Lucius Version of Ribociclib: Dosage and Administration, Indications, Precautions

Lucius Version of Ribociclib: Dosage and Administration, Indications, Precautions

Indication

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;

Fulvestrant as initial endocrine therapy or for postmenopausal women or men with disease progression following endocrine therapy.

Dosage and Administration

Ribociclib tablets can be taken orally together with an aromatase inhibitor or fulvestrant, either with food or on an empty stomach.

Recommended starting dose: 600 mg taken orally once daily, continuously for 21 days, followed by a 7-day drug-free period.

Decisions on whether to interrupt, reduce, and/or discontinue treatment should be based on individual safety and tolerability.

Use in Specific Populations

Lactation: Breastfeeding is not recommended.

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, discontinue the drug and conduct an evaluation. For patients with recurrent symptomatic or severe ILD/pneumonitis, permanently discontinue LuciRibo.

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 treatment with LuciRibo. Permanently discontinue LuciRibo in patients who develop SCAR or other life-threatening cutaneous reactions.

QT Interval Prolongation: Before initiating treatment with LuciRibo, monitor electrocardiogram (ECG) and electrolytes. Repeat ECG approximately on Day 14 of the first cycle and at the start of the second cycle, and perform additional monitoring based on clinical indications. During the 6 cycles, monitor electrolytes at the start of each cycle and as clinically indicated. Avoid concurrent use of LuciRibo with drugs known to prolong the QT interval and/or strong CYP3A inhibitors.

QT Interval Prolongation with Concomitant Tamoxifen Use: LuciRibo is not indicated for concurrent use with tamoxifen.

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

Neutropenia: Perform a complete blood count (CBC) before initiating treatment with LuciRibo. Monitor CBC every 2 weeks during the first 2 cycles, at the start of every 4 subsequent cycles, 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.

Drug Interactions

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

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

CYP3A Substrates: When used concomitantly with LuciRibo, dose reduction of sensitive CYP3A substrates with a narrow therapeutic index may be necessary.

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

Adverse Reactions

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

Contraindications

No specific contraindications have been identified.

Dosage Form

Tablets.

Storage

Store at 20°C to 25°C (68°F to 77°F), with short-term transport permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.