Talzenna

TALAZOPARIB

Manufacturer: Pfizer Laboratories Div Pfizer Inc

Score: 141.0

Quick Summary

Talzenna (Talazoparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor used for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer, and in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The recommended dosage is 1 mg once daily for breast cancer and 0.5 mg once daily in combination with enzalutamide for mCRPC. Talzenna can cause embryo-fetal harm and has warnings for myelodysplastic syndrome/acute myeloid leukemia and myelosuppression. Dose adjustments are recommended for patients with renal impairment and those taking P-glycoprotein inhibitors.

Key Clinical Findings and Indications

Talzenna is used for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer
Talzenna is used in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC)

Important Safety Information

Warning

Talzenna can cause embryo-fetal harm and has warnings for myelodysplastic syndrome/acute myeloid leukemia and myelosuppression

Contraindications

Adverse Reactions

Myelodysplastic syndrome/acute myeloid leukemia
Myelosuppression
Fatigue
Nausea
Decreased appetite
Diarrhea
Alopecia

Dosing Recommendations

General Guidance

Recommended for patients with renal impairment and those taking P-glycoprotein inhibitors

Breast cancer

Adult Dose

1 mg once daily

Pediatric Dose

Not established

mCRPC

Adult Dose

0.5 mg once daily in combination with enzalutamide

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Talzenna can cause embryo-fetal harm
Pregnant women and females of reproductive potential should be apprised of the potential risk to a fetus

Nursing Mothers

Pediatric Use

The safety and effectiveness of Talzenna have not been established in pediatric patients

Geriatric Use

No overall differences in safety or effectiveness of Talzenna were observed between older and younger patients

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