These highlights do not include all the information needed to use LYNPARZA safely and effectively. See full prescribing information for LYNPARZA.
LYNPARZA � (olaparib) tablets, for oral use
Initial U.S. Approval: 2014
RECENT MAJOR CHANGES
Indications and Usage (1.3) 1/2018
Dosage and Administration (2.4) 1/2018
Warnings and Precautions (5) 1/2018
INDICATIONS AND USAGE
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
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for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. ( 1.1)
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for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated ( gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.2, 2.3)
Breast cancer
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in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. ( 1.3, 2.4)
DOSAGE AND ADMINISTRATION
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To avoid substitution errors and overdose, do not substitute Lynparza tablets with Lynparza capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. ( 2.1)
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Recommended tablet dose is 300 mg taken orally twice daily with or without food. ( 2.2)
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Continue treatment until disease progression or unacceptable toxicity. ( 2.2)
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For adverse reactions, consider dose interruption or dose reduction. ( 2.5)
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For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 200 mg twice daily. ( 2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg, 100 mg ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
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Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to Lynparza monotherapy and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed. (5.1)
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Pneumonitis: Occurred in <1% of patients exposed to Lynparza, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed. ( 5.2)
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Embryo-Fetal Toxicity: Lynparza can cause fetal harm. Advise of the potential risk to a fetus and to use effective contraception. ( 5.3, 8.1, 8.3)
ADVERSE REACTIONS
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Most common adverse reactions (?20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, neutropenia leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis. (6.1)
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Most common laboratory abnormalities (?25%) were decrease in hemoglobin, increase in mean corpuscular volume, decrease in lymphocytes, decrease in leukocytes, decrease in absolute neutrophil count, increase in serum creatinine and decrease in platelets. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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CYP3A Inhibitors: Avoid concomitant use of strong or moderate CYP3A inhibitors. If the inhibitor cannot be avoided, reduce the olaparib dose. ( 2.6, 7.2, 12.3)
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CYP3A Inducers: Avoid concomitant use of strong or moderate CYP3A inducers as decreased efficacy can occur. ( 7.3, 12.3)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 2/2018