Active Ingredient: Talazoparib
Talazoparib is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 1 milligrams talazoparib, once daily.
The recommended dose is 1 mg talazoparib once daily. Patients should be treated until disease progression or unacceptable toxicity occurs.
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.
To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and clinical presentation should be considered (see Table 1). Recommended dose reduction levels for talazoparib monotherapy are indicated in Table 2.
Complete blood count should be obtained prior to starting talazoparib therapy and monitored monthly and as clinically indicated (see Table 1).
Table 1. Dose adjustments for adverse reactions:
| Withhold talazoparib until levels resolve to | Resume talazoparib | |
|---|---|---|
| Haemoglobin <8 g/dL | ≥9 g/dL | Resume talazoparib at next lower dose |
| Platelet count <50 000/μL | ≥75 000/μL | |
| Neutrophil count <1 000/μL | ≥1 500/μL | |
| Non-haematologic adverse reaction Grade 3 or Grade 4 | ≤ Grade 1 | Consider resuming talazoparib at next lower dose or discontinue |
Table 2. Dose reduction levels for talazoparib monotherapy:
| Talazoparib dose level | |
|---|---|
| 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 |
It can be taken with or without food.
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