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Talzenna is a brand name for Talazoparib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Take TALZENNA with or without food. 4 ) Breast Cancer • The recommended dosage of TALZENNA is 1 mg taken orally once daily until disease progression or unacceptable toxicity. 2 ) • For adverse reactions, consider dosing interruption or dose reduction.
5 mg taken orally once daily with enzalutamide until disease progression or unacceptable toxicity. 3 ) • Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
gov/companiondiagnostics . 1) ] . 2) ] . An FDA-approved test for the detection of HRR gene mutations for use with TALZENNA is not currently available. 2 Recommended Dosage for g BRCA m HER2-negative Locally Advanced or Metastatic Breast Cancer The recommended dosage of TALZENNA is 1 mg taken orally once daily, until disease progression or unacceptable toxicity.
5 mg taken orally once daily with enzalutamide until disease progression or unacceptable toxicity. Refer to the enzalutamide prescribing information for recommended enzalutamide dosing information. Patients receiving TALZENNA and enzalutamide should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
4 Administration Take TALZENNA with or without food. Swallow TALZENNA capsules whole. Do not open or dissolve. If a patient vomits or misses a dose of TALZENNA, instruct them to take the next prescribed dose at the usual time. 5 Dosage Modifications for Adverse Reactions To manage adverse reactions, consider interruption of treatment with or without dose reduction based on severity and clinical presentation.
Recommended dose reductions are indicated in Table 1 and Table 2. Treatment with TALZENNA should be discontinued if more than 3 dose reductions are required. g BRCA m HER2-negative Locally Advanced or Metastatic Breast Cancer Table 1.
25 mg once daily HRR Gene-mutated mCRPC Table 2. 1 mg once daily Refer to the enzalutamide prescribing information for dose modifications for adverse reactions associated with enzalutamide. 2) ] . Table 3. 7) ] . 7) ] . 7) ] . 7) ] . 7 Dosage Modifications for P-glycoprotein Inhibitors g BRCA m HER2-negative Locally Advanced or Metastatic Breast Cancer Avoid coadministration of TALZENNA with the following P-glycoprotein (P-gp) inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil.
2) ] Most common adverse reactions (≥20%) as a single agent, including laboratory abnormalities, are: • Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite.
1 ) Most common adverse reactions (≥10%) in combination with enzalutamide, including laboratory abnormalities, are: • Hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5 mg daily with enzalutamide in 511 patients enrolled in the TALAPRO-2 trial that included 197 patients with HRR gene-mutated mCRPC. 1) ] . EMBRACA was a randomized, open-label, multi-center study in which 412 patients received either TALZENNA 1 mg once daily (N=286) or a chemotherapy agent (capecitabine, eribulin, gemcitabine, or vinorelbine) of the healthcare provider's choice (N=126) until disease progression or unacceptable toxicity.
9 months in patients who received chemotherapy. 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).
5 WARNINGS AND PRECAUTIONS • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) : MDS/AML occurred in patients exposed to TALZENNA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed.
1 ) • Myelosuppression : TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. 2 ) • Embryo-Fetal Toxicity : TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception.
1 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. 4% (3 out of 788) of solid tumor patients treated with TALZENNA as a single agent in clinical studies.
1) ] . 3, 1, 2, 3, and 5 years. 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. 1) ] . Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 39%, 21%, and 15% of patients receiving TALZENNA as a single agent. 3% of patients. In TALAPRO-2, Grade ≥3 anemia, neutropenia, and thrombocytopenia were reported, respectively, in 48%, 19%, and 9% of patients receiving TALZENNA and enzalutamide.
Forty-two percent of patients (216/511) required a red blood cell transfusion, including 25% (127/511) who required more than one transfusion. 4% of patients. Withhold TALZENNA until patients have adequately recovered from hematological toxicity caused by previous therapy.
4 CONTRAINDICATIONS None. None. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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75 mg taken orally once daily. 1) ] . 5) ] .
Permanent discontinuation due to adverse reactions occurred in 5% of TALZENNA patients. Dosing interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA; dose reductions due to any cause occurred in 53% of TALZENNA patients.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, neutrophils decreased, lymphocytes decreased, platelets decreased, fatigue, glucose increased, aspartate aminotransferase increased, alkaline phosphatase increased, alanine aminotransferase increased, calcium decreased, nausea, headache, vomiting, alopecia, diarrhea, and decreased appetite.
