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Indications - Palbociclib is a kinase inhibitor indicated for the treatment of 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 Fulvestrant in women with disease progression following endocrine therapy.

Dosage & Administration - 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. Recommended Dose Modification for Adverse Reactions: Recommended Starting Dose: 125 mg/day First Dose Reduction: 100 mg/day Second Dose Reduction: 75 mg/day If further dose reduction below 75 mg/day is required, discontinue. Or, as directed by the registered physician. Use in Children: Palbociclib is not indicated for use in children.

Side Effects - Common side effects of Palbociclib include: WBC decreased, Neutrophils decreased, Neutropenia, Platelets decreased, infections, AST increased, ALT increased, Leukopenia, Fatigue, Nausea, Hair loss, Inflammation of the mouth and lips, Diarrhea, Anemia, Rash, Weakness/lethargy, Vomiting, Thrombocytopenia, Dry skin, Fever.

Contraindications - N/A

Others - 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.