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AboutAboutUnmet needs in HRRm mCRPCMOATALAPRO-2 study designBaseline patient characteristicsTreatment guidelinesHRRm Testing

HRRm Testing

Why and when to test

How to test

EfficacyEfficacyrPFS: Primary and follow-uprPFS in patient subgroupsOSORRPSASafetySafetyWarnings and precautionsAdverse reactionsDosingDosingDosing and administrationDose modificationsSoft gelatin capsuleTherapy management strategiesSupportSupportCoverage and accessPatient supportResourcesContact a rep
Prescribing Information for Soft Gelatin CapsulesPrescribing Information for Hard CapsulesIndicationPatient SiteSee Information on a Different Indication
Therapy Management and Adverse Reaction Monitoring StrategiesRecommendations that may help manage common adverse reactions reported with TALZENNA + XTANDIHemoglobin Decreased and Anemia

Grade/Symptoms

Therapy Management

Tips for Patients

Signs and Symptoms

A disorder characterized by a reduction in the amount of hemoglobin in 100 mL of blood. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability.

CTCAE Grades1
Scroll left to view table

Example

GRADE DESCRIPTION (Hemoglobin Count)*
1 < LLN–10.0 g/dL; < LLN–6.2 mmol/L; < LLN–100 g/L
2 < 10.0–8.0 g/dL; < 6.2–4.9 mmol/L; < 100–80 g/L
3 < 8.0 g/dL; < 4.9 mmol/L; < 80 g/L; transfusion indicated
4 Life-threatening consequences; urgent intervention indicated
CTCAE, Common Terminology Criteria for Adverse Events; LLN, lower limit of normal; NCI, National Cancer Institute.References*Based on the NCI Common Terminology Criteria for Adverse Events (version 4.03) severity scale for anemia.Reference:U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Washington, DC; 2017.
Incidence
  • Hemoglobin decreased in 79% of patients treated with TALZENNA + XTANDI (41% had Grade 3 and 0% had Grade 4)*1
  • Grade ≥ 3 anemia was reported in 45% of patients treated with TALZENNA + XTANDI*1
Dose Modifications to Help Manage Grade 3/4 Anemia1 Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.1

TALZENNA dosing information HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer.*Data presented in the 2 bullets represent patients with HRRm mCRPC in TALAPRO-2 (n = 197) and in the full USPI prostate cancer safety population (N = 511).1†Strategies were not evaluated specifically for TALZENNA and should not replace clinical judgment. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions associated with XTANDI.References:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.Referenced with permission from the NCCN Guidelines for Patients® for Anemia and Neutropenia - Low Red and White Blood Cell Counts, 2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 25, 2024. To view the most recent and complete version of the NCCN Guidelines for Patients, go online to NCCN.org/patientguidelines.American Cancer Society. Low red blood cell counts (anemia). Accessed September 12, 2024. https://www.cancer.org/content/dam/CRC/PDF/Public/7529.00.pdf
Tips for Your Patients to Help Manage Anemia *Strategies were not evaluated specifically for TALZENNA and should not replace clinical judgement. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions.References: American Cancer Society. Low red blood cell counts (anemia). Accessed September 12, 2024. https://www.cancer.org/content/dam/CRC/PDF/Public/7529.00.pdfU.S. Department of Health and Human Services: National Institutes of Health. Managing chemotherapy side effects: anemia. National Cancer Institute. September 12, 2024. https://cinj.org/sites/cinj/files/documents/NCI-anemia-sm.pdfCity of Hope. Anemia. Accessed September 12, 2024. https://www.cancercenter.com/integrative-care/anemiaCity of Hope. How to stay hydrated during cancer treatment. Accessed September 12, 2024. https://www.cancercenter.com/community/ blog/2020/06/staying-hydrated
Neutrophils Decreased and Neutropenia

Grade/Symptoms

Therapy Management

Tips for Patients


Signs and Symptoms

Signs and Symptoms

A finding based on laboratory test results that indicate a decrease in number of white blood cells in a blood specimen.

