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Talzenna

Talzenna

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
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.
Dosage/Direction for Use
1 mg once daily. Moderate renal impairment (CrCl ≥30 mL/min to <60 mL/min) 0.75 mg once daily. Severe renal impairment (CrCl ≥15 mL/min to <30 mL/min) 0.5 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not open/dissolve cap.
Contraindications
Special Precautions
Myelosuppression; myelodysplastic syndrome/acute myeloid leukaemia. Routinely monitor CBC & haematology parameters prior to & during therapy. May affect ability to drive & use machines. May impair fertility in men. Women of childbearing potential must use effective contraception prior to, during & for 7 mth after last dose. Men must use effective contraception during & for 4 mth after last dose. Not recommended during pregnancy. Not recommended during lactation & for 1 mth after last dose. Childn & adolescents <18 yr.
Adverse Reactions
Thrombocytopenia, anaemia, neutropenia, leucopenia; decreased appetite; dizziness, headache; vomiting, diarrhoea, nausea, abdominal pain; alopecia; fatigue. Lymphopenia; dysgeusia; stomatitis, dyspepsia.
Drug Interactions
Increased AUC & Cmax 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.
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.
Presentation/Packing
Form
Talzenna hard cap 0.25 mg
Packing/Price
30's
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