Lynparza (olaparib)

Safety Information

In this pooled safety data from four pivotal trials (SOLO-1, SOLO-2, Study 19 and OlympiAD*) the majority of adverse events (AEs) associated with LYNPARZA have been of mild to moderate severity (CTCAE Grade 1 or 2) and generally not requiring treatment discontinuation.1,6,20** In the SOLO-1 trial, the majority of adverse events were mild to moderate severity (CTCAE Grade 1 or 2); Grade 3–4 adverse events were generally reported in a small number of patients.1,6,15,19

Summary of most frequent adverse events in the key LYNPARZA Ovarian Cancer trials; SOLO-1, SOLO-2 and Study 19:

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

*OlympiAD is a Phase III, open label, randomised, controlled, multi-centre study to assess the efficacy and safety of olaparib monotherapy versus physician’s choice chemotherapy in the treatment of metastatic breast cancer patients with germline BRCA1/2 mutations. It has been included in this safety analysis to give a broader picture of the safety profile for Olaparib.

**Only adverse event occurring in >15% of patients at any grade are included in the above table.

  • Across all three maintenance trials (SOLO-1, SOLO-2 and Study 19), ~90% of women remained on LYNPARZA treatment without an adverse reaction-related discontinuation7,14,19
  • The majority of adverse reactions were resolved through dose reductions or dose interruptions1,6,14,18,19
  • Across three pivotal trials, LYNPARZA had no significant difference in health-related quality of life (HRQoL) outcomes when compared to placebo14,17

Summary of dose modifications and discontinuations throughout the key LYNPARZA Ovarian Cancer trials; SOLO-1, SOLO-2 and Study 19:

The most frequently observed adverse reactions across clinical trials in patients receiving LYNPARZA monotherapy (≥10%) were: nausea, fatigue (including asthenia), vomiting, anaemia, diarrhoea, decreased appetite, headache, cough, dysgeusia, dyspepsia, neutropenia, dizziness and leukopenia.1,6

The following adverse reactions have been identified in clinical trials with patients receiving LYNPARZA monotherapy where patient exposure is known1,6

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).

aAnaemia includes preferred terms (PTs) of anaemia, anaemia macrocytic, erythropenia, haematocrit decreased, haemoglobin decreased, normochromic anaemia, normochromic normocytic anaemia, normocytic anaemia and red blood cell count decreased; Neutropenia includes PTs of agranulocytosis, febrile neutropenia, granulocyte count decreased, granulocytopenia, idiopathic neutropenia, neutropenia, neutropenic infection, neutropenic sepsis and neutrophil count decreased; Thrombocytopenia includes PTs of platelet count decreased, platelet production decreased, plateletcrit decrease and thrombocytopenia; Leukopenia includes PTs of leukopenia and white blood cell count decreased; Lymphopenia includes PTs of B-lymphocyte count decreased, lymphocyte count decreased, lymphopenia and T-lymphocyte count decreased; Cough includes PTs of cough and productive cough; Rash includes PTs of exfoliative rash, generalised erythema, rash, rash erythematous, rash generalised, rash macular, rash maculo papular, rash papular and rash pruritic; Hypersensitivity includes PTs of drug hypersensitivity and hypersensitivity; Dermatitis includes PTs of dermatitis, dermatitis allergic and dermatitis exfoliative. Dyspnoea includes PTs of dyspnoea and dyspnoea exertional; Stomatitis includes PTs of aphthous ulcer, mouth ulceration and stomatitis.
*As observed in post-marketing setting

For women with advanced BRCAm ovarian cancer choose LYNPARZA tablets as standard of care at the earliest opportunity for maintenance treatment1,7,8

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