COMPOSITION

Each capsule of WEBACE contains Palbociclib 125 mg/ 100 mg / 75 mg for oral use.

CONTRAINDICATIONS

None.

DOSAGE AND ADMINISTRATION

Webace capsules are taken orally with food in combination with an aromatase inhibitor or Fulvestrant. Recommended starting dose: 125 mg once daily, taken with food for 21 days followed by 7 days off treatment.

INDICATION

Palbociclib is a CDK 4/ 6 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 (1.) an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men (2.) Fulvestrant in patients with disease progression following endocrine therapy.

WARNINGS AND PRECAUTIONS

Neutropenia: Monitor complete blood count prior to the start of WEBACE therapy and at the beginning of each cycle, as well as on Day 15 of the first two cycles, and as clinically indicated. Embryo-Fetal Toxicity: WEBACE can cause fetal harm.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhoea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia.

DRUG INTERACTIONS

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

2.CYP3A Inducers: Avoid concurrent use of WEBACE with strong CYP3A inducers.

3.CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with WEBACE.