palbociclib 125 mg
1 INDICATIONS AND USAGE IBRANCE is 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; or • fulvestrant in patients with disease progression following endocrine therapy. IBRANCE 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 ( 1) ; or • fulvestrant in patients with disease progression following endocrine therapy. ( 1 )
US Pharmaceuticals
OVAL PURPLE Pfizer PBC 125
Pfizer PBC 125 OVAL PURPLE
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16 HOW SUPPLIED/STORAGE AND HANDLING IBRANCE is supplied in the following strengths and package configurations: IBRANCE Tablets Package Configuration Tablet Strength (mg) NDC Tablet Description Monthly box containing 3 weekly blister packs of 7 tablets each (21 tablets total) 125 NDC 0069-0688-03 oval, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 125" on the other side. Monthly box containing 3 weekly blister packs of 7 tablets each (21 tablets total) 100 NDC 0069-0486-03 oval, green, film-coated tablets debossed with "Pfizer" on one side and "PBC 100" on the other side. Monthly box containing 3 weekly blister packs of 7 tablets each (21 tablets total) 75 NDC 0069-0284-03 round, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 75" on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Store in the original blister pack.
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