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Lynparza

Last reviewed on RxList: 11/13/2020
Lynparza Side Effects Center

What Is Lynparza?

Lynparza (olaparib) is an inhibitor of the mammalian polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme used as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

What Are Side Effects of Lynparza?

Common side effects of Lynparza include:

Dosage for Lynparza

The recommended dose of Lynparza is 400 mg (eight 50 mg capsules) taken twice daily, for a total daily dose of 800 mg.

What Drugs, Substances, or Supplements Interact with Lynparza?

Lynparza may interact with inhibitors or inducers of CYP3A and other myelosuppressive anticancer agents. Tell your doctor all medications and supplements you use.

Lynparza During Pregnancy and Breastfeeding

Lynparza is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Lynparza (olaparib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Signs of Cancer in Women: Symptoms You Can't Ignore See Slideshow
Lynparza Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, weakness, feeling light-headed or very tired;
  • mouth sores, skin sores;
  • easy bruising, unusual bleeding;
  • pain or burning when you urinate, blood in your urine or stools;
  • pale skin, cold hands and feet
  • weight loss; or
  • cough, wheezing, shortness of breath.

Your cancer treatments may be delayed if you have certain side effects.

Some people who take olaparib with a gonadotropin-releasing hormone (GnRH) medicine may develop a blood clot in the leg or in the lung. Call your doctor if you have pain or swelling in your arm or leg, shortness of breath, chest pain, rapid breathing, or fast heartbeats.

Common side effects may include:

  • low blood cell counts;
  • pain and burning when you urinate, painful urination;
  • nausea, vomiting, upper stomach pain, diarrhea;
  • heartburn, indigestion, loss of appetite;
  • dizziness, feeling weak or tired;
  • headache;
  • cough, shortness of breath; or
  • altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lynparza (Olaparib Capsules for Oral Administration)

QUESTION

Where does ovarian cancer occur? See Answer
Lynparza Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

  • Myelodysplastic Syndrome/Acute Myeloid Leukemia [see WARNINGS AND PRECAUTIONS]
  • Pneumonitis [see WARNINGS AND PRECAUTIONS]
  • Venous Thromboembolic Events [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

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.

The data described in the WARNINGS AND PRECAUTIONS reflect exposure to Lynparza as a single agent in 2351 patients; 1585 patients with exposure to 300 mg twice daily tablet dose including five controlled, randomized, trials (SOLO-1, SOLO-2, OlympiAD, POLO, and PROfound) and to 400 mg twice daily capsule dose in 766 patients in other trials that were pooled to conduct safety analyses. In these trials, 55% of patients were exposed for 6 months or longer and 31% were exposed for greater than one year in the Lynparza group.

In this pooled safety population, the most common adverse reactions in ≥10% of patients were nausea (60%), fatigue (55%), anemia (37%), vomiting (34%), diarrhea (25%), decreased appetite (23%), headache (16%), neutropenia (15%), dysgeusia (15%), cough (15%), dyspnea (14%), dizziness (12%), dyspepsia (12%), leukopenia (11%), thrombocytopenia (11%), and abdominal pain upper (10%).

First-Line Maintenance Treatment Of BRCA-mutated Advanced Ovarian Cancer

SOLO-1

The safety of Lynparza for the maintenance treatment of patients with BRCA-mutated advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was investigated in SOLO-1 [see Clinical Studies]. Patients received Lynparza tablets 300 mg orally twice daily (n=260) or placebo (n=130) until disease progression or unacceptable toxicity. The median duration of study treatment was 25 months for patients who received Lynparza and 14 months for patients who received placebo.

Among patients who received Lynparza, dose interruptions due to an adverse reaction of any grade occurred in 52% and dose reductions due to an adverse reaction occurred in 28%. The most frequent adverse reactions leading to dose interruption or reduction of Lynparza were anemia (23%), nausea (14%), and vomiting (10%). Discontinuation due to adverse reactions occurred in 12% of patients receiving Lynparza. The most frequent adverse reactions that led to discontinuation of Lynparza were fatigue (3.1%), anemia (2.3%), and nausea (2.3%).

Tables 2 and 3 summarize adverse reactions and laboratory abnormalities in SOLO-1.

