Usual Adult Dose for Breast Cancer

1 mg orally once a day until disease progression or unacceptable toxicity

Comments:

• Select patients based on the presence of germline BRCA mutations as determined by an FDA-approved test.

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 Adjustments

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.

• 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.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• 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

• What type of drug is Talzenna?