Zuellig Pharma
Concise Prescribing Info
Maintenance treatment of adult patients w/ deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 wk of 1st-line platinum-based chemotherapy regimen. In combination w/ bevacizumab for maintenance treatment of adult patients w/ advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy & whose cancer is associated w/ homologous recombination deficiency (HRD)-positive status. Monotherapy for adult patients w/ germline BRCA1/2-mutations who have HER2-negative metastatic breast cancer, previously have been treated w/ anthracycline & taxane in neoadjuvant, adjuvant or metastatic setting unless unsuitable for these treatments. Monotherapy for maintenance treatment of adult patients w/ platinum-sensitive relapsed 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. Prior treatment must have included at least 2 courses of platinum-based regimens.
Dosage/Direction for Use
300 mg bd, continue until underlying disease progression. Dose adjustments for AR Reduce to 250 mg bd or further reduction to 200 mg bd may be considered. Dose adjustments for co-administration w/ CYP3A inhibitors Reduce to 100 mg bd w/ strong inhibitors or 150 mg bd w/ moderate inhibitors. Moderate renal impairment (CrCl 31-50 mL/min) 200 mg bd.
May be taken with or without food: May be taken w/o regard to meals. Swallow whole, do not chew/crush/dissolve/divide.
Hypersensitivity. Lactation during & 1 mth after last dose.
Special Precautions
Haematological toxicity; myelodysplastic syndrome/acute myeloid leukaemia; pneumonitis, new or worsening resp symptoms eg, dyspnoea, cough & fever or radiological abnormality. Not recommended in co-administration w/ strong or moderate CYP3A inhibitors & inducers. Non-Caucasian patients. May affect ability to drive & use machines. Not recommended in severe renal & hepatic impairment or end-stage renal disease. Women of childbearing potential must use effective contraception during & 1 mth after last dose. Male patients must use effective contraception during & 3 mth after last dose. Not to be used during pregnancy. Not to be used while lactating during & 1 mth after last dose. Childn & adolescents. Elderly ≥75 yr.
Adverse Reactions
Anaemia, neutropenia, thrombocytopenia, leukopenia; decreased appetite; dizziness, headache, dysgeusia; cough, dyspnoea; vomiting, diarrhoea, nausea, dyspepsia, upper abdominal pain; fatigue, asthenia. Lymphopenia; rash; stomatitis; increased blood creatinine.
Drug Interactions
Potentiated & prolonged myelosuppressive toxicity w/ other anticancer drugs. Closely monitor patients co-administered w/ vaccines or immunosuppressives. Increased mean Cmax & AUC by itraconazole, telithromycin, clarithromycin, PIs boosted w/ ritonavir or cobicistat, boceprevir, telaprevir, erythromycin, diltiazem, fluconazole, verapamil; grapefruit juice. Decreased mean Cmax & AUC by phenytoin, rifampicin, rifapentine, carbamazepine, nevirapine, phenobarb, St. John's wort. Clinical monitoring w/ CYP3A substrates or substrates w/ narrow therapeutic margin (eg, simvastatin, cisapride, cyclosporine, ergot alkaloids, fentanyl, pimozide, sirolimus, tacrolimus, quetiapine) & P-gp substrates (eg, pravastatin, dabigatran, digoxin, colchicine). Reduced exposure to CYP1A2, 2B6 & 3A4, CYP2C9, CYP2C19 & P-gp substrates. Increased exposure to BRCP, OATP1B1, OCT1, OCT2, OAT3, MATE1 & MATE2K substrates. Moderate to strong CYP3A inducers eg, efavirenz, rifabutin.
ATC Classification
L01XK01 - olaparib ; Belongs to the class of poly (ADP-ribose) polymerase (PARP) inhibitors. Used in the treatment of cancer.
Lynparza FC tab 100 mg
7 × 8's
Lynparza FC tab 150 mg
7 × 8's
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