INDICATION AND USAGE 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 in postmenopausal women or in men; or ⚫ fulvestrant in patients with disease progression following endocrine therapy. PHARMACOLOGY Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of multiple signalling pathways which lead to cellular proliferation. DOSAGE AND ADMINISTRATION The recommended dose of PALBOXEN is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. PALBOXEN should be taken with food. Administer the recommended dose of an aromatase inhibitor when given with PALBOXEN. Please refer to the Full Prescribing Information for the aromatase inhibitor being used..

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