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

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

Indications

Palbociclib 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 for postmenopausal women or men with breast cancer;

Fulvestrant for patients with breast cancer whose disease has progressed following endocrine therapy.

Dosage and Administration

Palbociclib capsules are administered orally in combination with an aromatase inhibitor or fulvestrant.

Recommended starting dose: 125 mg taken orally once daily with food for 21 consecutive days, followed by a 7-day rest period.

Dose interruption and/or reduction are recommended based on individual safety and tolerability.

Use in Specific Populations

Lactation: Breastfeeding is not recommended.

Warnings and Precautions

Neutropenia: Monitor complete blood cell counts prior to initiating palbociclib therapy, at the start of each cycle, and on Day 15 of the first two cycles, as clinically indicated.

Embryo-Fetal Toxicity: Palbociclib can cause fetal harm. Inform patients of the potential risk to the fetus and advise the use of effective contraception.

Drug Interactions

CYP3A Inhibitors: Concomitant use of palbociclib with strong CYP3A inhibitors should be avoided. If coadministration with a strong inhibitor cannot be avoided, reduce the palbociclib dose.

CYP3A Inducers: Concomitant use of palbociclib with strong CYP3A inducers should be avoided.

CYP3A Substrates: When administered concomitantly with palbociclib, dosage reduction of sensitive CYP3A4 substrates with a narrow therapeutic index may be necessary.

Adverse Reactions

The most common adverse reactions (incidence ≥10%) are neutropenia, infection, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.

Contraindications

No specific contraindications have been identified.

Dosage Form

Capsules.

Storage

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