Palbociclib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of palbociclib.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
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.
Administration
Palbociclib tablets should be swallowed whole and taken with food to ensure consistent palbociclib exposure.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Females of childbearing potential
Galactosaemia
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
Pregnancy
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.
Lactation
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
Alopecia
Anaemia
Aphthous stomatitis
Asthenia
Blurred vision
Cheilitis
Cutaneous lupus erythematosus
Decrease in haemoglobin and haematocrit
Decreased appetite
Dermatitis
Diarrhoea
Dry eyes
Dry skin
Dysgeusia
Epistaxis
Fatigue
Febrile neutropenia
Glossitis
Glossodynia
Increase in serum ALT/AST
Infections
Interstitial lung disease
Lacrimation
Leucopenia
Mouth ulcers
Mucosal inflammation
Nausea
Neutropenia
Oral pain
Pneumonitis
Pyrexia
Rash
Reduced neutrophil count
Stomatitis
Thrombocytopenia
Vomiting
White blood cell count decreased
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2021
Reference Sources
MHRA Drug Safety Update June 2021
Available at: https://www.mhra.gov.uk
Last accessed: 18 August 2021
Summary of Product Characteristics: Ibrance 75mg, 100mg, 125mg film-coated tablets. Pfizer Limited. Revised June 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.