Lynparza

Warnings and Precautions (

Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:

Ovarian cancer

• •for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic
  BRCA
  -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.1 First-Line Maintenance Treatment of

  BRCA

  -mutated Advanced Ovarian Cancer

  Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic

  BRCA

  -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see

  Dosage and Administration (2.1)

  ]

  .
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )
• •in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
  • •a deleterious or suspected deleterious
    BRCA
    mutation, and/or
  • •genomic instability.
•  Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.2 First-line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab

  Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:

  • • •a deleterious or suspected deleterious
      BRCA
      mutation, and/or
    • •genomic instability.

  Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)].
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )
• •for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.3 Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer

  Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)].
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )

Breast cancer

• •for the adjuvant treatment of adult patients with deleterious or suspected deleterious g
  BRCA
  m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.4 Adjuvant Treatment of Germline

  BRCA

  -mutated HER2-negative High Risk Early Breast Cancer

  Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious

  gBRCA

  m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [

  see

  Dosage and Administration (2.1)].
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )
• •for the treatment of adult patients with deleterious or suspected deleterious
  gBRCA
  m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.5 Germline

  BRCA

  -mutated HER2-negative Metastatic Breast Cancer

  Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious

  gBRCA

  m, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)]

  .
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )

Pancreatic cancer

• •for the maintenance treatment of adult patients with deleterious or suspected deleterious
  gBRCA
  m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.6 First-Line Maintenance Treatment of Germline

  BRCA

  -mutated Metastatic Pancreatic Adenocarcinoma

  Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious

  gBRCA

  m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)]

  .
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )

Prostate cancer

• •for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.7 HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

  Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)].
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )
• •in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious
  BRCA
  -mutated (
  BRCA
  m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. (
  1.8 Treatment of

  BRCA

  -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

  Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza

  [see Dosage and Administration (2.1)]

  .
  ,
  2.1 Patient Selection

  Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

  Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

  Table 1 Biomarker Testing for Patient SelectionWhere testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test, if available.

  Indication	Biomarker	Sample type
  		Tumor	Blood	Plasma (ctDNA)
  First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer	BRCA1 m, BRCA2 m	X	X
  First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab	BRCA1 m, BRC A2m and/or genomic instability	X
  Maintenance treatment of germline or somatic BRCA m recurrent ovarian cancer	BRCA1 m, BRCA2 m	X	X
  Adjuvant treatment of gBRCA m HER2-negative high risk early breast cancer	gBRCA1 m , gBRCA2 m		X
  g BRCA m HER2-negative metastatic breast cancer	gBRCA1 m, gBRCA2 m		X
  First-line maintenance treatment of germline BRCA -mutated metastatic pancreatic adenocarcinoma	gBRCA1 m, gBRCA2 m		X
  Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer	ATM m, BRCA1 m , BRCA2 m, BARD1 m, BRIP1 m, CDK12 m, CHEK1 m, CHEK2 m, FANCL m, PALB2 m, RAD51B m, RAD51C m, RAD51D m, RAD54L m	X
  	g BRCA1 m, g BRCA2 m		X
  	ATM m , BRCA1 m, BRCA2 m			X
  BRCA -mutated metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone	BRCA1 m, BRCA2 m	X	X	X
  )

• •Recommended dosage is 300 mg taken orally twice daily with or without food. See Full Prescribing Information for the recommended duration.
  2.2 Recommended Dosage

  The recommended dosage of Lynparza is 300 mg taken orally twice daily, with or without food.

  If a patient misses a dose of Lynparza, instruct patient to take their next dose at its scheduled time.

  Instruct patients to swallow tablets whole. Do not chew, crush, dissolve, or divide tablet.

  First-Line Maintenance Treatment of

  BRCA

  -mutated Advanced Ovarian Cancer

  Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous treatment, can be treated beyond 2 years.

  First-Line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab

  Continue Lynparza treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous Lynparza treatment, can be treated beyond 2 years.

  When used with Lynparza, the recommended dose of bevacizumab is 15 mg/kg every three weeks. Bevacizumab should be given for a total of 15 months including the period given with chemotherapy and given as maintenance. Refer to the Prescribing Information for bevacizumab when used in combination with Lynparza for more information.

