Jadenu Sprinkle

Calculate dose to nearest whole tab or sachet (for granules). May be taken on an empty stomach or with a light meal (<7% fat content). Tabs: swallow whole with water at same time each day. If unable to swallow whole, tabs may be crushed and mixed with soft foods (eg, yogurt or apple sauce) immediately prior to administration. Oral granules: sprinkle full dose on soft foods immediately prior to administration. Transfusional iron overload: <2yrs: not established. ≥2yrs (with eGFR >60mL/min/1.73m²): initially 14mg/kg once daily; may adjust dose by 3.5mg/kg or 7mg/kg every 3–6 months based on serum ferritin levels or response. If inadequate control at 21mg/kg, may consider increasing up to max 28mg/kg. If serum ferritin <1000mcg/L at 2 consecutive visits, consider dose reduction (esp. if dose is >17.5mg/kg/day); interrupt therapy and continue monitoring if serum ferritin <500mcg/L. NTDT syndromes: <10yrs: not established. ≥10yrs (with eGFR >60mL/min/1.73m²): initially 7mg/kg once daily; if baseline LIC>15mg Fe/g dw, consider increasing dose to 14mg/kg/day after 4 weeks. Suspend therapy if serum ferritin <300mcg/L and obtain LIC to determine whether it has fallen to <3mg Fe/g dw. After 6 months, if LIC remains >7mg Fe/g dw, increase dose to max 14mg/kg/day. If after 6 months, LIC is 3–7mg Fe/g dw, continue with max 7mg/kg/day. When LIC is <3mg Fe/g dw, interrupt treatment and continue to monitor LIC. Restart when LIC rises again to >5mg Fe/g dw. Baseline hepatic impairment (moderate): reduce initial dose by 50%; (severe): avoid. Baseline renal impairment (eGFR 40–60mL/min/1.73m²): reduce initial dose by 50%; in pediatrics: caution and use the minimum effective dose; monitor frequently. Conversion from Exjade, dose modifications for decreases in renal function, others: see full labeling.