rade 1 in 20%, and Grade 2 in 8%.
#
Includes fatigue and asthenia.
Blood and lymphatic system disorders
Anemia† 53 38 1 18 4 1
Neutropenia‡ 35 18 3 43 20 16
Thrombocytopenia§ 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
Alopecia¶ 25 0 0 28 0 0
General disorders and administration site conditions
Fatigue# 62 3 0 50 5 0
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 4 Laboratory Abnormalities Reported in ≥25% of Patients in EMBRACA
EMBRACA Study
TALZENNA
N*=286 (%) Chemotherapy
N*=126 (%)
Parameter Grades 1–4 Grade 3 Grade 4 Grades 1–4 Grade 3 Grade 4
Abbreviation: N=number of patients.
*
This number represents the safety population. The derived values in the table are based on the total number of eva luable patients for each laboratory parameter.
†
This number represents non-fasting glucose.
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 glucose† 54 2 0 51 2 0
Increase in aspartate aminotransferase 37 2 0 48 3 0
Increase in alkaline phosphatase 36 2 0 34 2 0
Increase in alanine aminotransferase 33 1 0 37 2 0
Decrease in calcium 28 1 0 16 0 0
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on TALZENNA
Effect of P-gp Inhibitors
Coadministration with P-gp inhibitors may increase talazoparib exposure.
In the clinical studies, coadministration with P-gp inhibitors including amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil resulted in an approximate 45% increase in talazoparib exposure and an increase in the rate of TALZENNA dose reduction. If coadministration of TALZENNA with these P-gp inhibitors cannot be avoided, reduce the TALZENNA dose [see Dosage and Administration (2.5)]. When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the inhibitor) to the dose used prior to the initiation of the P-gp inhibitor [see Dosage and Administration (2.5), Cli |
