Brand Name
Talzenna
Generic Name
Talazoparib
View Brand Information FDA approval date: October 26, 2018
Classification: Poly(ADP-Ribose) Polymerase Inhibitor
Form: Capsule
What is Talzenna (Talazoparib)?
TALZENNA is a poly polymerase inhibitor indicated for: Breast Cancer As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.
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Brand Information
Talzenna (talazoparib)
1CONTRAINDICATIONS
None.
2ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Myelodysplastic Syndrome/Acute Myeloid Leukemia
- Myelosuppression
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in the WARNINGS AND PRECAUTIONS section reflect exposure to single agent TALZENNA in solid tumor clinical studies, including 286 patients enrolled in EMBRACA trial and to TALZENNA 0.5 mg daily with enzalutamide in 511 patients enrolled in the TALAPRO-2 trial that included 197 patients with HRR gene-mutated mCRPC.
3DESCRIPTION
Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8
Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as:
- 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or
- 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or
- 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or
- 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or
- 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or
- 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.
Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain hypromellose (HPMC), yellow iron oxide, red iron oxide and titanium dioxide; and the printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.
4HOW SUPPLIED/STORAGE AND HANDLING
TALZENNA is supplied in strengths and package configurations as described in Table 12:
5PATIENT COUNSELING INFORMATION
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 .
- Myelosuppression: Advise patients that TALZENNA may affect hematopoiesis and can cause anemia, leukopenia/neutropenia, and/or thrombocytopenia [see .
- 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 .
- 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 . Advise females of reproductive potential to use effective contraception during treatment with TALZENNA and for 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 4 months after receiving the last dose of TALZENNA [see .
- Lactation: Advise patients not to breastfeed while taking TALZENNA and for 1 month after receiving the last dose [see .
6PRINCIPAL DISPLAY PANEL - 1 mg Capsule Bottle Label
PROFESSIONAL SAMPLE-NOT FOR SALE
Pfizer
Talzenna
1 mg
30 Capsules
7PRINCIPAL DISPLAY PANEL - 1 mg Capsule Bottle Carton
PROFESSIONAL SAMPLE-NOT FOR SALE
Pfizer
Talzenna
1 mg
30 Capsules
8PRINCIPAL DISPLAY PANEL – 0.5 mg Capsule Bottle Label
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
Talzenna
0.5 mg
30 Capsules
9PRINCIPAL DISPLAY PANEL – 0.5 mg Capsule Bottle Carton
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
Talzenna
0.5 mg
30 Capsules
