Drug reference
Olaparib is a PARP inhibitor. PARP are enzymes that repair damaged DNA in cancer cells and, in the absence of functional BRCA, inhibition of PARP results in an inability of cancer cells to repair. Therefore inhibition of PARP results in an antineoplastic effect.
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Ovarian cancer (initiated by a specialist) | Fallopian tube cancer (initiated by a specialist) | Peritoneal cancer (initiated by a specialist) ▶BY MOUTH USING CAPSULES ▶Adult: 400 mg twice daily, patients should start treatment no later than 8 weeks after completion of their final dose of the platinum-containing regimen, for dose adjustments due to side-effects—consult product literature ▶BY MOUTH USING TABLETS ▶Adult: 300 mg twice daily, patients should start treatment no later than 8 weeks after completion of their final dose of the platinum-containing regimen, for dose adjustments due to side-effects—consult product literature
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of moderate inhibitors of CYP3A4 is unavoidable, reduce dose of capsules to 200 mg twice daily and tablets to 150 mg twice daily. ▶Manufacturer advises if concurrent use of potent inhibitors of CYP3A4 is unavoidable, reduce dose of capsules to 150 mg twice daily and tablets to 100 mg twice daily. DOSE EQUIVALENCE AND CONVERSION ▶Manufacturer advises capsules and tablets are not interchangeable on a milligram-for-milligram basis due to differences in dosing and bioavailability.
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NICE decisions ▶Olaparib for maintenance treatment of BRCA mutation- positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy (August 2019) NICE TA598 Olaparib (Lynparza ®) is recommended for use within the Immune system and malignant disease Cancer Drugs Fund as an option for the maintenance treatment of BRCA mutation-positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for olaparib are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta598 ▶Olaparib for maintenance treatment of relapsed platinum- sensitive ovarian, fallopian tube or peritoneal cancer (January 2020) NICE TA620 Olaparib (Lynparza ®) is recommended as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy only if: . they have a BRCA1 or BRCA2 mutation, and . they have had three or more courses of platinum-based chemotherapy, and . the manufacturer provides olaparib according to the commercial arrangement. Olaparib (Lynparza ®) is recommended for use within the Cancer Drugs Fund as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum- based chemotherapy only if: . they have a BRCA1 or BRCA2 mutation, and . they have had two courses of platinum-based chemotherapy, and . the conditions in the managed access agreement for olaparib are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta620 Scottish Medicines Consortium (SMC) decisions SMC No. 1047/15 The Scottish Medicines Consortium has advised (November 2016) that olaparib (Lynparza ®) is accepted for use within NHS Scotland as monotherapy for the maintenance treatment of adults 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. SMC No. SMC2209 The Scottish Medicines Consortium has advised (December 2019) that olaparib (Lynparza ®) is accepted for use within NHS Scotland for the maintenance treatment of adults 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 completion of first-line platinum-based chemotherapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938. MHRA/CHM ADVICE: LYNPARZA ® (OLAPARIB): RISK OF MEDICATION ERRORS WITH NEW PHARMACEUTICAL FORM (MAY 2018) A tablet formulation of olaparib was approved by the Immune system and malignant disease European Commission in May 2018. Capsules and tablets are not to be substituted on a milligram-to-milligram basis due to differences in dosing and bioavailability of each formulation. Prescribers should specify the formulation and dosage of olaparib on each prescription and pharmacists should ensure that the correct formulation and dose is dispensed. Patients should be instructed on the correct dose they should take for their capsules or tablets and if switched, informed of the difference in dosing.
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→Appendix 1: olaparib
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▶Common or very common Agranulocytosis. anaemia. appetite decreased. asthenia. cough. decreased leucocytes. diarrhoea. dizziness. dyspnoea. erythropenia . gastrointestinal discomfort. headache. nausea. neutropenia. neutropenic infection. neutropenic sepsis. oral disorders. skin reactions. taste altered. thrombocytopenia. vomiting ▶Frequency not known Haematotoxicity. neoplasms. pneumonitis SIDE-EFFECTS, FURTHER INFORMATION Haematological toxicity Withhold treatment if severe haematological toxicity develops; further analysis recommended if toxicity still present 4 weeks after treatment withdrawal. Pneumonitis If dyspnoea, cough and fever, or radiological abnormalities develop, withhold treatment and investigate; if pneumonitis confirmed, discontinue.
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Manufacturer advises effective contraception during treatment and for 1 month after receiving the last dose. Consider an additional non- hormonal method of contraception.
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Manufacturer advises avoid—toxicity in animal studies.
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Manufacturer advises avoid during treatment and for 1 month after last dose—no information available.
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Manufacturer advises avoid in severe impairment (no information available).
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Manufacturer advises avoid in severe impairment unless benefit outweighs potential risk—no information available. Dose adjustments For capsules, manufacturer advises reduce dose to 300 mg twice daily in moderate impairment. For tablets, manufacturer advises reduce dose to 200 mg twice daily in moderate impairment.
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Manufacturer advises monitor full blood count before treatment initiation, then every month for the first 12 months of treatment and periodically thereafter.
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Manufacturer advises capsules should be taken at least 1 hour after food, and food should preferably be avoided for up to 2 hours after administration.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Lynparza (AstraZeneca UK Ltd) Olaparib 100 mg Lynparza 100mg tablets | 56 tablet P £2,317.50 DT = £2,317.50 Olaparib 150 mg Lynparza 150mg tablets | 56 tablet P £2,317.50 DT = £2,317.50 Capsule CAUTIONARY AND ADVISORY LABELS 25 ▶Lynparza (AstraZeneca UK Ltd) Olaparib 50 mg Lynparza 50mg capsules | 448 capsule P £3,550.00 DT = £3,550.00
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Driving and skilled tasks Manufacturer advises patients should be counselled on the effects on driving and performance of skilled tasks—increased risk of malaise and dizziness.
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400 mg twice daily, patients should start
First-line fragment. Read the complete Indications and Dose section above.
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300 mg twice daily, patients should start
First-line fragment. Read the complete Indications and Dose section above.
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