LYNPARZA 100 MG — DIN 02475200

What is LYNPARZA?

LYNPARZA 100 MG contains OLAPARIB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02475200, held by ASTRAZENECA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 23-May-2018. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is LYNPARZA used for?

LYNPARZA (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before LYNPARZA treatment is initiated. LYNPARZA is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2- negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have progressed on or be considered inappropriate for endocrine therapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated. LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with advanced BRCA-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. Patients must have confirmation of BRCA mutation (identified by either germline or tumour testing) before LYNPARZA treatment is initiated. LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. Platinum-sensitive relapse is defined as disease progression occurring at least 6 months following completion of platinum chemotherapy. LYNPARZA is indicated as an add-on maintenance treatment to bevacizumab of adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer: who are in response (complete or partial) to prior treatment with first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability. BRCA mutation status (germline or somatic) and/or genomic instability must be confirmed before LYNPARZA treatment is initiated. LYNPARZA is indicated as monotherapy for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated. LYNPARZA is indicated as monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA or ATM mutated metastatic castration-resistant Prostate Cancer (mCRPC) who have progressed following prior treatment with a new hormonal agent. BRCA or ATM mutations must be confirmed before LYNPARZA treatment is initiated. LYNPARZA is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious germline and/or somatic BRCA mutated metastatic castration resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. BRCA mutation must be confirmed before LYNPARZA treatment is initiated.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

The recommended total daily dose of LYNPARZA tablets is 600 mg, taken as two 150 mg tablets twice daily. The 100 mg tablet is available for dose reduction. For adjuvant treatment of gBRCAm HER2-negative high risk early breast cancer: It is recommended that patients are treated for a total of 1 year, or until disease recurrence or unacceptable toxicity, whichever occurs first. Patients with hormone receptor positive breast cancer should continue concurrent treatment with endocrine therapy as per current clinical practice guidelines. For treatment of metastatic HER2-negative gBRCAm breast cancer: It is recommended that LYNPARZA treatment be continued until progression of the underlying disease or unacceptable toxicity. For maintenance treatment of patients with BRCAm advanced ovarian cancer who are in response to first-line platinum-based chemotherapy: Patients can continue treatment for 2 years or until disease progression. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous treatment, can be treated beyond 2 years. For maintenance treatment of PSR ovarian cancer: Patients should start treatment with LYNPARZA no later than 8 weeks after completion of their final dose of the platinum-containing regimen. Patients should have recovered from prior hematologic toxicities prior to starting LYNPARZA therapy (hemoglobin, platelet, and neutrophil levels should be ≤ CTCAE grade 1). It is recommended that LYNPARZA treatment be continued until progression of the underlying disease or unacceptable toxicity. As an add-on maintenance treatment to bevacizumab for patients with HRD-positive advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to prior treatment with first-line platinum-based chemotherapy in combination with bevacizumab: Continue LYNPARZA until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with no radiological evidence of disease at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating physician can derive further benefit from continuous treatment, can be treated beyond 2 years. When used with LYNPARZA, the dose of bevacizumab is 15 mg/kg once every 3 weeks for up to a total of 15 months, including the period given with chemotherapy and given as maintenance. For maintenance treatment of patients with gBRCAm metastatic adenocarcinoma of the pancreas who are in response to first-line platinum-based chemotherapy: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity. As monotherapy for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and mutations in the BRCA and ATM genes: It is recommended that LYNPARZA treatment be continued until progression of the underlying disease or unacceptable toxicity. Patients receiving LYNPARZA for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have had bilateral orchiectomy. In combination with abiraterone and prednisone or prednisolone for the treatment of BRCA mutated metastatic castration-resistant prostate cancer (mCRPC): When LYNPARZA is used in combination with abiraterone for the treatment of BRCA mutated mCRPC, the dose of abiraterone is 1000 mg orally once daily. Abiraterone should be given with prednisone or prednisolone 5 mg orally twice daily. It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity. For Adverse Events: Treatment may be interrupted to manage adverse events and dose reduction can be considered. The recommended reduced total daily dose of LYNPARZA (olaparib tablets) is 500 mg. If a further dose reduction is required, the recommended reduced total daily dose of LYNPARZA (olaparib tablets) is 400 mg. For Co-administration with CYP3A Inhibitors: 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 reduced total daily dose of LYNPARZA (olaparib tablets) is 200 mg. If a moderate CYP3A inhibitor must be co-administered, the recommended reduced total daily dose of LYNPARZA (olaparib tablets) is 300 mg. For Patients with Renal Insufficiency: For patients with moderate renal impairment (creatinine clearance 31 - 50 ml/min) the recommended reduced total daily dose of LYNPARZA (olaparib tablets) is 400 mg. LYNPARZA is not recommended for 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 can be administered to patients with mild renal impairment (creatinine clearance 51 - 80 ml/min) with no dose adjustment. LYNPARZA is for oral use. LYNPARZA tablets should be swallowed whole and not chewed, crushed, dissolved or divided. LYNPARZA tablets can be taken with or without food. If a patient misses a dose of LYNPARZA, they should take their next normal dose at its scheduled time. The patient should not take a double dose to make up for forgotten tablets.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

