Ibrance

Ibrance

palbociclib

Manufacturer:

Pfizer

Distributor:

Pfizer
Concise Prescribing Info
Contents
Palbociclib
Indications/Uses
Hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer in combination w/ an aromatase inhibitor as initial endocrine-based therapy; fulvestrant in patients who have received prior therapy.
Dosage/Direction for Use
125 mg once daily for 21 consecutive days followed by 7 days off-treatment to complete 28 days cycle.
Administration
Should be taken with food: Take at the same time each day. Swallow whole, do not chew/crush/open.
Contraindications
Special Precautions
Dose interruption/reduction or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Anemia, thrombocytopenia has been reported. Permanently discontinue therapy in patients w/ severe interstitial lung disease or pneumonitis. Monitor CBC prior to start of therapy & at the beginning of each cycle, as well as on Day 15 of the 1st 2 cycles & as clinically indicated. Monitor patients for signs & symptoms of infection or any episodes of fever. Consider sperm preservation prior to beginning of therapy in men. Potential to impair reproductive function & fertility in males. May affect ability to drive & use machines. Hepatic & renal impairment. Pregnancy & lactation. Women of childbearing potential. Childn & adolescent ≤18 yr.
Adverse Reactions
Neutropenia, infections, leukopenia, nausea, fatigue, alopecia, stomatitis, anemia & diarrhea.
Drug Interactions
May increase plasma conc w/ CYP3A inhibitors (eg, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole & grapefruit or grapefruit juice). May decrease plasma conc w/ CYP3A inducers (eg, carbamazepine, enzalutamide, felbamate, nevirapine, phenobarb, phenytoin, primidone, rifabutin, rifampin, rifapentin & St. John's wort). Decreased Cmax w/ rabeprazole (in multiple doses). Increases AUCinf & Cmax of midazolam (in multiple doses).
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 cap 75 mg
Packing/Price
21's;7's
Form
Ibrance cap 100 mg
Packing/Price
21's;7's
Form
Ibrance cap 125 mg
Packing/Price
21's;7's
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