Pegloticase
پگلوتیکاز
🦴 Musculo-Skeletal SystemPEGylated uricase
Market / country: 🇺🇸 USA
Krystexxa (US)
🧮 Dose calculator
Gout · Regimen source: FDA Krystexxa · 2.2
- • Methotrexate and folic acid at least 4 weeks before. Stop oral urate-lowering drugs. Premedicate with antihistamine and corticosteroid. Check uric acid before each infusion (two consecutive >6 mg/dL: stop). FDA Krystexxa · 2.2FDA Krystexxa · 2FDA Krystexxa · Boxed Warning
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ G6PD deficiency; prior serious hypersensitivity to pegloticase. FDA Krystexxa · 4
Warnings
- • Boxed warning: anaphylaxis and infusion reactions (healthcare setting only); haemolysis and methaemoglobinaemia in G6PD deficiency — screen for G6PD first. FDA Krystexxa · Boxed Warning
- • Gout flares at initiation; congestive heart failure. FDA Krystexxa · 5
Formulations
- 8 mg/mL vial (to be diluted) — injection 🇺🇸 USA FDA Krystexxa · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Krystexxa · 8.1
“Risk Summary There are no adequate and well-controlled studies of KRYSTEXXA in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Krystexxa · 8.2
“Therefore, KRYSTEXXA should not be used when breastfeeding unless the clear benefit to the mother can overcome the unknown risk to the newborn/infant.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Krystexxa · 8.4
“The safety and effectiveness of KRYSTEXXA in pediatric patients less than 18 years of age have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Krystexxa · 8.5
“No dose adjustment is needed for patients 65 years of age and older.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA125293
- DailyMed (FDA label)FDA Krystexxa
- MedlinePlus (NIH)Pegloticase Injection
- WHO ATC/DDDM04AX02
- Darooyab (Iran)Pegloticase
🇮🇷 Not found in Iran list Darooyab · G-4694/Pegloticase
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Krystexxa · 3FDA Krystexxa · 2.2FDA Krystexxa · 2FDA Krystexxa · Boxed WarningFDA Krystexxa · 4FDA Krystexxa · 5FDA Krystexxa · 8.1FDA Krystexxa · 8.2FDA Krystexxa · 8.4FDA Krystexxa · 8.5FDA Krystexxa · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4694/Pegloticase
- Clinical review⚠ Unverified