HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TALZENNA (talazoparib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
TALZENNA Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 BRCA-mutated (gBRCAm) HER2-negative Locally Advanced or Metastatic Breast Cancer
...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Information on the FDA-approved...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Myelodysplastic Syndrome/Acute Myeloid Leukemia [see...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on TALZENNA
Effect of P-gp Inhibitors
...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
Did you find an answer to your question?
Yes
No
Overdosage
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...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme. The chemical name of talazoparib tosylate is (8S,9R...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
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...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with talazoparib.
...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
14.1 Deleterious or Suspected Deleterious Germline BRCA-mutated HER2-negative Locally Advanced or Metastatic Breast Cancer
...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
TALZENNA is supplied in strengths and package configurations as described in Table 12:
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- •
- MDS/AML: Advise patients to contact their healthcare...
Did you find an answer to your question?
Yes
No
Other
This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.pfizer.com.
...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.