Talzenna

— THERAPEUTIC CATEGORIES —
  • Breast cancer
  • Prostate and other male cancers
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Talzenna Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Talazoparib 0.1mg, 0.25mg, 0.5mg, 0.75mg, 1mg; caps.

    Pharmacological Class

    Poly (ADP-ribose) polymerase (PARP) inhibitor.

    How Supplied

    Caps—30

    Manufacturer

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Talazoparib, a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor, plays a role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA 1 and 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis.

    Talzenna Indications

    Indications

    In adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer, as detected by an FDA-approved test.

    Talzenna Dosage and Administration

    Adult

    Swallow whole. 1mg once daily. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Renal impairment (moderate [CrCl 30–59mL/min]): 0.75mg once daily; (severe [CrCl 15–29mL/min]): 0.5mg once daily. Concomitant certain P-gp inhibitors (if unavoidable): reduce to 0.75mg once daily; increase to previous dose once inhibitor is discontinued.

    Children

    Not established.

    Talzenna Contraindications

    Not Applicable

    Talzenna Boxed Warnings

    Not Applicable

    Talzenna Warnings/Precautions

    Warnings/Precautions

    Monitor CBCs for cytopenia at baseline and monthly thereafter. Do not start therapy until recovery from hematological toxicity due to previous chemotherapy. Prolonged hematological toxicities: interrupt and monitor blood counts weekly until recovery; if levels not recovered after 4 weeks, consult hematologist. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Myelosuppression. Moderate or severe renal impairment (see Adult dose); if severe, monitor and adjust dosing accordingly. Hemodialysis: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥7 months after last dose. Advise males (w. female partners) to use effective contraception during and for ≥4 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after last dose).

    Talzenna Pharmacokinetics

    Absorption

    • Median time to Cmax: 1 to 2 hours after dosing.

    Distribution

    • Apparent volume of distribution: 420 L.

    • 74% protein bound.

    Metabolism

    • Hepatic (minimal).

    Elimination

    • Renal (68.7%), fecal (19.7%).
    • Half-life: 90 hours.
    • Apparent oral clearance: 6.45 L/h.

    Talzenna Interactions

    Interactions

    May be potentiated by P-gp inhibitors (eg, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil); for breast cancer: if unavoidable, reduce dose (see Adults); for mCRPC: not studied, monitor and adjust dose as needed. May be potentiated by BCRP inhibitors; if unavoidable, monitor for increased adverse reactions.

    Talzenna Adverse Reactions

    Adverse Reactions

    Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite; also in combination with enzalutamide: fractures, dysgeusia; lab abnormalities (see full labeling).

    Talzenna Clinical Trials

    See Literature

    Talzenna Note

    Not Applicable

    Talzenna Patient Counseling

    See Literature

    Talzenna Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Talazoparib 0.1mg, 0.25mg, 0.5mg, 0.75mg, 1mg; caps.

    Pharmacological Class

    Poly (ADP-ribose) polymerase (PARP) inhibitor.

    How Supplied

    Caps—30

    Manufacturer

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Talazoparib, a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor, plays a role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA 1 and 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis.

    Talzenna Indications

    Indications

    In combination with enzalutamide for adults with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

    Talzenna Dosage and Administration

    Adult

    Select patients based on the presence of HRR gene mutations. Swallow whole. 0.5mg once daily in combination with enzalutamide. Continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling. Renal impairment (moderate [CrCl 30–59mL/min]): 0.35mg once daily in combination with enzalutamide; (severe [CrCl 15–29mL/min]): 0.25mg once daily in combination with enzalutamide.

    Children

    Not established.

    Talzenna Contraindications

    Not Applicable

    Talzenna Boxed Warnings

    Not Applicable

    Talzenna Warnings/Precautions

    Warnings/Precautions

    Monitor CBCs for cytopenia at baseline and monthly thereafter. Do not start therapy until recovery from hematological toxicity due to previous chemotherapy. Prolonged hematological toxicities: interrupt and monitor blood counts weekly until recovery; if levels not recovered after 4 weeks, consult hematologist. Discontinue if myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) is confirmed. Myelosuppression. Moderate or severe renal impairment (see Adult dose); if severe, monitor and adjust dosing accordingly. Hemodialysis: not studied. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥7 months after last dose. Advise males (w. female partners) to use effective contraception during and for ≥4 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after last dose).

    Talzenna Pharmacokinetics

    Absorption

    • Median time to Cmax: 1 to 2 hours after dosing.

    Distribution

    • Apparent volume of distribution: 420 L.

    • 74% protein bound.

    Metabolism

    • Hepatic (minimal).

    Elimination

    • Renal (68.7%), fecal (19.7%).
    • Half-life: 90 hours.
    • Apparent oral clearance: 6.45 L/h.

    Talzenna Interactions

    Interactions

    May be potentiated by P-gp inhibitors (eg, amiodarone, carvedilol, clarithromycin, itraconazole, verapamil); for breast cancer: if unavoidable, reduce dose (see Adults); for mCRPC: not studied, monitor and adjust dose as needed. May be potentiated by BCRP inhibitors; if unavoidable, monitor for increased adverse reactions.

    Talzenna Adverse Reactions

    Adverse Reactions

    Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite; also in combination with enzalutamide: fractures, dysgeusia; lab abnormalities (see full labeling).

    Talzenna Clinical Trials

    See Literature

    Talzenna Note

    Not Applicable

    Talzenna Patient Counseling

    See Literature

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