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Lynparza is a brand name for Olaparib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ovarian cancer Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection First-line maintenance treatment of BRCA-mutated advanced ovarian cancer: Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
Maintenance treatment of platinum-sensitive relapsed ovarian cancer:
There is no requirement for BRCA1/2 testing prior to using Lynparza for the monotherapy maintenance treatment of relapsed EOC, FTC or PPC who are in a complete or partial response to platinum-based therapy. 1). 1).
Monotherapy treatment of gBRCA1/2-mutated HER2-negative metastatic breast cancer:
For germline breast cancer susceptibility genes (gBRCA1/2) mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated.
gBRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method. Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available. First-line maintenance treatment of gBRCA-mutated metastatic adenocarcinoma of the pancreas: For first-line maintenance treatment of germline BRCA1/2-mutated metastatic adenocarcinoma of the pancreas, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated.
gBRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method. Data demonstrating clinical validation of tumour BRCA1/2 tests in adenocarcinoma of the pancreas are not currently available. 1).
BRCA1/2 mutation status should be determined by an experienced laboratory using a validated test method.
Treatment of mCRPC in combination with abiraterone and prednisone or prednisolone:
Summary of the safety profile Lynparza has been associated with adverse reactions generally of mild or moderate severity (CTCAE grade 1 or 2) and generally not requiring treatment discontinuation. The most frequently observed adverse reactions across clinical trials in patients receiving Lynparza monotherapy (≥10%) were nausea, fatigue/asthenia, anaemia, vomiting, diarrhoea, decreased appetite, headache, neutropenia, dysgeusia, cough, leukopenia, dizziness, dyspnoea and dyspepsia.
The Grade ≥3 adverse reactions occurring in > 2% of patients were anaemia (14%), neutropenia (5%), fatigue/asthenia (4%), leukopenia (2%) and thrombocytopenia (2%). 12 Adverse reactions that most commonly led to dose interruptions and/ or reductions in monotherapy were anaemia (16%), nausea (7%), fatigue/asthenia (6%), neutropenia (6%) and vomiting (6%).
5%). When Lynparza is used in combination with bevacizumab for ovarian cancer, in combination with abiraterone and prednisone or prednisolone for prostate cancer, or in combination with durvalumab following treatment with durvalumab in combination with platinum-based chemotherapy for endometrial cancer, the safety profile is generally consistent with that of the individual therapies.
When used in combination with bevacizumab, adverse events led to dose interruption and/ or reduction of olaparib in 57% of patients and led to permanent discontinuation of treatment with olaparib and placebo in 21% and 6% of patients, respectively.
6%). 5%). 8% of patients, respectively. 1%). 3%). 9% of patients. 1%). 6%) and neutropenia (1%). Tabulated list of adverse reactions The safety profile is based on pooled data from 4499 patients with solid tumours treated with Lynparza monotherapy in clinical trials at the recommended dose.
The following adverse reactions have been identified in clinical trials with patients receiving Lynparza monotherapy where patient exposure is known. Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 1.
Haematological toxicity Haematological toxicity has been reported in patients treated with Lynparza, including clinical diagnoses and/or laboratory findings of generally mild or moderate (CTCAE grade 1 or 2) anaemia, neutropenia, thrombocytopenia and lymphopenia.
8) and/or autoimmune haemolytic anaemia (AIHA) have been reported when Lynparza has been used in combination with durvalumab. Patients should not start treatment with Lynparza until they have recovered from haematological toxicity caused by previous anticancer therapy (haemoglobin, platelet and neutrophil levels should be ≤CTCAE grade 1).
8). If a patient develops severe haematological toxicity or blood transfusion dependence, treatment with Lynparza should be interrupted and appropriate haematological testing should be initiated. If the blood parameters remain clinically abnormal after 4 weeks of Lynparza dose interruption, bone marrow analysis and/or blood cytogenetic analysis are recommended.
If PRCA or AIHA are confirmed, treatment with Lynparza and durvalumab should be discontinued. 8). The majority of events had a fatal outcome. Patients with BRCAm platinum-sensitive relapsed ovarian cancer who had received at least two prior lines of platinum chemotherapy were at higher risk to experience MDS/AML.
The duration of therapy with olaparib in patients who developed MDS/AML varied from < 6 months to > 4 years. If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics.
If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, Lynparza should be discontinued and the patient treated appropriately. Venous Thromboembolic Events Venous thromboembolic events, predominantly events of pulmonary embolism, have occurred in patients treated with Lynparza and had no consistent clinical pattern.
