KRYSTEXXA® (Pegloticase)

KRYSTEXXA®

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Important Safety Information

KRYSTEXXA® (pegloticase) is an infusion medication used to treat adults with uncontrolled chronic gout. It is possible to experience serious allergic reactions while on KRYSTEXXA® — usually occurring within two hours from an infusion treatment. Seek medical attention immediately if you experience any signs of such a reaction — including itching, hives, rash, feeling warm, reddening of the face, swelling of the tongue, lips, and/or face, trouble swallowing, weak heartbeat, dizziness, or fainting. Your physician may prescribe additional medications (antihistamines or corticosteroids) to reduce the risk of an allergic reaction.

What is the most important information I should know about KRYSTEXXA®?

Do not use KRYSTEXXA® if you have glucose 6-phosphate dehydrogenase (G6DP) deficiency, favism, or a history of high blood pressure or cardiovascular issues. Tell your physician about all medications you’re currently taking — whether they’re prescribed, over-the-counter, herbal supplements, or vitamins. Do not take any additional medications to lower your uric acid levels while undergoing treatment with KRYSTEXXA®.

It is unknown whether KRYSTEXXA® could harm your unborn baby. Talk to your doctor if you’re pregnant, think you could be pregnant, or are planning on becoming pregnant. Also, talk with your doctor if you’re breastfeeding or planning to breastfeed.

Side Effects of KRYSTEXXA®

As with any prescription medication, KRYSTEXXA® carries a risk of side effects. The most common ones include:

  • Allergic reactions
  • Sore throat
  • Congestion
  • Bruising
  • Nausea
  • Vomiting
  • Constipation
  • Chest pain
  • Gout flare-ups
  • Hives
  • Chest pain
  • Flushing

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

KRYSTEXXA® should be administered 8mg every two weeks for no less than 120 minutes. Medical providers should test uric acid levels prior to treatment and during each infusion. Gout preventive measures should be taken for at least the first six months of infusion therapy with KRYSTEXXA®.

Please refer to the full prescribing information.