AdultPediatricDosage Forms & Strengths injectable solution 8mg/mL Gout Indicated for treatment of chronic gout in adults refractory to conventional treatment 8 mg IV infusion q2wk coadministered with methotrexate 15 mg PO qWeek If coadministering with methotrexate, initiate weekly methotrexate and folic acid or folinic acid supplementation at least 4 weeks before to initiating, and throughout pegloticase treatment Pegloticase alone may be used in patients for whom methotrexate is contraindicated or not clinically appropriate Dosage Modifications Renal impairment No dosage adjustment required Hepatic impairment Not studied Dosing Considerations Limitations of use Not recommended for asymptomatic hyperuricemia Precautions before initiating Discontinue oral urate-lowering medications Do NOT initiate oral urate-lowering agents while taking pegloticase Monitoring Risk of infusion reactions, including anaphylaxis, is higher in patients who have lost therapeutic response Monitor serum uric acid levels before each infusion and discontinue treatment if levels increase to >6 mg/dL, particularly when 2 consecutive levels >6 mg/dL are observed <18 years: Safety and efficacy not establishedInteraction CheckerEnter a drug name and pegloticaseNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (0)Monitor Closely (10)certolizumab pegolpegloticase will decrease the level or effect of certolizumab pegol by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegademasepegloticase will decrease the level or effect of pegademase by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegaptanibpegloticase will decrease the level or effect of pegaptanib by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegaspargasepegloticase will decrease the level or effect of pegaspargase by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegfilgrastimpegloticase will decrease the level or effect of pegfilgrastim by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpeginterferon alfa 2apegloticase will decrease the level or effect of peginterferon alfa 2a by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpeginterferon alfa 2bpegloticase will decrease the level or effect of peginterferon alfa 2b by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegvaliasepegvaliase, pegloticase. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.pegvisomantpegloticase will decrease the level or effect of pegvisomant by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownsiponimodsiponimod and pegloticase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.Minor (0)certolizumab pegolMonitor Closely (1)pegloticase will decrease the level or effect of certolizumab pegol by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegademaseMonitor Closely (1)pegloticase will decrease the level or effect of pegademase by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegaptanibMonitor Closely (1)pegloticase will decrease the level or effect of pegaptanib by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegaspargaseMonitor Closely (1)pegloticase will decrease the level or effect of pegaspargase by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegfilgrastimMonitor Closely (1)pegloticase will decrease the level or effect of pegfilgrastim by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpeginterferon alfa 2aMonitor Closely (1)pegloticase will decrease the level or effect of peginterferon alfa 2a by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpeginterferon alfa 2bMonitor Closely (1)pegloticase will decrease the level or effect of peginterferon alfa 2b by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownpegvaliaseMonitor Closely (1)pegvaliase, pegloticase. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.pegvisomantMonitor Closely (1)pegloticase will decrease the level or effect of pegvisomant by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknownsiponimodMonitor Closely (1)siponimod and pegloticase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects. >10% Gout flares (77%) Infusion reactions (26%) Nausea (12%) Urticaria (10.6%) 1-10% Chest discomfort (9.5%) Chest pain (9.5%) Erythema (9.5%) Pruritus (9.5%) Nasopharyngitis (7%) Anaphylaxis (5%) Postmarketing Reports Hemolysis and methemoglobinemia in patients with G6PD deficiency Congestive heart failure Asthenia Malaise Peripheral swelling Black Box Warnings Anaphylaxis and infusion reactions have been reported; these reactions may occur with any infusion, including the first, and typically manifest within 2 h of infusion (although delayed-type hypersensitivity has also been reported) Only administer in a healthcare setting, and monitor for appropriate period following infusion Premedicate with antihistamines and corticosteroids Risk for anaphylaxis is higher if serum uric acid level >6 mg/dL, monitor serum uric acid levels before infusion and consider discontinuing if levels increase to >6 mg/dL (particularly if 2 consecutive levels of >6 mg/dL are observed) Do not administer to patients with history of G6PD Deficiency; Screen patients at risk for G6PD Deficiency prior to initiating therapy; Life threatening hemolytic reactions and methemoglobinemia have been reported