Note: Due to differences in dosing and bioavailability, in international markets where capsules may be available, do not substitute capsules for tablets (or vice versa) on a mg-per-mg basis. Select patients for therapy based on an approved olaparib companion diagnostic test for detection of genetic mutations for all indications except ovarian cancer, recurrent (maintenance therapy). Do not initiate treatment with olaparib until after hematologic toxicity due to prior chemotherapy has resolved to ≤ grade 1.
Breast cancer, early, high-risk, HER2-negative, germline BRCA-mutated, adjuvant therapy: Oral: Tablets: 300 mg twice daily for 1 year or until disease progression or unacceptable toxicity, whichever occurs first (Tutt 2021).
Breast cancer, metastatic, HER2-negative, germline BRCA-mutated: Oral: Tablets: 300 mg twice daily until disease progression or unacceptable toxicity (Robson 2017).
Ovarian cancer, advanced, germline or somatic BRCA -mutated , first-line maintenance therapy (monotherapy): Oral: Tablets: 300 mg twice daily until disease progression or unacceptable toxicity or completion of 2 years of therapy. Patients with a complete response (no radiologic evidence of disease) at 2 years should discontinue olaparib; patients with evidence of disease at 2 years may continue treatment (beyond 2 years) if further olaparib treatment may provide benefit (ASCO [Tew 2022]; Moore 2018).
Ovarian cancer, advanced, homologous recombination deficient-positive, first-line maintenance therapy (combination therapy): Oral: Tablets: 300 mg twice daily (in combination with bevacizumab) until disease progression or unacceptable toxicity or completion of 2 years of therapy (Ray-Coquard 2019). Patients with a complete response (no radiologic evidence of disease) at 2 years should discontinue olaparib; patients with evidence of disease at 2 years may continue treatment (beyond 2 years) if further olaparib treatment may provide benefit. Bevacizumab duration is for a total of 15 months (including when administered with chemotherapy as well as maintenance).
Ovarian cancer, recurrent, maintenance therapy: Oral: Tablets: 300 mg twice daily until disease progression or unacceptable toxicity (Poveda 2021; Pujade-Lauraine 2017).
Pancreatic cancer, metastatic, germline BRCA-mutated , first-line maintenance therapy: Oral: Tablets: 300 mg twice daily until disease progression or unacceptable toxicity (Golan 2019).
Prostate cancer, metastatic, castration-resistant, homologous recombination repair gene-mutated: Oral: Tablets: 300 mg twice daily until disease progression or unacceptable toxicity (de Bono 2020; Hussain 2020). Patients should also receive a gonadotropin-releasing hormone analog or have had bilateral orchiectomy.
Missed doses: If a dose is missed, administer the next dose at its scheduled time.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Renal function estimated by Cockcroft-Gault equation.
CrCl 51 to 80 mL/minute: No dosage adjustment necessary.
CrCl 31 to 50 mL/minute: Tablets: Reduce dose to 200 mg twice daily.
CrCl ≤30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
End-stage renal disease: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Mild to moderate impairment (Child-Pugh classes A and B): Tablets: No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Tablets: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
Consider therapy interruption or dose reduction if adverse reactions occur.
Tablets: The recommended first dose reduction is to 250 mg twice daily; if further reduction is required, reduce dose to 200 mg twice daily.
Hematologic toxicity: Prolonged hematologic toxicity: Interrupt treatment and monitor blood counts weekly until recovery. If counts do not recover to ≤ grade 1 after 4 weeks, further evaluation (including bone marrow and cytogenetic analyses) is necessary.
Anemia (ASCO [Tew 2020]):
Hemoglobin <8 mg/dL and/or requiring a blood transfusion for symptom relief: Monitor.
Repeated anemia: Reduce olaparib dose to avoid multiple transfusions.
Neutropenia (grade 4 lasting ≥5 to 7 days or associated with fever): Withhold olaparib until recovery of infection and granulocyte count, then re-initiate with the olaparib dose reduced; WBC growth factor support may be used while olaparib is withheld for neutropenia; however, growth factors are not indicated during daily olaparib dosing (ASCO (Tew 2020]).
Thrombocytopenia: Persistent thrombocytopenia or significant bleeding despite dose reduction: Discontinue olaparib (ASCO [Tew 2020]).
Secondary acute myeloid leukemia/myelodysplastic syndrome: Discontinue olaparib with confirmed secondary acute myeloid leukemia/myelodysplastic syndrome.
