Exjade Film-Coated Tablet 360 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medicine is recommended after transfusion of approximately 20 units of packed red blood cells (equivalent to 100mL/kg), or when clinical monitoring shows 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 strength closest to the calculated dose should be used. When patients currently receiving chelation therapy with Exjade dispersible tablets switch to this medicine, the dose should be calculated as 30% lower than the dose of Exjade dispersible tablets, and tablets of the strength closest to the calculated dose should be used. Starting dose: 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 > 1000 μg/L Alternative starting dose: 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) Starting dose: 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 (fewer than 2 units per month in adults) Patients well controlled with deferoxamine: Exjade dispersible tablets, 1/2 of the deferoxamine dose; Exjade film-coated tablets, 1/3 of the deferoxamine dose Monitoring: monthly Target range: 500-1000 μg/L Dose adjustment steps (every 3-6 months) Dose increase: > 2500 μg/L — Exjade dispersible tablets 5-10 mg/kg/day. Maximum 40 mg/kg/day; Exjade film-coated tablets 3.5-7 mg/kg/day. Maximum 28 mg/kg/day Dose reduction: <2500 μg/L — For patients receiving more than 30mg/kg/day, reduce the dose by 5-10 mg/kg/day until the target is reached; for patients receiving more than 21mg/kg/day, reduce the dose by 3.5-7 mg/kg/day until the target is reached Maximum dose: Exjade dispersible tablets 40 mg/kg/day, Exjade film-coated tablets 28 mg/kg/day Consider discontinuing treatment: < 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 (not applicable to deferoxamine) Exjade dispersible tablets 40 mg/kg — Exjade film-coated tablets 28 mg/kg (not applicable to deferoxamine) The recommended starting dose 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 (fewer than 2 units per month in adults) who need to maintain their iron levels. For patients who have already responded well to deferoxamine treatment, the starting dose of this medicine should be considered at an amount equivalent to 1/3 of the deferoxamine dose. (For example, a patient receiving deferoxamine 40mg/kg/day for 5 days each week or an equivalent dose may start treatment with this medicine at 14mg/kg/day.) Serum ferritin should be monitored monthly, and it is recommended that the dose of this medicine 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). For patients not adequately controlled at a dose of 21mg/kg (for example, when serum ferritin levels remain above 2500μg/L and show no downward trend over time), an increase in the dose to 28mg/kg may be considered. Since experience with doses exceeding 28mg/kg/day is limited, doses exceeding 28mg/kg/day are not recommended. For patients whose serum ferritin has reached the target level (usually in 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 excessive chelation (overchelation). Treatment with this medicine should be discontinued if serum ferritin is below 500μg/L in several consecutive measurements. The recommended starting dose for patients with renal impairment is the same as for adults in general. 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. For patients with moderate hepatic impairment (Child-Pugh B), the starting dose should be reduced by up to approximately 50%; 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. This medicine 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. Swallow the tablets whole with water. Patients who have difficulty swallowing the tablets should crush this medicine, sprinkle it over soft food such as yogurt or apple puree, and consume the entire amount. This medicine should be taken immediately after crushing and must not be stored for later use.

Child dose

Ages 2 to under 6 years: 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. Under 2 years: Do not administer.

This drug may affect kidney and liver function, so renal and liver functions should be regularly monitored before and during administration. Patients with impaired renal function or liver disorders should exercise greater caution, and dosage may need to be adjusted or treatment may be discontinued as necessary. This drug may cause gastrointestinal issues such as gastrointestinal bleeding or ulcers, so patients at high risk of gastrointestinal bleeding should use it with caution. There may be abnormalities in blood cell counts, requiring regular blood tests, and treatment can be stopped if cytopenia occurs. Allergic reactions may rarely occur, so if any allergy symptoms appear, cease use immediately and consult a healthcare provider. Women who are pregnant or nursing are advised to avoid this medication and consult a professional if necessary. Children, elderly patients, and those with impaired kidney or liver function should be treated with extra caution. It should not be used in conjunction with other iron chelators and may interact with specific drugs, so it is crucial to inform your healthcare provider of any medications being taken. During treatment, regular hearing and vision tests are recommended. In case of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, and immediate medical attention should be sought. Store this medication in a cool and dry place below 30 degrees Celsius, and keep it out of the reach of children.

• Renal failure
• liver failure
• gastrointestinal bleeding
• increased serum creatinine
• tubular nephropathy
• metabolic acidosis
• gastrointestinal irritation
• upper gastrointestinal irritation
• gastrointestinal ulcer
• gastrointestinal bleeding

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

Biconvex oval film-coated tablets with dark blue color and rounded edges

Package unit

30 tablets (10 tablets/PTP packaging x 3)