Home > About EXJADE > Dosing > Non–Transfusion-Dependent Thalassemia

Monitor Treatment for Optimal Results and Safety

Recommended monitoring during EXJADE® treatment
Baseline In the first month after
initiation of EXJADE
Monthly Every 3 months Yearly
SF
LIC
(for pediatric patients only,
if SF is ≤800 µg/l)
Serum creatinine 2X Weekly1
Creatinine clearance and/or plasma cystatin C 2X Weekly1
Proteinuria
Serum transaminases,
bilirubin, alkaline phosphatase
Every 2 Weeks
Body weight, height,
and sexual development
pediatric patients)
Auditory/ophthalmic testing
(including fundoscopy)
Other markers of renal
tubular function:
(such as glycosuria in non-
diabetics and low levels of
serum potassium,
phosphate, magnesium or
urate, phosphaturia,
aminoaciduria)
As needed As needed As needed As needed

1Also applies to first month after any dose modification.

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  • If serious hypersensitivity reactions (such as anaphylaxis and angioedema) occur, EXJADE should be discontinued and appropriate medical intervention instituted
  • It is recommended that serum ferritin be monitored every month. After every 3 to 6 months of treatment, a dose increase in increments of 5 to 10 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well. Doses above 20 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassemia syndromes
  • In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg. For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l
  • Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin <300 µg/l), treatment should be stopped. There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended
  • Renal tubulopathy has been mainly reported in children and adolescents with β-thalassemia treated with EXJADE. Tests for proteinuria should be performed monthly. As needed, additional markers of renal tubular function (eg, glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria) may also be monitored. Dose reduction or interruption may be considered if there are abnormalities in levels of tubular markers and/or if clinically indicated