Ibrance Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Palbociclib

Indications/Uses

Hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve 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/ LH-releasing hormone (LHRH) agonist for pre- or perimenopausal women.

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Dosage/Direction for Use

Recommended dose: 125 mg once daily for 21 consecutive days followed by 7-day off period (schedule 3/1) to complete 28-day cycle. In combination w/ fulvestrant 500 mg fulvestrant IM on days 1, 15, 29 & once mthly thereafter. Dose modification for adverse reactions 1st dose reduction: 100 mg daily, 2nd dose reduction: 75 mg daily. Severe hepatic impairment (Child-Pugh class C) 75 mg once daily on schedule 3/1.

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Overdosage

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Administration

Should be taken with food: Do not take w/ grapefruit or grapefruit juice. Swallow whole, do not chew/crush/open.

Contraindications

Hypersensitivity. St. John's wort-containing prep.

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Warnings

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Special Precautions

Discontinue in patients w/ new or worsening resp symptoms & developed ILD/pneumonitis. Mandatory ovarian ablation or suppression w/ LHRH agonist in pre-/perimenopausal women treated in combination w/ an aromatase inhibitor. Patients w/ critical visceral disease; who develop Grade 3 or 4 neutropenia. Monitor for pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of infection. Galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Avoid in concomitant use w/ strong CYP3A inhibitors & inducers during treatment. May affect ability to drive & use machines. Moderate or severe hepatic & renal impairment. Women of childbearing potential & men should use adequate contraceptive methods during therapy & for at least 3 wk or 14 wk after completing therapy. Not recommended in women of childbearing potential not using contraception & during pregnancy. Not to breastfeed during treatment. Childn & adolescents <18 yr.

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Use In Pregnancy & Lactation

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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.

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Drug Interactions

Increased AUC_inf & C_maxw/ itraconazole. Decreased AUC_inf& C_max w/ rifampin, modafinil, rabeprazole. Concomitant use w/ strong CYP3A inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole & grapefruit or grapefruit juice; strong CYP3A inducers eg, carbamazepine, enzalutamide, phenytoin, rifampin & St. John's wort. Increased AUC_inf & C_max of midazolam. Increased exposure of sensitive CYP3A substrates w/ narrow therapeutic index eg, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus & tacrolimus; medical product substrates of uptake transporter organic cationic transporter OCT1 eg, metformin. Tamoxifen. Increased therapeutic effect & adverse reactions of P-gp substrates eg, digoxin, dabigatran, colchicine or BCRP eg, pravastatin, rosuvastatin, sulfasalazine.

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Caution For Usage

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Storage

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Description

View Ibrance description for details of the chemical structure and excipients (inactive components).

Action

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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.

Thai FDA Category

Presentation/Packing

Form

Ibrance cap 100 mg

Packing/Price

1 × 7's

Form

Ibrance cap 125 mg

Packing/Price

1 × 7's

Form

Ibrance cap 75 mg

Packing/Price

1 × 7's

Ibrance

palbociclib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

Pfizer