung symptoms suggestive of ILD/pneumonia. If the patient develops new or worsening respiratory symptoms, suspected to be caused by ILD/pneumonia, medication should be interrupted and evaluated. LuciRibo should be permanently discontinued for patients with recurrent symptomatic or severe ILD/pneumonia.
• Serious skin adverse reactions (scar): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (ten), and drug reactions with eosinophilia and systemic symptoms (dress) may occur with LuciRibo treatment. LuciRibo should be permanently discontinued for patients with scar or other life-threatening skin reactions.
• Prolonged QT interval: electrocardiogram (ECG) and electrolytes should be monitored before starting treatment with LuciRibo. Electrocardiograms are repeated around day 14 of the first cycle and at the beginning of the second cycle and as clinically indicated. Electrolytes are monitored at the beginning of each cycle over 6 cycles and as clinically indicated. Avoid LuciRibo with medications known to prolong the QT interval and/or potent CYP3A inhibitors.
• concomitant use with Tamoxifen results in prolonged QT intervals: LuciRibo is not indicated for concomitant use with Tamoxifen.
• Hepatobiliary toxicity: Increased serum transaminase levels have been observed. Before starting LuciRibo treatment, perform a liver function test (LFT). LFT is monitored every 2 weeks for the first 2 cycles and every 4 cycles thereafter and as clinically indicated.
• Neutropenia: Complete blood count (CBC) should be performed before starting treatment with LuciRibo. The CBC is monitored every 2 weeks for the first 2 cycles and every 4 cycles thereafter and as clinically indicated.
• Embryo-fetal toxicity: May cause harm to the fetus. Women of childbearing potential are advised to be aware of the potential risks to the fetus and to use effective contraception during treatment.

Medication risks

Adverse Reactions
The most common (incidence ≥ 20%) adverse reactions, including laboratory abnormalities, are leukopenia, neutropenia, hemoglobin decreased, lymphopenia, aspartate aminotransferase increased, gamma-glutamyltransferase increased, alanine aminotransferase increased, infection, nausea, creatinine increased, fatigue, thrombocytopenia, diarrhea, vomiting, headache, constipation, hair loss, cough, rash, backache, and serum glucose decreased.