Ibrance

Ibrance

palbociclib

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Palbociclib
Indications/Uses
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, in combination w/ letrozole. In combination w/ luteinizing hormone-releasing hormone (LHRH) agonist for pre- or perimenopausal women.
Dosage/Direction for Use
125 mg once daily for 21 consecutive days followed by 7 days off treatment (schedule 3/1) to complete a 28-day cycle. In combination w/ letrozole: Administer Ibrance w/ letrozole 2.5 mg once daily continuously throughout the 28-day cycle. Treatment of pre-/perimenopausal women w/ the combination of palbociclib + an aromatase inhibitor should always be combined w/ an LHRH agonist. Dose modification for adverse reactions: Recommended dose: 125 mg/day. 1st dose reduction: 100 mg/day. 2nd dose reduction: 75 mg/day. Severe hepatic impairment 75 mg once daily on schedule 3/1.
Administration
Should be taken with food: Take at the same time each day. Swallow whole, do not chew/crush/open. Avoid grapefruit products.
Contraindications
Hypersensitivity. Prep containing St. John's wort.
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. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (eg, hypoxia, cough, dyspnea). Permanently discontinue if patients w/ severe ILD or pneumonitis. Monitor for signs & symptoms of infection. Patients w/ critical visceral disease. Concomitant use w/ CYP3A4 inhibitors or inducers. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption. May influence ability to drive & use machines. Moderate or severe hepatic or renal impairment w/ close monitoring of signs of toxicity. Women of childbearing potential & male partners must use a highly effective method of contraception during therapy & for at least 21 days or 97 days after completing therapy for females & males, respectively. Pregnancy & lactation. Childn & adolescents ≤18 yr.
Adverse Reactions
Neutropenia, ILD/pneumonitis, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, dysgeusia.
Drug Interactions
Increased plasma conc w/ strong CYP3A 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) CYP3A inducers. Increased AUCinf & Cmax of midazolam. Increase therapeutic effect & adverse reactions of P-gp substrates (eg, digoxin, dabigatran, colchicine) or BCRP (eg, pravastatin, rosuvastatin, sulfasalazine). Increased exposure of OCT1 transporter substrates (eg, metformin).
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 75 mg
Packing/Price
1 × 7's (Rp12,380,949/boks)
Form
Ibrance hard cap 125 mg
Packing/Price
1 × 7's (Rp12,380,949/boks)
Form
Ibrance hard cap 100 mg
Packing/Price
1 × 7's (Rp12,380,949/boks)
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