Palvored 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 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 Fulvestrant: 500 mg on days 1, 15, 29 & once mthly thereafter. Concomitant use w/ strong CYP3A inhibitors 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

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Administration

Should be taken with food: Swallow whole, do not chew/crush/open.

Contraindications

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

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Special Precautions

Permanently discontinue use if severe ILD or pneumonitis occurs. Interrupt dose if grade 3 or 4 neutropenia develops, new or worsening resp symptoms occur & suspected to develop pneumonitis. Critical visceral disease. Monitor for signs & symptoms of infection. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use w/ strong CYP3A4 inhibitors/inducers. May affect ability to drive & use machines. Moderate or severe renal & hepatic impairment. May affect male fertility. Women of childbearing potential & male partners should use effective contraception during & for at least 3 wk or 14 wk after last dose. Not recommended during pregnancy. Not to be used during lactation.

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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_max w/ strong CYP3A inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole; grapefruit/grapefruit juice. Decreased AUC_inf & C_max w/ strong (eg, carbamazepine, enzalutamide, phenytoin, rifampin, St. John's wort) & moderate (eg, modafinil) CYP3A inducers. Decreased C_max w/ rabeprazole. Increased AUC_inf & C_max of midazolam. Increased exposure of alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus; metformin. Increased therapeutic effect & ARs of P-gp (eg, digoxin, dabigatran, colchicine) or BCRP (eg, pravastatin, rosuvastatin, sulfasalazine) substrates.

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Storage

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Description

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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

Presentation/Packing

Form

Palvored hard-gelatin cap 100 mg

Packing/Price

7's

Form

Palvored hard-gelatin cap 125 mg

Packing/Price

7's

Form

Palvored hard-gelatin cap 75 mg

Packing/Price

7's

Palvored

palbociclib

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH