rience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on TALZENNA
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of advanced breast cancer with TALZENNA based on the presence of germline BRCA mutations [see Indications and Usage (1), Clinical Studies (14)]. Information on the FDA-approved test for the detection of BRCA mutations is available at http://www.fda.gov/companiondiagnostics.
2.2 Recommended Dosing
The recommended dose of TALZENNA is 1 mg taken orally once daily, with or without food.
The 0.25 mg capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable toxicity occurs.
The hard capsules should be swallowed whole and must not be opened or dissolved. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
2.3 Dose 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 three dose reductions are required.
Table 1. Dose Reduction Levels for Adverse Reactions
Dose Level Dose
Recommended starting dose 1 mg (one 1 mg capsule) once daily
First dose reduction 0.75 mg (three 0.25 mg capsules) once daily
Second dose reduction 0.5 mg (two 0.25 mg capsules) once daily
Third dose reduction 0.25 mg (one 0.25 mg capsule) once daily
Table 2. Dose Modification and Management
Monitor complete blood counts monthly and as clinically indicated [see Warnings and Precautions (5.2)].
Adverse Reactions Withhold TALZENNA until levels resolve to Resume TALZENNA
Hemoglobin <8 g/dL ≥9 g/dL Resume TALZENNA at a reduced dose
Platelet count <50,000/μL ≥75,000/μL
Neutrophil count <1,000/μL ≥1500/µL
Non-hematologic Grade 3 or Grade 4 ≤Grade 1 Consider resuming TALZENNA at a reduced dose or discontinue
2.4 Dose Modifications for Patients with Renal Impairment
For patients with mode |