Nonhematologic toxicity:
GI toxicity: Persistent nausea requiring daily antiemetics, resulting in performance status reduction and/or resulting in >5% weight loss: Consider olaparib dose reduction (ASCO [Tew 2020]).
Pneumonitis: Interrupt treatment and evaluate promptly for new or worsening respiratory symptoms (eg, cough, dyspnea, fever, wheezing) or for radiologic abnormalities. Discontinue olaparib if pneumonitis is confirmed.
Thromboembolic events (venous thrombosis and pulmonary embolism): Treat as medically appropriate; may include long-term anticoagulation as clinically indicated.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Lynparza: 100 mg, 150 mg
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Lynparza: 50 mg [DSC]
Tablet, Oral:
Lynparza: 100 mg, 150 mg
Olaparib is available through the authorized specialty pharmacy providers. For further information on patient assistance, product availability, and prescribing instructions, please refer to the following website: https://providerportal.myaccess360.com or call 1-844-275-2360.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Lynparza tablets: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208558s026lbl.pdf#page=54
Oral: Administer approximately every 12 hours with or without food. Swallow tablets whole; do not chew, crush, dissolve, or divide tablet.
Based on a pharmacokinetic study (in tablets), the rate of absorption was slower and the peak exposure was decreased when administered with a high-fat meal; however, the extent of absorption was not affected; nausea and vomiting were reported more frequently when olaparib was administered in a fasted state (Plummer 2015).
Due to differences in dosing and bioavailability, in international markets where capsules may be available, do not substitute capsules for tablets (or vice versa) on a mg-per-mg basis.
This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Olaparib may cause reproductive toxicity, teratogenicity, and genotoxicity.
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Breast cancer, early, high-risk, HER2-negative, germline BRCA-mutated, adjuvant therapy: Tablets: Adjuvant treatment of deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, high-risk, early breast cancer in adults who have been treated with neoadjuvant or adjuvant chemotherapy (select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen).
Breast cancer, metastatic ( BRCA -mutated, HER2-negative): Tablets: Treatment of deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer in adults who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor-positive disease should have received a prior endocrine therapy or be considered inappropriate for endocrine therapy (select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen).
Ovarian cancer, advanced ( BRCA -mutated), first-line maintenance therapy: Tablets: First-line maintenance treatment (as monotherapy) of deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who are in complete or partial response to first-line, platinum-based chemotherapy (select patients for therapy based on an approved olaparib companion diagnostic test for BRCA1m or BRCA2m in tumor or blood specimen).
Ovarian cancer, advanced (homologous recombination deficient-positive), first-line maintenance therapy: Tablets: First-line maintenance treatment (in combination with bevacizumab) of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who are in complete or partial response to first-line, platinum-based chemotherapy 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 (select patients for therapy based on an approved olaparib companion diagnostic test for BRCA1m, BRCA2m, and/or genomic instability in tumor specimen).
Ovarian cancer, recurrent (maintenance therapy): Tablets: Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who are in complete or partial response to platinum-based chemotherapy.
Pancreatic cancer, metastatic (BRCA-mutated), first-line maintenance therapy: Tablets: First-line maintenance treatment of deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma in adults whose disease has not progressed on at least 16 weeks of a first-line, platinum-based chemotherapy regimen (select patients for therapy based on an approved olaparib companion diagnostic test for gBRCA1m or gBRCA2m in blood specimen).
Prostate cancer, metastatic, castration-resistant (homologous recombination repair gene-mutated): Tablets: Treatment of deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer in adults who have progressed following prior enzalutamide or abiraterone treatment (select patients for therapy based on an approved olaparib companion diagnostic test for ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, or RAD54Lm in tumor specimen, for gBRCA1m or gBRCA2m in blood specimen, or for ATMm, BRCA1m, or BRCA2m in plasma specimen).
Olaparib may be confused with niraparib, olaratumab. osimertinib, rucaparib, talazoparib.
Lynparza may be confused with lenvatinib, Lenvima.
