Palbobrest® (Palbociclib)

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Capsule 75- 100 - 125 mg

Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation.

INDICATIONS

PALBOBREST 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

• Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment.

• Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability.

WARNINGS AND PRECAUTIONS

• Neutropenia: Monitor complete blood count prior to start of PALBOBREST therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.

• Embryo-Fetal Toxicity: PALBOBREST can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

DRUG INTERACTIONS

Some of major drug interactions include:

• CYP3A Inhibitors (Ciprofloxacin, Clarithromycin Fluconazole, Voriconazole, Itraconazole, Ketokonazol, Lopinavir/Ritonavir, Nelfinavir, …). If the strong inhibitor cannot be avoided, reduce the PALBOBREST dose.

• CYP3A Inducers (Phenytoin, Rifampin, Carbamazepine, Enzalutamide, and St John’s Wort) may decrease PALBOBREST plasma concentrations.

• CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices (Midazolam, Alfentanil, Cyclosporine, Dihydroergotamine, Ergotamine, Everolimus, Fentanyl, Pimozide, Quinidine, Sirolimus, and Tacrolimus) may need to be reduced when given concurrently with PALBOBREST.

Palbobrest

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