(Most critical safety information)
Severe neutropenia is very common and is the main dose-limiting toxicity → regular full blood count monitoring is essential.
Infections, including serious and fatal infections, have been reported due to neutropenia.
Febrile neutropenia can occur and requires urgent medical attention.
Interstitial lung disease (ILD) / pneumonitis, including fatal cases, has been reported → new or worsening cough or shortness of breath requires prompt evaluation and treatment interruption.
Strong CYP3A inhibitors and inducers significantly affect palbociclib levels → avoid or adjust dosing.
Not safe in pregnancy or breastfeeding → effective contraception required.
Swallow capsules whole — do not crush, chew, or open.
Generic name: Palbociclib
Drug class: Cyclin-dependent kinase (CDK) 4/6 inhibitor
Formulation: Hard capsules
Strengths: 75 mg, 100 mg, 125 mg
Route: Oral
Scheduling status: S4
Hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer
In combination with an aromatase inhibitor as initial endocrine-based therapy
In combination with fulvestrant in patients with disease progression following endocrine therapy
Premenopausal or perimenopausal women require ovarian suppression
125 mg once daily
Taken for 21 consecutive days, followed by 7 days off (28-day cycle)
Take with food
Take at the same time each day
If a dose is missed or vomited, do not replace the dose
Starting dose: 125 mg once daily
First reduction: 100 mg once daily
Second reduction: 75 mg once daily
If further reduction required: discontinue treatment
Grade 3: withhold until recovery, then resume at same or reduced dose
Grade 4 or recurrent Grade 3: withhold until recovery and resume at reduced dose
Must be used in combination with endocrine therapy:
Aromatase inhibitor or
Fulvestrant
GnRH agonist required in pre- or perimenopausal women
Hypersensitivity to palbociclib or excipients
Pregnancy
Breastfeeding
FBC:
Baseline
Day 1 and Day 15 of the first 2 cycles
Day 1 of subsequent cycles
As clinically indicated
Signs of infection or fever
Respiratory symptoms suggestive of ILD/pneumonitis
General tolerability and fatigue
Neutropenia
Leukopenia
Fatigue
Infections
Nausea
Stomatitis
Alopecia
Diarrhoea
Thrombocytopenia
Anaemia
Rash
Decreased appetite
Vomiting
Asthenia
Febrile neutropenia
Interstitial lung disease / pneumonitis
Severe infections
CYP3A inhibitors (e.g. clarithromycin, ketoconazole): increase palbociclib exposure → dose reduction required
CYP3A inducers (e.g. rifampicin, carbamazepine): reduce efficacy → avoid
Grapefruit and grapefruit juice: avoid
Pregnancy: Contraindicated
Breastfeeding: Contraindicated
Hepatic impairment: Use with caution
Renal impairment: No adjustment required in mild to moderate impairment
Men: May impair fertility
Continue treatment until:
Disease progression, or
Unacceptable toxicity
Permanently discontinue if:
Recurrent severe neutropenia despite dose reductions
Confirmed ILD/pneumonitis
Inability to tolerate lowest dose
Hold treatment
Resume at reduced dose once recovered
Urgent assessment
Withhold palbociclib until resolution
Interrupt treatment immediately
Investigate for ILD/pneumonitis
Permanently discontinue if confirmed
| Trade Name | |
|---|---|
| Drug Class | CDK 4/6 Inhibitors |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Breast Cancer |
| Dosage |