Kisqali LuciRibo Ribociclib tablets 200mg

Product Name: LuciRibo

Chinese Name: Ribociclib Tablets

English Name: Ribociclib Tablets

Specification: 200 mg/tablet; 21 tablets/box

[Indications]

LuciRibo is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with:

An aromatase inhibitor as initial endocrine-based therapy; or

Fulvestrant as initial endocrine-based therapy or for patients with disease progression following endocrine therapy in postmenopausal women or men.

[Dosage and Administration]

LuciRibo tablets are taken orally in combination with an aromatase inhibitor or fulvestrant. They may be taken with or without food.

Recommended Starting Dose: 600 mg taken orally once daily for 21 consecutive days, followed by 7 days off treatment.

Dose interruption, reduction, and/or discontinuation should be determined based on individual safety and tolerability.

[Contraindications] None.

[Warnings and Precautions]

Interstitial Lung Disease (ILD)/Pneumonitis: Patients receiving CDK 4/6 inhibitors should be monitored for pulmonary symptoms suggestive of ILD/pneumonitis. If a patient develops new or worsening respiratory symptoms suspected to be caused by ILD/pneumonitis, treatment should be interrupted and the patient evaluated. LuciRibo should be permanently discontinued in patients with recurrent symptomatic or severe ILD/pneumonitis.

Severe Cutaneous Adverse Reactions (SCAR): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) may occur during LuciRibo treatment. LuciRibo should be permanently discontinued in patients who experience SCAR or other life-threatening cutaneous reactions.

QT Interval Prolongation: Electrocardiograms (ECGs) and electrolytes should be monitored prior to initiating LuciRibo treatment. ECGs should be repeated around Day 14 of the first cycle and at the beginning of the second cycle, and as clinically indicated. During the first 6 cycles, monitor electrolytes at the beginning of each cycle, and monitor thereafter as clinically indicated. Avoid concomitant use of LuciRibo with drugs known to prolong the QT interval and/or with strong CYP3A inhibitors.

Concomitant use with Tamoxifen may result in QT interval prolongation; LuciRibo is not indicated for use in combination with Tamoxifen.

Hepatobiliary Toxicity: Elevated serum transaminase levels have been observed. Perform liver function tests (LFTs) prior to initiating treatment with LuciRibo. Monitor LFTs every 2 weeks during the first 2 cycles, at the beginning of every subsequent 4 cycles, and as clinically indicated.

Neutropenia: Perform a complete blood count (CBC) prior to initiating treatment with LuciRibo. Monitor CBCs every 2 weeks during the first 2 cycles, at the beginning of every subsequent 4 cycles, and as clinically indicated.

Embryo-Fetal Toxicity: May cause fetal harm. Advise women of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment.

[Adverse Reactions]

The most common adverse reactions (incidence ≥20%), including laboratory abnormalities, were leukopenia, neutropenia, decreased hemoglobin, lymphopenia, elevated aspartate aminotransferase (AST), elevated gamma-glutamyl transferase (GGT), elevated alanine aminotransferase (ALT), infections, nausea, elevated creatinine, fatigue, thrombocytopenia, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, back pain, and decreased serum glucose.

[Drug Interactions]

CYP3A4 Inhibitors: Avoid concomitant use of LuciRibo with strong CYP3A inhibitors. If concomitant use with a strong inhibitor cannot be avoided, reduce the dose of LuciRibo.

CYP3A4 Inducers: Avoid concomitant use of LuciRibo with strong CYP3A inducers. CYP3A Substrates: When used concomitantly with LuciRibo, a dose reduction may be required for sensitive CYP3A substrates with a narrow therapeutic index.

Drugs Known to Prolong the QT Interval: Avoid concomitant use of drugs known to prolong the QT interval, such as antiarrhythmic agents.

[Use in Specific Populations]

Lactation: Breastfeeding is not recommended.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.