TALZENNA SIDE EFFECTS
- Generic Name: talazoparib capsules
- Brand Name: Talzenna
- Drug Class: How Do PARP Inhibitors Work?
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelodysplastic Syndrome/Acute Myeloid Leukemia
- Myelosuppression
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.
Treatment Of gBRCAm HER2-Negative Locally Advanced Or Metastatic Breast Cancer
EMBRACA
The safety of TALZENNA as monotherapy was evaluated in gBRCAm patients with HER2-negative locally advanced or metastatic breast cancer who had previously received no more than 3 lines of chemotherapy for the treatment of locally advanced/metastatic disease. 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. The median duration of study treatment was 6.1 months in patients who received TALZENNA and 3.9 months in patients who received chemotherapy. Dosing interruptions due to an adverse reaction of any grade occurred in 65% of patients receiving TALZENNA and 50% of those receiving chemotherapy; dose reductions due to any cause occurred in 53% of TALZENNA patients and 40% of chemotherapy patients. Permanent discontinuation due to adverse reactions occurred in 5% of TALZENNA patients and 6% chemotherapy patients.
Table 1 and Table 2 summarize the most common adverse reactions and laboratory abnormalities, respectively, in patients treated with TALZENNA or chemotherapy in the EMBRACA study.
Table 1. Adverse Reactionsa (in ≥20% of Patients Receiving TALZENNA) in EMBRACA
| Adverse Reactions | TALZENNA N=286 (%) |
Chemotherapy N=126 (%) |
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| Grades 1-4 |
Grade 3 | Grade 4 | Grades 1-4 |
Grade 3 | Grade 4 | |
| Blood and lymphatic system disorders | ||||||
| Anemiab | 53 | 38 | 1 | 18 | 4 | 1 |
| Neutropeniac | 35 | 18 | 3 | 43 | 20 | 16 |
| Thrombocytopeniad | 27 | 11 | 4 | 7 | 2 | 0 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 21 | <1 | 0 | 22 | 1 | 0 |
| Nervous system disorders | ||||||
| Headache | 33 | 2 | 0 | 22 | 1 | 0 |
| Gastrointestinal disorders | ||||||
| Nausea | 49 | <1 | 0 | 47 | 2 | 0 |
| Vomiting | 25 | 2 | 0 | 23 | 2 | 0 |
| Diarrhea | 22 | 1 | 0 | 26 | 6 | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopeciae | 25 | 0 | 0 | 28 | 0 | 0 |
| General disorders and administration site conditions | ||||||
| Fatiguef | 62 | 3 | 0 | 50 | 5 | 0 |
| Abbreviations: AR=adverse reaction; CTCAE=Common Terminology Criteria for Adverse Events; NCI=National Cancer Institute; N=number of patients. a. Graded according to NCI CTCAE 4.03. b. Includes anemia, hematocrit decreased, hemoglobin decreased, and red blood cell count decreased. c. Includes febrile neutropenia, neutropenia and neutrophil count decreased. d. Includes thrombocytopenia and platelet count decreased. e. For TALZENNA, Grade 1 in 23%, and Grade 2 in 2%. For the chemotherapy arm, Grade 1 in 20%, and Grade 2 in 8%. f. Includes fatigue and asthenia. |
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The following adverse reactions have been identified in <20% of the 286 patients receiving TALZENNA, and thus were not included in Table 3: abdominal pain (19%), dizziness (17%), leukopenia (17%), dysgeusia (10%), dyspepsia (10%), stomatitis (8%), and lymphopenia (7%).
Table 2 Laboratory Abnormalities Reported in ≥25% of Patients in EMBRACA
| EMBRACA Study | ||||||
| TALZENNA Na=286 (%) |
Chemotherapy Na=126 (%) |
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| Parameter | Grades 1-4 | Grade 3 | Grade 4 | Grades 1-4 | Grade 3 | Grade 4 |
| Decrease in hemoglobin | 90 | 39 | 0 | 77 | 6 | 0 |
| Decrease in leukocytes | 84 | 14 | 0.3 | 73 | 22 | 2 |
| Decrease in neutrophils | 68 | 17 | 3 | 70 | 21 | 17 |
| Decrease in lymphocytes | 76 | 17 | 0.7 | 53 | 8 | 0.8 |
| Decrease in platelets | 55 | 11 | 4 | 29 | 2 | 0 |
| Increase in glucoseb | 54 | 2 | 0 | 51 | 2 | 0 |
| Increase in aspartat aminotransferase | 37 | 2 | 0 | 48 | 3 | 0 |
| Increase in alkaline phosphatase | 36 0 | 2 | 0 | 34 | 2 | 0 |
| Increase in alanine aminotransferase | 33 | 1 | 0 | 37 | 2 | 0 |
| Decrease in calcium | 28 | 1 | 0 | 16 | 0 | 0 |
| Abbreviation: N=number of patients. a. 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. b. This number represents non-fasting glucose. |
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SRC: NLM .