1. 6). 8
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No genomic testing is required prior to using Lynparza in combination with abiraterone and prednisone or prednisolone for the treatment of patients with mCRPC. 1). Genetic counselling for patients tested for mutations in BRCA1/2 genes should be performed according to local regulations.
Posology Lynparza is available as 100 mg and 150 mg tablets. The recommended dose of Lynparza in monotherapy or in combination with other agents is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg.
The 100 mg tablet is available for dose reduction. 5 Lynparza monotherapy Patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
Lynparza in combination with bevacizumab When Lynparza is used in combination with bevacizumab for the first-line maintenance treatment of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer following completion of first-line platinum-based therapy with bevacizumab, the dose of bevacizumab is 15 mg/kg once every 3 weeks.
1). Lynparza in combination with endocrine therapy Please refer to the full product information of the endocrine therapy combination partner(s) (aromatase inhibitor/anti-oestrogen agent and/or LHRH) for the recommended posology. 1). Abiraterone should be given with prednisone or prednisolone 5 mg orally twice daily.
Please refer to the full product information for abiraterone. 1). Please refer to the full product information for […]
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).
13 Table 1 Tabulated list of adverse reactions Adverse reactions MedDRA System Organ Class Frequency of All CTCAE grades Frequency of CTCAE grade 3 and above Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon Myelodysplastic syndrome/ Acute myeloid leukaemiaa Uncommon Myelodysplastic syndrome/ Acute myeloid leukaemia Blood and lymphatic system disordersb Very common Anaemiaa, Neutropeniaa, Leukopeniaa Common Lymphopeniaa, Thrombocytopeniaa Very common Anaemiaa Common Neutropeniaa, Thrombocytopeniaa, Leukopeniaa, Lymphopeniaa Immune system disorders Uncommon Hypersensitivitya Rare Angioedema* Rare Hypersensitivitya Hepatobiliary disorders Common Transaminases increaseda Not known Drug-induced liver injury* Metabolism and nutrition disorders Very common Decreased appetite Uncommon Decreased appetite Nervous system disorders Very common Dizziness, Headache, Dysgeusiaa Uncommon Dizziness, Headache Respiratory, thoracic and mediastinal disorders Very common Cougha, Dyspnoeaa Uncommon Pneumonitisa Common Dyspnoeaa Uncommon Cougha, Pneumonitisa Gastrointestinal disorders Very common Vomiting, Diarrhoea, Nausea, Dyspepsia Common Stomatitisa, Upper abdominal pain Common Vomiting, Nausea Uncommon Stomatitisa, Diarrhoea Rare Dyspepsia, Upper abdominal pain 14 Adverse reactions MedDRA System Organ Class Frequency of All CTCAE grades Frequency of CTCAE grade 3 and above Skin and subcutaneous tissue disorders Common Rasha Uncommon Dermatitisa Rare Erythema nodosum Uncommon Rasha Rare Dermatitisa General disorders and administration site conditions Very common Fatigue (including asthenia) Common Fatigue (including asthenia) Investigationsb Common Blood creatinine increased Uncommon Mean cell volume increased Rare […]
8). Monitor patients for clinical signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Patients with a prior history of VTE may be more at risk of a further occurrence and should be monitored appropriately.
8). If patients present with new or worsening respiratory symptoms such as dyspnoea, cough and fever, or an abnormal chest radiologic finding is observed, Lynparza treatment should be interrupted and prompt investigation initiated. If pneumonitis is confirmed, Lynparza treatment should be discontinued and the patient treated appropriately.
8). If clinical symptoms or signs suggestive of hepatotoxicity develop, prompt clinical evaluation of the patient and measurement of liver function tests should be performed. In case of suspected drug- 9 induced liver injury (DILI), treatment should be interrupted.
In case of severe DILI treatment discontinuation should be considered as clinically appropriate. Embryofoetal toxicity Based on its mechanism of action (PARP inhibition), Lynparza could cause foetal harm when administered to a pregnant woman.
Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 300 mg twice daily. Pregnancy/contraception Lynparza should not be used during pregnancy.
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza treatment, during therapy and for 6 months after receiving the last dose of Lynparza. Two highly effective and complementary forms of contraception are recommended.
6). 5). 5). Lynparza co-administration with strong or moderate CYP3A inducers is not recommended. 5). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg or 150 mg tablet, that is to say essentially “sodium-free”.