Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Treatment with Lynparza should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Patients must have confirmation of a deleterious or suspected deleterious breast cancer susceptibility gene (BRCA) mutation (either germline or tumour) before Lynparza treatment is initiated. BRCA mutation status should be determined by an experienced laboratory using a validated test method (see section 5.1).
Genetic counselling for patients with BRCA1/2 mutations should be performed according to local regulations.
The recommended dose of Lynparza is 400 mg (eight capsules) taken twice daily, equivalent to a total daily dose of 800 mg.
Patients should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity. There are no data on retreatment with Lynparza following subsequent relapse (see section 5.1).
Lynparza capsules (50 mg) should not be substituted for Lynparza tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Therefore, the specific dose recommendations for each formulation should be followed.
If a patient misses a dose of Lynparza, they should take their next normal dose at its scheduled time.
Treatment may be interrupted to manage adverse reactions such as nausea, vomiting, diarrhoea and anaemia and dose reduction can be considered (see section 4.8).
The recommended dose reduction is to 200 mg twice daily (equivalent to a total daily dose of 400 mg).
If a further dose reduction is required, then reduction to 100 mg twice daily (equivalent to a total daily dose of 200 mg) is recommended.
Concomitant use of strong or moderate CYP3A inhibitors is not recommended and alternative agents should be considered. If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg). If a moderate CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) (see sections 4.4 and 4.5).
No adjustment in starting dose is required for elderly patients. There are limited clinical data in patients aged 75 years and over.
For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Lynparza can be administered in patients with mild renal impairment (creatinine clearance 51 to 80 ml/min) with no dose adjustment.
Lynparza is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance ≤30 ml/min) as safety and pharmacokinetics have not been studied in these patients. Lynparza may only be used in patients with severe renal impairment if the benefit outweighs the potential risk, and the patient should be carefully monitored for renal function and adverse events.
Lynparza can be administered to patients with mild or moderate hepatic impairment (Child-Pugh classification A or B) with no dose adjustment (see section 5.2). Lynparza is not recommended for use in patients with severe hepatic impairment (Child-Pugh classification C), as safety and pharmacokinetics have not been studied in these patients.
There are limited clinical data available in non-Caucasian patients. However, no dose adjustment is required on the basis of ethnicity (see section 5.2).
The safety and efficacy of Lynparza in children and adolescents has not been established.
No data are available.
Lynparza is for oral use.
Due to the effect of food on olaparib absorption, patients should take Lynparza at least one hour after food, and refrain from eating preferably for up to 2 hours afterwards.
Symptoms of overdose are not established and there is no specific treatment in the event of Lynparza overdose. In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically.
2 years.
Store in a refrigerator (2°C-8°C).
Do not freeze. Any capsules that have been frozen must be discarded.
Lynparza capsules can be stored for up to 3 months below 30°C. The capsules must be discarded after this period.
HDPE plastic bottle with a child-resistant closure containing 112 hard capsules.
Pack of 448 capsules (4 bottles of 112 capsules).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
