Talzenna 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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Talazoparib

Indications/Uses

Monotherapy for adults w/ germline BRCA1/2-mutations, HER2 -ve locally advanced or metastatic breast cancer previously treated w/ anthracycline &/or taxane in the neoadjuvant, locally advanced or metastatic setting unless unsuitable. Patients w/ hormone-receptor +ve breast cancer should have been treated w/ prior or be considered unsuitable for endocrine-based therapy.

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Dosage/Direction for Use

1 mg once daily. Moderate renal impairment (CrCl ≥30 to <60 mL/min) 0.75 mg once daily. Severe renal impairment (CrCl ≥15 to <30 mL/min) 0.5 mg once daily.

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Overdosage

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

Administration

May be taken with or without food: Swallow whole, do not open/dissolve.

Contraindications

Hypersensitivity. Lactation.

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Special Precautions

Discontinue use if myelodysplastic syndrome/AML is confirmed. Myelosuppression. Routinely monitor CBC & haematology parameters prior to & during therapy. May affect ability to drive & use machines. May impair male fertility. Men must use effective contraception during & for 4 mth after last dose. Women of childbearing potential must use effective contraception prior to, during & for 7 mth after last dose. Not recommended during pregnancy. Not recommended during lactation & for 1 mth after last dose. Childn & adolescents <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Thrombocytopenia, anaemia, neutropenia, leucopenia; decreased appetite; dizziness, headache; vomiting, diarrhoea, nausea, abdominal pain; alopecia; fatigue. Lymphopenia; dysgeusia; stomatitis, dyspepsia.

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Drug Interactions

Increased AUC & C_max w/ P-gp inhibitors eg, amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil. Decreased exposure w/ P-gp inducers eg, carbamazepine, phenytoin, St. John's wort. Increased exposure w/ strong BCRP inhibitors eg, curcumin, cyclosporine.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Talzenna detailed prescribing information

Storage

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Description

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

Action

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MIMS Class

Targeted Cancer Therapy

ATC Classification

L01XK04 - talazoparib ; Belongs to the class of poly (ADP-ribose) polymerase (PARP) inhibitors. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Talzenna hard cap 0.25 mg

Packing/Price

30's

Talzenna

talazoparib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma