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AboutMechanism of ActionNCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)Identifying Patients With gBRCA MutationsAboutEfficacy &
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Prescribing Information Indication Patient Site
Safety ProfileTALZENNA offers proven safety and tolerabilityAdverse Reactions* (in ≥20% of Patients Receiving TALZENNA) in EMBRACA1

  • 25.2% of patients who received TALZENNA experienced alopecia, of which 22.7% was Grade 1# (hair loss of <50%) and 2.4% was Grade 2** (hair loss of ≥50%) vs 27.8% of patients who received chemotherapy (19.8% Grade 1; 7.9% Grade 2)1-3

CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute.Graded according to NCI CTCAE 4.03.Includes fatigue and asthenia.TitleThe most common hematologic adverse reactions to TALZENNA were transient4With appropriate management, the median duration of Grade 3-4 anemia, neutropenia, and thrombocytopenia was ≤8 days vs ≤18 days with chemotherapy4The majority of nonhematologic adverse events in the TALZENNA group were Grade 1 in severity5
  • The median duration of study treatment was 6.1 months in patients who received TALZENNA and 3.9 months in patients who received chemotherapy1
Laboratory abnormalitiesLaboratory Abnormalities Reported in ≥25% of Patients in EMBRACA1 Abbreviation: N=number of patients.This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.This number represents non-fasting glucose.Discontinuations and dose reductions

  • 95% of patients did not discontinue TALZENNA due to an adverse reaction1

  • Permanent discontinuation due to an adverse reaction occurred TALZENNA patients1

  • Most adverse events were managed with dose interruption/reduction or standard supportive medical therapy4,5

  • The median time to first dose reduction due to an adverse reaction was 19.3 weeks for TALZENNA vs 9.3 weeks with oral chemotherapy (capecitabine)4,6

    • Dose interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA1

    • ​​Dose reductions due to any cause occurred in 53% of TALZENNA patients1

Warnings and Precautions

Myelodysplastic Syndrome/Acute Myeloid Leukemia
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA.

Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. In TALAPRO-2, MDS/AML occurred in 2 out of 511 (0.4%) patients treated with TALZENNA and enzalutamide and in 0 out of 517 (0%) patients treated with placebo and enzalutamide. The durations of TALZENNA treatment in these five patients prior to developing MDS/AML were 0.3, 1, 2, 3, and 5 years, respectively. Most of these patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous chemotherapy. Monitor blood counts monthly during treatment with TALZENNA. For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue TALZENNA.

Myelosuppression
Myelosuppression consisting of anemia, 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 as a single agent. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 45%, 18%, and 8% of patients receiving TALZENNA and enzalutamide. Overall, 39% of patients (199/511) required a red blood cell transfusion, including 22% (111/511) who required multiple transfusions. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 7%, 3%, and 0.4% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics .

Embryo-fetal toxicity
Based on its mechanism of action and findings from animal data, TALZENNA can cause fetal harm when administered to a pregnant woman. In an animal reproduction study, administration of talazoparib to pregnant rats during the period of organogenesis caused fetal malformations and structural skeletal variations, and embryo-fetal death at exposures that were 0.24 times the area under the concentration-time curve (AUC) in patients receiving the recommended human dose of 1 mg daily. Apprise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of TALZENNA.

Based on findings from genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 4 months following the last dose of TALZENNA.

References:TALZENNA [prescribing information]. New York, NY: Pfizer Inc.; 2023.Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. doi:10.1056/NEJMoa1802905; supplementary appendix:1-22.National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Revised June 2010, version 4.03. NIH publication 09-5410.Hurvitz SA, Goncalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA-mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial. Oncologist. 2019;24:1-12. doi:10.1634/theoncologist.2019-0493.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.Data on File. Pfizer, Inc, New York, NY.
GIVE YOUR PATIENTS A BIOMARKER-DRIVEN TREATMENT THAT'S JUST FOR THEM Efficacy & Safety Identifying patients with gBRCA mutations Learn about the guidelines for gBRCA testing View testing guidelines Loading Mechanism of action

TALZENNA is an inhibitor of PARP enzymes, including PARP1 and PARP2, which play a role in DNA repair1

 Review the MOA Loading Demonstrated clinical benefit1

The efficacy of TALZENNA was evaluated in an open-label, 2:1 randomized Phase 3 study1,6

 Review efficacy data Loading

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INDICATION

TALZENNA is indicated as a single agent 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.

Important Safety Information

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with a fatal outcome, has been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 0.4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies. The duration of TALZENNA treatment in these three patients prior to developing MDS/AML was 4 months, 24 months, and 60 months respectively. These patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed.

Myelosuppression consisting of anemia, 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 as a single agent. Discontinuation due to anemia, neutropenia, and thrombocytopenia occurred, respectively, in 0.7%, 0.3%, and 0.3% of patients.

Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy. Monitor blood counts monthly during treatment with TALZENNA. If hematological toxicities do not resolve within 28 days, discontinue TALZENNA and refer the patient to a hematologist for further investigations including bone marrow analysis and blood sample for cytogenetics. 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 7 months following the last dose of TALZENNA. Verify pregnancy status in 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 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 1 month after receiving the last dose because of the potential for serious adverse reactions in a breastfed child.

Serious adverse reactions of TALZENNA occurred in 32% of patients. Serious adverse reactions reported in >2% of patients included anemia (6%) and pyrexia (2%). Fatal adverse reactions occurred in 1% of patients, including cerebral hemorrhage, liver disorder, veno-occlusive liver disease, and worsening neurological symptoms (1 patient each).

The most common (≥20%) adverse reactions of any grade for TALZENNA vs chemotherapy, including laboratory abnormalities, were hemoglobin decreased (90% vs 77%), neutrophils decreased (68% vs 70%), lymphocytes decreased (76% vs 53%), platelets decreased (55% vs 29%), fatigue (62% vs 50%), glucose increased (54% vs 51%), aspartate aminotransferase increased (37% vs 48%), alkaline phosphatase increased (36% vs 34%), alanine aminotransferase increased (33% vs 37%), calcium decreased (28% vs 16%), nausea (49% vs 47%), headache (33% vs 22%), vomiting (25% vs 23%), alopecia (25% vs 28%), diarrhea (22% vs 26%), and decreased appetite (21% vs 22%).

Clinically relevant adverse reactions in <20% of patients who received TALZENNA included abdominal pain (19%), dizziness (17%), dysgeusia (10%), dyspepsia (10%), stomatitis (8%), and febrile neutropenia (0.3%).

Effect of P-gp Inhibitors: Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the dose of TALZENNA. When the P‑gp inhibitor is discontinued, increase the dose of TALZENNA. Coadministration of TALZENNA with these P‑gp inhibitors increased talazoparib concentrations, which may increase the risk of adverse reactions.

Monitor for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with other P‑gp inhibitors.

Effect of BCRP Inhibitors: Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor. Coadministration of TALZENNA with BCRP inhibitors may increase talazoparib exposure, which may increase the risk of adverse reactions.

Reduce the recommended dosage of TALZENNA in patients with moderate (CLcr 30 – 59 mL/min) and severe (CLcr 15 – 29 mL/min) renal impairment. Monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions. No dose adjustment is recommended for patients with mild renal impairment (CLcr 60 – 89 mL/min). TALZENNA has not been studied in patients requiring hemodialysis.

Indication

TALZENNA is indicated as a single agent 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.