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The recommended dose of Palbociclib is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib tablet may be taken with or without food.
Administer the recommended dose of an aromatase inhibitor when given with Palbociclib. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.
When given with Palbociclib, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.
Patients should be encouraged to take their dose of Palbociclib at approximately the same time each day.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. Palbociclib tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination Palbociclib plus an aromatase inhibitor or fulvestrant therapy should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.
For men treated with combination Palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards.
from FDA，2022.12
