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AboutTALZENNA MoATalzenna MoAgBRCA testingIdentifying patientsGuidelinesStudy designStudy designBaseline characteristicsEfficacy & SafetyTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesPrescribing InformationSupport & ResourcesSupport & ResourcesMaterialsElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
Presribing Information Talzenna ® 0.1 mg, 0.25 mg and 1 mg hard capsules IE Prescribing information: 

Before prescribing Talzenna (talazoparib) please refer to the full Summary of Product Characteristics (SmPC). Presentation: Each 0.1 mg hard capsule contains talazoparib tosylate equivalent to 0.1 mg talazoparib.  Each 0.25 mg hard capsule contains talazoparib tosylate equivalent to 0.25 mg talazoparib.  Each 1 mg hard capsule contains talazoparib tosylate equivalent to 1 mg talazoparib.  Indications: Breast cancer – Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2‑mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.  Prostate cancer – Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.  Dosage and Administration: Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.  Breast cancer – patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable.  Prostate cancer – There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.  Talazenna monotherapy (breast cancer) - the recommended dose is 1 mg talazoparib once daily. Patients should be treated until disease progression or unacceptable toxicity occurs.  Talzenna in combination with enzalutamide (prostate cancer) – the recommended dose is 0.5 mg talazoparib in combination with 160 mg enzalutamide once daily. Patients should be treated until disease progression or unacceptable toxicity occurs.  Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.  Please refer to the full enzalutamide product information for the recommended posology.  To manage adverse drug reactions, interruption of treatment or dose reduction based on severity and clinical presentation should be considered (see SmPC section 4.2).  Complete blood count should be obtained prior to starting talazoparib therapy and monitored monthly and as clinically indicated.  Please refer to the full enzalutamide product information for dose adjustment for adverse reactions associated with enzalutamide.  The intended use of the 0.1 mg capsule is to support dose modifications and it is not interchangeable with other strengths.  .  Special populations: Hepatic impairment: See SmPC section 4.2. No dose adjustment is required for patients with mild, moderate or severe hepatic impairment (see SmPC section 5.2). Talzenna in combination with enzalutamide is not recommended for use in patients with severe hepatic impairment (Child-Pugh classification C), as pharmacokinetics and safety have not been established in these patients. Renal impairment: See SmPC section 4.2. Breast cancer – no dose adjustment is required for patients with mild renal impairment. For patients with moderate renal impairment, the recommended starting dose of Talzenna is 0.75 mg once daily. For patients with severe renal impairment, the recommended starting dose of Talzenna is 0.5 mg once daily. Talzenna has not been studied in patients with CrCL < 15 mL/min or patients requiring haemodialysis. Prostate cancer – no dose adjustment is necessary for patients with mild renal impairment. For patients with moderate renal impairment the recommended dose of Talzenna is 0.35 mg once daily in combination with enzalutamide orally once daily. For patients with severe renal impairment the recommended dose of Talzenna is 0.25 mg once daily in combination with enzalutamide once daily. Talzenna has not been studied in patients with CrCL < 15 mL/min or patients requiring haemodialysis.  Elderly: No dose adjustment is necessary in elderly (≥ 65 years of age) patients.  Paediatric population: The safety and efficacy of Talzenna in children and adolescents < 18 years of age have not been established. Method of administration: Talzenna is for oral use. To avoid contact with the capsule content, the capsules should be swallowed whole, and must not be opened or dissolved. They can be taken with or without food (See SmPC section 5.2). Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Breast-feeding.  Special Warnings and Precautions: Myelosuppression: Myelosuppression consisting of anaemia, leukopenia/neutropenia, and/or thrombocytopenia, have been reported in patients treated with talazoparib (see section 4.8). Talazoparib should not be started until patients have recovered from haematological toxicity caused by previous therapy (≤ Grade 1).  Precautions should be taken to routinely monitor haematology parameters and signs and symptoms associated with anaemia, leukopenia/neutropenia, and/or thrombocytopenia in patients receiving talazoparib. If such events occur, dose modifications (reduction or interruption) are recommended.  Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate. Myelodysplastic syndrome/Acute myeloid leukaemia: Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib. Overall, MDS/AML has been reported in < 1% of solid tumour patients treated with talazoparib in clinical studies (see SmPC section 4.8). Potential contributing factors for the development of MDS/AML include previous platinum-containing chemotherapy, other DNA damaging agents or radiotherapy. Complete blood counts should be obtained at baseline and monitored monthly for signs of haematologic toxicity during treatment. If MDS/AML is confirmed, talazoparib should be discontinued.  Venous thromboembolic events: In patients with mCRPC a higher incidence of venous thromboembolic events was observed with Talzenna in combination with enzalutamide compared with enzalutamide alone. Patients should be monitored for clinical signs and symptoms of deep venous thrombosis and pulmonary embolism and treated as medically appropriate (see SmPC section 4.8).  Contraception in women of childbearing potential: 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 but not mutagenic in Ames assay (see section 5.3), and may cause foetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to the foetus (see section 4.6). Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment.  A highly effective method of contraception is required for female patients during treatment with Talzenna, and for at least 7 months after completing therapy. Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used.  Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy), during treatment with Talzenna and for at least 4 months after the final dose. Interactions: Talazoparib is a substrate for drug transporters P-gp and breast cancer resistance protein (BCRP) and it is mainly eliminated by renal clearance as unchanged compound.  Agents that may affect talazoparib plasma concentrations: P-gp inhibitors: Effect of enzalutamide: Co-administration with 160 mg enzalutamide increases talazoparib exposure approximately 2-fold. Administration of talazoparib 0.5 mg daily in combination with enzalutamide achieves approximately the same steady-state trough (Ctrough) concentration reported for talazoparib 1 mg daily (see SmPC section 5.2). When Talzenna is co-administered with enzalutamide, the Talzenna starting dose is 0.5 mg (see SmPC section 4.2). The interaction effect of doses other than 160 mg enzalutamide on talazoparib has not been quantified. The effect of co-administration of other P-gp inhibitors on talazoparib exposure when talazoparib is given in combination with enzalutamide has not been studied. If co-administration of P-gp inhibitors cannot be avoided, when Talzenna is given with enzalutamide, the patient should be monitored for potential increased adverse reactions. Effect of other P-gp inhibitors: Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co‑administration of multiple daily doses of a P-gp inhibitor, itraconazole 100 mg twice daily with a single 0.5 mg talazoparib dose increased talazoparib total exposure (AUCinf) and peak concentration (Cmax) by approximately 56% and 40%, respectively, relative to a single 0.5 mg talazoparib dose administered alone. Population pharmacokinetic (PK) analysis has also shown that concomitant use of strong P-gp inhibitors increased talazoparib exposure by 45%, relative to talazoparib given alone. Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, and verapamil) should be avoided. If co-administration with a strong P-gp inhibitor is unavoidable, the Talzenna dose should be reduced (see SmPC section 4.2). P-gp inducers: Data from a drug-drug interaction study in patients with advanced solid tumours indicated that co‑administration of single 1 mg talazoparib dose with multiple daily doses of a P-gp inducer, rifampin 600 mg, with rifampin co-administered 30 minutes before talazoparib on the day of talazoparib dosing, increased talazoparib Cmax by approximately 37% whereas AUCinf was not affected relative to a single 1 mg talazoparib dose administered alone. This is probably the net effect of both P-gp induction and inhibition by rifampin under the tested conditions in the drug-drug interaction study. No talazoparib dose adjustments are required when co‑administered with rifampin. However, the effect of other P-gp inducers on talazoparib exposure has not been studied. Other P-gp inducers (including but not limited to carbamazepine, phenytoin, and St. John’s wort) may decrease talazoparib exposure. BCRP inhibitors: The effect of BCRP inhibitors on PK of talazoparib has not been studied in vivo. Co-administration of talazoparib with BCRP inhibitors may increase talazoparib exposure. Concomitant use of strong BCRP inhibitors (including but not limited to curcumin and cyclosporine) should be avoided. If co administration of strong BCRP inhibitors cannot be avoided, patient should be monitored for potential increased adverse reactions.  