Merck Lynparza page 2 of 5 4C IMPORTANT SAFETY INFORMATION (Cont’d) ADVERSE REACTIONS—Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Most common adverse reactions (Grades 1-4) in ≥10% of patients who received LYNPARZA/ abiraterone with a difference of ≥5% compared to placebo/abiraterone for PROpel were: anemia (48%), fatigue (including asthenia) (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%). Most common laboratory abnormalities (Grades 1-4) in ≥20% of patients who received LYNPARZA/abiraterone for PROpel were: decrease in hemoglobin (97%), decrease in lymphocytes (70%), decrease in platelets (23%), and decrease in absolute neutrophil count (23%). DRUG INTERACTIONS Anticancer Agents: Clinical studies of LYNPARZA with other myelosuppressive anticancer agents, including DNA-damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity. CYP3A Inhibitors: Avoid coadministration of strong or moderate CYP3A inhibitors when using LYNPARZA. If a strong or moderate CYP3A inhibitor must be coadministered, reduce the dose of LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during LYNPARZA treatment. CYP3A Inducers: Avoid coadministration of strong or moderate CYP3A inducers when using LYNPARZA. USE IN SPECIFIC POPULATIONS Lactation: No data are available regarding the presence of olaparib in human milk, its effects on the breastfed infant or on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise a lactating woman not to breastfeed during treatment with LYNPARZA and for 1 month after receiving the final dose. Pediatric Use: The safety and efficacy of LYNPARZA have not been established in pediatric patients. Hepatic Impairment: No adjustment to the starting dose is required in patients with mild or moderate hepatic impairment (Child-Pugh classification A and B). There are no data in patients with severe hepatic impairment (Child- Pugh classification C). Renal Impairment: No dosage modification is recommended in patients with mild renal impairment (CLcr 51-80 mL/min estimated by Cockcroft-Gault). In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice daily. There are no data in patients with severe renal impairment or end-stage renal disease (CLcr ≤30 mL/min). Please see accompanying Brief Summary of Prescribing Information on the following pages. You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. BRCAm=breast cancer-associated gene mutation; CLcr=creatinine clearance; gBRCAm=germline breast cancer-associated gene mutation; HRD=homologous recombination deficiency; HRR=homologous recombination repair; HRRm=homologous recombination repair gene– mutated; mCRPC=metastatic castration-resistant prostate cancer; NCCN=National Comprehensive Cancer Network® (NCCN®); PARPi=poly (ADP- ribose) polymerase inhibitor; VA=Veterans Affairs. References: 1. How VA is Advancing Prostate Cancer Care. VA National Oncology Program. Accessed March 10, 2026. https://www.cancer.va.gov/prostate.html 2. Bytnar JA, McGlynn KA, Nealeigh MD, Shriver CD, Zhu K. Cancer incidence in the US military: an updated analysis. Cancer. 2024;130(1):96‐106. doi:10.1002/ cncr.34978 3. Olaparib tab. VA Formulary Advisor. Accessed March 10, 2026. https://www.va.gov/ formularyadvisor/drugs/4036896-OLAPARIB-TAB 4. Current VA Health Care Copay Rates. U.S. Department of Veterans Affairs. Accessed March 10, 2026. https:// www.va.gov/health-care/copay-rates/ 5. Oncology Clinical Pathways: Prostate Cancer. Accessed March 10, 2026. https://www.cancer.va.gov/assets/pdf/clinical- pathways/prostate.pdf 6. Clinical Pathways. VA National Oncology Program. Accessed March 10, 2026. https:// www.cancer.va.gov/CANCER/clinical-pathways.html 7. LYNPARZA® (olaparib) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 8. Rubraca® (rucaparib) [prescribing information]. Vienna, Austria: zr pharma& GmbH; 2025. 9. Talzenna® (talazoparib) [prescribing information]. New York, NY: Pfizer Inc.; 2025. 10. Zejula® (niraparib) [prescribing information]. Durham, NC: GlaxoSmithKline; 2025. 11. Akeega® (niraparib and abiraterone acetate) [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2025. LYNPARZA is a registered trademark of the AstraZeneca group of companies. ©2026 AstraZeneca. All rights reserved. US-110112 3/26 Consider LYNPARZA for your appropriate VA patients with mCRPC LYNPARZA is the sole PARPi recommended for mCRPC in the VA Oncology Clinical Pathways 5,* * Clinical pathways standardize evidence-based practices to ensure high-quality, cost-effective care for Veterans at each point in their care plan.6 LYNPARZA is available on the VA National Formulary - Tier 33 • The Tiered Copayment Medication Structure established copayments for 30-day prescriptions at $11 for Tier 3 (sole source/brand name)4 Source: www.va.gov/formularyadvisor/, March 2026. Restrictions may apply. Formulary status is believed to be accurate at the time of printing and/or distribution but cannot be guaranteed. Formulary status for national plans may not reflect plan variation at the local level. Updated VA National Formulary status information may be available: https://www.va.gov/formularyadvisor/ Learn more about LYNPARZA—the first and only PARPi FDA-approved as a combination therapy and monotherapy for certain patients with mCRPC7-11
View this content as a flipbook by clicking here.