b'B:16"T:15.75"S:14.75"KRYSTEXXA is the only treatment indicated for uncontrolled gout 1,2 SEE THE RESULTSKRYSTEXXA with methotrexateAvailable soon through the VAs Pharmaceutical Prime Vendor,McKessonKRYSTEXXA CO-ADMINISTRATION WITH METHOTREXATE SHOWED A 74% RELATIVE IMPROVEMENT IN COMPLETE TOPHI RESOLUTION VS KRYSTEXXA ALONE 1KRYSTEXXA co-administered with methotrexate* provided IMPROVED EFFICACYand REDUCED RISK OF INFUSION REACTIONSvs KRYSTEXXA alone 1 Improved ecacy: 80% relative improvement in patient response; 71% (71/100) vs 39% (20/52) sUA-lowering response compared to KRYSTEXXA alone during Month 6 1 Reduced risk of infusion reactions: 87% relative reduction in infusion reactions; 4% (4/96) vs 31% (15/49) compared to KRYSTEXXA alone 1Baseline Week 52 Baseline Week 52Photos from a patient in the MIRROR trial.Discover how KRYSTEXXA with methotrexate can The optimal treatment duration has not been established.1 Individual results may vary.help your VA patients at KRYSTEXXAhcp.comSecondary endpoint: complete tophi resolution 3QD, every day; QW, weekly; Q2W, every 2 weeks; sUA, serum uric acid; VA, Veterans Aairs.54% (28/52) of patients in the KRYSTEXXA with methotrexate group and 31% (9/29) of patients in S:9.75" T:10.75" B:11"Study design: a 52-week, randomized, double-blind trial conducted in adult patients with chronic gout refractoryto conventional therapy the KRYSTEXXA alone group achieved a complete response at Month 12 1to evaluate administration of 8 mg KRYSTEXXA Q2W co-administered with 15 mg oral methotrexate QW and 1 mg oral folic acid QD vs1DeKRYSTEXXA alone.ned as 100% resolution of at least 1 target tophus, no new tophi appearing, and no single*KRYSTEXXA alone may be used in patients forwhom methotrexate is contraindicated or not clinically appropriate.1 tophus showing progression 1sUA-lowering response: the primary ecacy endpointwas the proportion of responders, dened as patients achieving and maintainingsUA levels 6 mg/dLfor at least 80% ofthe time during Month 6.1 Among patients with digital photography of tophi at baseline (53.3% of patients [81/152]).1INDICATION WARNINGS AND PRECAUTIONS ADVERSE REACTIONSKRYSTEXXA (pegloticase) is indicated for theproviders prepared to manage anaphylaxisGout Flares: An increase in goutares isThe most commonly reported adverse reactions treatment of chronic gout in adult patients whoand infusion reactions. frequently observed upon initiation of anti- (5%) are:have failed to normalize serum uric acid andPremedicate with antihistamines andhyperuricemic therapy, including KRYSTEXXA.KRYSTEXXA co-administration with whose signs and symptoms are inadequately corticosteroids and closely monitor for Goutare prophylaxis with a non-steroidalmethotrexate trial:controlled with xanthine oxidase inhibitors at anaphylaxis for an appropriate periodanti-in ammatory drug (NSAID) or colchicineKRYSTEXXA with methotrexate: goutares, the maximum medically appropriate dose or for after administration of KRYSTEXXA. is recommended starting at least 1 weekarthralgia, COVID-19, nausea, and fatigue; whom these drugs are contraindicated.Monitor serum uric acid levels prior to eachbefore initiation of KRYSTEXXA therapy andKRYSTEXXA alone: goutares, arthralgia, Limitations of Use: KRYSTEXXA is not recommended infusion and discontinue treatment if levelslasting at least 6 months, unless medicallyCOVID-19, nausea, fatigue, infusion reaction, forthe treatment of asymptomatic hyperuricemia. increase to above 6 mg/dL, particularly contraindicated or not tolerated. pain in extremity, hypertension, and vomiting.IMPORTANT SAFETY INFORMATION when 2 consecutive levels above 6 mg/dL Congestive Heart Failure: KRYSTEXXA hasKRYSTEXXA pre-marketing placebo-are observed. not been formally studied in patients withcontrolled trials:WARNING: ANAPHYLAXIS AND INFUSION Screen patients at risk for glucose-6- congestive heart failure, but some patients in thegoutares, infusion reactions, nausea, contusion REACTIONS, G6PD DEFICIENCY ASSOCIATEDphosphate dehydrogenase (G6PD) deciency pre-marketing placebo-controlled clinical trialsor ecchymosis, nasopharyngitis, constipation, HEMOLYSIS AND METHEMOGLOBINEMIA prior to starting KRYSTEXXA. Hemolysis and experienced exacerbation. Exercise caution inchest pain, anaphylaxis, and vomiting. Anaphylaxis and infusion reactions havemethemoglobinemia have been reported patients who have congestive heart failure and been reported to occur during and after with KRYSTEXXA in patients with G6PD monitor patients closely following infusion. Please see Brief Summary of Prescribing administration of KRYSTEXXA. deciency. KRYSTEXXA is contraindicated in Information, including Boxed Warning, forAnaphylaxis may occur with any infusion,patients with G6PD deciency. KRYSTEXXA on the following pages. including a rst infusion, and generally CONTRAINDICATIONS: manifests within 2 hours of the infusion.References: 1. KRYSTEXXA (pegloticase) [prescribing information] Horizon. 2. FDA approves KRYSTEXXA(TM) (pegloticase) for the treatment of chronic In patients with G6PD deciency. gout in adult patients refractory to conventional therapy. Fierce Biotech. September 15, 2010. Accessed May 12, 2023. https://www. ercebiotech.com/Delayed hypersensitivity reactions haveIn patients with history of serious hypersensitivity biotech/fda-approves-krystexxa-tm-pegloticase-for-treatment-of-chronic-gout-adult-patients 3. Botson JK, et al. Arthritis Rheumatol. 2023;75:293-304.also been reported. reactions, including anaphylaxis, to KRYSTEXXAKRYSTEXXA should be administered inor any of its components.healthcare settings and by healthcare 2024 Amgen Inc. All rights reserved. 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