Medically reviewed by Drugs.com. Last updated on Oct 17, 2023.
Applies to the following strengths: 0.25 mg; 0.1 mg; 1 mg; 0.35 mg; 0.5 mg; 0.75 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer
1 mg orally once a day until disease progression or unacceptable toxicity
- Select patients based on the presence of germline BRCA mutations as determined by an FDA-approved test.
Use: For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer
Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate renal impairment (CrCl 30 to 59 mL/min): 0.75 mg orally once a day
Severe renal impairment (CrCl 15 to 29 mL/min): 0.5 mg orally once a day
Liver Dose Adjustments
No adjustment recommended
DOSE REDUCTIONS FOR ADVERSE REACTIONS:
- Recommended starting dose: 1 mg orally once daily
- First dose reduction: 0.75 mg orally once a day
- Second dose reduction: 0.5 mg orally once a day
- Third dose reduction: 0.25 mg orally once a day
- Hemoglobin less than 8 g/dL: Withhold therapy until levels resolve to 9 g/dL or greater; resume therapy at a reduced dose.
- Platelet count less than 50,000/microliters: Withhold therapy until levels resolve to 75,000 microliters or greater; resume therapy at a reduced dose.
- Neutrophil count less than 1000/microliters: Withhold therapy until levels resolve to 1500 microliters or greater; resume therapy at a reduced dose.
- Nonhematologic Grade 3 or 4: Withhold therapy until levels resolve to Grade 1 or less; Consider resuming therapy at a reduced dose or discontinue therapy.
DOSE MODIFICATIONS FOR USE WITH P-GLYCOPROTEIN (P-GP) INHIBITORS:
- Reduce the dose to 0.75 mg once daily when coadministered with certain P-gp inhibitors.
- When the P-gp inhibitor is discontinued, increase the dose (after 3 to 5 half-lives of the P-gp inhibitor) to the dose used prior to the initiation of the P-gp inhibitor.
This drug is not recommended for use in children.
Consult WARNINGS section for additional precautions.
Data not available
- This drug may be taken with or without food.
- The capsules should be swallowed whole and not opened or dissolved.
- If the patient vomits or misses a dose, an additional dose should not be taken; take the next prescribed dose at the usual time.
- Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
- Monitor complete blood counts monthly.
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
- Patients should contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions.
- Females should inform their healthcare provider if they are pregnant or become pregnant.
- Inform female patients of the risk to a fetus and potential loss of the pregnancy.
Frequently asked questions
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