Table 2 : Adverse Reactions* in SOLO-1 (≥10% of Patients Who Received Lynparza)

Adverse ReactionLynparza tablets
n=260
Placebo
n=130
All Grades (%)Grades 3 - 4 (%)All Grades (%)Grades 3 - 4 (%)
Gastrointestinal Disorders
Nausea771380
Abdominal pain†452351
Vomiting400151
Diarrhea‡373260
Constipation280190
Dyspepsia170120
Stomatitis§11020
General Disorders and Administration Site Conditions
Fatigue¶674422
Blood and Lymphatic System Disorders
Anemia382192
Neutropenia#17673
LeukopeniaÞ13380
Thrombocytopenia?11142
Infections and Infestations
Upper respiratory tract infection/ influenza/nasopharyngitis/bronchitis280230
UTIà13170
Nervous System Disorders
Dysgeusia26040
Dizziness200151
Metabolism and Nutrition Disorders
Decreased appetite200100
Respiratory, Thoracic and Mediastinal Disorders
Dyspneaè15060
* Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
† Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal distension, abdominal discomfort, and abdominal tenderness.
‡ Includes colitis, diarrhea, and gastroenteritis.
§ Includes stomatitis, aphthous ulcer; and mouth ulceration.
¶ Includes asthenia, fatigue, lethargy, and malaise.
# Includes neutropenia, and febrile neutropenia.
Þ Includes leukopenia, and white blood cell count decreased.
? Includes platelet count decreased, and thrombocytopenia.
à Includes urosepsis, urinary tract infection, urinary tract pain, nd pyuria.
è Includes dyspnea, and dyspnea exertional.

In addition, the adverse reactions observed in SOLO-1 that occurred in <10% of patients receiving Lynparza were increased blood creatinine (8%), lymphopenia (6%), hypersensitivity (2%), dermatitis (1%), and increased mean cell volume (0.4%).

Table 3 : Laboratory Abnormalities Reported in ≥25% of Patients in SOLO-1

Laboratory Parameter*Lynparza tablets n†=260Placebo n†=130
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Decrease in hemoglobin8719632
Increase in mean corpuscular volume87-43-
Decrease in leukocytes707521
Decrease in lymphocytes6714295
Decrease in absolute neutrophil count519386
Decrease in platelets351202
Increase in serum creatinine340180
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

First-line Maintenance Treatment Of HRD-positive Advanced Ovarian Cancer In Combination With Bevacizumab
PAOLA-1

The safety of Lynparza in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer following first-line treatment containing platinum-based chemotherapy and bevacizumab was investigated in PAOLA-1 [see Clinical Studies]. This study was a placebo-controlled, double-blind study in which 802 patients received either Lynparza 300 mg BID in combination with bevacizumab (n=535) or placebo in combination with bevacizumab (n=267) until disease progression or unacceptable toxicity. The median duration of treatment with Lynparza was 17.3 months and 11 months for bevacizumab post-randomization on the Lynparza/bevacizumab arm.

Fatal adverse reactions occurred in 1 patient due to concurrent pneumonia and aplastic anemia. Serious adverse reactions occurred in 31% of patients who received Lynparza/bevacizumab. Serious adverse reactions in >5% of patients included hypertension (19%) and anemia (17%).

Dose interruptions due to an adverse reaction of any grade occurred in 54% of patients receiving Lynparza/bevacizumab and dose reductions due to an adverse reaction occurred in 41% of patients who received Lynparza/bevacizumab.

The most frequent adverse reactions leading to dose interruption in the Lynparza/bevacizumab arm were anemia (21%), nausea (7%), vomiting (3%), and fatigue (3%), and the most frequent adverse reactions leading to reduction in the Lynparza/bevacizumab arm were anemia (19%), nausea (7%), and fatigue (4%).

Discontinuation due to adverse reactions occurred in 20% of patients receiving Lynparza/bevacizumab. Specific adverse reactions that most frequently led to discontinuation in patients treated with Lynparza/bevacizumab were anemia (4%) and nausea (3%).

Tables 4 and 5 summarize adverse reactions and laboratory abnormalities in PAOLA-1, respectively.

