atients who received PARP inhibitors [see Warnings and Precautions (5.1)].
Myelosuppression: Advise patients that TALZENNA may affect hematopoiesis and can cause anemia, leukopenia/neutropenia, and/or thrombocytopenia [see Warnings and Precautions (5.2)].
Administration Instructions: Advise patients that TALZENNA can be taken once daily with or without food. Instruct patients that if they miss a dose of TALZENNA, they should take their next normal dose at the usual time. Also advise patients to swallow each capsule whole, and that capsules must not be opened or dissolved [see Dosage and Administration (2.2)].
Embryo-Fetal Toxicity: Advise females to 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 [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with TALZENNA and for at least 7 months after the last dose. Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for at least 4 months after receiving the last dose of TALZENNA [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].
Lactation: Advise patients not to breastfeed while taking TALZENNA and for at least 1 month after receiving the last dose [see Use in Specific Populations (8.2)].
This product's label may have been updated. For current full prescribing information, please visit www.talzenna.com.
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LAB-1271-1.0
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued 10/2018
PATIENT INFORMATION
TALZENNA™ (Tal-ZEN-ah)
(talazoparib)
capsules
What is the most important information I should know about TALZENNA?
TALZENNA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with TALZENNA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with TALZENNA.
Symptoms of low blood cell counts are common during treatment with TALZENNA, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with TALZENNA:
weakness
weight loss
fever
frequent infections
blood in urine or stool
shortness of breath
feeling very tired
bruising or bleeding more easily
Your healthcare provider will do blood tests to check your blood cell counts:
before treatment with TALZENNA
every month during treatment with TALZENNA
weekly if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with TALZENNA until your blood cell counts improve.
See "What are the possible side effects of TALZENNA?" below for other side effects of TALZENNA.
What is TALZENNA?
TALZENNA is a prescription medicine used to treat adults with:
a certain type of breast cancer (human epidermal growth factor receptor 2 [HER2]-negative), and
an abnormal inherited BRCA gene, and
whose cancer has spread to other parts of the body (locally advanced or metastatic).
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