Krystexxa (Pegloticase Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Krystexxa

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What is gout? What is hyperuricemia?

Gout is a disease that results from an overload of uric acid in the body. This overload of uric acid leads to the formation of tiny crystals of urate that deposit in tissues of the body, especially the joints. When crystals form in the joints, it causes recurring attacks of joint inflammation (arthritis). Gout is considered a chronic and progressive disease. Chronic gout can also lead to deposits of hard lumps of uric acid in the tissues, particularly in and around the joints and may cause joint destruction, decreased kidney function, and kidney stones (nephrolithiasis).

Gout has the unique distinction of being one of the most frequently recorded medical illnesses throughout history. It is often related to an inherited abnormality in the body's ability to process uric acid. Uric acid is a breakdown product of purines that are part of many foods we eat. An abnormality in handling uric acid can cause attacks of p...

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KRYSTEXXA™
(pegloticase) Injection, for Intravenous Infusion

WARNING

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 (pegloticase injection) should be administered of care in health care settings and by health providers prepared to manage anaphylaxis and infusion reactions.
Patients should be pre medicated with antihistamines and corticosteroids.
Patients should be closely monitorèd for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA (pegloticase injection) .
Monitor serum uric acid levels prior to infusions and consider discontinuing 2 consecutive levels treatment if levels increase to above 6 mg/dL, particularly when above 6 mg/dL are observed.

DRUG 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 (pegloticase injection) 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 (pegloticase injection) 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 (NaGl), 0.43 mg Sodium Dihydrogen Phosphate Dihydrate (NaH₂PO₄•2H₂O), and Water for Injection to deliver 8 mg of pegloticase (as uricase protein).

What are the precautions when taking pegloticase injection (Krystexxa)?

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.

If you are of African or Mediterranean 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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal...

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Last reviewed on RxList: 10/18/2010
This monograph has been modified to include the generic and brand name in many instances.