Important Safety Information
WARNING: ANAPHYLAXIS and INFUSION REACTIONS
- Anaphylaxis and infusion reactions have been reported to occur during and after
administration of KRYSTEXXA®(pegloticase).
- 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.
Glucose-6-phosphate dehydrogenase (G6PD) Deficiency: Before starting KRYSTEXXA,
patients at higher risk for G6PD deficiency (e.g., those of African and Mediterranean
ancestry) should be screened due to the risk of hemolysis and methemoglobinemia.
WARNINGS AND PRECAUTIONS
- Anaphylaxis: Anaphylaxis occurred in patients treated with KRYSTEXXA. 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. Patients should be pre-medicated
with antihistamines and corticosteroids. Patients should be closely monitored for
an appropriate period of time for anaphylaxis after administration of KRYSTEXXA.
- Infusion Reactions: Infusion reactions occurred in patients treated with KRYSTEXXA.
KRYSTEXXA should be administered in a healthcare setting and by healthcare providers
prepared to manage infusion reactions. Patients should be pre-medicated with antihistamines
and corticosteroids. Monitor patients closely for signs and symptoms of infusion
reactions. In the event of an infusion reaction, the infusion should be slowed,
or stopped and restarted at a slower rate. If a severe infusion reaction occurs,
discontinue infusion and institute treatment as needed. The risk of an infusion
reaction is higher in patients who have lost therapeutic response.
- Gout Flares: An increase in gout flares is frequently observed upon initiation of
anti-hyperuricemic therapy, including treatment with KRYSTEXXA. If a gout flare
occurs during treatment, KRYSTEXXA need not be discontinued. Gout flare prophylaxis
(i.e., non-steroidal anti-inflammatory drugs [NSAIDs] or colchicine upon initiation
of treatment) is recommended for at least the first 6 months of therapy unless medically
contraindicated or not tolerated.
- Congestive Heart Failure: KRYSTEXXA has not been formally studied in patients with
congestive heart failure, but some patients in clinical trials experienced exacerbation.
Exercise caution when using KRYSTEXXA in patients who have congestive heart failure
and monitor patients closely following infusion.
- Re-treatment: Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.
The most commonly reported serious adverse reactions are anaphylaxis, infusion reactions
and gout flares. Most common adverse reactions: gout flares (77%), infusion reactions
(26%), nausea (12%), contusion
or ecchymosis (11%), nasopharyngitis (7%), constipation
(6%), chest pain (6%), anaphylaxis (5%), and vomiting (5%).
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Full Prescribing Information, including Boxed Warning and the Medication