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    AboutAbout

    Mechanism of ActionNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)Identifying Patients With gBRCA Mutations
    Efficacy & SafetyEfficacy & SafetyStudy DesignEfficacySafety profileDosingDosing

    Dosing and Modifications
    Support & OrderSupport & Order

    EventsVideosMaterialsAccess & Patient Support

    Dosing and Modifications

    TALZENNA provides convenient, once-daily dosing1​​​​​​​​​​​​​​

    ** This is an optional area where footnotes can live.

    • The recommended starting dose of TALZENNA is 1 mg taken orally once daily, with or without food1
    • The 0.25 mg capsule is available for dose reduction1
    • Patients should be treated until disease progression or unacceptable toxicity occurs1
    • The capsules should be swallowed whole and must not be opened or dissolved1

    • If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time1

    Dose modifications

    For patients who require dose modification, TALZENNA offers flexible dosing options1

    • ​​​​​​​To manage adverse reactions, consider interruption of treatment or dose reduction based on severity and clinical presentation

    ** This is an optional area where footnotes can live.

    Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.

    ​​​​​​​Dose modification for adverse reactions1

    Monitor complete blood counts monthly and as clinically indicated.

    Dose modifications for patients with renal impairment1

    • For patients with moderate renal impairment (CLcr 30-59 mL/min), the recommended dose of TALZENNA is 0.75 mg once daily
    • For patients with severe renal impairment (CLcr 15-29 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily

    Dose modifications for use with P-glycoprotein (P-gp) inhibitors1

    • Reduce the TALZENNA dose to 0.75 mg once daily when coadministered with certain P-gp inhibitors*
    • When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3-5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor

       *In the clinical studies, coadministration with P-gp inhibitors, including amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil, resulted in an approximate 45% increase in TALZENNA exposure and an increase in the rate of TALZENNA dose reduction.

    GIVE YOUR PATIENTS A BIOMARKER-DRIVEN TREATMENT THAT'S ​​​​​​​JUST FOR THEM

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    Demonstrated clinical benefit1

    The efficacy of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study1,2

    Review efficacy data

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    Safety and tolerability profile

    The safety of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study1,8

    Review safety profile

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    Identifying patients with gBRCA mutations

    Learn about the guidelines for gBRCA ​​​​​​​testing

    View testing guidelines

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    Access and patient support

    Personalized patient support and financial assistance resources from Pfizer Oncology Together

    Learn more

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    References:
    1. TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2020.
    2. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.

    Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these two patients prior to developing MDS/AML was 4 months and 24 months, respectively. Both patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

    Myelosuppression consisting of anemia, leukopenia/neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 39%, 21%, and 15% of patients receiving TALZENNA. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

    Monitor complete blood counts for cytopenia at baseline and monthly thereafter. Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. If hematological toxicity occurs, dose modifications (dosing interruption with or without dose reduction) are recommended. With respect to MDS/AML, for prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If the levels have not recovered after 4 weeks, refer the patient to a hematologist for further investigations. If MDS/AML is confirmed, discontinue TALZENNA.

    TALZENNA can cause fetal harm when administered to pregnant women. Advise women of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose. A pregnancy test is recommended for females of reproductive potential prior to initiating TALZENNA treatment. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment with TALZENNA and for at least 4 months after receiving the last dose. Based on animal studies, TALZENNA may impair fertility in males of reproductive potential. Advise women not to breastfeed while taking TALZENNA and for at least 1 month after receiving the last dose because of the potential for serious adverse reactions in nursing infants.

    The most common adverse reactions (≥20%) of any grade for TALZENNA vs chemotherapy were fatigue (62% vs 50%), anemia (53% vs 18%), nausea (49% vs 47%), neutropenia (35% vs 43%), headache (33% vs 22%), thrombocytopenia (27% vs 7%), vomiting (25% vs 23%), alopecia (25% vs 28%), diarrhea (22% vs 26%), and decreased appetite (21% vs 22%).

    The most frequently reported Grade ≥3 adverse reactions (≥10%) for TALZENNA vs chemotherapy were anemia (39% vs 5%), neutropenia (21% vs 35%), and thrombocytopenia (15% vs 2%).

    The most common lab abnormalities (≥25%) for TALZENNA vs chemotherapy were decreases in hemoglobin (90% vs 77%), leukocytes (84% vs 73%), lymphocytes (76% vs 53%), neutrophils (68% vs 70%), platelets (55% vs 29%), and calcium (28% vs 16%) and increases in glucose (54% vs 51%), aspartate aminotransferase (37% vs 48%), alkaline phosphatase (36% vs 34%), and alanine aminotransferase (33% vs 37%).

    Coadministration with P-gp inhibitors or BCRP inhibitors may increase TALZENNA exposure. If coadministering with the P-gp inhibitors amiodarone, carvedilol, clarithromycin, itraconazole, or verapamil is unavoidable, reduce the TALZENNA dose to 0.75 mg once daily. When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor. When coadministering TALZENNA with other known P-gp inhibitors or BCRP inhibitors, monitor patients for potential increased adverse reactions.

    For patients with moderate renal impairment, the recommended dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment, the recommended dose of TALZENNA is 0.5 mg once daily. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

    TALZENNA has not been studied in patients with moderate or severe hepatic impairment. No dose adjustment is required for patients with mild hepatic impairment.

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA ​​​​​.

    Please see full Prescribing Information.

    Indication

    TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.