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its lists of drug classes which have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Dermatologic: Skin rash (5% to 15%)
Endocrine & metabolic: Hypomagnesemia (14%)
Gastrointestinal: Abdominal pain (45%; upper abdominal pain: 5% to 7%), constipation (23% to 28%), decreased appetite (13% to 25%), diarrhea (18% to 37%; grades 3/4: ≤3%), dysgeusia (11% to 27%), dyspepsia (5% to 11%), nausea (45% to 77%; grades 3/4: ≤3%), stomatitis (10% to 20%; grades 3/4: ≤1%), vomiting (20% to 40%; grades 3/4: ≤3%)
Genitourinary: Urinary tract infection (13%)
Hematologic & oncologic: Anemia (24% to 44%; grades 3/4: 9% to 21%), increased MCV (≤89%), leukopenia (5% to 17%; grades 3/4: 3%), neutropenia (12% to 19%; grades 3/4: 4% to 6%), thrombocytopenia (4% to 14%; grades 3/4: 1% to 3%)
Infection: Influenza (≤36%)
Nervous system: Asthenia (≤67%), dizziness (7% to 20%), fatigue (≤67%), headache (7% to 26%)
Neuromuscular & skeletal: Arthralgia (≤30%), back pain (19%), myalgia (≤30%)
Renal: Increased serum creatinine (2% to 99%)
Respiratory: Bronchitis (≤28%), cough (9% to 18%), dyspnea (4% to 15%), nasopharyngitis (≤36%), rhinitis (≤36%), sinusitis (≤36%), upper respiratory tract infection (≤36%)
1% to 10%:
Cardiovascular: Edema (8%), venous thromboembolism (≤5%; including severe pulmonary embolism)
Dermatologic: Dermatitis (≤1%)
Hematologic & oncologic: Lymphocytopenia (1% to 7%), myelodysplastic syndrome (≤8%), myeloid leukemia (acute: ≤8%)
Hypersensitivity: Hypersensitivity reaction (≤2%)
<1%: Respiratory: Pneumonitis
Postmarketing:
Dermatologic: Erythema nodosum
Hypersensitivity: Angioedema
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to olaparib or any component of the formulation.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions, including rash, dermatitis, and angioedema, have been reported.
• Pulmonary toxicity: Pneumonitis (including some fatalities) has occurred rarely in studies of single-agent olaparib in patients with various cancers. New or worsening respiratory symptoms include cough, dyspnea, fever, and/or wheezing.
• Secondary malignancy: Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) have been reported (rarely) in clinical trials of patients with various cancers who received single-agent olaparib, including fatal cases. The median duration of olaparib therapy prior to development of the secondary cancers was 2 years (range: 6 months to >10 years). All patients had received prior chemotherapy with platinum agents and/or other DNA-damaging agents, including radiation therapy. If prolonged hematologic toxicity occurs and blood counts do not recover to ≤ grade 1 after 4 weeks, further evaluation (including bone marrow and cytogenetic analyses) is necessary.
• Thromboembolic events: Thromboembolic events, including severe or fatal pulmonary embolism, have been reported. In a study of patients with metastatic castration-resistant prostate cancer who received olaparib plus androgen deprivation therapy (ADT), venous thromboembolic events occurred at a higher rate compared to patients who received enzalutamide or abiraterone plus ADT.
Other warnings/precautions:
• Appropriate use: When treating with olaparib as maintenance therapy for recurrent ovarian cancer, biomarker testing is not required. For other indications, select patients for olaparib therapy based on genetic mutations, biomarker status, and tumor sample type. Information on approved tests for the detection of genetic mutations may be found at http://www.fda.gov/companiondiagnostics. If testing fails or tissue sample is unavailable, or when germline testing is negative, consider using an alternative test (if available).
Substrate of CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Bitter Orange: May increase the serum concentration of Olaparib. Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
CYP3A4 Inducers (Moderate): May decrease the serum concentration of Olaparib. Risk X: Avoid combination
CYP3A4 Inducers (Strong): May decrease the serum concentration of Olaparib. Risk X: Avoid combination
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Olaparib. Management: Avoid use of moderate CYP3A4 inhibitors with olaparib, if possible. If such concurrent use cannot be avoided, the dose of olaparib tablets should be reduced to 150 mg twice daily and the dose of olaparib capsules should be reduced to 200 mg twice daily. Risk D: Consider therapy modification
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Olaparib. Management: Avoid use of strong CYP3A4 inhibitors with olaparib, if possible. If such concurrent use cannot be avoided, the dose of olaparib tablets should be reduced to 100 mg twice daily and the dose of olaparib capsules should be reduced to 150 mg twice daily. Risk D: Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Grapefruit Juice: May increase the serum concentration of Olaparib. Risk X: Avoid combination
Myelosuppressive Agents: May enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Coadministration with grapefruit, grapefruit juice, Seville oranges, or Seville orange juice may increase olaparib plasma concentrations. Management: Avoid concomitant administration with grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
Pregnancy testing is recommended prior to treatment initiation in patients who could become pregnant. Patients who could become pregnant should use highly effective contraception during therapy and for at least 6 months after the last olaparib dose. Patients with partners who could become or are pregnant should use effective contraception during treatment and for 3 months after the last olaparib dose; patients also should not donate sperm during therapy and for 3 months following the last olaparib dose.
