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Ibrance
palbociclib
Adult Dosing .
Dosage forms: CAP: 75 mg, 100 mg, 125 mg; TAB: 75 mg, 100 mg, 125 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
hormone receptor-positive HER2-negative breast CA, advanced or metastatic
- [initial tx]
- Dose: 125 mg PO qd on days 1-21 of 28-day cycle; Info: use w/ aromatase inhibitor; give w/ LHRH agonist in pre/perimenopausal patients; consider giving w/ LHRH agonist in male patients; give caps w/ food; do not open cap; do not cut/crush/chew tab
- [progressive disease]
- Dose: 125 mg PO qd on days 1-21 of 28-day cycle; Info: use w/ fulvestrant; give w/ LHRH agonist in pre/perimenopausal patients; give caps w/ food; do not open cap; do not cut/crush/chew tab
PIK3CA-mutated hormone receptor-positive HER2-negative breast CA, locally advanced or metastatic
- [125 mg PO qd on days 1-21 of 28-day cycle]
- Info: for recurrent endocrine-resistant disease; use w/ inavolisib and fulvestrant; give w/ LHRH agonist in pre/perimenopausal patients; consider giving w/ LHRH agonist in male patients; give caps w/ food; do not open cap; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class C: 75 mg qd on days 1-21 of 28-day cycle
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- ANC <1000
- avoid: breastfeeding during tx and x3wk after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: hepatic impairment, Child-Pugh Class C
Drug Interactions .
Overview
palbociclib
kinase inhibitor
- CYP3A4 substrate
- CYP3A4 inhibitor, weak
- immunomodulatory effects
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- cisapride
- dengue vaccine, live
- eliglustat
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adagrasib
- alprazolam
- apalutamide
- atazanavir
- bosentan
- butalbital
- carbamazepine
- cenobamate
- ceritinib
- chloramphenicol
- cladribine oral
- clarithromycin
- cobicistat
- codeine
- colchicine
- dabrafenib
- deferiprone
- dexrazoxane
- efavirenz
- encorafenib
- enzalutamide
- etravirine
- fexinidazole
- fosphenytoin
- ganciclovir
- grapefruit
- hydrocodone
- idelalisib
- itraconazole
- ivosidenib
- ketoconazole
- levoketoconazole
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- mavacamten
- meperidine
- methadone
- mifepristone
- mitapivat
- mitotane
- modafinil
- nafcillin
- nefazodone
- nelfinavir
- oxycodone
- pacritinib
- palifermin
- penicillamine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimozide
- posaconazole
- pralsetinib
- primaquine
- primidone
- propafenone
- rabies vaccine
- radium Ra 223 dichloride
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- ropeginterferon alfa-2b
- simvastatin
- sotorasib
- St. John's wort
- tipranavir
- tucatinib
- valganciclovir
- voriconazole
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- albendazole
- alemtuzumab
- alfentanil
- allopurinol
- amiodarone
- anthrax vaccine
- anti-thymocyte globulin
- aprepitant
- asenapine
- atidarsagene autotemcel
- auranofin
- avacopan
- avanafil
- avapritinib
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- berotralstat
- betibeglogene autotemcel
- brigatinib
- capivasertib
- chikungunya vaccine
- cidofovir
- ciprofloxacin
- clofazimine
- clozapine
- conivaptan
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cyclosporine
- danazol
- dapsone
- darunavir
- deferasirox
- deuruxolitinib
- dihydroergotamine
- diltiazem
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- disopyramide
- docetaxel
- dofetilide
- domperidone
- dronedarone
- duvelisib
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- entrectinib
- ergotamine
- erythromycin
- everolimus
- exagamglogene autotemcel
- fedratinib
- felodipine
- fentanyl
- filgrastim (G-CSF)
- finerenone
- flibanserin
- fluconazole
- flucytosine
- fluphenazine
- fosamprenavir
- foscarnet
- fostamatinib
- gepirone
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- imatinib
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isavuconazonium
- ivabradine
- ixabepilone
- Japanese encephalitis vaccine
- lefamulin
- leflunomide
- lemborexant
- lenacapavir
- letermovir
- linezolid
- lomitapide
- lovastatin
- lovotibeglogene autotemcel
- lumateperone
- lurasidone
- lurbinectedin
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- midazolam
- mobocertinib
- mycophenolate mofetil
- mycophenolic acid
- netupitant
- nifedipine
- nilotinib
- nimodipine
- nirogacestat
- nisoldipine
- oliceridine
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pemigatinib
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- proguanil
- pyrimethamine
- quinidine (antiarrhythmic)
- red yeast rice
- respiratory syncytial virus vaccine
- ribavirin
- rilzabrutinib
- rituximab
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selpercatinib
- selumetinib
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sufentanil
- sulfasalazine
- tacrolimus
- tadalafil
- taletrectinib
- temsirolimus
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- tolvaptan
- triazolam
- trimethoprim
- typhoid vaccine
- ubrogepant
- upadacitinib
- valproic acid
- vancomycin
- vardenafil
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- warfarin
- zanubrutinib
- zidovudine
Caution Advised
- armodafinil
- artemether/lumefantrine
- belzutifan
- bexarotene
- cariprazine
- clobazam
- cobimetinib
- danshen
- daridorexant
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- enasidenib
- eplerenone
- eslicarbazepine acetate
- felbamate
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- griseofulvin
- meropenem
- methylergonovine
- nevirapine
- odevixibat
- olutasidenib
- omaveloxolone
- oxcarbazepine
- palovarotene
- perampanel
- pioglitazone
- prednisone
- roflumilast
- roflumilast topical
- rufinamide
- sirolimus topical
- sunvozertinib
- suzetrigine
- tazemetostat
- tecovirimat
- telotristat ethyl
- topiramate
- tovorafenib
- vaborbactam
- vamorolone
- vemurafenib
- vorasidenib
Adverse Reactions .
Serious Reactions
- myelosuppression
- febrile neutropenia
- infection, serious
- interstitial lung disease
- pneumonitis, non-infectious
- hand-foot syndrome
- venous thromboembolism
Common Reactions
- neutropenia
- anemia
- infection
- leukopenia
- fatigue
- nausea
- stomatitis
- alopecia
- diarrhea
- thrombocytopenia
- rash
- vomiting
- appetite decr.
- asthenia
- fever
- xeroderma
- dysgeusia
- epistaxis
- blurred vision
- Cr incr.
- LFTs incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC w/ diff at baseline, q2wk x6wk, then prior to each cycle; signs/symptoms of interstitial lung disease
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; risk of embryo-fetal toxicity based on animal data at 4x and 9x systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 3wk after D/C in patients of childbearing potential and during tx and for at least 3mo after D/C in male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x3wk after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver primarily; CYP450: 3A substrate
Excretion: feces 74.1% (2.3% unchanged), urine 17.5% (6.9% unchanged); Half-life: 29h
Subclass: Kinase Inhibitors, CDK Inhibitors
Mechanism of Action
inhibits cyclin-dependent kinase (CDK) 4 and 6, leading to decr. malignant cellular proliferation
Formulary .
No Formulary Selected
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