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.
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.
|Recommended starting dose||1 mg once daily|
|First dose reduction||0.75 mg once daily|
|Second dose reduction||0.5 mg once daily|
|Third dose reduction||0.25 mg 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 moderate renal impairment (CLcr 30 – 59 mL/min), the recommended dose of TALZENNA is 0.75 mg once daily. For patients with severe renal impairment (CLcr 15 – 29 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Dose Modifications for Use with P-glycoprotein (P-gp) Inhibitors
Reduce the TALZENNA dose to 0.75 mg once daily when coadministered with certain P-gp inhibitors. For additional information on interacting P-gp inhibitors, see Drug Interactions (7.1) and Clinical Pharmacology (12.3).
When the P-gp inhibitor is discontinued, increase the TALZENNA dose (after 3–5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].