Active Ingredient: Talazoparib
Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 0.5 milligrams talazoparib, once daily.
The recommended dose is 0.5 mg talazoparib in combination with 160 mg enzalutamide once daily. Patients should be treated until disease progression or unacceptable toxicity occurs.
Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Please refer to the full enzalutamide product information for the recommended posology.
If the patient vomits or misses a dose of talazoparib, 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 when used in combination with enzalutamide 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 when used in combination with enzalutamide (prostate cancer):
Talazoparib dose level (prostate cancer) | |
---|---|
Recommended starting dose | 0.5 mg once daily |
First dose reduction | 0.35 mg once daily |
Second dose reduction | 0.25 mg once daily |
Third dose reduction | 0.1 mg once daily |
Please refer to the full enzalutamide product information for dose adjustment for adverse reactions associated with enzalutamide.
The intended use of the 0.1 mg capsule is to support dose modifications and it is not interchangeable with other strengths.
It can be taken with or without food.
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