CTCAE Grades1

CTCAE Grades1

Scroll left to view table

Example

GRADE DESCRIPTION (White Blood Cell Count)
1 < LLN–3000/µL; < LLN–3.0 X 10e9/L
2 < 3000–2000/µL; < 3.0–2.0 X 10e9/L
3 < 2000–1000/µL; < 2.0–1.0 X 10e9/L
4 < 1000/µL; < 1.0 x 10e9/L
CTCAE, Common Terminology Criteria for Adverse Events; LLN, lower limit of normal.Reference: U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Washington, DC; 2017.
Incidence
  • Neutrophils decreased in 60% of patients treated with TALZENNA + XTANDI (19% of patients had Grade 3/4 neutropenia)*1
  • Grade ≥ 3 neutropenia was reported in 18% of patients treated with TALZENNA + XTANDI*1
Dose Modifications to Help Manage Grade 3/4 Neutropenia1 Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.1

TALZENNA dosing information HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer.*Data presented in the 2 bullets represent patients with HRRm mCRPC in TALAPRO-2 (n = 197) and in the full USPI prostate cancer safety population (N = 511).1†Strategies were not evaluated specifically for TALZENNA and should not replace clinical judgment. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions associated with XTANDI.References:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.U.S. Department of Health and Human Services: National Institutes of Health. Infection and neutropenia during cancer treatment. National Cancer Institute. Accessed September 12, 2024. https://www.cancer.gov/about-cancer/treatment/side-effects/infectionReferenced with permission from the NCCN Guidelines for Patients® for Anemia and Neutropenia - Low Red and White Blood Cell Counts, 2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 25, 2024. To view the most recent and complete version of the NCCN Guidelines for Patients, go online to NCCN.org/patientguidelines.
Tips for Your Patients to Help Manage Neutropenia1 Reference:
U.S. Department of Health and Human Services: National Institutes of Health. Infection and neutropenia during cancer treatment. National Cancer Institute. Accessed September 12, 2024. https://www.cancer.gov/about-cancer/treatment/side-effects/infection
Platelets Decreased and Thrombocytopenia

Grade/Symptoms

Therapy Management

Tips for Patients

Signs and Symptoms

A disorder characterized by a decrease in the number of platelets in a blood specimen.

CTCAE Grades1
Scroll left to view table
GRADE DESCRIPTION (Platelet Count)
1 < LLN–75,000/µL; < LLN–75.0 X 10e9/L
2 < 75,000–50,000/µL; < 75.0–50.0 X 10e9/L
3 < 50,000–25,000/µL; < 50.0–25.0 X 10e9/L
4 < 25,000/µL; < 25.0 x 10e9/L

Example

CTCAE, Common Terminology Criteria for Adverse Events; LLN, lower limit of normal.Reference: U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Washington, DC; 2017.
Incidence
  • Platelets decreased in 45% of patients treated with TALZENNA + XTANDI (9% of patients had Grade 3/4)*1
  • Grade ≥ 3 thrombocytopenia was reported in 8% of patients treated with TALZENNA + XTANDI*1
Dose Modifications to Help Manage Grade 3/4 Thrombocytopenia1 Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.1

TALZENNA dosing information HRRm, homologous recombination repair gene-mutated; mCRPC, metastatic castration-resistant prostate cancer.*Data presented in the 2 bullets represent patients with HRRm mCRPC in TALAPRO-2 (n = 197) and in the full USPI prostate cancer safety population (N = 511).1†Strategies were not evaluated specifically for TALZENNA and should not replace clinical judgment. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions associated with XTANDI.References:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.U.S. Department of Health and Human Services: National Cancer Institute. Bleeding and bruising (thrombocytopenia) and cancer treatment. Reviewed December 29, 2022. Accessed September 12, 2024. https://www.cancer.gov/about-cancer/treatment/side-effects/bleeding-bruisingReferenced with permission from the NCCN Guidelines for Patients® for Anemia and Neutropenia - Low Red and White Blood Cell Counts, 2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 25, 2024. To view the most recent and complete version of the NCCN Guidelines for Patients, go online to NCCN.org/patientguidelines.
Tips for Your Patients to Help Manage Thrombocytopenia References: American Cancer Society. Thrombocytopenia (low platelet count). Accessed September 12, 2024. https://www.cancer.org/content/dam/CRC/PDF/Public/8900.00.pdfU.S. Department of Health and Human Services: National Institutes of Health. Bleeding and bruising (thrombocytopenia) and cancer treatment. National Cancer Institute. Accessed September 12, 2024. https://www.cancer.gov/about-cancer/treatment/side-effects/bleeding-bruising
Fatigue

