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Palbociclib oral


Oral formulations of palbociclib.

Drugs List

  • IBRANCE 100mg film coated tablets
  • IBRANCE 125mg film coated tablets
  • IBRANCE 75mg film coated tablets
  • palbociclib 100mg film coated tablets
  • palbociclib 125mg film coated tablets
  • palbociclib 75mg film coated tablets
  • Therapeutic Indications


    Hormone receptor +ve, HER2 -ve locally advanced or metastatic breast cancer

    Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.
    In combination with an aromatase inhibitor.
    In combination with fulvestrant in women who have received prior endocrine therapy.
    In pre- or perimenopausal women, the endocrine therapy should be continued with a luteinizing hormone-releasing hormone (LHRH) agonist.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    The recommended dose is 125mg once daily for 21 days followed by 7 day rest period (28 day cycle).

    Patients with Hepatic Impairment

    Severe hepatic impairment
    The recommended dose is 75mg once daily for 21 days followed by 7 day rest period (28 day cycle).

    Additional Dosage Information

    Dose reductions for adverse reactions
    First reduction: 100mg per day
    Second reduction: 75mg per day
    If further dose reduction is required treatment should be discontinued.

    Haematological toxicities
    Grade 3, day 1 of cycle
    Withhold treatment until recovered to Grade 2 or below, resume treatment at same dose.
    Grade 3, day 15 of first 2 cycles
    Complete current cycle at current dose. Consider dose reduction if recovery takes more than 1 week or recurrent Grade 3 neutropenia occurs in subsequent cycles.
    Grade 3, Absolute neutrophil count (ANC) (500 to 1000 per cubic mm) with fever above 38.5 degrees C and/or infection
    Withhold treatment until recovery to Grade 2 or lower. Resume treatment at reduced dose.
    Grade 4
    Withhold treatment until recovery to Grade 2 or below. Resume treatment at reduced dose.

    Non-Haematological toxicities
    Grade 3 or higher
    Withhold treatment until recovery to Grade 1 (or Grade 2 if not considered a risk to patient). Resume treatment at reduced dose.

    Concomitant treatment with CYP3A4 inhibitors
    Strong CYP3A4 inhibitors may lead to increased toxicity, co-administration should therefore only be considered after evaluating the potential risks and benefits. If co-administration is unavoidable, reduce palbociclib dose to 75mg once daily. Following discontinuation (and 3 to 5 half lives) of the CYP3A4 inhibitor the dose of palbociclib should be increased to the level used prior to initiation of strong CYP3A4 inhibitor.

    Missed Doses
    If the patient vomits or a dose is missed, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time.


    Palbociclib tablets should be swallowed whole and taken with food to ensure consistent palbociclib exposure.


    Children under 18 years

    Precautions and Warnings

    Females of childbearing potential
    Glucose-galactose malabsorption syndrome
    Hepatic impairment - Child-Pugh score greater than 7
    Lactose intolerance
    Renal impairment - creatinine clearance below 60ml/minute

    Reduce dose in patients with severe hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Treatment to be initiated and supervised by a specialist
    Some formulations contain lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor blood count prior to each cycle and on day 15 of 1st and 2nd cycles
    Monitor for signs and symptoms of interstitial lung disease
    Monitor for signs and symptoms of pneumonitis
    Monitor full blood counts every 3 months
    Monitor patient for signs of serious infection
    Monitor patients with hepatic impairment for toxic effects
    Monitor patients with renal impairment for toxic effects
    Advise patient to report any symptoms of interstitial lung disease
    Advise patient to report incidences of fever
    Advise patients at risk of neutropenia to report any signs of infection
    Discontinue treatment if interstitial lung disease develops
    Suspend treatment if pneumonitis is suspected
    Discontinue if treatment related pneumonitis is diagnosed
    Suspend treatment and/or reduce dose if grade 3 or greater neutropenia
    Suspend treatment and/or reduce dose in grade 3 non-haematological toxicity
    Suspend treatment if interstitial lung disease is suspected
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products
    Female: Contraception required during and for 3 weeks after treatment
    Male: Contraception required during and for 14 weeks after treatment

    Pre/perimenopausal women who are administered this product in combination with an aromatase inhibitor must undergo ovarian suppression or ablation with an luteinizing hormone-releasing hormone (LHRH) agonist. This is due to the mechanism of action of aromatase inhibitors. In pre/perimenopausal women, the use of palbociclib with fulvestrant has only been studied in patients receiving an LHRH agonist.

    Pregnancy and Lactation


    Palbociclib is contraindicated during pregnancy.

    The manufacturer does not recommend using palbociclib during pregnancy. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Palbociclib is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking palbociclib. The presence of palbociclib in human breast milk and its effect on exposed infants are unknown.

    Side Effects

    Aphthous stomatitis
    Blurred vision
    Cutaneous lupus erythematosus
    Decrease in haemoglobin and haematocrit
    Decreased appetite
    Dry eyes
    Dry skin
    Febrile neutropenia
    Increase in serum ALT/AST
    Interstitial lung disease
    Mouth ulcers
    Mucosal inflammation
    Oral pain
    Reduced neutrophil count
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2021

    Reference Sources

    MHRA Drug Safety Update June 2021
    Available at:
    Last accessed: 18 August 2021

    Summary of Product Characteristics: Ibrance 75mg, 100mg, 125mg film-coated tablets. Pfizer Limited. Revised June 2021.

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