Table 4 : Adverse Reactions* Occurring in ≥10% of Patients Treated with Lynparza/bevacizumab in PAOLA-1 and at ≥5% Frequency Compared to the Placebo/bevacizumab Arm

Adverse ReactionsLynparza/ bevacizum ab
n=535
Placebo/ bevacizumab
n=267
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
General Disorders and Administration Site Conditions
Fatigue (including asthenia)†535321.5
Gastrointestinal Disorders
Nausea532.4220.7
Vomiting221.7111.9
Blood and Lymphatic Disorders
Anemia‡4117100.4
Lymphopenia§24791.1
Leukopenia||181.9101.5
* Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
† Includes asthenia, and fatigue.
‡ Includes anemia, anemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anemia, normochromic normocytic anemia, normocytic anemia, and red blood cell count decreased. Includes B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia, and T-lymphocyte count decreased.
§ Includes B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia, and T-lymphocyte count decreased.
|| Includes leukopenia, and white blood cell count decreased.

The most common adverse reactions (≥ 10%) for patients receiving Lynparza/bevacizumab irrespective of the frequency compared with the placebo/bevacizumab arm were nausea (53%), fatigue (including asthenia) (53%), anemia (41%), lymphopenia, vomiting (22%), diarrhea (18%), neutropenia (18%), leukopenia (18%), urinary tract infection (15%), and headache (14%).

The adverse reactions that occurred in <10% of patients receiving Lynparza/bevacizumab were dysgeusia (8%), dyspnea (8%), stomatitis (5%), dyspepsia (4.3%), erythema (3%), dizziness (2.6%), and hypersensitivity (1.7%).

In addition, venous thromboembolic events occurred more commonly in patients receiving Lynparza/bevacizumab (5%) than in those receiving placebo/bevacizumab (1.9%).

Table 5 : Laboratory Abnormalities Reported in ≥25% of Patients in PAOLA-1*

Laboratory Parameter†Lynparza /bevacizum ab
n†=535
Placebo /bevacizumab
n‡=267
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Decrease in hemoglobin7913550.4
Decrease in lymphocytes6310423.0
Increase in serum creatinine610.4360.4
Decrease in leukocytes593.4452.2
Decrease in absolute neutrophil count357303.7
Decrease in platelets352.4280.4
* Reported within 30 days of the last dose.
† Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
‡ This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

Maintenance Treatment Of Recurrent Ovarian Cancer

SOLO-2

The safety of Lynparza for the maintenance treatment of patients with platinum sensitive gBRCAm ovarian cancer was investigated in SOLO-2 [see Clinical Studies]. Patients received Lynparza tablets 300 mg orally twice daily (n=195) or placebo (n=99) until disease progression or unacceptable toxicity. The median duration of study treatment was 19.4 months for patients who received Lynparza and 5.6 months for patients who received placebo.

Among patients who received Lynparza, dose interruptions due to an adverse reaction of any grade occurred in 45% and dose reductions due to an adverse reaction occurred in 27%. The most frequent adverse reactions leading to dose interruption or reduction of Lynparza were anemia (22%), neutropenia (9%), and fatigue/asthenia (8%). Discontinuation due to an adverse reaction occurred in 11% of patients receiving Lynparza.

Tables 6 and 7 summarize adverse reactions and laboratory abnormalities in SOLO-2.

Table 6 : Adverse Reactions* in SOLO-2 (≥20% of Patients Who Received Lynparza)

Adverse ReactionLynparza tablets
n=195
Placebo
n=99
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Gastrointestinal Disorders
Nausea763330
Vomiting373191
Diarrhea332220
Stomatitis†201160
General Disorders and Administration Site Conditions
Fatigue including asthenia664392
Blood and Lymphatic Disorders
Anemia‡442092
Infections and Infestations
Nasopharyngitis/URI/sinusitis/ rhinitis/influenza360290
Musculoskeletal and Connective Tissue Disorders
Arthralgia/myalgia300280
Nervous System Disorders
Dysgeusia27070
Headache261140
Metabolism and Nutrition Disorders
Decreased appetite220110
* Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.
† Represents grouped term consisting of abscess oral, aphthous ulcer, gingival abscess, gingival disorder, gingival pain, gingivitis, mouth ulceration, mucosal infection, mucosal inflammation, oral candidiasis, oral discomfort, oral herpes, oral infection, oral mucosal erythema, oral pain, oropharyngeal discomfort, and oropharyngeal pain.
‡ Represents grouped term consisting of anemia, hematocrit decreased, hemoglobin decreased, iron deficiency, mean cell volume increased and red blood cell count decreased.

