Zalcocib

Palbociclib capsules for oral administration contain

• 125 mg
• 100 mg
• 75 mg palbociclib

Palbociclib is a kinase inhibitor.

Molecular formula

C24H29N7O2

Molecular weight

447.54 daltons

Chemical name

6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one

Palbociclib is a yellow to orange powder.

At or below pH 4, palbociclib behaves as a high-solubility compound.

Above pH 4, the solubility reduces significantly.

Palbociclib is indicated for treatment of adult patients with hormone receptor (HR)-positive, 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.

Palbociclib is an oral medicine used to treat specific types of breast cancer in adults.

It is used in combination with

• Aromatase inhibitors
• Fulvestrant

Palbociclib is a targeted therapy which blocks CDK4 and CDK6 enzymes important for cell division.

Blocking these proteins helps slow down cancer cell growth.

• Based on mechanism of action, palbociclib can cause fetal harm.

• Females of reproductive potential should use effective contraception:
• during treatment
• for at least 3 weeks after last dose

• Palbociclib may impair fertility in males.

• Has potential to cause genotoxicity.

Recommended dose

• 125 mg once daily for 21 consecutive days
• Followed by 7 days off treatment
• This forms a complete 28-day cycle

Treatment should continue

• As long as patient derives clinical benefit
• Until unacceptable toxicity occurs

When coadministered with palbociclib

• Aromatase inhibitor should be administered according to recommended schedule

For pre/perimenopausal women

• Combination therapy with palbociclib plus aromatase inhibitor should always be combined with an LHRH agonist.