b'INDICATIONS Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelinesEPKINLY is indicated for the treatment of adults with: and administer supportive care as appropriate. relapsed or refractory diffuse large B-cell lymphomaInfections (DLBCL), not otherwise specified (NOS), including DLBCLarising from indolent lymphoma, and high-grade B-cellEPKINLY can cause serious and fatal infections. Serious lymphoma (HGBCL) after 2 or more lines of systemic therapy.infections, including opportunistic infections, were reported inrelapsed or refractory follicular lymphoma (FL) after 2 or15% of patients with LBCL in the clinical trial (most common: more lines of systemic therapy. 4.5% sepsis, 3.2% pneumonia). Fatal infections occurred in 1.3% of patients (1.3% COVID-19). These indications are approved under accelerated approval basedon response rate and durability of response. Continued approvalSerious infections, including opportunistic infections, were for these indications may be contingent upon verification andreported in 40% of patients with FL receiving the 2-step up description of clinical benefit in confirmatory trials. dosage schedule in the clinical trial (most common: 20% COVID-19, 13% pneumonia, 3% urinary tract infections). Fatal infections occurred in 6% of patients (5% COVID-19, 0.8% IMPORTANT SAFETY INFORMATION pneumonia, 0.8% sepsis).BOXED WARNINGS Monitor patients for signs and symptoms of infection prior to and NOW APPROVED FOR ADULTS WITH3L+ FLCytokine release syndrome (CRS), including serious or during treatment and treat appropriately. Avoid administration inlife-threatening reactions, can occur in patients patients with active infections. Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior to starting receiving EPKINLY. Initiate treatment with the EPKINLYThe first-and-onlystep-up dosage schedule to reduce the incidence andEPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) severity of CRS. Withhold EPKINLY until CRS resolves or prophylaxis and consider prophylaxis against herpes virus.permanently discontinue based on severity. Cytopeniasbispecific antibodyImmuneeffectorcellassociatedneurotoxicitysyndromeEPKINLY can cause serious or severe cytopenias. In the clinical (ICANS), including life-threatening and fatal reactions, trial of patients with LBCL, grade 3 or 4 events occurred in 32% can occur with EPKINLY. Monitor patients for neurological (neutrophils decreased), 12% (hemoglobin decreased), and 12% signs or symptoms of ICANS during treatment. Withhold (platelets decreased). Febrile neutropenia occurred in 2.5%.approved in both EPKINLY until ICANS resolves or permanently discontinuedosage schedule, grade 3 or 4 events occurred in 30% based on severity. In the clinical trial of patients with FL receiving the 2-step up (neutrophils decreased), 10% (hemoglobin decreased), and 8% CRS (platelets decreased). Febrile neutropenia occurred in 3.1%.3L+ DLBCL and 3L+ FL 1(LBCL) in the clinical trial (37% grade 1, 17% grade 2, and 2.5%Monitor complete blood counts throughout treatment. Based on CRS occurred in 51% of patients with large B-cell lymphoma grade 3) and recurred in 16% of patients. Most events (92%)severity of cytopenias, temporarily withhold or permanently occurred during cycle 1, with 61% occurring after the 48 mg dosediscontinue EPKINLY. Consider prophylactic granulocyte colony-on cycle 1, day 15. stimulating factor administration as applicable. Embryo-FetalToxicityCRS occurred in 49% of patients with FL receiving the Granted accelerated approval based on response rate and durability of response. Continued approvalrecommended 3-step up dosage schedule in the clinical trialEPKINLY may cause fetal harm when administered to a pregnant (45% grade 1, 9% grade 2) and recurred in 23% of patients. Mostwoman. Advise females of reproductive potential to use effective for these indications may be contingent upon verification and description of clinical benefit inevents (88%) occurred during cycle 1, with 49% occurring aftercontraception during treatment with EPKINLY and for 4 months confirmatory trials. the 48 mg dose on cycle 1, day 22. after the last dose. Verify pregnancy status in females ofreproductive