Ibrance Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Palbociclib

Indications/Uses

In combination w/ aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or fulvestrant in women who have received prior endocrine therapy for hormone receptor +ve, human epidermal growth factor 2 (HER2) -ve locally advanced or metastatic breast cancer. In combination w/ LH-releasing hormone agonist for pre- or perimenopausal women.

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Dosage/Direction for Use

125 mg once daily for 21 consecutive days followed by 7-day off-treatment to complete 28 days. In combination w/ fulvestrant 500 mg on days 1, 15, 29 & once mthly thereafter. Concomitant use w/ strong CYP3A inhibitor Reduce dose to 75 mg once daily. Severe hepatic impairment (Child-Pugh class C) 75 mg once daily for 21 consecutive days followed by 7-day off-treatment to complete 28 days.

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Overdosage

View Ibrance overdosage for action to be taken in the event of an overdose.

Administration

Hard-gelatin cap: Should be taken with food: Swallow whole, do not chew/crush/open. FC tab: May be taken with or without food: Swallow whole, do not chew/crush/split.

Special Precautions

Permanently discontinue use if severe ILD or pneumonitis occur. Interrupt dose if grade 3 or 4 neutropenia develops, new or worsening resp symptoms occur & suspected to develop pneumonitis. Myelosuppression or infection. Monitor CBC prior to, at the beginning of each cycle & on day 15 of 1st 2 cycles. Avoid concomitant use w/ strong CYP3A inhibitors & inducers. Hemodialysis patients. May impair male fertility. Women of childbearing potential & male partners should use effective contraception during & at least 3 wk after last dose. Not to be used during pregnancy, lactation & for 3 wk after last dose. Ped <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Neutropenia, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, dysgeusia; increased ALT & AST, epistaxis, increased lacrimation, dry eye, blurred vision, febrile neutropenia; ILD/non-infectious pneumonitis; palmar-plantar erythrodysesthesia syndrome.

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Drug Interactions

Increased plasma conc w/ strong CYP3A inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; grapefruit/grapefruit juice. Decreased plasma conc w/ strong CYP3A inducers eg, phenytoin, rifampin, carbamazepine, enzalutamide, St. John's wort. Increased exposure of midazolam, alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus.

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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.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Ibrance FC tab 100 mg

Packing/Price

7's

Form

Ibrance FC tab 125 mg

Packing/Price

7's

Form

Ibrance FC tab 75 mg

Packing/Price

7's

Form

Ibrance hard-gelatin cap 100 mg

Packing/Price

7's

Form

Ibrance hard-gelatin cap 125 mg

Packing/Price

7's

Form

Ibrance hard-gelatin cap 75 mg

Packing/Price

7's

Ibrance

palbociclib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma