TALZENNA 7 Warnings And Precautions

talazoparib

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General  
In order to receive TALZENNA, patients must have a deleterious or suspected deleterious germline mutation in a BRCA gene, as confirmed by an experienced laboratory using a validated BRCA assay. In the EMBRACA study, a majority of patient samples were sent to a centralized lab (Myriad Genetics) to confirm BRCA mutation status (BRACAnalysis).

Carcinogenesis and Mutagenesis 
Secondary primary malignancies have been reported in patients that received TALZENNA.

Myelodysplastic syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these two patients prior to developing MDS/AML was 4 months and 24 months, respectively. Both patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Complete blood counts should be obtained at baseline and monitored monthly for signs of hematologic toxicity during treatment. If MDS/AML is confirmed, TALZENNA should be discontinued.

Driving and Operating Machinery

Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. No studies have been conducted on the effects of talazoparib on the ability to drive or operate machinery. However, patients experiencing fatigue/asthenia or dizziness while taking talazoparib should exercise caution when driving or operating machinery.

Hematologic  
Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. The frequency of Grade ≥ 3 for each event in patients who received TALZENNA at 1 mg daily in clinical studies was 35.2%, 17.4%, and 16.8%, respectively. The frequency of dose modifications for anemia, neutropenia, and thrombocytopenia was 33.0%, 15.8%, and 13.4%, respectively. Discontinuations due to these events were 0.6%, 0.2%, and 0.2%, respectively (see Section 8.1 Adverse Reaction Overview).

Do not start TALZENNA until patients have recovered from hematological toxicity caused by previous therapy (≤ Grade 1).

Precautions should be taken to monitor monthly for the first 12 months of treatment and periodically thereafter for hematology parameters (complete blood counts) and signs and symptoms associated with anemia, leukopenia/neutropenia, and/or thrombocytopenia in patients receiving TALZENNA. If such events occur, dose modifications (reduction or interruption) are recommended (see Section 8.1 Adverse Reaction Overview).

Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.

Sexual Health 
Reproduction 
Based on the mechanism of action and animal studies, talazoparib has demonstrated genotoxicity, reproductive organ toxicity, and embryofetal toxicity at subtherapeutic thresholds (see Fertility, section 7.1 Special Populations, Pregnant Women and Section 16 Non-Clinical-Toxicology). Therefore, talazoparib should not be given to pregnant patients or those who plan to become pregnant during treatment. Advise pregnant women of the potential risk to the fetus as TALZENNA can cause fetal harm when administered to a pregnant woman.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving TALZENNA. A highly effective method of contraception is required for female patients of childbearing potential during treatment with TALZENNA, and for at least 7 months after completing therapy.

Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception (even after vasectomy), during treatment with TALZENNA and for at least 4 months after the final dose.

Male and female patients should not donate sperm or eggs during treatment and for 4 and 7 months after the last dose of TALZENNA, respectively.

Fertility 
There is no information on fertility in patients. Based on non-clinical findings in the testes and ovary, male and female fertility may be compromised by treatment with TALZENNA (see Section 16 Non-Clinical Toxicology).

Monitoring and Laboratory Tests

BRCA Testing 
Prior to treatment initiation, detection of a deleterious or suspected deleterious germline mutation(s) in a BRCA gene must be confirmed by an experienced laboratory using a validated test method.

Hematological testing  
Complete blood counts should be obtained at baseline and monitored monthly for the first 12 months of treatment and periodically thereafter for signs of hematologic toxicity during treatment. 

Pregnancy Testing  
A pregnancy test is recommended for females of reproductive potential prior to initiating TALZENNA treatment.

7.1 Special Populations

7.1.1 Pregnant Women

There are no clinical data from the use of TALZENNA in pregnant women. However, studies in animals have demonstrated genotoxicity and embryo-fetal toxicity including fetal malformations, decreased fetal weight, structural variations in bones and embryo-fetal death at sub therapeutic thresholds (see Section 16 Non-Clinical Toxicology). Therefore, TALZENNA can cause fetal harm when administered to a pregnant woman. TALZENNA should not be used during pregnancy or for women of childbearing potential not using contraception.

Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception (even after vasectomy), during treatment with TALZENNA and for at least 4 months after the final dose. If a female partner of a male patient receiving TALZENNA becomes pregnant, she should be apprised of the potential hazard to the fetus and the potential loss of the pregnancy.

7.1.2 Breast-feeding

It is unknown whether TALZENNA is excreted in human breast milk. A serious risk to newborns/infants cannot be excluded. Therefore, breastfeeding is not recommended during treatment with TALZENNA and for at least 1 month after the final dose.

7.1.3 Pediatrics

Pediatrics (<18 years of age): The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥65 years of age): Of the 494 patients who received TALZENNA, 85 patients were ≥65 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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7 Warnings And Precautions

General  
In order to receive TALZENNA, patients must have a deleterious or suspected deleterious germline mutation in a BRCA gene, as confirmed by an experienced laboratory using a validated BRCA assay. In the EMBRACA study, a majority of patient samples were sent to a centralized lab (Myriad Genetics) to confirm BRCA mutation status (BRACAnalysis).

Carcinogenesis and Mutagenesis 
Secondary primary malignancies have been reported in patients that received TALZENNA.

Myelodysplastic syndrome/Acute Myeloid Leukemia (MDS/AML) have been reported in patients who received TALZENNA. Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumor patients treated with TALZENNA in clinical studies. The duration of TALZENNA treatment in these two patients prior to developing MDS/AML was 4 months and 24 months, respectively. Both patients had received previous chemotherapy with platinum agents and/or other DNA damaging agents including radiotherapy.

Complete blood counts should be obtained at baseline and monitored monthly for signs of hematologic toxicity during treatment. If MDS/AML is confirmed, TALZENNA should be discontinued.

Driving and Operating Machinery

Due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. No studies have been conducted on the effects of talazoparib on the ability to drive or operate machinery. However, patients experiencing fatigue/asthenia or dizziness while taking talazoparib should exercise caution when driving or operating machinery.

Hematologic  
Myelosuppression consisting of anemia, neutropenia, and/or thrombocytopenia, have been reported in patients treated with TALZENNA. The frequency of Grade ≥ 3 for each event in patients who received TALZENNA at 1 mg daily in clinical studies was 35.2%, 17.4%, and 16.8%, respectively. The frequency of dose modifications for anemia, neutropenia, and thrombocytopenia was 33.0%, 15.8%, and 13.4%, respectively. Discontinuations due to these events were 0.6%, 0.2%, and 0.2%, respectively (see Section 8.1 Adverse Reaction Overview).

Do not start TALZENNA until patients have recovered from hematological toxicity caused by previous therapy (≤ Grade 1).

Precautions should be taken to monitor monthly for the first 12 months of treatment and periodically thereafter for hematology parameters (complete blood counts) and signs and symptoms associated with anemia, leukopenia/neutropenia, and/or thrombocytopenia in patients receiving TALZENNA. If such events occur, dose modifications (reduction or interruption) are recommended (see Section 8.1 Adverse Reaction Overview).

Supportive care with or without blood and/or platelet transfusions and/or administration of colony stimulating factors may be used as appropriate.

Sexual Health 
Reproduction 
Based on the mechanism of action and animal studies, talazoparib has demonstrated genotoxicity, reproductive organ toxicity, and embryofetal toxicity at subtherapeutic thresholds (see Fertility, section 7.1 Special Populations, Pregnant Women and Section 16 Non-Clinical-Toxicology). Therefore, talazoparib should not be given to pregnant patients or those who plan to become pregnant during treatment. Advise pregnant women of the potential risk to the fetus as TALZENNA can cause fetal harm when administered to a pregnant woman.

Women of childbearing potential should be advised to avoid becoming pregnant while receiving TALZENNA. A highly effective method of contraception is required for female patients of childbearing potential during treatment with TALZENNA, and for at least 7 months after completing therapy.

Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception (even after vasectomy), during treatment with TALZENNA and for at least 4 months after the final dose.

Male and female patients should not donate sperm or eggs during treatment and for 4 and 7 months after the last dose of TALZENNA, respectively.

Fertility 
There is no information on fertility in patients. Based on non-clinical findings in the testes and ovary, male and female fertility may be compromised by treatment with TALZENNA (see Section 16 Non-Clinical Toxicology).

Monitoring and Laboratory Tests

BRCA Testing 
Prior to treatment initiation, detection of a deleterious or suspected deleterious germline mutation(s) in a BRCA gene must be confirmed by an experienced laboratory using a validated test method.

Hematological testing  
Complete blood counts should be obtained at baseline and monitored monthly for the first 12 months of treatment and periodically thereafter for signs of hematologic toxicity during treatment. 

Pregnancy Testing  
A pregnancy test is recommended for females of reproductive potential prior to initiating TALZENNA treatment.

7.1 Special Populations

7.1.1 Pregnant Women

There are no clinical data from the use of TALZENNA in pregnant women. However, studies in animals have demonstrated genotoxicity and embryo-fetal toxicity including fetal malformations, decreased fetal weight, structural variations in bones and embryo-fetal death at sub therapeutic thresholds (see Section 16 Non-Clinical Toxicology). Therefore, TALZENNA can cause fetal harm when administered to a pregnant woman. TALZENNA should not be used during pregnancy or for women of childbearing potential not using contraception.

Advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception (even after vasectomy), during treatment with TALZENNA and for at least 4 months after the final dose. If a female partner of a male patient receiving TALZENNA becomes pregnant, she should be apprised of the potential hazard to the fetus and the potential loss of the pregnancy.

7.1.2 Breast-feeding

It is unknown whether TALZENNA is excreted in human breast milk. A serious risk to newborns/infants cannot be excluded. Therefore, breastfeeding is not recommended during treatment with TALZENNA and for at least 1 month after the final dose.

7.1.3 Pediatrics

Pediatrics (<18 years of age): The safety and efficacy of TALZENNA in children and adolescents <18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥65 years of age): Of the 494 patients who received TALZENNA, 85 patients were ≥65 years of age. No overall differences in safety or effectiveness of TALZENNA were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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