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  • KRYSTEXXA®
    / Medison


    Active Ingredient
    Pegloticase 32 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    single-dose vial: 2 ml X 8 mg/ml

    not in the basket chart

    Related information


    Dosage

    The recommended dose and regimen of KRYSTEXXA® for adult patients is 8 mg (uricase protein) given as an intravenous infusion every two weeks.
    The optimal treatment duration with KRYSTEXXA® has not been established.
    Pediatric Use: The safety and effectiveness of KRYSTEXXA® in pediatric patients less than 18 years of age have not been established.
    Geriatric Use: No dose adjustment is needed for patients 65 years of age and older.
    Renal Impairment: No dose adjustment is required for patients with renal impairment.
    For Preparation and Administration, please refer to prescribing information.


    Indications

    KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
    Important Limitations of Use: KRYSTEXXA® is not recommended for the treatment of asymptomatic hyperuricemia.


    Contra-Indications

    Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Anaphylaxis: During pre-marketing clinical trials, anaphylaxis was reported with a frequency of 6.5% (8/123) of patients treated with KRYSTEXXA® every 2 weeks and 4.8% (6/126) for the every 4-week dosing regimen. KRYSTEXXA® should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis. Patients should be pre-treated with antihistamines and corticosteroids. 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. Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration of KRYSTEXXA®. Patients should be informed of the symptoms and signs of anaphylaxis and instructed to seek immediate medical care should anaphylaxis occur after discharge from the healthcare setting.
    Infusion Reactions: During pre-marketing controlled clinical trials, infusion reactions were reported in 26% of patients treated with KRYSTEXXA® 8 mg every 2 weeks, and 41% of patients treated with KRYSTEXXA® 8 mg every 4 weeks, compared to 5% of patients treated with placebo. These infusion reactions occurred in patients being pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen. This pre-treatment may have blunted or obscured symptoms or signs of infusion reactions and therefore the reported frequency may be an underestimate.
    G6PD Deficiency Associated Hemolysis and Methemoglobinemia: Life threatening hemolytic reactions and methemoglobinemia have been reported with KRYSTEXXA® in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
    Because of the risk of hemolysis and methemoglobinemia, do not administer KRYSTEXXA® to patients with G6PD deficiency. Screen patients at risk for G6PD deficiency prior to starting KRYSTEXXA®.
    For example, patients of African, Mediterranean (including  Southern European and Middle Eastern), and Southern Asian ancestry are at increased risk for G6PD deficiency.
    Gout Flares: Gout flares may occur after initiation of KRYSTEXXA®. An increase in gout flares is frequently observed upon initiation of anti-hyperuricemic therapy, due to changing serum uric acid levels resulting in mobilization of urate
    from tissue deposits. Gout flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended starting at least 1 week before initiation of KRYSTEXXA® therapy and lasting at least 6 months, unless medically contraindicated or not tolerated. KRYSTEXXA® does not need to be discontinued because of a gout flare. The gout flare should be managed concurrently as appropriate for the individual patient.
    Congestive Heart Failure: KRYSTEXXA® has not been formally studied in patients with congestive heart failure, but some patients in the clinical trials experienced exacerbation. Exercise caution when using KRYSTEXXA® in patients who have congestive heart failure and monitor patients closely following infusion.
    Re-treatment with KRYSTEXXA: No controlled trial data are available on the safety and efficacy of re-treatment with KRYSTEXXA® after stopping treatment for longer than 4 weeks. Due to the immunogenicity of KRYSTEXXA®, patients receiving re-treatment may be at increased risk of anaphylaxis and infusion reactions. Therefore, patients receiving re-treatment after a drug-free interval should be monitored carefully.
    See prescribing information for full details.


    Side Effects

    The most commonly reported adverse reactions that occurred in greater than or equal to 5% of patients treated with KRYSTEXXA® 8 mg every 2 weeks are: Gout flare, Infusion reaction, Nausea, Contusionb or Ecchymosis,
    Nasopharyngitis, Constipation, Chest Pain, Anaphylaxis, Vomiting.
    See prescribing information for full details.


    Drug interactions

    No studies of interactions of KRYSTEXXA® with other drugs have been conducted.
    Because anti-pegloticase antibodies appear to bind to the PEG portion of the drug, there may be potential for binding with other PEGylated products. The impact of anti-PEG antibodies on patients’ responses to other PEG-containing therapeutics is unknown.


    Pregnancy and Lactation

    Pregnancy: There are no adequate and well-controlled studies of KRYSTEXXA® in pregnant women.
    Lactation: It is not known whether this drug is excreted in human milk. Therefore, KRYSTEXXA® should not be used when breastfeeding unless the clear benefit to the mother can overcome the unknown risk to the newborn/infant.
    See prescribing information for full details.


    Overdose

    No reports of overdosage with KRYSTEXXA® have been reported. The maximum dose that has been administered as a single intravenous dose is 12 mg as uricase protein.
    Patients suspected of receiving an overdose should be monitored, and general supportive measures should be initiated as no specific antidote has been identified.


    Important notes

    Storage and Handling: Before the preparation for use, KRYSTEXXA® must be stored in the carton and maintained at all times under refrigeration between 2° to 8°C. Protect from light. Do not shake or freeze.
    After dilution, store under refrigeration between 2° to 8°C or between 20°-25°C and use within 4 hours.
    Protect from light. Do not freeze.
    The expiry date of the product is indicated on the packaging materials. Do not use beyond the expiration date stamped.


    Manufacturer
    Horizon Pharma Rheumatology, IL
    Licence holder
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