Safety Data

Lynparza has a generally well-tolerated safety profile1,2

About the… Safety profile of Lynparza observed in Study 19 and SOLO2

Adverse events (any grade) in ≥15% of patients overall and grade ≥3 events in ≥3% of patients in either treatment group in either Study 19 and SOLO2 studies1,2,4,8*

Includes patients with anaemia, haemoglobin decreased, red blood cell count decreased and haematocrit decreased

* Diarrhoea (All Grades) occurred in 27% of patients receiving LYNPARZA in Study 19 and 24% of patients receiving placebo, while 2% of patients reported diarrhoea at Grade ≥3 in each treatment group. In SOLO2, 33% of patients receiving LYNPARZA and 20% of patients receiving  placebo experiences diarrhoea, where 1% and 0% of these patients reported diarrhoea at Grade ≥3 in each treatment group, respectively. 

The majority of patients in both studies remained on treatment until progression1,2,4,8,9

  • 94% of patients in Study 19, and 89% of patients in SOLO2 were able to continue treatment until disease progression4,9
  • The majority of adverse reactions were resolved through dose reductions or dose interruptions1,2,4,8,9
  • Quality of life was similar for patients receiving Lynparza, compared with placebo, for both the capsule and tablet formulation3,4

Lynparza monotherapy (both tablets and capsules) has been associated with adverse reactions generally of mild or moderate severity (CTCAE 1 or 2) and generally not requiring treatment discontinuation.1,2

The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥ 10%) were: nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache, dysgeusia, decreased appetite, dizziness, cough and anaemia.1,2

 

The safety profile is based on pooled data from 1,248 patients treated with Lynparza monotherapy in clinical trials in the therapeutic indication at the recommended dose.1,2

The following adverse reactions have been identified in clinical trials with patients receiving Lynparza monotherapy where patient exposure is known.1,2

Adverse reactions1,2
MedDRA System Organ Class Frequency of All CTCAE grades Frequency of CTCAE grade 3 and above
Blood and lymphatic system disorders

Very common

Anaemiaa

Common

Neutropeniaa, Thrombocytopeniaa,Leukopeniaa

Uncommon

Lymphopenia

Very common

Anaemiaa

Common

Neutropeniaa, Thrombocytopeniaa, Leukopeniaa

Uncommon

Lymphopenia

Immune system disorders

Common

Rasha

Uncommon

Hypersensitivitya, Dermatitisa

-
Metabolism and nutrition disorders

Very common

Decreased appetite

Uncommon

Decreased appetite

Nervous system disorders

Very common

Dizziness, Headache, Dysgeusia

Uncommon

Dizziness, Headache

Respiratory, thoracic and mediastinal disorders

Very common

Cougha

Uncommon

Cougha

Gastrointestinal disorders

Very common

Vomiting, Diarrhoea, Nausea, Dyspepsia

Common

Stomatitis, Upper abdominal pain

Common

Vomiting, Diarrhoea, Nausea

Uncommon

Stomatitis, Upper abdominal pain

General disorders and administration site conditions

Very common

Fatigue (including asthenia)

Common

Fatigue (including asthenia)

Investigations

Common

Increase in blood creatinine

Uncommon

Mean corpuscular volume elevationb

Uncommon

Increase in blood creatinine

Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term level in Table 1. Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).

a Anaemia includes preferred terms (PTs) of anaemia, haemoglobin decreased, red blood cell count decreased, erythropenia and haematocrit decreased; Neutropenia includes PTs of neutropenia, granulocytopenia, granulocyte count decreased and neutrophil count decreased, febrile neutropenia, neutropenic infection and neutropenic sepsis; Thrombocytopenia includes PTs of thrombocytopenia, platelet count decreased, platelet production decreased and plateletcrit decreased; Leukopenia includes PTs of leukopenia and white blood cell count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of rash, rash erythematous, rash generalised, rash macular, rash maculo papular, rash papular, rash pruritic, exfoliative rash and generalised erythema; Hypersensitivity includes PTs of hypersensitivity and drug hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative.
b Represents the incidence of laboratory findings of elevations in mean corpuscular volume from baseline to above the upper limit of normal (ULN), not of reported adverse reactions.