Grade/Symptoms

Therapy Management

Tips for Patients

Signs and Symptoms

A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.

CTCAE Grades1
Scroll left to view table

Example

GRADE DESCRIPTION
1 Fatigue relieved by rest
2 Fatigue not relieved by rest, limiting instrumental activities of daily living
3 Fatigue not relieved by rest, limiting self-care activities of daily living
CTCAE, Common Terminology Criteria for Adverse Events.Reference: U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Washington, DC; 2017.
Incidence
  • Fatigue occurred in 49% of patients treated with TALZENNA + XTANDI (4% of patients had Grade 3)1
Dose Modifications to Help Manage Grade 3 Fatigue1 Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.1

TALZENNA dosing informationReference:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.
Tips for Your Patients to Help Manage Cancer-Related FatigueStrategies were not evaluated specifically for TALZENNA and should not replace clinical judgement. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions. References: Mustian KM, Sprod LK, Janelsins M, Peppone LJ, Mohile S. Exercise recommendations for cancer-related fatigue, cognitive impairment, sleep problems, depression, pain, anxiety, and physical dysfunction: a review. Oncol Hematol Rev 2013;8(2):81-8. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cancer-Related Fatigue V2.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed January 14, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. U.S. Department of Veterans Affairs. Nutrition and cancer-related fatigue. Accessed September 12, 2024. https://www.nutrition.va.gov/docs/Oncology/NutritionandCancerRelatedFatigue2022.pdf
Nausea

Grade/Symptoms

Therapy Management

Tips for Patients

Signs and SymptomsA disorder characterized by a queasy sensation and/or the urge to vomit.

CTCAE Grades1
Scroll left to view table
GRADE DESCRIPTION
1 Loss of appetite without alteration in eating habits
2 Oral intake decreased without significant weight loss, dehydration, or
malnutrition
3 Inadequate oral caloric or fluid intake; tube feeding, total parenteral nutrition (TPN), or hospitalization indicated

Example

CTCAE, Common Terminology Criteria for Adverse Events.Reference: U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. Washington, DC; 2017.
Incidence
  • Nausea occurred in 21% of patients treated with TALZENNA + XTANDI (2% of patients had Grade 3)1
Dose Modifications to Help Manage Grade 3 Nausea1 Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required.1

TALZENNA dosing information *Strategies were not evaluated specifically for TALZENNA and should not replace clinical judgment. Refer to the XTANDI Prescribing Information for dose modifications for adverse reactions associated with XTANDI.References:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc.Referenced with permission from the NCCN Guidelines for Patients® for Nausea and Vomiting, 2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 25, 2024. To view the most recent and complete version of the NCCN Guidelines for Patients, go online to NCCN.org/patientguidelines.
Tips for Your Patients to Help Manage Nausea1 Reference:Referenced with permission from the NCCN Guidelines for Patients® for Nausea and Vomiting, 2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 25, 2024. To view the most recent and complete version of the NCCN Guidelines for Patients, go online to NCCN.org/patientguidelines.
Proactively monitor for potential adverse reactions and lab abnormalities1Monitoring patients’ hematologic toxicity1
  • Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy
  • Monitor blood counts monthly during treatment withTALZENNA
  • ​​​​​​​For prolonged hematological toxicities, interrupt TALZENNA and monitor blood counts weekly until recovery. If counts do not recover within 4 weeks, discontinue TALZENNA and refer patients to a hematologist
  • Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy​​​​​
  • 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, discontinue TALZENNA and refer patients to a hematologist
  • Do not start TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy
  • 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, discontinue TALZENNA and refer patients to a hematologist
Monitoring adverse reactions for patients on P-gp inhibitors1
  • The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with XTANDI has not been studied
  • Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor
Monitoring patients taking breast cancer resistance protein (BCRP) inhibitors1
  • Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor
Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a BCRP inhibitor.

