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Talazoparib (Talzenna)

Trade Name : Talzenna

Pfizer Laboratories Div Pfizer Inc

CAPSULE

Strength 0.25 mg/1

TALAZOPARIB TOSYLATE Poly(ADP-Ribose) Polymerase Inhibitor [EPC],Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Talazoparib (Talzenna) which is also known as Talzenna and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 0.25 mg/1 per ml. Read more

Talazoparib (Talzenna) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated () human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA .
  • TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated 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. ()
  • No data
  • The recommended dose of TALZENNA is 1 mg taken as a single oral daily dose, with or without food. ()
  • Patients should be treated until disease progression or unacceptable toxicity occurs. ()
  • For adverse reactions, consider dosing interruption or dose reduction. ()
  • For patients with moderate renal impairment (CLcr 30 u2013 59 mL/min), the recommended dose of TALZENNA is 0.75 mg once daily. ()
  • For patients with severe renal impairment (Clcr 15 u2013 29 mL/min), the recommended dose of TALZENNA is 0.5 mg once daily. ()
  • Capsules:
  • Capsules: 0.25 mg, 1 mg ()
  • None.
  • None. ()
  • No data
  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. ()
  • Myelosuppression: TALZENNA may affect hematopoiesis and can cause anemia, neutropenia, and/or thrombocytopenia. ()
  • Embryo-Fetal Toxicity: TALZENNA can cause fetal harm. Advise of the potential risk to the fetus and to use effective contraception. (, , )
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Most common (u226520%) adverse reactions of any grade were: Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite. ()
  • Most common laboratory abnormalities (u226525%) were: Decreases in hemoglobin, platelets, neutrophils, lymphocytes, leukocytes, and calcium. Increases in glucose, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. ()
  • No data
  • P-gp Inhibitors: Reduce TALZENNA dose for certain P-gp inhibitors, and monitor for potential increased adverse reactions as appropriate. (, , )
  • BCRP Inhibitors: Monitor for potential increased adverse reactions. ()
  • No data
  • Lactation: Advise women not to breastfeed. ()
  • Severe Renal Impairment: Reduce TALZENNA dose and monitor for potential increased adverse reactions as appropriate. (, )
  • 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 decontamination, follow general supportive measures, and treat symptomatically.
  • Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme. The chemical name of talazoparib tosylate is (8,9)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3-pyrido[4,3,2-]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is CHFNOS, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below:
  • Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as a 0.25 mg hard hypromellose (HPMC) capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base or as a 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 white/ivory and white/light red opaque capsule shells contain 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.
  • No data
  • Carcinogenicity studies have not been conducted with talazoparib.
  • Talazoparib was clastogenic in an in vitro chromosomal aberration assay in human peripheral blood lymphocytes and in an in vivo bone marrow micronucleus assay in rats. This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of talazoparib, indicating the potential for genotoxicity in humans. Talazoparib was not mutagenic in a bacterial reverse mutation (Ames) test.
  • Fertility studies in animals have not been conducted with talazoparib. In repeat-dose toxicity studies up to 3-months duration, talazoparib-related findings in the testis and epididymis at doses u22650.04 mg/kg/day in rats and u22650.01 mg/kg/day in dogs included decreased organ weights, luminal cellular debris, reduced sperm, and degeneration/atrophy. These doses in rats and dogs resulted in approximately 1.0 times and 0.2 times, respectively, the exposure (AUC) in humans at the recommended dose. Follicular atresia of the ovary was observed in rats at doses u22651 mg/kg/day talazoparib, approximately 9.5 times the AUC in patients at the recommended dose.
  • EMBRACA Study (NCT01945775)
  • TALZENNA is supplied in strengths and package configurations as described in Table 6:
  • Storage
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F).
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • This product's label may have been updated. For current full prescribing information, please visit www.talzenna.com.
  • LAB-1271-3.0
  • No data
  • Pfizer
  • NDC 0069-0296-30
  • Talzennau2122(talazoparib) capsules
  • 0.25 mg
  • 30 CapsulesRx only
  • Pfizer
  • NDC 0069-0296-30
  • Talzennau2122(talazoparib)capsules
  • 0.25 mg
  • 30 CapsulesRx only
  • Pfizer
  • NDC 0069-1195-30
  • Talzennau2122(talazoparib) capsules
  • 1 mg
  • 30 CapsulesRx only
  • Pfizer
  • NDC 0069-1195-30
  • Talzennau2122(talazoparib)capsules
  • 1 mg
  • 30 CapsulesRx only

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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