In addition, the adverse reactions observed in SOLO-2 that occurred in <20% of patients receiving Lynparza were neutropenia (19%), cough (18%), leukopenia (16%), hypomagnesemia (14%), thrombocytopenia (14%), dizziness (13%), dyspepsia (11%), increased creatinine (11%), edema (8%), rash (6%), and lymphopenia (1%).

Table 7 : Laboratory Abnormalities Reported in ≥25% of Patients in SOLO-2

Laboratory Parameter*Lynparza tablets
n†=195
Placebo
n†=99
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Increase in mean corpuscular volume‡89-52-
Decrease in hemoglobin8317690
Decrease in leukocytes695481
Decrease in lymphocytes6711371
Decrease in absolute neutrophil count517343
Increase in serum creatinine440290
Decrease in platelets422221
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
‡ Represents the proportion of subjects whose mean corpuscular volume was > upper limit of normal (ULN).

Study 19

The safety of Lynparza as maintenance monotherapy was evaluated in patients with platinum sensitive ovarian cancer who had received 2 or more previous platinum containing regimens in Study 19 [see Clinical Studies]. Patients received Lynparza capsules 400 mg orally twice daily (n=136) or placebo (n=128). At the time of final analysis, the median duration of exposure was 8.7 months in patients who received Lynparza and 4.6 months in patients who received placebo.

Adverse reactions led to dose interruptions in 35% of patients receiving Lynparza; dose reductions in 26% and discontinuation in 6% of patients receiving Lynparza.

Tables 8 and 9 summarize adverse reactions and laboratory abnormalities in Study 19.

Table 8 : Adverse Reactions* in Study 19 (≥20% of Patients Who Received Lynparza)

Adverse ReactionLynparza capsules
n=136
Placebo
n=128
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Gastrointestinal Disorders
Nausea712360
Vomiting352141
Diarrhea282252
Constipation221120
Dyspepsia20090
General Disorders and Administration Site Conditions
Fatigue (including asthenia)639463
Blood and Lymphatic Disorders
Anemia†23771
Infections and Infestations
Respiratory tract infection222110
Metabolism and Nutrition Disorders
Decreased appetite210130
Nervous System Disorders
Headache210131
* Graded according to NCI CTCAE v4.0.
† Represents grouped terms of related terms that reflect the medical concept of the adverse reaction.

In addition, the adverse reactions in Study 19 that occurred in <20% of patients receiving Lynparza were dysgeusia (16%), dizziness (15%), dyspnea (13%), pyrexia (10%), stomatitis (9%), edema (9%), increase in creatinine (7%), neutropenia (5%), thrombocytopenia (4%), leukopenia (2%), and lymphopenia (1%).

Table 9 : Laboratory Abnormalities Reported in ≥25% of Patients in Study 19

Laboratory Parameter*Lynparza capsules
n†=136
Placebo
n†=129
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Decrease in hemoglobin828581
Increase in mean corpuscular volume‡82-51-
Decrease in leukocytes584372
Decrease in lymphocytes5210323
Decrease in absolute neutrophil count477402
Increase in serum creatinine450140
Decrease in platelets364180
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
‡ Represents the proportion of subjects whose mean corpuscular volume was > ULN.

Advanced Germline BRCA-mutated Ovarian Cancer After 3 Or More Lines Of Chemotherapy

Pooled Data

The safety of Lynparza was investigated in 223 patients (pooled from 6 studies) with gBRCAm advanced ovarian cancer who had received 3 or more prior lines of chemotherapy [see Clinical Studies]. Patients received Lynparza capsules 400 mg orally twice daily until disease progression or unacceptable tolerability. The median exposure to Lynparza in these patients was 5.2 months.

