Exjade Film-Coated Tablets 90 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this drug is recommended after approximately 20 units of packed red blood cells (equivalent to 100mL/kg) have been transfused, or when clinical monitoring indicates clinical evidence of chronic iron accumulation (serum ferritin > 1000μg/L or liver iron concentration > 2mg Fe/g dry weight). The dose should be calculated in mg/kg, and whole tablets of the closest available strength should be used. When patients currently receiving chelation therapy with Exjade dispersible tablets switch to this drug, the dose should be calculated as 30% lower than the dose of Exjade dispersible tablets, using tablets of the closest available strength. Exjade dispersible tablets 20 mg/kg/day → Exjade film-coated tablets 14 mg/kg/day: approximately 20 units of packed red blood cells (equivalent to 100mL/kg) or serum ferritin level > 1000 μg/L Exjade dispersible tablets 30 mg/kg/day → Exjade film-coated tablets 21 mg/kg/day: more than 14 mL/kg/month of packed red blood cells (more than 4 units per month in adults) Exjade dispersible tablets 10 mg/kg/day → Exjade film-coated tablets 7 mg/kg/day: less than 7 mL/kg/month of packed red blood cells (less than 2 units per month in adults) Patients well controlled with deferoxamine: 1/2 of the deferoxamine dose → 1/3 of the deferoxamine dose Monitoring: monthly Target range: 500-1000 μg/L Dose increase: serum ferritin > 2500 μg/L, by 5-10 mg/kg/day. Maximum 40 mg/kg/day; film-coated tablets 3.5-7 mg/kg/day. Maximum 28 mg/kg/day Dose reduction: serum ferritin <2500 μg/L, for patients receiving more than 30mg/kg/day, reduce by 5-10 mg/kg/day until the target is reached; for patients receiving more than 21mg/kg/day, reduce by 3.5-7 mg/kg/day until the target is reached Maximum dose: 40 mg/kg/day; film-coated tablets 28 mg/kg/day Consider discontinuing treatment: serum ferritin < 500 μg/L Deferoxamine (if well controlled) 10 mg/kg → Exjade dispersible tablets 5 mg/kg → Exjade film-coated tablets 3.5 mg/kg Deferoxamine (if well controlled) 20 mg/kg → Exjade dispersible tablets 10 mg/kg → Exjade film-coated tablets 7 mg/kg Deferoxamine (if well controlled) 30 mg/kg → Exjade dispersible tablets 15 mg/kg → Exjade film-coated tablets 10.5 mg/kg Deferoxamine (if well controlled) 40 mg/kg → Exjade dispersible tablets 20 mg/kg → Exjade film-coated tablets 14 mg/kg Deferoxamine (if well controlled) 50 mg/kg → Exjade dispersible tablets 25 mg/kg → Exjade film-coated tablets 17.5 mg/kg Deferoxamine (if well controlled) 60 mg/kg → Exjade dispersible tablets 30 mg/kg → Exjade film-coated tablets 21 mg/kg Exjade dispersible tablets 35 mg/kg → Exjade film-coated tablets 24.5 mg/kg (no corresponding deferoxamine dose) Exjade dispersible tablets 40 mg/kg → Exjade film-coated tablets 28 mg/kg (no corresponding deferoxamine dose) The recommended starting dose of this drug is 14mg/kg once daily. A starting dose of 21mg/kg/day may be considered in patients receiving more than 14mL/kg/month of packed red blood cells (more than 4 units per month in adults) who require a reduction in iron overload. A starting dose of 7mg/kg/day may be considered in patients receiving less than 7mL/kg/month of packed red blood cells (less than 2 units per month in adults) who need to maintain their iron concentration. In patients who have already responded well to deferoxamine treatment, the starting dose of this drug should be considered at a dose equivalent to 1/3 of the deferoxamine dose. (For example, patients receiving deferoxamine 40mg/kg/day for 5 days each week, or an equivalent dose, may start treatment with this drug at a dose of 14mg/kg/day.) Serum ferritin should be monitored monthly, and the dose of this drug is recommended to be adjusted every 3-6 months, as needed, according to changes in serum ferritin. The dose may be adjusted in increments of 3.5-7mg/kg, individually according to the patient's response and treatment goal (maintenance or reduction of iron burden). In patients not adequately controlled with a dose of 21mg/kg (for example, when serum ferritin levels remain above 2500μg/L and show no downward trend over time), dose increases up to 28mg/kg may be considered. Since experience with doses exceeding 28mg/kg/day is limited, doses exceeding 28mg/kg/day are not recommended. In patients whose serum ferritin has reached the target level (usually within the range of 500-1,000μg/L), dose reductions in increments of 3.5-7 mg/kg should be considered to maintain levels within the target range and minimize the risk of overchelation. Treatment with this drug should be discontinued if serum ferritin is below 500μg/L on several consecutive measurements. The recommended starting dose for patients with renal impairment is the same as for general adult patients. Serum creatinine should be monitored monthly in all patients, and the daily dose may be reduced to 7mg/kg if necessary. Do not administer to patients with creatinine clearance below 60ml/min. The starting dose should be reduced by up to approximately 50% in patients with moderate hepatic impairment (Child-Pugh B); do not administer to patients with severe hepatic impairment (Child-Pugh C). In patients with mild (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B), efficacy and the occurrence of adverse reactions that may require dose adjustment should be closely monitored. The recommended dose for elderly patients is the same as for adult patients. Closely monitor for adverse reactions that may require dose adjustment. This drug should be taken once daily, preferably at the same time each day, on an empty stomach at least 30 minutes before food, or with a light meal.

Child dose

Children aged 2 to under 6 years: A higher dose than that required in adults may be needed. However, the starting dose should be the same as in adults and should be adjusted individually thereafter. Monthly measurement of serum ferritin is recommended to assess the patient's response to treatment and prevent excessive chelation. When calculating the dose, take into account changes in the pediatric patient's body weight over time. Children under 2 years: This medicine should not be administered to children under 2 years of age because there are insufficient data on its efficacy and safety in this age group.

This medication may affect kidney and liver function; therefore, a blood test should be performed to check the status of the kidneys and liver before starting treatment. Patients with impaired kidney function or liver problems should use this medication with great caution, and it is essential to regularly check serum creatinine and liver enzyme levels; if any abnormalities are detected, healthcare providers should be notified immediately. This medication may irritate the gastrointestinal tract, leading to symptoms such as nausea, vomiting, diarrhea, and abdominal pain. Rarely, gastrointestinal bleeding or ulcers may occur, so if symptoms are severe, consult a doctor immediately. It may affect blood cell counts, resulting in thrombocytopenia or leukopenia; thus, regular blood tests to monitor blood cell levels are essential. An allergic reaction may occur; therefore, if any hypersensitivity, rash, or breathing difficulties develop after taking this medication, stop taking it immediately and inform healthcare personnel. Use of this medication is not recommended during pregnancy or breastfeeding, and particularly during pregnancy, a careful decision should be made considering the effects on the fetus. When used in conjunction with other iron chelators, the safety has not been confirmed; thus, it is not recommended to use them together. It may interact with certain medications, so it is vital to inform healthcare providers of any other medications being taken. Additionally, when used at high doses, it may place extra burden on kidney function, thus strict dosage adherence and regular kidney function tests are necessary. Special caution is required for children, elderly patients, or those with kidney or liver problems, and if any unusual symptoms occur during treatment, consultation with a specialist should be sought immediately. Finally, this medication should be stored away from moisture and direct sunlight and out of reach of children, with precautions taken to avoid exceeding the prescribed dosage.

• Renal failure
• liver failure
• gastrointestinal bleeding
• increased serum creatinine
• renal tubular disease
• metabolic acidosis
• proteinuria
• diabetes
• decreased plasma potassium
• decreased phosphate

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is at room temperature, between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance

A film-coated tablet that is oval, convex on both sides, with light blue color and rounded edges.

Package unit

30 tablets (10 tablets/PTP packaging x 3)