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Pegloticase

Also known as: Krystexxa

Uric Acid-specific Enzyme

Route: Intravenous

3 interactions on record⛔ Black Box Warning

Pegloticase has 3 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Allopurinol, Allopurinol Sodium, Methotrexate. Patients taking Pegloticase should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Contraindicated: 2
Moderate: 1

Contraindicated (2)

Pegloticase + Allopurinol— Discontinue and refrain from initiating treatment with allopurinol when using pegloticase.
Pegloticase + Allopurinol Sodium— Discontinue and do not institute allopurinol therapy during treatment with pegloticase.

Moderate (1)

Pegloticase + Methotrexate— Co-administration of methotrexate with pegloticase may increase pegloticase concentration compared to pegloticase alone.

Pegloticase + Allopurinol⛔Contraindicated

Discontinue and refrain from initiating treatment with allopurinol when using pegloticase.

Pegloticase + Allopurinol Sodium⛔Contraindicated

Discontinue and do not institute allopurinol therapy during treatment with pegloticase.

Pegloticase + Methotrexate🟡Moderate

Co-administration of methotrexate with pegloticase may increase pegloticase concentration compared to pegloticase alone.

⛔ FDA Black Box Warning

WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, and generally manifests within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. ( 5.1 , 5.2 ) Premedicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Monitor serum uric acid levels prior to each infusion and discontinue treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed. ( 5.2 ) Screen patients at risk for G6PD deficiency prior to starting KRYSTEXXA. Hemolysis and methemoglobinemia have been reported with KRYSTEXXA in patients with G6PD deficiency. KRYSTEXXA is contraindicated in patients with G6PD deficiency. ( 4 , 5.3 ) WARNING: ANAPHYLAXIS and INFUSION REACTIONS, G6PD DEFICIENCY ASSOCIATED HEMOLYSIS and METHEMOGLOBINEMIA See full prescribing information for complete boxed warning. Anaphylaxis and infusion reactions have been reported to occur during and after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Anaphylaxis may occur with any infusion, including a first infusion, and generally manifest within 2 hours of the infusion. However, delayed hypersensitivity reactions have also been reported. ( 5.1 ) KRYSTEXXA should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions. ( 5.1 , 5.2 ) Pre-medicate with antihistamines and corticosteroids and closely monitor for anaphylaxis for an appropriate period of time after administration of KRYSTEXXA. ( 5.1 , 5.2 ) Monitor serum uric ac

Contraindications

4 CONTRAINDICATIONS KRYSTEXXA is contraindicated in: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency [see Warnings and Precautions (5.3) ]. Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components. Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 4 ) Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of KRYSTEXXA in pregnant women. Based on animal reproduction studies, no structural abnormalities were observed when pegloticase was administered by subcutaneous injection to pregnant rats and rabbits during the period of organogenesis at doses up to 50 and 75 times, respectively, the maximum recommended human dose (MRHD). Decreases in mean fetal and pup body weights were observed at approximately 50 and 75 times the MRHD, respectively [see Data ]. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinical recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In 2 separate embryo-fetal developmental studies, pregnant rats and rabbits received pegloticase during the period of organogenesis at doses up to approximately 50 and 75 times the MRHD, respectively (on a mg/m 2 basis at maternal doses up to 40 and 30 mg/kg twice weekly, in rats and rabbits, respectively). No evidence of structural abnormalities was observed in rats or rabbits. However, decreases in mean fetal and pup body weights were observed at approximately 50 and 75 times the MRHD in rats and rabbits, respectively (on a mg/m 2 basis at maternal doses up to 40 and 30 mg/kg every other day, in rats and rabbits, respectively). No effects on mean fetal body weights were observed at approximately 10 and 25 times the MRHD in rats and rabbits, respectively (on a mg/m 2 basis at maternal doses up to 10 mg/kg twice weekly in both species).

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.