There were 8 (4%) patients with adverse reactions leading to death, two were attributed to acute leukemia, and one each was attributed to COPD, cerebrovascular accident, intestinal perforation, pulmonary embolism, sepsis, and suture rupture. Adverse reactions led to dose interruption in 40% of patients, dose reduction in 4%, and discontinuation in 7%.

Tables 10 and 11 summarize the adverse reactions and laboratory abnormalities from the pooled studies.

Table 10 : Adverse Reactions Reported in Pooled Data (≥20% of Patients Who Received Lynparza)

Adverse ReactionLynparza capsules
n=223
Grades 1-4 (%)Grades 3-4 (%)
General Disorders
Fatigue/asthenia668
Gastrointestinal Disorders
Nausea643
Vomiting434
Diarrhea311
Dyspepsia250
Decreased appetite221
Blood and Lymphatic Disorders
Anemia3418
Infections and Infestations
Nasopharyngitis/URI260
Musculoskeletal and Connective Tissue Disorders
Arthralgia/musculoskeletal pain210
Myalgia220

Table 11 : Laboratory Abnormalities Reported in ≥25% of Patients in Pooled Data

Laboratory Parameter*Lynparza capsules
n†=223
Grades 1-4 (%)Grades 3-4 (%)
Decrease in hemoglobin9015
Mean corpuscular volume elevation57-
Decrease in lymphocytes5617
Decrease in platelets303
Increase in creatinine302
Decrease in absolute neutrophil count257
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

The following adverse reactions and laboratory abnormalities have been identified in ≥10 to <20% of the 223 patients receiving Lynparza and not included in the table: cough (16%), constipation (16%), dysgeusia (16%), headache (15%), peripheral edema (14%), back pain (14%), urinary tract infection (14%), dyspnea (13%), and dizziness (11%).

The following adverse reactions and laboratory abnormalities have been identified in <10% of the 223 patients receiving Lynparza and not included in the table: leukopenia (9%), pyrexia (8%), peripheral neuropathy (5%), hypomagnesemia (5%), rash (5%), stomatitis (4%), and venous thrombosis (including pulmonary embolism) (1%).

Germline BRCA-mutated HER2-negative Metastatic Breast Cancer

OlympiAD

The safety of Lynparza was evaluated in gBRCAm patients with HER2-negative metastatic breast cancer who had previously received up to two lines of chemotherapy for the treatment of metastatic disease in OlympiAD [see Clinical Studies]. Patients received either Lynparza tablets 300 mg orally twice daily (n=205) or a chemotherapy (capecitabine, eribulin, or vinorelbine) of the healthcare provider's choice (n=91) until disease progression or unacceptable toxicity. The median duration of study treatment was 8.2 months in patients who received Lynparza and 3.4 months in patients who received chemotherapy.

Among patients who received Lynparza, dose interruptions due to an adverse reaction of any grade occurred in 35% and dose reductions due to an adverse reaction occurred in 25%. Discontinuation due to an adverse reaction occurred in 5% of patients receiving Lynparza.

Tables 12 and 13 summarize the adverse reactions and laboratory abnormalities in OlympiAD.

Table 12 : Adverse Reactions* in OlympiAD (≥20% of Patients Who Received Lynparza)

Adverse ReactionLynparza tablets
n=205
Chemotherapy
n=91
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Gastrointestinal Disorders
Nausea580351
Vomiting300151
Diarrhea211220
Blood and Lymphatic Disorders
Anemia†4016264
Neutropenia‡2795026
Leukopenia§2553113
General Disorders and Administration Site Conditions
Fatigue (including asthenia)374361
Infections and Infestations
Respiratory tract infection||271220
Nervous System Disorders
Headache201152
* Graded according to NCI CTCAE v4.0.
† Represents grouped terms consisting of anemia (anemia erythropenia, hematocrit decreased, hemoglobin decreased and red blood cell count decreased).
‡Represents grouped terms consisting of neutropenia (febrile neutropenia, granulocyte count decreased, granulocytopenia, neutropenia, neutropenic infection, neutropenic sepsis, and neutrophil count decreased).
§ Represents grouped terms consisting of leukopenia (leukopenia and white blood cell count decreased).
|| Represents grouped terms consisting of bronchitis, influenza, lower respiratory tract infection, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.