Effect of acid-reducing agents: Population PK analysis indicates that co-administration of acid-reducing agents including proton pump inhibitors and histamine receptor 2 antagonists (H2RA), or other acid reducing agents had no significant impact on the absorption of talazoparib.  Systemic hormonal contraception: Drug-drug interaction studies between talazoparib and oral contraceptives have not been conducted. Fertility, pregnancy and lactation: Fertility: There is no information on fertility in patients. Based on non-clinical findings in testes (partially reversible) and ovary (reversible), Talzenna may impair fertility in males of reproductive potential.  Women of childbearing potential should not become pregnant while receiving Talzenna and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to treatment.  Women of childbearing potential must use highly effective forms of contraception prior to starting treatment with talazoparib, during treatment, and for 7 months after stopping treatment with talazoparib. Since the use of hormonal contraception is not recommended in patients with breast cancer, two non-hormonal and complementary contraception methods should be used. Male patients with female partners of reproductive potential or pregnant partners should be advised to use effective contraception (even after vasectomy) during treatment with Talzenna, and for at least 4 months after the final.  Pregnancy: There are no data from the use of Talzenna in pregnant women. Studies in animals have shown embryo foetal toxicity. Talzenna may cause foetal harm when administered to a pregnant woman. Talzenna is not recommended during pregnancy or for women of childbearing potential not using contraception.  Breast-feeding: It is unknown whether talazoparib is excreted in human breast milk. A risk to breast-fed children cannot be excluded and therefore breast-feeding is contraindicated (SmPC section 4.3) during treatment with Talzenna and for at least 1 month after the final dose.  Undesirable Effects:  The overall safety profile of Talzenna is based on pooled data from 1 088 patients, including 690 patients who received talazoparib monotherapy at 1 mg daily in clinical studies for solid tumours and 398 patients with mCRPC who received talazoparib 0.5 mg in combination with enzalutamide 160 mg in the TALAPRO‑2 study.  The most common (≥ 20%) adverse reactions in patients receiving talazoparib in these clinical studies were anaemia (55.6%), fatigue (52.5%), nausea (35.8%), neutropenia (30.3%), thrombocytopenia (25.2%) and decreased appetite (21.1%). The most common (≥ 10%) Grade ≥ 3 adverse reactions of talazoparib were anaemia (39.2%), neutropenia (16.5%) and thrombocytopenia (11.1%).  Dose modifications (dose reductions or dose interruptions) due to any adverse reaction occurred in 58.7% of patients receiving Talzenna 1 mg monotherapy. The most common adverse reactions leading to dose modifications were anaemia (33.5%), neutropenia (11.7%) and thrombocytopenia (9.9%). Permanent discontinuation due to an adverse reaction occurred in 2.9% of patients receiving Talzenna; the most common was anaemia (0.6%). The median duration of exposure was 5.6 months (range 0.0 to 70.2). Dose interruptions of Talzenna due to adverse reactions occurred in 62.1% of patients with mCRPC receiving Talzenna in combination with enzalutamide; the most common was anaemia (44%). Dose reductions of Talzenna due to adverse reactions occurred in 52.8% of patients; the most common was anaemia (43.2%). Permanent discontinuation of Talzenna due to adverse reactions occurred in 18.8% of patients; the most common was anaemia (8.3%). The median duration of talazoparib exposure was 86 weeks (range 0.29 to 186.14). Very common adverse reactions (>1/10) are Thrombocytopenia, Anaemia, Neutropenia, Leukopenia, Decreased appetite, Dizziness, Headache, Vomiting, Diarrhoea, Nausea, Abdominal pain, Alopecia and Fatigue. Commonly reported adverse reactions (>1/100 to <1/10), are Lymphopenia, Dysgeusia, Venous thromboembolism, Stomatitis and Dyspepsia. Uncommonly reported adverse reactions (≥ 1/1 000 to < 1/100) are Myelodysplastic syndrome/Acute myeloid leukaemia. Refer to SmPC section 4.8 for further information on side effects. Legal Category: Product subject to prescription which may not be renewed (A): S1A. Marketing Authorisation Number: Talzenna 0.1 mg hard capsules – EU/1/19/1377/007; Talzenna 0.25 mg hard capsules – EU/1/19/1377/001-004; Talzenna 1 mg hard capsules – EU/1/19/1377/005-006. Marketing Authorisation Holder:  Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.
For further information on this medicine please contact: Pfizer Medical Information on 1800 633 363 or at [email protected]. For queries regarding product availability please contact: Pfizer Healthcare Ireland, Pfizer Building 9, Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24 + 353 1 4676500.

Date of Preparation:  02/2024

Ref: TE 5_0

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0115 September 2024
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