  Adjuvant Treatment of Germline

  BRCA

  -mutated HER2-negative High Risk Early Breast Cancer

  Continue treatment for a total of 1 year, or until disease recurrence, or unacceptable toxicity, whichever occurs first. Patients receiving Lynparza for hormone receptor positive HER2-negative breast cancer should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines.

  Germline or Somatic

  BRCA

  -mutated Recurrent Ovarian Cancer, Germline

  BRCA

  -mutated HER2-negative Metastatic Breast Cancer, Germline

  BRCA

  -mutated Metastatic Pancreatic Adenocarcinoma, and HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

  Continue treatment until disease progression or unacceptable toxicity for:

  • • •Maintenance treatment of germline or somatic
      BRCA
      -mutated recurrent ovarian cancer.
    • •Germline
      BRCA
      -mutated HER-2 negative metastatic breast cancer.
    • •First-line maintenance treatment of germline
      BRCA
      -mutated metastatic pancreatic adenocarcinoma.
    • •HRR gene-mutated metastatic castration-resistant prostate cancer.

  BRCA

  -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

  Continue treatment until disease progression or unacceptable toxicity.

  When used with Lynparza, the recommended dose of abiraterone is 1000 mg taken orally once daily. Abiraterone should be given in combination with prednisone or prednisolone 5 mg orally twice daily. Refer to the Prescribing Information for abiraterone for dosing information.

  Patients with mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
• •Patients receiving Lynparza for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
  2.2 Recommended Dosage

  The recommended dosage of Lynparza is 300 mg taken orally twice daily, with or without food.

  If a patient misses a dose of Lynparza, instruct patient to take their next dose at its scheduled time.

  Instruct patients to swallow tablets whole. Do not chew, crush, dissolve, or divide tablet.

  First-Line Maintenance Treatment of

  BRCA

  -mutated Advanced Ovarian Cancer

  Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous treatment, can be treated beyond 2 years.

  First-Line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab

  Continue Lynparza treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous Lynparza treatment, can be treated beyond 2 years.

  When used with Lynparza, the recommended dose of bevacizumab is 15 mg/kg every three weeks. Bevacizumab should be given for a total of 15 months including the period given with chemotherapy and given as maintenance. Refer to the Prescribing Information for bevacizumab when used in combination with Lynparza for more information.

  Adjuvant Treatment of Germline

  BRCA

  -mutated HER2-negative High Risk Early Breast Cancer

  Continue treatment for a total of 1 year, or until disease recurrence, or unacceptable toxicity, whichever occurs first. Patients receiving Lynparza for hormone receptor positive HER2-negative breast cancer should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines.

  Germline or Somatic

  BRCA

  -mutated Recurrent Ovarian Cancer, Germline

  BRCA

  -mutated HER2-negative Metastatic Breast Cancer, Germline

  BRCA

  -mutated Metastatic Pancreatic Adenocarcinoma, and HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

  Continue treatment until disease progression or unacceptable toxicity for:

  • • •Maintenance treatment of germline or somatic
      BRCA
      -mutated recurrent ovarian cancer.
    • •Germline
      BRCA
      -mutated HER-2 negative metastatic breast cancer.
    • •First-line maintenance treatment of germline
      BRCA
      -mutated metastatic pancreatic adenocarcinoma.
    • •HRR gene-mutated metastatic castration-resistant prostate cancer.

  BRCA

  -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone

  Continue treatment until disease progression or unacceptable toxicity.

  When used with Lynparza, the recommended dose of abiraterone is 1000 mg taken orally once daily. Abiraterone should be given in combination with prednisone or prednisolone 5 mg orally twice daily. Refer to the Prescribing Information for abiraterone for dosing information.

  Patients with mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
• •For moderate renal impairment (CLcr 31-50 mL/min), reduce Lynparza dosage to 200 mg orally twice daily.
  2.5 Dosage Modifications for Renal Impairment

  Moderate Renal Impairment

  In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the Lynparza dosage to 200 mg orally twice daily

  [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].

Tablets:

• •150 mg: green to green/grey, oval, bi-convex, film-coated, with debossment ‘OP150’ on one side and plain on the reverse side.
• •100 mg: yellow to dark yellow, oval, bi-convex, film-coated, with debossment ‘OP100’ on one side and plain on the reverse side.

Lactation: Advise women not to breastfeed.