Posology : מינונים

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)].

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.

To avoid contact with the capsule content, TALZENNA 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             Resume TALZENNA levels resolve to
Hemoglobin <8 g/dL                          ≥9 g/dL
Platelet count <50,000/μL                   ≥75,000/μL                          Resume TALZENNA at a reduced dose
Neutrophil count <1,000/μL                  ≥1500/µL
Consider resuming TALZENNA
Non-hematologic Grade 3 or Grade 4          Grade 1 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 (8.7), 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)].

Pediatric Use

TALZENNA is not indicated for pediatric patients.
The safety and effectiveness of TALZENNA have not been established in pediatric patients.