Riboxil is 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

LuciRibo simple instructions

Please use under the guidance of a physician

Product Name: LuciRibo

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Riboxil tablets

English name: Ribociclib tablets

Drug approval number: 09 L 1191/24

 

【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 therapy; or

• Fulvestrant as initial endocrine therapy or for postmenopausal women or men whose disease has progressed after endocrine therapy.

 

【Usage and Dosage】

LuciRibo tablets can be taken orally with an aromatase inhibitor or fulvestrant, with or without food.

• Recommended starting dose: 600 mg orally once daily for 21 consecutive days, followed by a 7-day break.

• Decide whether to interrupt, reduce, and/or discontinue medication based on individual safety and tolerability.

 

【Specification】

200 mg/tablet, 21 tablets/box.

 

【 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 due to ILD/pneumonitis, the drug should be withheld and evaluated. LuciRibo should be permanently discontinued in patients with recurrent symptomatic or severe ILD/pneumonitis.

• Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) may occur with LuciRibo treatment. LuciRibo should be permanently discontinued in patients who develop SCARs or other life-threatening cutaneous reactions.

• QT Interval Prolongation: Monitor electrocardiogram (ECG) and electrolytes prior to initiating treatment with LuciRibo. Repeat ECG around day 14 of the first cycle and at the start of the second cycle, and as clinically indicated. Monitor electrolytes at the start of each cycle for 6 cycles, and as clinically indicated. Avoid use of LuciRibo with drugs known to prolong the QT interval and/or strong CYP3A inhibitors.

• Concomitant use with Tamoxifen may cause QT prolongation: LuciRibo is not indicated for concomitant use 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 start of every 4 cycles thereafter, and as clinically indicated.

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

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

 

【Adverse Reactions】

The most common (incidence ≥ 20%) adverse reactions, including laboratory abnormalities, were leukopenia, neutropenia, hemoglobin decrease, lymphocytopenia, aspartate aminotransferase increase, gamma-glutamyltransferase increase, alanine aminotransferase increase, infection, nausea, creatinine increase, fatigue, thrombocytopenia, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, back pain, and serum glucose decrease.

【Drug Interactions】

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

• CYP3A4 Inducers: Avoid concomitant use of LuciRibo with strong CYP3A inducers.

• CYP3A Substrates: Dose reduction of sensitive CYP3A substrates with narrow therapeutic indices may be necessary when used concomitantly with LuciRibo.

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

 

【Use by specific groups】

Lactation: Breastfeeding is not recommended.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.