LYNPARZA (olaparib) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Treatment with LYNPARZA (olaparib) should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) has been reported in patients exposed to LYNPARZA. The majority of the reports have been fatal. Pneumonitis has been reported in a small number of patients receiving LYNPARZA, and some reports have been fatal. LYNPARZA could cause fetal harm when administered to a pregnant woman.

Warnings and precautions

Treatment with LYNPARZA (olaparib) should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) has been reported in patients exposed to LYNPARZA. The majority of the reports have been fatal. Pneumonitis has been reported in a small number of patients receiving LYNPARZA, and some reports have been fatal. LYNPARZA could cause fetal harm when administered to a pregnant woman. Co-administration of LYNPARZA (olaparib) with strong or moderate CYP3A inhibitors is not recommended. If a strong CYP3A inhibitor must be co-administered, the dose of LYNPARZA should be reduced. Co-administration of LYNPARZA with strong or moderate CYP3A inducers is not recommended. In the event that a patient already receiving LYNPARZA requires treatment with a strong or moderate CYP3A inducer, the prescriber should be aware that the efficacy of LYNPARZA may be substantially reduced. Hematological toxicity has been reported in patients treated with LYNPARZA, including clinical diagnoses and/or laboratory findings of generally mild or moderate (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) anemia, neutropenia, thrombocytopenia and lymphopenia, however, there were reports of CTCAE grade 3 and higher events. Anemia was the most common CTCAE grade ≥3 adverse reaction reported in clinical studies. Patients should not start treatment with LYNPARZA until they have recovered from hematological toxicity caused by previous anti-cancer therapy (hemoglobin, platelet, and neutrophil levels should be ≤CTCAE grade 1). Baseline testing, followed by monthly monitoring of complete blood counts, is recommended for the first 12 months of treatment and periodically after this time to monitor for clinically significant changes in any parameter during treatment. If a patient develops severe hematological toxicity or blood transfusion dependence, treatment with LYNPARZA should be interrupted and appropriate hematological 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. Cases of hepatotoxicity have been reported in patients treated with olaparib. 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-induced liver injury (DILI), treatment should be interrupted. In case of severe DILI treatment discontinuation should be considered as clinically appropriate. Venous thromboembolic events (VTE), including pulmonary embolism, have occurred in patients treated with LYNPARZA and had no consistent clinical pattern. A higher incidence was observed in patients with metastatic castration-resistant prostate cancer who, also received androgen deprivation therapy, compared with other approved indications. Monitor patients for clinical signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate. Asthenia, fatigue and dizziness have been reported in patients receiving LYNPARZA treatment. Patients experiencing these symptoms should use caution when driving or operating machines.