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Krystexxa

Last reviewed on RxList: 5/23/2016
Krystexxa Side Effects Center

Last reviewed on RxList 3/17/2016

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. Krystexxa is usually given after other gout medications have been tried without successful treatment of symptoms. Common side effects of Krystexxa include:

The recommended dose and regimen of Krystexxa for adult patients is 8 mg (uricase protein) given as an intravenous infusion every two weeks. Krystexxa may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Krystexxa should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Krystexxa (pegloticase) Injection, for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Krystexxa Consumer Information

Some people receiving a pegloticase injection have had a reaction to the infusion (when the medicine is injected into the vein). Infusion reactions may also occur after the injection is given. Tell your caregiver right away if you feel itchy, nervous, light-headed, short of breath, or have a fast heartbeat, chest discomfort, or redness of your skin during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain; or
  • flushing (warmth, redness, or tingly feeling).

Less serious side effects may include:

  • new gout flares;
  • nausea, vomiting, constipation;
  • easy bruising; or
  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Krystexxa (Pegloticase Injection)

Krystexxa Professional Information

KRYSTEXXA®
(pegloticase) Injection for Intravenous Infusion

WARNING

ANAPHYLAXIS AND INFUSION REACTIONS

  • Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. [see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported.
  • KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
  • Patients should be premedicated with antihistamines and corticosteroids.
  • Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
  • Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

DESCRIPTION

KRYSTEXXA (pegloticase) is a uric acid specific enzyme which is a PEGylated product that consists of recombinant modified mammalian urate oxidase (uricase) produced by a genetically modified strain of Escherichia coli. Uricase is covalently conjugated to monomethoxypoly (ethylene glycol) [mPEG] (10 kDa molecular weight). The cDNA coding for uricase is based on mammalian sequences. Each uricase subunit has a molecular weight of approximately 34 kDa per subunit. The average molecular weight of pegloticase (tetrameric enzyme conjugated to mPEG) is approximately 540 kDa.

KRYSTEXXA is intended for intravenous infusion.

KRYSTEXXA is a sterile, clear, colorless solution containing 8 mg/mL pegloticase in phosphate-buffered saline.

KRYSTEXXA (pegloticase) concentrations are expressed as concentrations of uricase protein. Each mL of KRYSTEXXA contains 8 mg of uricase protein (conjugated to 24 mg of 10 kDa mPEG), 2.18 mg Disodium Hydrogen Phosphate Dihydrate (Na2HPO4•2H2O), 8.77 mg Sodium Chloride (NaCl), 0.43 mg Sodium Dihydrogen Phosphate Dihydrate (NaH2PO4•2H2O), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).

Read the entire FDA prescribing information for Krystexxa (Pegloticase Injection)

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© Krystexxa Patient Information is supplied by Cerner Multum, Inc. and Krystexxa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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