pegloticase (Rx)

Brand and Other Names:Krystexxa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 8mg/mL

Gout

Indicated for treatment of chronic gout in adult patients refractory to conventional treatment

8 mg IV infusion q2wk (see Administration)

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and pegloticase

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (10)

                • certolizumab pegol

                  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 unknown

                • pegademase

                  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 unknown

                • pegaptanib

                  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 unknown

                • pegaspargase

                  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 unknown

                • pegfilgrastim

                  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 unknown

                • peginterferon alfa 2a

                  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 unknown

                • peginterferon alfa 2b

                  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 unknown

                • pegvaliase

                  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.

                • pegvisomant

                  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 unknown

                • siponimod

                  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.

                Minor (0)

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                  Adverse 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

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                  Warnings

                  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 patients

                  Contraindications

                  Hypersensitivity

                  G6PD-deficiency (increased risk of hemolysis and methemoglobinemia)

                  Cautions

                  Gout flare frequently observed (initiate gout flare prophylaxis with NSAID or colchicine at least 1 wk before starting pegloticase); gout flare prophylaxis recommended for at least first 6 months

                  Screen patients at higher risk of G6PD deficiency, especially those of African and Mediterranean ancestry

                  Caution with congestive heart failure (not formally studied in patients with CHF); congestive heart failure exacerbation may occur; monitor patients closely following infusion

                  Unknown if retreatment after stopping for longer than 4 wk increases risk of anaphylaxis, infusion reactions, or immunogenicity

                  Risk of infusion reaction is increased in patients whose uric acid is >6 mg/dL; if less than severe infusion reactions occur, may slow infusion or infusion stopped and restarted at lower rate at physician's discretion

                  Discontinue use of oral antihyperuricemic agents prior to therapy; do not initiate during course of therapy; agents may delay interpretation of ineffective pegloticase treatment

                  Patients may be at increased risk for anaphylaxis and infusion reactions, when treatment is discontinued for >4 weeks, due to potential to immunogenicity

                  Administered by IV infusion over no less than 120 min via gravity feed, syringe-type pump, or infusion pump

                  Pre-medicate patients with antihistamines and corticosteroids before treating

                  Monitor serum uric acid levels before each infusion

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                  Pregnancy & Lactation

                  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.

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                  Pharmacology

                  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

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                  Administration

                  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
                  • Stability: Admixture is stable for 4 hr at 2-8 degrees C (36-46 degrees F) or at room temperature (20-25 degrees C, 68-77 degrees F)

                  IV Administration

                  Do NOT administer as IV push or bolus

                  Premedicate with antihistamines and corticosteroids

                  Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to >6 mg/dL (especially if 2 consecutive levels > 6 mg/dL observed)

                  Administer IV infusion over at least 2 hr via gravity feed or volumetric infusion pump

                  Storage

                  Store refrigerated in original carton (do not freeze)

                  Protect from light

                  Do not shake

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  Patient Education
                  pegloticase 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 infusion. Your doctor should prescribe other medications (such as antihistamines, corticosteroids) to help prevent an allergic reaction. However, serious allergic reactions may still occur in a few patients. Get medical help right away if you develop any signs of an allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/pain.Do not use this medication if you have a certain metabolic disorder called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African, Mediterranean, or Southern Asian descent, you may be at higher risk for G6PD deficiency and should be tested to see if you have this condition before starting this medication.

                  USES: Pegloticase is used to treat gout which has not responded to the usual treatments. It works by lowering high levels of uric acid in your body. Increased uric acid in your body can cause gout.

                  HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using pegloticase and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are taking other medications (such as allopurinol, febuxostat) by mouth to lower the level of uric acid in your body, your doctor will direct you to stop the medication before starting and during treatment with pegloticase. Taking these drugs with pegloticase may lessen how well it works.This medication is given by injection into a vein (over at least 2 hours) by a healthcare professional. It is usually given every 2 weeks.Use this medication regularly in order to get the most benefit from it. Remember to receive it every 2 weeks. It may help to mark your calendar with a reminder.You may experience more gout attacks for several months after starting this medicine while your body removes extra uric acid. Your doctor may prescribe additional medication (such as colchicine, nonsteroidal anti-inflammatory drugs-NSAIDs) to help prevent and treat these gout attacks.Tell your doctor if your condition persists or worsens.

                  SIDE EFFECTS: See also Warning section.Nausea, vomiting, sore throat, or runny nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: See also Warning section.Before receiving pegloticase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain metabolic disorder (G6PD deficiency), favism, heart failure.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Do not take other medications (such as allopurinol, febuxostat) taken by mouth to lower the level of uric acid in your body before and during treatment with pegloticase. (See also How to Use section.)

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: Laboratory and/or medical tests (such as uric acid levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                  MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                  STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
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