NEW
Ibrance

Ibrance

palbociclib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

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/ aromatase inhibitor as initial endocrine-based therapy in women or men, or w/ fulvestrant in women who have received prior endocrine therapy. In combination w/ luteinizing hormone-releasing hormone (LHRH) agonist for pre- or perimenopausal women.
Dosage/Direction for Use
Recommended dose: 125 mg once daily for 21 consecutive days followed by a 7-day off period (schedule 3/1) to complete 28-day cycle. In combination w/ fulvestrant: Recommended dose of fulvestrant: 500 mg as IM on Days 1, 15, 29 & once mthly, thereafter. Treat pre-/perimenopausal women w/ LHRH agonists prior to start & throughout duration of combination therapy. Dose modification for adverse reactions: 1st dose reduction: 100 mg/day. 2nd dose reduction: 75 mg/day. Severe hepatic impairment (Child-Pugh class C) 75 mg once daily on schedule 3/1.
Administration
Should be taken with food: Do not take w/ grapefruit or grapefruit juice. Swallow whole, do not chew/crush/open.
Contraindications
Hypersensitivity. Prep containing St. John's wort.
Special Precautions
Ovarian ablation or suppression in pre-/perimenopausal women during therapy in combination w/ aromatase inhibitor. Critical visceral disease. Dose interruption, reduction or delay in starting treatment cycle for patients who develop Grade 3 or 4 neutropenia. Monitor patients for pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis; for signs & symptoms of infection; episodes of fever. Permanently discontinue therapy in patients w/ severe ILD or pneumonitis. Avoid concomitant use w/ strong CYP3A inhibitors & CYP3A4 inducers. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Moderate or severe hepatic or renal impairment. Women of childbearing potential & male partners must use adequate & highly effective contraceptive methods (eg, double-barrier contraception) during therapy & for at least 3 or 14 wk after therapy completion. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infections; neutropenia, leukopenia, anaemia, thrombocytopenia; decreased appetite; stomatitis, nausea, diarrhoea, vomiting; rash, alopecia, dry skin; fatigue, asthenia, pyrexia; increased ALT/AST. Febrile neutropenia; dysgeusia; blurred vision, increased lacrimation, dry eye; epistaxis, ILD/pneumonitis.
Drug Interactions
Increased AUCinf & Cmax w/ itraconazole. Decreased AUCinf & Cmax w/ rifampin, modafinil, rabeprazole. Concomitant use w/ strong CYP3A inhibitors including clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole & grapefruit or grapefruit juice; strong CYP3A inducers including carbamazepine, enzalutamide, phenytoin, rifampin & St. John's wort. Increase AUCinf & Cmax of midazolam. May increase exposure of sensitive CYP3A substrates w/ narrow therapeutic index (eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus & tacrolimus); drug substrates of uptake transporter organic cationic transporter OCT1 (eg, metformin). Tamoxifen. May increase therapeutic effect & adverse reactions of P-gp substrates (eg, digoxin, dabigatran, colchicine) or breast cancer resistance protein (eg, pravastatin, rosuvastatin, sulfasalazine).
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
1 × 7's
Form
Ibrance cap 125 mg
Packing/Price
1 × 7's
Form
Ibrance cap 100 mg
Packing/Price
1 × 7's
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