Table 5 and Table 6 summarize the most common adverse reactions and laboratory abnormalities, respectively, in patients treated with TALZENNA or chemotherapy in the EMBRACA study. Table 5. 03. (≥20%) in Patients Receiving TALZENNA in EMBRACA Adverse Reactions TALZENNA N=286 (%) Chemotherapy N=126 (%) Grades 1–4 Grade 3 Grade 4 Grades 1–4 Grade 3 Grade 4 Abbreviation: N=number of patients.
General Disorders and Administration Site Conditions Fatigue Includes fatigue and asthenia. 3%). Table 6. Select Laboratory Abnormalities (≥25%) of Patients in EMBRACA TALZENNA N 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.
=286 (%) Chemotherapy N =126 (%) Parameter Grades 1–4 Grade 3 Grade 4 Grades 1–4 Grade 3 Grade 4 Abbreviation: N=number of patients. 8 Platelets decreased 55 11 4 29 2 0 Glucose increased This number represents non-fasting glucose. 2) ] .
5 mg with enzalutamide 160 mg once daily (n=197), or placebo with enzalutamide 160 mg once daily (n=199) until disease progression or unacceptable toxicity. Among patients receiving TALZENNA, 86% were exposed for 6 months or longer, 60% were exposed for greater than one year, and 18% were exposed for greater than two years.
Serious adverse reactions of TALZENNA with enzalutamide occurred in 30% of patients. Serious adverse reactions reported in >2% of patients included anemia (9%) and fracture (3%). 5% of patients, including pneumonia, COVID infection, and sepsis (1 patient each).
Permanent discontinuation of TALZENNA due to adverse reactions occurred in 10% of patients treated in the TALZENNA with enzalutamide arm. The most common adverse reactions which resulted in permanent discontinuation of TALZENNA were anemia (4%), fatigue, bone fracture, ischemic heart disease, and spinal cord compression (1% each).
Dosage interruption of TALZENNA due to adverse reactions occurred in 58% of patients treated in the TALZENNA with enzalutamide arm. The most common adverse reactions which resulted in dose interruption of TALZENNA were anemia (42%), neutropenia (15%), and platelet count decreased (9%) and fatigue (5%).
Dose reduction of TALZENNA due to adverse reactions occurred in 52% of patients treated in the TALZENNA with enzalutamide arm. The most common adverse reactions which resulted in dose reduction of TALZENNA were anemia (43%), neutrophil count decreased (15%), platelet count decreased (6%), and fatigue (4%).
The most common adverse reactions (≥10%), including laboratory abnormalities, in patients who received TALZENNA with enzalutamide were hemoglobin decreased, neutrophils decreased, lymphocytes decreased, fatigue, platelets decreased, calcium decreased, nausea, decreased appetite, sodium decreased, phosphate decreased, fractures, magnesium decreased, dizziness, bilirubin increased, potassium decreased, and dysgeusia.
Table 7 and Table 8 summarize the most common adverse reactions and laboratory abnormalities, respectively, in the TALAPRO-2 study. Table 7. 03. (≥10%) in Patients Receiving TALZENNA (with a Difference Between Arms of ≥2%) in TALAPRO-2 Abbreviation: N=number of patients.
TALZENNA with Enzalutamide N=197 Placebo with Enzalutamide N=199 Grades 1-4 % Grade 3 % Grade 4 % Grades 1-4 % Grade 3 % Grade 4 % Fatigue Includes fatigue and asthenia. 5 Decreased appetite 20 1 0 14 1 1 Fractures Fractures include multiple similar terms.
5 0 Dizziness Includes dizziness, dizziness postural, vertigo. 5 0 Dysgeusia Includes ageusia, anosmia, dysgeusia. 5 0 0 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%).
Table 8. Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received TALZENNA in TALAPRO-2 Abbreviation: N=number of patients. Laboratory Abnormality TALZENNA with Enzalutamide N=197 The denominator used to calculate the rate varied from 198 to 199 in the placebo with enzalutamide arm based on the number of patients with a baseline value and at least one post-treatment value.
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Monitor blood counts monthly during treatment with TALZENNA. 5) ] . 3 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. 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. 1) ] . 1) ] .