Zuellig Pharma
Concise Prescribing Info
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination w/ an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women or in combination w/ fulvestrant in women w/ disease progression following endocrine therapy.
Dosage/Direction for Use
125 mg once daily for 21 consecutive days followed by 7 days off-treatment (schedule 3/1) to complete 28-day cycle. In combination w/ an aromatase inhibitor Administer the aromatase inhibitor according to dose prescribed in its approved product information. In combination w/ fulvestrant Administer Ibrance w/ fulvestrant 500 mg IM on days 1, 15, 29 & once mthly thereafter. Treat pre- or perimenopausal women w/ luteinizing hormone-releasing hormone agonists prior to start of, & throughout treatment w/ the combination of palbociclib + fulvestrant. Dose modification for adverse events: 1st dose reduction: 100 mg/day. 2nd dose reduction: 75 mg/day. Severe hepatic impairment 75 mg once daily (schedule 3/1).
Should be taken with food: Take at the same time each day. Swallow whole, do not chew/crush/open. Avoid grapefruit or grapefruit juice.
Special Precautions
Monitor complete blood count prior to start of therapy & at the beginning of each cycle, as well as on day 15 of the first 2 cycles, & as clinically indicated. Dosing interruption, dose reduction or delay in starting treatment cycles in patients who develop Grade 3 or 4 neutropenia. Permanently discontinue in patients w/ severe interstitial lung disease or pneumonitis. Monitor for signs & symptoms of infection & pulmonary embolism; episodes of fever. Patients experiencing fatigue should exercise caution when driving or operating machinery. Male patients should consider sperm preservation prior to beginning therapy. Females of childbearing potential or their male partners should use adequate contraceptive methods during therapy & for at least 21- or 97 days after therapy. Not recommended in pregnancy & breastfeeding women.

Adverse Reactions
Infections; neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, stomatitis, nausea, diarrhoea, vomiting, rash, alopecia; fatigue, asthenia, pyrexia. Febrile neutropenia, dysgeusia, blurred vision, increased lacrimation, dry eye, epistaxis, interstitial lung disease/pneumonitis, dry skin, increased ALT & AST.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors (eg, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole & grapefruit or grapefruit juice). Decreased plasma conc w/ strong (eg, carbamazepine, enzalutamide, felbamate, nevirapine, phenobarb, phenytoin, primidone, rifabutin, rifampin, rifapentin & St. John's wort) & moderate (eg, bosentan, efavirenz, etravirine, modafinil & nafcillin) CYP3A4 inducers. Increased AUCinf & Cmax of midazolam.
ATC Classification
L01XE33 - palbociclib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Ibrance hard cap 100 mg
Ibrance hard cap 125 mg
Ibrance hard cap 75 mg
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