treatment and before each subsequent treatment.
Anaphylaxis and Infusion Reactions
Anaphylaxis and infusion reactions can occur at any infusion while on therapy. Counsel patients on the importance of adhering to any prescribed medications to help prevent or lessen the severity of these reactions.
Educate patients on the signs and symptoms of anaphylaxis, including wheezing, peri-oral or lingual edema, hemodynamic instability, and rash or urticaria.
Educate patients on the most common signs and symptoms of an infusion reaction, including urticaria (skin rash), erythema (redness of the skin), dyspnea (difficulty breathing), flushing, chest discomfort, chest pain, and rash.
Advise patients to seek medical care immediately if they experience any symptoms of an allergic reaction during or at any time after the infusion of Krystexxa. [see Warnings and Precautions (5.1, 5.2), Adverse Reactions (6.1)]
Advise patients to discontinue any oral urate-lowering agents before starting on Krystexxa and not to take any oral urate-lowering agents while on Krystexxa.
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)]
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.
400 Crossing Boulevard
Bridgewater, NJ 08807
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 m |
