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TALZENNA (talazoparib)

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TALZENNA Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm)...

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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...

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3 DOSAGE FORMS AND STRENGTHS

Capsules:

  • 0.25 mg capsule with an ivory cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black)
  • 0.5 mg capsule with a light pink...
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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia

Myelodysplastic Syndrome/Acute...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelodysplastic Syndrome/Acute Myeloid Leukemia [see

    6...

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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on TALZENNA

Effect of P-gp Inhibitors...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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10 OVERDOSAGE

There is no specific treatment in the event of TALZENNA overdose, and symptoms of overdose have not been established. In the event of overdose, discontinue treatment with TALZENNA, consider gastric...

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11 DESCRIPTION

Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme. The chemical name of talazoparib tosylate is (8S,9R...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with talazoparib.

...

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14 CLINICAL STUDIES

EMBRACA Study (NCT01945775)

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

TALZENNA is supplied in strengths and package configurations as described in Table 6:

...
Table 6. TALZENNA Capsules
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • MDS/AML: Advise patients to contact their...
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This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.talzenna.com.

...

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