TALZENNA SIDE EFFECTS

  • Generic Name: talazoparib capsules
  • Brand Name: Talzenna
  • Drug Class: How Do PARP Inhibitors Work?
Last updated on MDtodate: 10/12/2022

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 (%)
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.

 

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 (%)
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.

 

SRC: NLM .