in these patientsContraindications History of serious hypersensitivity, including anaphylaxis, to pegloticase or its components G6PD-deficiency (increased risk of hemolysis and methemoglobinemia) Cautions Life threatening hemolytic reactions and methemoglobinemia reported with G6PD deficiency; screen patients at risk for G6PD deficiency before initiating (eg, patients of African, Mediterranean [including Southern European and Middle Eastern], and Southern Asian ancestry); do not administer to patients with G6PD deficiency Gout flares may occur after initiating owing to changing serum uric acid levels resulting in mobilization of urate from tissue deposits; gout flare prophylaxis with an NSAID or colchicine is recommended starting at least 1 week before starting and during pegloticase treatment and for at least 6 months, unless medically contraindicated or not tolerated Exacerbation of pre-existing CHF reported; exercise caution when using this drug in patients who have congestive heart failure and monitor patients closely following infusion No controlled trial data are available regarding safety and efficacy of retreatment with pegloticase after stopping treatment for >4 weeks; owing to immunogenicity of pegloticase, patients receiving retreatment may be at increased risk of anaphylaxis and infusion reactions Anaphylaxis Anaphylaxis reported; pretreat with antihistamines and corticosteroids before each infusion; risk increased with uric acid level >6 mg/dL (especially when 2 consecutive level >6 mg/dL observed); monitor serum uric acid levels prior to infusions and discontinue treatment if levels increase to above 6 mg/dL Therapy should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis; patients should be pre-treated with antihistamines and corticosteroids Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hr of the infusion; however, delayed-type hypersensitivity reactions have also been reported Patients should be closely monitored for appropriate period of time for anaphylaxis after administration of the drug; patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting Infusion reactions Infusion reactions may occur; manifestations include urticaria, dyspnea, chest discomfort, chest pain, erythema, and pruritus (symptoms overlap with anaphylaxis); risk of infusion reactions increased with uric acid level >6 mg/dL; monitor serum uric acid levels prior to infusions and discontinue treatment if levels increase to above 6 mg/dL Because of the possibility that concomitant use of oral urate-lowering therapy and this medication may potentially blunt the rise of serum uric acid levels, it is recommended that before starting therapy patients discontinue oral urate-lowering medications and not institute therapy with oral urate-lowering agents while taking this medication Pregnancy There are no adequate and well-controlled studies in pregnant women Animal data No structural abnormalities were observed on animal reproduction studies, when pegloticase administered by subcutaneous injection to pregnant rats and rabbits during period of organogenesis at doses up to 50 and 75 times, respectively, the maximum recommended human dose (MRHD); decreases in mean fetal and pup body weights were observed at approximately 50 and 75 times MRHD, respectively Lactation Not known whether drug is excreted in human milk; drug should not be used when breastfeeding unless clear benefit to mother can overcome unknown risk to newborn/infant.Pregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Recombinant, pegylated uric acid specific enzyme; achieves its therapeutic effect by catalyzing oxidation of uric acid to allantoin, thereby lowering serum uric acid levels Pharmacokinetics Onset of action: 24 hr Duration: 12.5 days Half-life: 14 days IV Compatibilities Solution: 0.9% NaCl, 0.45% NaCl IV Preparation IV infusion Withdraw 1 mL from vial (discard any unused portion) and add to a single 250 mL bag of 0.9% or 0.45% NaCl Invert infusion bag a number of times to ensure thorough mixing DO NOT SHAKE Stable for 4 hr at room temperature (20-25ºC [68-77ºF]); however, recommended to store refrigerated and use within 4 hr IV Administration Do NOT administer as IV push or bolus Premedicate with antihistamines and corticosteroids Administer IV infusion over at least 2 hr via gravity feed or volumetric infusion pump If an infusion reaction occurs, may slow, or stop and restart infusion at slower rate, at the discretion of the physician Infusion reactions can occur after completion; observe patient ~1 hr post-infusion Storage Protect from light Do not shake Unopened vials Refrigerate at 2-8ºC (36-46ºF) in original carton Admixture Recommended to refrigerate at 2-8ºC (36-46ºF) May store at room temperature (20-25ºC [68-77ºF]) Use within 4 hr No images available for this drug. No images available for this drug.Print Patient Educationpegloticase intravenous PEGLOTICASE - INJECTION (peg-LOE-ti-kase) COMMON BRAND NAME(S): Krystexxa WARNING: Pegloticase may rarely cause a serious allergic reaction. This may occur during or after the infusion of the medication. Your doctor will check your blood before each treatment and monitor you closely during and after