Palbociclib INN 125 mg
Composition: Each capsule contains Palbociclib INN 125 mg capsule.
Palbociclib 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 in postmenopausal women or in men; or • Fulvestrant in patients with disease progression following endocrine therapy.
Dosage & Administration: Recommended Dose and Schedule: The recommended dose of Palbociclib 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. Palbociclib should be taken with food. Patients should be encouraged to take their dose of Palbociclib at approximately the same time each day. For men treated with combination Palbociclib plus aromatase inhibitor therapy, consider treatment with an LHRH agonist according to current clinical practice standards. Or, as directed by the registered physician.
Use in Pregnancy & Lactation: Palbociclib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Packaging: Each box contains
21capsules in a blister pack.