ergic reaction during or at any time after the infusion of KRYSTEXXA. [see Warnings and Precautions (5.1, 5.2), Adverse Reactions (6.1)]
17.3 Glucose-6-phosphate dehydrogenase (G6PD) Deficiency
Inform patients not to take KRYSTEXXA if they have a condition known as G6PD deficiency. Explain to patients that G6PD deficiency is more frequently found in individuals of African or Mediterranean ancestry and that they may be tested to determine if they have G6PD deficiency, unless already known. [See Contraindications (4)]
17.4 Gout Flares
Explain to patients that gout flares may initially increase when starting treatment with KRYSTEXXA, and that medications to help reduce flares may need to be taken regularly for the first few months after KRYSTEXXA is started. [see Warnings and Precautions (5.3), Adverse Reactions (6.1)] Advise patients that they should not stop KRYSTEXXA therapy if they have a flare.
Manufactured by:
Savient Pharmaceuticals, Inc.
One Tower Center, 14th Floor
East Brunswick, NJ 08816
Medication Guide
KRYSTEXXA™ (Phonetic spelling: Kris-TEX-a)
(pegloticase) Injection
For Intravenous Infusion
Read this Medication Guide before you start receiving KRYSTEXXA and before each treatment. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about your treatment with KRYSTEXXA.
What is the most important information I should know about KRYSTEXXA?
Serious allergic reactions may happen in some people who receive KRYSTEXXA. These allergic reactions can be life threatening and usually happen within 2 hours of the infusion.
KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:
wheezing, shortness of breath, cough, chest tightness, chest pain, or trouble breathing
dizziness, fainting, fast or weak heartbeat or feeling nervous
reddening of the face, itching, hives, or feeling warm
swelling of the throat or tongue, throat tightness, hoarse voice or trouble swallowing
What is KRYSTEXXA?
KRYSTEXXA is a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
People with gout have too much uric acid in their body. Uric acid crystals collect in joints, kidneys, and other organs. This may cause pain, redness and swelling (inflammation). KRYSTEXXA works to lower blood levels of uric acid.
It is not known if KRYSTEXXA is safe and effective in children.
Who should not receive KRYSTEXXA?
Do not receive KRYSTEXXA if you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
What should I tell my doctor before receiving treatment with KRYSTEXXA?
Before you receive KRYSTEXXA, tell your doctor if you:
know you have G6PD deficiency
ever had any heart problems or high blood pressure
are pregnant or plan to become pregnant. It is not known if KRYSTEXXA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
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