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HRRm Testing
Why and when to test
How to test
reduction in the risk of radiographic disease progression or death with TALZENNA + XTANDI1,2
Superior rPFS vs XTANDI + placebo in 1L BRCAm and non-BRCA* HRRm mCRPC†‡1,2
HR = 0.45 [95% CI, 0.33-0.61]; P < 0.0001. Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with XTANDI + placebo + ADT in TALAPRO-2.1,2
TALAPRO-2: a phase 3, randomized, double-blind, placebo-controlled, multinational study compared TALZENNA + XTANDI (n = 200) vs XTANDI + placebo (n = 199) in patients with HRR gene-mutated (HRRm) mCRPC.1,2
reduction in the risk of radiographic disease progression or death with TALZENNA + XTANDI1,2
Superior rPFS vs XTANDI + placebo in 1L BRCAm and non-BRCA* HRRm mCRPC†‡1,2
HR = 0.45 [95% CI, 0.33-0.61]; P < 0.0001. Number of rPFS events by BICR: 66 (33%) with TALZENNA + XTANDI + ADT vs 104 (52%) with XTANDI + placebo + ADT in TALAPRO-2.1,2
TALAPRO-2: a phase 3, randomized, double-blind, placebo-controlled, multinational study compared TALZENNA + XTANDI (n = 200) vs XTANDI + placebo (n = 199) in patients with HRR gene-mutated (HRRm) mCRPC.1,2
Start with TALZENNA + XTANDI, the first and only PARPi + ARi combination for the 1L treatment of BRCAm and non-BRCA* HRRm mCRPC1,2
Start with TALZENNA + XTANDI, the first and only PARPi + ARi combination for the 1L treatment of BRCAm and non-BRCA* HRRm mCRPC1,2
Test patients with mCRPC for HRR alterations1
Select patients for the treatment of HRRm mCRPC with TALZENNA based on the presence of alterations in genes directly or indirectly involved in HRR: ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, and RAD51C
See additional information about these Warnings and Precautions and Important Safety Information in the safety section below.
See key criteria from TALAPRO-2, including baseline HRR gene alteration status
Review the demonstrated safety profile for TALZENNA + XTANDI from the TALAPRO-2 study
Learn about TALZENNA once-daily oral dosing with no fasting or food restrictions
To report an adverse event, please call 1-800-438-1985
Pfizer for Professionals 1-800-505-4426
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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).
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 has 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 (Grade ≥10, all Grades), including laboratory abnormalities, for patients in the TALAPR0-2 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 Full Prescribing Information for soft gelatin capsules and hard capsules for TALZENNA.
Please see the XTANDI Prescribing Information for safety information about XTANDI.