Krystexxa 8 mg concentrate for solution for infusion. Visually inspect krystexxa for pariculate matter and discoloration before administration, whenever solution and container permit. Use outside of these guidelines may result in nonpayment unless approved under an exception process. Prescribing information, including boxed warning, and medication guide. The potency of this product should not be compared to the one of another pegylated or nonpegylated protein of the. Krystexxa pegloticase notice this policy contains information which is clinical in nature. The information in this policy is used by wellmark to make determinations whether. Krystexxa will not be used concomitantly with oral uratelowering therapies b. Aetna precertification notification 503 sunport lane, orlando, fl 32809 phone. Your primary krystexxa contact, daytoday account specialist, and resource to help meet all of your needs.
Krystexxa, innpegloticase european medicines agency. When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding. The complete flumazenil package insert including contraindications, warnings, and precautions should be consulted prior to use. Krystexxa pegloticase is not recommended for the treatment of asymptomatic hyperuricemia. Pegloticase is a protein that is designed to treat severe chronic gout when other more common treatments have failed or. Krystexxa pegloticase injection, for intravenous infusion.
Learn more about clinical trial data, safety, dosing, and patient access. Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Beovu brolucizumabdbll injection is a treatment for wet agerelated macular degeneration wet amd. See full prescribing information including boxed warning on serious infections. Unitedhealthcare commercial medical benefit drug policy. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vimpat lacosamide. Krystexxa fda prescribing information, side effects and uses. Dailymed krystexxa pegloticase injection, solution. Storage and handling before the preparation for use, krystexxa must be stored in the carton and maintained at all times under refrigeration between 2 to 8c 36 to 46f. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vimpat lacosamide skip to.
Monitor patients and discontinue rituxan infusion for severe reactions 5. See full prescribing information for complete boxed warning. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc. Dosage forms and strengths 3 use appropriate aseptic technique. This was a business decision and was not related to any efficacy, safety or clinical concerns with lesinurad. Krystexxa pegloticase injection for intravenous infusion.
Serious allergic reactions may happen in some patients who receive krystexxa. Krystexxa is supplied in a singleuse 2 ml glass vial with a teflon coated latexfree rubber injection stopper to deliver krystexxa as 8 mg of uricase protein in 1 ml volume. What is the most important information i should know about krystexxa pegloticase. Highlights of prescribing information an initial dose of 600. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Approximately 24 hours following the first dose of krystexxa, mean plasma uric acid levels for subjects in the krystexxa groups were 0. John albert, a rheumatologist at the rheumatic disease center in southeastern wisconsin, discusses a new inpractice patient series presented at the american college of.
Krystexxa sgm p2017 cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Full prescribing information 1 indications and usage copaxone is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Krystexxa is not recommended for the treatment of asymptomatic hyperuricemia. Patients should be premedicated with antihistamines and corticosteroids. Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. Oct 02, 2019 methotrexate package insert pdf to more effectively utilize new gout drug, krystexxa, approved search go.
Krystexxa is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Highlights of prescribing information these highlights do not include all the information needed to use dupixent safely and effectively. Please see the medication guide and prescribing information for more information. Kr ystexxatm pegloticase is a pegylated uric acid specific enzyme indicated.
Methotrexate and krystexxa pegloticase study for chronic. Fdaapproved package labeling or a medically accepted indication. Gout is a common arthritis caused by deposition of monosodium urate crystals within joints that can also deposit in tissues and the kidneys. Is prescribed a dose and duration of therapy that is consistent with fdaapproved package. The effect of ambien may be slowed by ingestion with or immediately after a meal. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. The optimal treatment duration with krystexxa has not been established.
Do not administer krystexxa to patients with g6pd deficiency. However it is recommended that diluted solutions be stored under refrigeration, not frozen, protected from light, and used within 4 hours of dilution. You are encouraged to report negative side effects of prescription drugs to the. The information in this policy is used by wellmark to make determinations whether medical treatment is covered under the terms of a wellmark members health benefit plan. Dupixent dupilumab injection, for subcutaneous use initial u. In the article the rheumatology of gout sundy js, advances in chronic kidney disease 19. Please accept our privacy terms we use cookies and similar technologies to improve your browsing experience, personalize content and offers, show targeted ads, analyze traffic, and better understand you. Highlights of prescribing information an initial dose. Systematic nonpharmacololgic and pharmacologic therapeutic approatches to hyperuricemia. Aug 22, 2019 krystexxa is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. Krystexxa is usually given after other gout medications have been tried without successful treatment of symptoms. In comparison, the mean plasma uric acid level for the placebo group was 8. Diazepam injection fda prescribing information, side. Use outside of these guidelines may result in nonpayment unless approved under an exception.
Zurampic prescribing information ironwood discontinued u. Atgam lymphocyte immune globulin, antithymocyte globulin equine sterile solution this product information is intended only for residents of the united states. Please accept our privacy terms we use cookies and similar technologies to. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Gout is a common arthritis caused by deposition of monosodium urate crystals within joints that can also. Cimzia certolizumab pegol an fdaapproved biologic treatment. Read the medication guide provided by your pharmacist before you start using pegloticase and each time you get a refill. Krystexxa pegloticase is proven for the treatment of chronic gout refractory to. Severe mucocutaneous reactions, some with fatal outcomes 5. Important reminder the purpose of this medical policy is to provide a guide to coverage.
Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of krystexxa. Based on posthoc analyses of the clinical trial data, if krystexxa had been stopped when a patients uric acid level rose to greater than 6 mgdl on a single. Not to be copied, reproduced or distributed without the expressed prior knowledge, consent and permission of avmed. Krystexxa should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. Krystexxa is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. Dosage the recommended dose and regimen of krystexxa for adult patients is 8 mg uricase protein given as an intravenous infusion every two weeks. Sep 15, 2012 1 95% confidence interval for differences in responder rate between pegloticase group vs. Krystexxa is a clear, colorless, sterile 8 mgml solution of pegloticase in a 2 ml singledose vial, expressed as amounts of uricase protein. Chapter 7a prescription medications prior authorization number. Krystexxa is a clear, colorless, sterile 8 mgml solution of pegloticase in a 2 ml singleuse vial, expressed as amounts of uricase protein. Works directly with the office to support reimbursement questions and works. Krystexxa is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Pegloticase krystexxa injectable aetna precertification.
Side effects of krystexxa pegloticase injection, warnings, uses. A fieldbased clinical and medical expert pharmd, phd, or md on horizon medicines. These highlights do not include all the information needed to use uloric safely and effectively. These highlights do not include all the information needed to. Erratum to the rheumatology of gout advances in chronic. Please refer to the hmsa medical policy web site for the fax form. Krystexxa pegloticase is covered under the medical benefit when used within the following guidelines. Krystexxa diluted in infusion bags is stable for 4 hours at 2. Service request form krystexxaconnect please fax completed form with a copy of the front and back of the patients insurance card. Please see full prescribing information, including boxed warning. Member has had an inadequate response to or a clinical reason for not completing at least a threemonth trial see. Dosage and administration approvals may be subject to dosing limits in accordance with fda approved labeling, accepted compendia, andor evidencebased practice guidelines. Krystexxa pegloticase injection for intravenous infusion is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine and is used to treat chronic gout.
Member has had an inadequate response to or a clinical reason for not completing at least a threemonth trial see appendix with the following medications at the medically appropriate maximum doses. Krystexxa pegloticase is a pegylated uric acid specific enzyme indicated for. Methotrexate package insert pdf to life in pills2020. Sep 16, 2019 krystexxa diluted in infusion bags is stable for 4 hours at 2. Highlights of prescribing information may worsen during.
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