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PALBOXEN Capsule :Each capsule contains Palbociclib INN 125 mg.
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.
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.
The following clinically significant adverse reactions are: