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Palbociclib Dosage

Applies to the following strength(s): 75 mg ; 100 mg ; 125 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Breast Cancer

28-day cycle: 125 mg orally once a day for 21 consecutive days followed by 7 days off treatment

Comments: Take with food in combination with letrozole 2.5 mg orally once a day throughout the 28-day cycle.

Use: In combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Adverse reactions:
-Starting dose: 125 mg orally once a day
-First dose reduction: 100 mg orally once a day
-Second dose reduction: 75 mg orally once a day
-Discontinue treatment if further dose reduction below 75 mg/day required

Hematologic Toxicities:
-Grade 1 or 2: No adjustment recommended
-Grade 3 (except lymphopenia unless associated with clinical events, e.g. opportunistic infections): Withhold initiation of next cycle until recovery to Grade 2 or below. Consider repeating complete blood count monitoring 1 week later.
-Grade 3 ANC (less than 1000 to 500/mm3) with Fever 38.5 degrees Celsius or higher and/or infection: Withhold drug and initiation of next cycle until recovery to Grade 2 or below (1000/mm3 or more). Resume at next lower dose upon restarting.
-Grade 4 (except lymphopenia unless associated with clinical events, e.g. opportunistic infections): Withhold drug and initiation of next cycle until recovery to Grade 2 or below (1000/mm3 or less). Resume at next lower dose upon restarting.

Non-Hematologic Toxicities:
-Grade 1 or 2: No adjustment recommended
-Grade 3 or higher (if persisting despite medical treatment): Withhold drug until symptoms resolve to Grade 1 or less, or Grade 2 or less if not considered a patient safety risk. Resume at next lower dose upon restarting.

Concomitant Use with Strong CYP450 3A Inhibitors:
-Avoid concomitant use if possible or reduce palbociclib dose to 75 mg orally once a day.
-If use of strong CYP450 3A inhibitor discontinued, increase palbociclib dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to initiation of the inhibitor.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be taken at approximately the same time each day.
-If a dose is missed, the next dose should be taken at the usual time without doubling up the dose.
-This drug should be swallowed whole; do not chew, crush, or open capsules.
-Drug capsules should not be ingested if broken, cracked, or otherwise not intact.

General:
-Accelerated FDA approval based on progression-free survival. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Monitoring:
-Hematologic: CBC (prior to treatment initiation, at beginning of each cycle, on Day 14 of first two cycles, and as clinically indicated)
-Infections/Infestations: Signs and symptoms of infection
-Respiratory: Signs and symptoms of pulmonary embolism

Patient advice:
-Avoid grapefruit, grapefruit juice, and grapefruit products during treatment.

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