In addition, adverse reactions in OlympiAD that occurred in <20% of patients receiving Lynparza were cough (18%), decreased appetite (16%), thrombocytopenia (11%), dysgeusia (9%), lymphopenia (8%), dyspepsia (8%), dizziness (7%), stomatitis (7%), upper abdominal pain (7%), rash (5%), increase in serum creatinine (3%), and dermatitis (1%).

Table 13 : Laboratory Abnormalities Reported in ≥25% of Patients in OlympiAD

Laboratory Parameter*Lynparza tablets
n†= 205
Chemotherapy
n†= 91
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Decrease in hemoglobin8217663
Decrease in lymphocytes7321633
Decrease in leukocytes7187023
Increase in mean corpuscular volume‡71-33-
Decrease in absolute neutrophil count46116538
Decrease in platelets333280
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
‡ Represents the proportion of subjects whose mean corpuscular volume was > ULN.

First-line Maintenance Treatment Of Germline BRCA-mutated Metastatic Pancreatic Adenocarcinoma

POLO

The safety of Lynparza as maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma following first-line treatment with platinum-based chemotherapy was evaluated in POLO [see Clinical Studies]. Patients received Lynparza tablets 300 mg orally twice daily (n=90) or placebo (n=61) until disease progression or unacceptable toxicity. Among patients receiving Lynparza, 34% were exposed for 6 months or longer and 25% were exposed for greater than one year.

Among patients who received Lynparza, dosage interruptions due to an adverse reaction of any grade occurred in 35% and dosage reductions due to an adverse reaction occurred in 17%. The most frequent adverse reactions leading to dosage interruption or reduction in patients who received Lynparza were anemia (11%), vomiting (5%), abdominal pain (4%), asthenia (3%), and fatigue (2%). Discontinuation due to adverse reactions occurred in 6% of patients receiving Lynparza. The most frequent adverse reaction that led to discontinuation of Lynparza was fatigue (2.2%).

Tables 14 and 15 summarize the adverse reactions and laboratory abnormalities in patients in POLO.

Table 14 : Adverse Reactions* in POLO (Occurring in ≥10% of Patients who Received Lynparza)

Adverse ReactionLynparza tablets
(n=91)†
Placebo
(n=60)†
All Grades (%)Grades 3 - 4 (%)All Grades (%)Grades 3 - 4 (%)
General Disorders and Administration Site Conditions
Fatigue‡605352
Gastrointestinal Disorders
Nausea450232
Abdominal pain^342375
Diarrhea290150
Constipation230100
Vomiting201152
Stomatitis§10050
Blood and Lymphatic System Disorders
Anemia2711173
Thrombocytopenia||14370
Neutropenia¶12483
Metabolism and Nutrition Disorders
Decreased appetite25370
Musculoskeletal and Connective Tissue Disorders
Back pain190172
Arthralgia151100
Skin and Subcutaneous Tissue Disorder
Rash#15050
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea**13052
Infections and Infestations
Nasopharyngitis12030
Nervous System Disorders
Dysgeusia11050
* Graded according to NCI CTCAE, version 4.0
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
‡ Includes asthenia and fatigue
^ Includes abdominal pain, abdominal pain upper, abdominal pain lower
§ Includes stomatitis and mouth ulceration
|| Includes platelets count decreased and thrombocytopenia
¶ Includes neutropenia, febrile neutropenia and neutrophil count decreased
# Includes rash erythematous, rash macular and rash maculo-papular
**Includes dyspnea and dyspnea exertional

In addition, the adverse reactions observed in POLO that occurred in <10% of patients receiving Lynparza were cough (9%), abdominal pain upper (7%), blood creatinine increased (7%), dizziness (7%), headache (7%), dyspepsia (5%), leukopenia (5%), hypersensitivity (2%), and lymphopenia (2%).

Table 15 : Laboratory Abnormalities Reported in ≥25% of Patients in POLO

Laboratory Parameter*Lynparza tablets
n†=91
Placebo
n†=60
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Increase in serum creatinine992850
Decrease in hemoglobin8611650
Increase in mean corpuscular volume‡71-30-
Decrease in lymphocytes619270
Decrease in platelets562390
Decrease in leukocytes503230
Decrease in absolute neutrophil count253100
* Patients were allowed to enter POLO with hemoglobin ≥9 g/dL (CTCAE Grade 2) and other laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.
‡ Represents the proportion of subjects whose mean corpuscular volume was > ULN.