potential prior to initiating EPKINLY.In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, andAdverse ReactionsNCCN Clinical Practice Guidelines in Oncologytachycardia. Concurrent neurological adverse reactionsassociated with CRS occurred in 2.5% of patients with LBCLDLBCL/HGBCL: Most common (20%) adverse reactions were (NCCN Guidelines) Recommended (reactions included headache, confusional state, tremors,CRS, fatigue, musculoskeletal pain, injection site reactions, dizziness, and ataxia) and 4.7% of patients with FL (reactionspyrexia, abdominal pain, nausea, and diarrhea. Most common included headache and dizziness). grade 3 to 4 laboratory abnormalities (10%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, Administer pretreatment medications to reduce the risk of CRS. The NCCN Guidelines recommend epcoritamab-bysp (EPKINLY) as an NCCN Category decreased hemoglobin, and decreased platelets.2A treatment option after 2 or more lines of systemic therapy for patients with 2 *:Patients with DLBCL or high-grade B-cell lymphoma should beFL: Most common (20%) adverse reactions were injection site hospitalized for 24 hours following administration of the first fullreactions, CRS, COVID-19, fatigue, upper respiratory tract 48 mg dose. infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough,Histological transformation and headache. The most common grade 3 to 4 laboratory Monitor patients for potential CRS. At the first signs or symptoms R/R DLBCL R/R FLof CRS, manage per current practice guidelines and administerabnormalities (10%) were decreased lymphocytes, decreased CATEGORY 2A PREFERRED of indolent lymphoma to DLBCLCATEGORY 2A PREFERRED supportive care as appropriate.neutrophils, decreased white blood cells, and decreased CATEGORY 2A RECOMMENDED ICANS hemoglobin. UseinSpecificPopulationsICANS occurred in 6% of patients with LBCL in the clinical trial (4.5% grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, Lactation: Advise women not to breastfeed during treatment and NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2 9 occurred in cycle 1 of treatment.for 4 months after the last dose of EPKINLY. Geriatric Use: In patients with relapsed or refractory FL who *See NCCN Guidelines for the NCCN definitions of Categories of Preference and Categories of Evidence and Consensus. ICANS occurred in 6% of patients with FL receiving the 2-step up dosage schedule in the clinical trial (3.9% grade 1, 2.4% grade 2). received EPKINLY in the clinical trial, 52% were 65 years old, and13% were 75 years old. A higher rate of fatal adverse reactions, The onset of ICANS can be concurrent with CRS, followingprimarily infections, including COVID-19, was observed in patients Off-the-shelf subcutaneous EPKINLY enables accelerated treatment initiation 1 resolution of CRS, or in the absence of CRS. Clinical65 years old compared to younger adult patients. No overall manifestations of ICANS included, but were not limited to,difference in efficacy was observed.Prior to starting EPKINLY, provide Pneumocystis jirovecii confusional state, lethargy, tremor, dysgraphia, aphasia, andpneumonia prophylaxis and consider initiatingnon-convulsive status epilepticus. Please see accompanying Brief Summary of full Prescribingprophylaxis against herpes virus to prevent herpes zoster reactivationInformation, including Boxed Warnings, on the following pages.Discover data for DLBCL and FLReferences: 1. EPKINLY [package insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2024. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-Cell Lymphoma. V.2.2024.National EPKINLYhcp.com Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 26, 2024. To view the most recent and complete version of the guidelines, go online to NCCN.org.Distributed and marketed by Genmab US Inc. 777 Scudders Mill Road, Plainsboro, NJ 08536.Distributed and marketed by AbbVie Inc. 1 North Waukegan Road, North Chicago, IL 60064. EPKINLY is a registered trademark of Genmab A/S.2024 Genmab A/S and AbbVie. All rights reserved.3L=third line; DLBCL=diffuse large B-cell lymphoma; FL=follicular lymphoma; NCCN=National Comprehensive Cancer Network; R/R=relapsed/refractory. 07/2024 COM-US-EPK-0000849'