Ibrance

Ibrance

palbociclib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Palbociclib
Indications/Uses
In combination w/ aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or fulvestrant in women who have received prior endocrine therapy for hormone receptor +ve, human epidermal growth factor 2 (HER2) -ve locally advanced or metastatic breast cancer.
Dosage/Direction for Use
125 mg once daily for 21 consecutive days followed by 7-day off-treatment to complete 28 days. Combination: Fulvestrant 500 mg on days 1, 15, 29 & once mthly thereafter. Concomitant use w/ strong CYP3A inhibitors Reduce dose to 75 mg once daily. Severe hepatic impairment 75 mg once daily for 21 consecutive days followed by 7-day off-treatment to complete 28 days.
Administration
Should be taken with food: Take at the same time each day. Swallow whole, do not chew/crush/open.
Special Precautions
Permanently discontinue use if severe interstitial lung disease (ILD) or pneumonitis occur. Interrupt dose if grade 3 or 4 neutropenia develops, new or worsening resp symptoms occur & suspected to develop pneumonitis. Monitor complete blood count prior to, at the beginning of each cycle & on day 15 of 1st 2 cycles. Avoid concomitant use w/ strong CYP3A inhibitors. Severe hepatic impairment. May impair male fertility. Women of childbearing potential should use effective contraception during & at least 3 wk after last dose. Not to be used during pregnancy & lactation. Ped patients.
Adverse Reactions
Neutropenia, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, dysgeusia; increased alanine & aspartate aminotransferase, epistaxis, increased lacrimation, dry eye, blurred vision, febrile neutropenia; ILD/non-infectious pneumonitis.
Drug Interactions
Increased plasma conc w/ strong CYP3A inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; grapefruit/grapefruit juice. Decreased plasma conc w/ strong CYP3A inducers eg, phenytoin, rifampin, carbamazepine, enzalutamide, St. John's wort. Increased exposure of midazolam, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EF01 - palbociclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Ibrance hard cap 100 mg
Packing/Price
7's
Form
Ibrance hard cap 125 mg
Packing/Price
7's
Form
Ibrance hard cap 75 mg
Packing/Price
7's
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