Lynparza olaparib 150 mg Tablet, Film Coated, 60-count — NDC 0310-0679-60 (Billing 00310-0679-60)

1 INDICATIONS AND USAGE 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 , 2.1 ) • 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 , 2.1 ) • 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 , 2.1 ) 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 , 2.1 ) • 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 , 2.1 ) 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 , 2.1 ) 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 , 2.1 ) • 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 , 2.1 )

1.1First-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) ] .

1.2First-line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab Lynparza is indicate… [Excerpted — this section continues on DailyMed.]

2 DOSAGE AND ADMINISTRATION • Recommended dosage is 300 mg taken orally twice daily with or without food. See Full Prescribing Information for the recommended duration. (2.2) • Patients receiving Lynparza for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (2.2) • For moderate renal impairment (CLcr 31-50 mL/min), reduce Lynparza dosage to 200 mg orally twice daily. (2.5)

2.1Patient 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 Selection Where 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

2.2Recommended 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… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS 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. Tablets: 150 mg, 100 mg (3)

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). 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 ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukemia’ (AML) which have been reported in patients treated with Lynparza [see Warnings and Precautions (5.1) ] .

Pneumonitis Advise patients to contact their healthcare provider if they experience any new or worsening respiratory symptoms including shortness of breath, fever, cough, or wheezing [see Warnings and Precautions (5.2) ] . Venous Thromboembolism Advise patients to immediately report any signs or symptoms of thromboembolism such as pain or swelling in an extremity, shortness of breath, chest pain, tachypnea, and tachycardia [see Warnings and Precautions (5.3) ] . Hepatotoxicity, Including Drug-Induced Liver Injury Inform patients that liver problems, including drug-induced liver injury and abnormalities in liver tests, may develop during Lynparza treatment.

Advise patients to contact their healthcare provider immediately if they experience abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Inform pregnant women of the risk to a fetus and potential loss of the pregnancy. Advise females to inform their healthcare provider of known or suspected pregnancy [see Use in Specific Populations (8.1) ] .

Advise females of reproductive potential to use effective contraception during treatment with Lynparza and for 6 months after the last dose [see Use in Specific Populations (8.3) ] . Advise male patients with female partners of reproductive potential or who are pregnant to use effective contraception during treatment and for 3 months after receiving the last dose of Lynparza. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Lynparza [see Warnings and Precautions (5.5) and Use in Specific Populations (8.3) ].

Lactation Advise patients not to breastfeed while taking Lynparza and for one month after receiving the last dose [see Use in Specific Populations (8.2) ] . Drug Interactions Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice while taking Lynparza [see Drug Interactions (7.2) ] .

Nausea/Vomiting Advise patients that mild or moderate nausea and/or vomiting is very common in patients receiving Lynparza and that they should contact their healthcare provider who will advise on available antiemetic treatment options [see Adverse Reactions (6.1) ] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 © AstraZeneca 2025

Medication Guide Lynparza ® (Lin-par-zah) (olaparib) tablets What is the most important information I should know about Lynparza? Lynparza may cause serious side effects, including: • Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have received previous treatment with chemotherapy, radiotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with Lynparza.

MDS or AML may lead to death. Symptoms of low blood cell counts are common during treatment with Lynparza, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include: ∘ weakness ∘ weight loss ∘ fever ∘ frequent infections ∘ blood in urine or stool ∘ shortness of breath ∘ feeling very tired ∘ bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: ∘ before treatment with Lynparza ∘ every month during treatment with Lynparza ∘ weekly if you have low blood cell counts that last a long time. • Lung problems (Pneumonitis).

Lynparza can cause serious lung problems that can lead to death. Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. • Blood clots (Venous Thromboembolism, [VTE]).

Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis), or a clot in the lungs (pulmonary embolism, [PE]) which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine. • Liver problems, including Drug-Induced Liver Injury (DILI).

People taking Lynparza may develop liver problems which may be severe and can lead to death. Your healthcare provider should do blood tests before and during your treatment with Lynparza. Tell your healthcare provider right away if you notice discomfort on the right side of your stomach-area (abdominal), dark or “tea-colored” urine, or yellowing of your skin or the whites of your eyes (jaundice).

Your healthcare provide may change your dose, temporarily stop, or permanently stop treatment with Lynparza if you get certain side effects. See “What are the possible side effects of LYNPARZA?” for more information about side effects. What is Lynparza?

Lynparza is a prescription medicine used to treat adults who have: • ovarian, fallopian tube, or primary peritoneal cancer: ∘ that is advanced and has a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. Lynparza is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. ∘ in combination with another anti-cancer medicine called bevacizumab when your cancer is advanced and homologous recombination deficiency (HRD) positive, which is identified by a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability.

Lynparza is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. ∘ that has come back and has a certain type of inherited or acquired abnormal BRCA gene. Lynparza is used as maintenance treatment after the cancer has responded to treatment with platinum-based chemotherapy. • human epidermal growth factor receptor 2 (HER2)-negative breast cancer with a certain type of inherited abnormal BRCA gene: ∘ with a high risk of recurrence. Lynparza is given after surgery (treatment after surgery is called adjuvant therapy).

You should have received chemotherapy medicines before or after surgery to remove the tumor. ∘ that has spread to oth… [Excerpted — this section continues on DailyMed.]