TALZENNA is supplied in strengths and package configurations as described in Table 6:
|Package Configuration||Capsule Strength (mg)||NDC|
|Bottles of 30 capsules||0.25||NDC: 0069-0296-30||Ivory cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.25” in black).|
|Bottles of 30 capsules||0.5||NDC: 0069-1501-30||Light pink cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.5” in black).|
|Bottles of 30 capsules||0.75||NDC: 0069-1751-30||Light orange cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 0.75” in black).|
|Bottles of 30 capsules||1||NDC: 0069-1195-30||Light red cap (printed with “Pfizer” in black) and a white body (printed with “TLZ 1” in black).|
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- MDS/AML: Advise patients to 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. This may be a sign of hematological toxicity or a more serious uncommon bone marrow problem called MDS or AML, which have been reported in patients 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 labeling may have been updated. For the most recent prescribing information, please visit http://www.talzenna.com.
|This Patient Information has been approved by the U.S. Food and Drug Administration.||Issued 9/2021|
|PATIENT INFORMATIONTALZENNA® (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:|
|Your healthcare provider will do blood tests to check your blood cell counts:|
|What is TALZENNA? TALZENNA is a prescription medicine used to treat adults with:|
|Before taking TALZENNA, tell your healthcare provider about all of your medical conditions, including if you: |
|How should I take TALZENNA? |
|What are the possible side effects of TALZENNA?TALZENNA may cause serious side effects, including: See “What is the most important information I should know about TALZENNA?“The most common side effects of TALZENNA include:|
|TALZENNA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of TALZENNA.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store TALZENNA? Store TALZENNA at 68°F to 77°F (20°C to 25°C ).Keep TALZENNA and all medicines out of the reach of children.|
|General information about the safe and effective use of TALZENNA. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TALZENNA for a condition for which it is not prescribed. Do not give TALZENNA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TALZENNA that is written for health professionals.|
|What are the ingredients in TALZENNA?Active ingredient: talazoparib tosylateInactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide. The printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.|
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