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

PROfound

The safety of Lynparza as monotherapy was evaluated in patients with mCRPC and HRR gene mutations who have progressed following prior treatment with enzalutamide or abiraterone in PROfound [see Clinical Studies]. This study was a randomized, open-label, multi-center study in which 386 patients received either Lynparza tablets 300 mg orally twice daily (n=256) or investigator's choice of enzalutamide or abiraterone acetate (n=130) until disease progression or unacceptable toxicity. Among patients receiving Lynparza, 62% were exposed for 6 months or longer and 20% were exposed for greater than one year.

Fatal adverse reactions occurred in 4% of patients treated with Lynparza. These included pneumonia (1.2%), cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%), intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure (0.4%).

Serious adverse reactions occurred in 36% of patients receiving Lynparza. The most frequent serious adverse reactions (≥2%) were anemia (9%), pneumonia (4%), pulmonary embolism (2%), fatigue/asthenia (2%), and urinary tract infection (2%).

Dose interruptions due to an adverse reaction of any grade occurred in 45% of patients receiving Lynparza; dose reductions due to an adverse reaction occurred in 22% of Lynparza patients. The most frequent adverse reactions leading to dose interruption of Lynparza were anemia (25%) and thrombocytopenia (6%) and the most frequent adverse reaction leading to reduction of Lynparza was anemia (16%). Discontinuation due to adverse reactions occurred in 18% of Lynparza. The adverse reaction that most frequently led to discontinuation of Lynparza was anemia (7%).

Tables 16 and 17 summarize the adverse reactions and laboratory abnormalities, respectively, in patients in PROfound.

Table 16 : Adverse Reactions* Reported in ≥10% of Patients in PROfound

Adverse ReactionsLynparza tablets
n=256
Enzalutamide or abiraterone
n=130
Grades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%)
Blood and lymphatic disorders
Anemia†4621155
Thrombocytopenia‡12430
Gastrointestinal disorders
Nausea411190
Diarrhea21170
Vomiting182121
General disorders and administration site conditions
Fatigue (including asthenia)413325
Metabolism and nutrition disorders
Decreased appetite301181
Respiratory, thoracic, and mediastinal disorders
Cough11020
Dyspnea10230
* Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03
† Includes anemia and hemoglobin decreased
‡ Includes platelet count decreased and thrombocytopenia

In addition, adverse reactions of clinical relevance in PROfound that occurred in <10% of patients receiving Lynparza were neutropenia (9%), venous thromboembolic events (7%), dizziness (7%), dysgeusia (7%), dyspepsia (7%), headache (6%), pneumonia (5%), stomatitis (5%), rash (4%), blood creatinine increase (4%), pneumonitis (2%), upper abdominal pain (2%), and hypersensitivity (1%).

Table 17 : Laboratory Abnormalities Reported in ≥25% of Patients in PROfound

Laboratory Parameter*Lynparza tablets
n†= 256
Enzalutamide or abiraterone
n†=130
Grades 1-4
n= 247 (%)
Grades 3-4
n=247 (%)
Grades 1-4
n=124 (%)
Grades 3-4
n=124 (%)
Decrease in hemoglobin242 (98)33 (13)91 (73)5 (4)
Decrease in lymphocytes154 (62)57 (23)42 (34)16 (13)
Decrease in leukocytes130 (53)9 (4)26 (21)0
Decrease in absolute neutrophil count83 (34)8 (3)11 (9)0
* Patients were allowed to enter clinical studies with laboratory values of CTCAE Grade 1.
† This number represents the safety population. The derived values in the table are based on the total number of evaluable patients for each laboratory parameter.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Lynparza. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (rash/dermatitis/angioedema).

Read the entire FDA prescribing information for Lynparza (Olaparib Capsules for Oral Administration)

Related Resources for Lynparza

Related Health

© Lynparza Patient Information is supplied by Cerner Multum, Inc. and Lynparza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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