Based on the mechanism of action, and data from animal reproduction studies, in utero exposure to olaparib may cause fetal harm.
It is not known if olaparib is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that patients should not breastfeed during treatment and for 1 month after the last olaparib dose.
Avoid grapefruit, grapefruit juice, Seville oranges, or Seville orange juice.
BRCA-mutation status (metastatic breast cancer, advanced ovarian cancer, first-line monotherapy maintenance treatment of advanced ovarian cancer, metastatic pancreatic cancer, and early breast cancer [off-label use]); homologous recombination deficiency (HRD) positive status (first-line combination maintenance treatment of advanced ovarian cancer); homologous recombination repair (HRR) gene mutation (in metastatic castration-resistant prostate cancer).
Genetic mutations or biomarker status: For early high-risk breast cancer, metastatic breast cancer, or advanced ovarian cancer (BRCA-mutated), test for germline BRCA1-mutated (gBRCA1m) or gBRCA2m in blood specimen. For first-line maintenance therapy for advanced ovarian cancer (BRCA-mutated), test for BRCA1m or BRCA2m in tumor or blood specimen. For first-line maintenance therapy for advanced ovarian cancer (homologous recombination deficient-positive), test for BRCA1m, BRCA2m, and/or genomic instability in tumor specimen. For first-line maintenance therapy for metastatic pancreatic cancer (BRCA-mutated), test for gBRCA1m or gBRCA2m in blood specimen. For metastatic castration-resistant prostate cancer (homologous recombination repair gene-mutated), test for ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, or RAD54Lm in tumor specimen, for gBRCA1m or gBRCA2m in blood specimen, or for ATMm, BRCA1m, or BRCA2m in plasma specimen. Consider an alternative test when testing fails, tissue sample is unavailable/insufficient, or when germline testing is negative. BRCA-mutation status in early breast cancer (off-label use). When treating with olaparib as maintenance therapy for recurrent ovarian cancer, biomarker testing is not required.
CBC at baseline and monthly thereafter, or as clinically indicated (weekly until recovery for prolonged hematologic toxicity), renal function. Evaluate pregnancy status (prior to treatment initiation in patients who could become pregnant). Monitor for signs/symptoms of venous thrombosis, pulmonary embolism, and pneumonitis (evaluate promptly for new or worsening respiratory symptoms such as cough, dyspnea, fever, wheezing, or for radiologic abnormalities). Monitor for signs of acute myeloid leukemia/myelodysplastic syndrome (if prolonged hematologic toxicity occurs and blood counts do not recover to ≤ grade 1 after 4 weeks, further evaluation, including bone marrow and cytogenetic analyses is necessary). Monitor adherence.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Olaparib is a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor, including PARP1, PARP2, and PARP3. PARP enzymes are involved in DNA transcription, cell cycle regulation, and DNA repair. Olaparib is a potent oral PARP inhibitor which induces synthetic lethality in BRCA1/2 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, which leads to disruption of cellular homeostasis and cell death (Ledermann 2012).
Absorption: Rapid; delayed with a high-fat/high-calorie meal (extent of absorption not significantly altered).
Distribution: Tablet: 158 ± 136 L.
Protein binding: ~82%.
Metabolism: Primarily hepatic via CYP3A; the majority of metabolism is through oxidation with some metabolites undergoing subsequent glucuronide or sulfate conjugation.
Half-life elimination, terminal: Tablet: 14.9 ± 8.2 hours.
Time to peak: Tablet: 1.5 hours.
Excretion: Urine (44%, mostly as metabolites); feces (42%, mostly as metabolites).
Clearance: Tablet: 7.4 ± 3.9 hours.
Altered kidney function:
Tablets: The mean AUC and Cmax increased by 24% and 15%, respectively, in patients with mild renal impairment (CrCl 51 to 80 mL/minute), and by 44% and 26%, respectively, in patients with moderate renal impairment (CrCl 31 to 50 mL/minute) compared with patients with normal renal function.
Hepatic function impairment: Tablets: The mean AUC and the mean Cmax increased by 15% and 13%, respectively, in patients with mild impairment (Child-Pugh class A), compared with patients with normal hepatic function. The mean AUC increased by 8% and the mean Cmax decreased by 13% in patients with moderate impairment (Child-Pugh class B), compared with patients with normal hepatic function.
Tablets (Lynparza Oral)
100 mg (per each): $148.82
150 mg (per each): $148.82
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