Lynparza

Lynparza

olaparib

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Olaparib
Indications/Uses
FC tab Monotherapy for the maintenance treatment of adult patients w/ advanced (FIGO stages III & IV) BRCA1/2-mutated (germline &/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following completion of 1st-line platinum-based chemotherapy. Monotherapy for the maintenance treatment of adult patients w/ platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Monotherapy for the treatment of adult patients w/ germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer, in which patients should have previously been treated w/ an anthracycline & a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients w/ hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Cap Monotherapy for the maintenance treatment of adult patients w/ platinum-sensitive relapsed breast cancer susceptibility gene (BRCA)-mutated (germline &/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Dosage/Direction for Use
Patients w/ platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy, start treatment no later than 8 wk after completion of final dose of the platinum-containing regimen. FC tab 300 mg (two 150 mg tab) bd. For 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer, continue until radiological disease progression, unacceptable toxicity or for up to 2 yr if there is no radiological evidence of disease after 2 yr of treatment. Patients w/ evidence of disease at 2 yr can be treated beyond 2 yr. For maintenance treatment of platinum-sensitive relapsed ovarian cancer, continue until progression of the underlying disease or unacceptable toxicity. For gBRCA1/2-mutated HER2-negative metastatic breast cancer, continue until progression of the underlying disease or unacceptable toxicity. Moderate renal impairment (CrCl 31-50 ml/min) 200 mg (two 100 mg tab) bd. Cap 400 mg (8 cap) bd. Moderate renal impairment (CrCl 31-50 mL/min) 300 mg (6 cap) bd.
Administration
FC tab: May be taken with or without food: Swallow whole, do not chew/crush/dissolve/divide. Cap: Should be taken on an empty stomach: Take at least 1 hr after meal and refrain from eating for 2 hr after intake.
Contraindications
Hypersensitivity. Lactation (during treatment & 1 mth after last dose).
Special Precautions
Lynparza tab should not be substituted for Lynparza cap on a mg-to-mg basis. Haematological toxicity; myelodysplastic syndrome/acute myeloid leukaemia; pneumonitis; embryofoetal toxicity. Perform baseline testing, followed by mthly monitoring, of CBC for the 1st 12 mth of treatment & periodically thereafter. Concomitant use w/ strong or moderate CYP3A inducers or inhibitors. May affect ability to drive & use machines. Should not be used during pregnancy. Women of childbearing potential should not become pregnant while on treatment & at the beginning of treatment. Male patients & their female partners of childbearing potential should use reliable contraception during therapy & for 3 mth after receiving the last dose. Elderly ≥75 yr. Childn & adolescents. Not recommended for use in patients w/ severe renal impairment or end-stage renal disease. FC tab Not recommended for use in patients w/ severe hepatic impairment. Cap Not recommended for use in patients w/ moderate or severe hepatic impairment.
Adverse Reactions
Anaemia, neutropenia, thrombocytopenia, lymphophenia; decreased appetite; headache, dizziness, dysgeusia; nausea, vomiting, diarrhoea, dyspepsia; upper abdominal pain, stomatitis; fatigue (including asthenia); increase in blood creatinine. FC tab Cough, dyspnoea; leukopenia; rash. Cap Mean corpuscular vol elevation.
Drug Interactions
Potentiated & prolonged myelosuppressive toxicity w/ other anticancer drugs including DNA damaging agents. Use w/ caution when co-administered w/ vaccines or immunosuppressant agents. Increased mean Cmax & mean AUC w/ strong (eg, itraconazole, telithromycin, clarithromycin, PI boosted w/ ritonavir or cobicistat, boceprevir, telaprevir) or moderate (eg, erythromycin, diltiazem, fluconazole, verapamil) CYP3A inhibitors. Not recommended w/ grapefruit juice. Decreased mean Cmax & mean AUC w/ strong CYP3A inducers (eg, phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarb, St. John's wort). Not recommended w/ moderate to strong CYP3A inducers (eg, efavirenz, rifabutin). Increased exposure of CYP3A substrates or substrates w/ narrow therapeutic index (eg, simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus & quetiapine); substrates of BCRP (eg, methotrexate, rosuvastatin), OATP1B1 (eg, bosentan, glibenclamide, repaglinide, statins, valsartan), OCT1 (eg, metformin), OCT2 (eg, serum creatinine), OAT3 (eg, furosemide, methotrexate), MATE1 (eg, metformin) & MATE2K (eg, metformin). May reduce exposure of CYP2B6, CYP2C9, CYP2C19 & P-gp substrates. May reduce efficacy of hormonal contraceptives. Possible interaction w/ P-gp substrates (eg, simvastatin, pravastatin, dabigatran, digoxin, colchicine).
ATC Classification
L01XX46 - olaparib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Lynparza hard cap 50 mg
Packing/Price
112's
Form
Lynparza FC tab 100 mg
Packing/Price
7 × 8's
Form
Lynparza FC tab 150 mg
Packing/Price
7 × 8's
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