Monitoring patients with renal impairment1

  • ​​​​​​​
  • No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis
  • The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30–59 mL/min) is 0.35 mg taken orally once daily in combination with XTANDI orally once daily
  • The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15–29 mL/min) is 0.25 mg taken orally once daily in combination with XTANDI orally once daily
  • Monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions
  • No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis
  • The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily in combination with enzalutamide​​​​​
  • The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide
  • Monitor patients with severe renal impairment for increased adverse reactions and modify the dosage as recommended for adverse reactions
  • No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis
CLcr, creatinine clearance; P-gp, P-glycoprotein.*CLcr 15 - 29 mL/min is considered severe renal impairment.Reference:TALZENNA [package insert] for Soft Gelatin Capsule. New York, NY: Pfizer Inc. DosingDownload the Therapy Management Guide Download the guide LoadingReview baseline patient characteristics from TALAPRO-2 Learn more Loading

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INDICATION

TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

WARNINGS and PRECAUTIONS

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 consisting of anemia, neutropenia, and/or thrombocytopenia have been reported in patients treated with TALZENNA. 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 TALZENNA can cause fetal harm when administered to pregnant women. 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. 

ADVERSE REACTIONS

Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). Fatal adverse reactions occurred in 1.5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).

The most common adverse reactions (≥ 10%, all Grades), including laboratory abnormalities, for patients in the TALAPRO-2 study who received TALZENNA in combination with enzalutamide vs patients receiving placebo with enzalutamide were hemoglobin decreased (79% vs 34%), neutrophils decreased (60% vs 18%), lymphocytes decreased (58% vs 36%), fatigue (49% vs 40%), platelets decreased (45% vs 8%), calcium decreased (25% vs 11%), nausea (21% vs 17%), decreased appetite (20% vs 14%), sodium decreased (22% vs 20%), phosphate decreased (17% vs 13%), fractures (14% vs 10%), magnesium decreased (14% vs 12%), dizziness (13% vs 9%), bilirubin increased (11% vs 7%), potassium decreased (11% vs 7%), and dysgeusia (10% vs 4.5%).

Clinically relevant adverse reactions in <10% of patients who received TALZENNA with enzalutamide included abdominal pain (9%), vomiting (9%), alopecia (7%), dyspepsia (4%), venous thromboembolism (3%) and stomatitis (2%).

Based on animal studies, TALZENNA may impair fertility in males of reproductive potential.

DRUG INTERACTIONS

Coadministration with P-gp inhibitors The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken in combination with enzalutamide has not been studied. Monitor patients for increased adverse reactions and modify the dosage as recommended for adverse reactions when TALZENNA is coadministered with a P-gp inhibitor.

Coadministration with 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.

USE IN SPECIFIC POPULATIONS

Renal Impairment The recommended dosage of TALZENNA for patients with moderate renal impairment (CLcr 30 - 59 mL/min) is 0.35 mg taken orally once daily in combination with enzalutamide. The recommended dosage of TALZENNA for patients with severe renal impairment (CLcr 15 - 29 mL/min) is 0.25 mg taken orally once daily in combination with enzalutamide. No dose adjustment is required for patients with mild renal impairment. TALZENNA has not been studied in patients requiring hemodialysis.

Please see the Full Prescribing Information for soft gelatin capsules and hard capsules for TALZENNA.

Please see the XTANDI Prescribing Information for safety information about XTANDI.

INDICATION
TALZENNA (talazoparib) is indicated in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).