Hemosirox Diffusion Tablet 500 Milligrams (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). Calculate the dose in mg/kg and use whole tablets of the strength closest to the calculated dose. 1) Starting dose The recommended starting dose of this medicine is 20mg/kg once daily. A starting dose of 30mg/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 10mg/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 iron levels. For patients who have already responded well to deferoxamine treatment, the starting dose of this medicine should be considered at half the deferoxamine dose. (For example, in a patient receiving deferoxamine 40mg/kg/day for 5 days each week or an equivalent dose, treatment may be initiated with this medicine at 20mg/kg/day.) 2) Maintenance dose Serum ferritin should be monitored monthly, and the dose of this medicine 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 5-10mg/kg, individually according to the patient's response and treatment goal (maintenance or reduction of iron burden). For patients whose condition is not adequately controlled at a dose of 30mg/kg (for example, when serum ferritin levels persistently exceed 2500μg/L and show no decreasing trend over time), an increase to 40mg/kg may be considered. As experience with doses exceeding 40mg/kg/day is limited, doses exceeding 40mg/kg/day are not recommended. If serum ferritin is below 500μg/L on several consecutive measurements, treatment with this medicine should be discontinued. Urinary iron excretion is not an appropriate parameter for monitoring treatment. 3) Patients with renal impairment Use this medicine with caution in patients with serum creatinine levels above the upper limit of the appropriate normal range for their age. Particular caution is required in patients with additional risk factors that may impair renal function, such as concomitant medications, dehydration, or severe infection. The recommended starting dose for patients with renal impairment is the same as that for adults in general. Serum creatinine should be monitored monthly in all patients, and the daily dose may be reduced by up to 10mg/kg if necessary. 4) Patients with hepatic impairment Reduce the starting dose by 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), closely monitor efficacy and the occurrence of adverse reactions that may require dose adjustment. In all patients, liver function should be monitored before treatment begins, every 2 weeks during the first month of treatment, and monthly thereafter. 6) Older patients The recommended dose for older patients is the same as that for adults. In clinical trials, adverse reactions occurred more frequently in older patients than in younger patients; therefore, closely monitor for adverse reactions that may require dose adjustment. 2. Administration This medicine should be taken once daily, preferably at the same time each day, on an empty stomach at least 30 minutes before food. Mix and disperse this medicine thoroughly in water, apple juice, or orange juice (100-200mL) until a uniform suspension is formed. After taking the suspension, resuspend any remaining residue with a small amount of water, apple juice, or orange juice and take it. Do not chew this medicine or swallow the tablets whole.

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 subsequently be adjusted individually. When calculating the dose, take into account changes in the child's body weight over time. Children under 2 years of age: Use is not recommended in this age group because data on the efficacy and safety of this medicine in children under 2 years of age are insufficient.

This medication can affect kidney and liver function, so regular renal and liver function tests should be conducted before and during treatment. Patients with renal disease, impaired liver function, the elderly, and those with low platelet counts should exercise increased caution. This medication can irritate the gastrointestinal tract and may cause symptoms such as nausea, vomiting, diarrhea, and abdominal pain; in severe cases, gastrointestinal bleeding or ulcers may occur, necessitating caution. Blood cell counts may decline, so regular blood tests should be performed to monitor cell counts, and if abnormalities occur, a physician should be consulted. Allergic reactions may rarely occur, so if any signs of allergy appear during early treatment, immediate notification to healthcare professionals is required. This medication is not administered to patients with certain genetic issues, and women who are pregnant or breastfeeding should consult a physician before determining whether to take it. There may be interactions with other iron chelators or specific medications, so it is essential to inform of any ongoing medications. Taking this medication with food may affect absorption, so it is recommended to take it at specific times on an empty stomach. Overdosing may lead to symptoms such as nausea, vomiting, headache, and diarrhea, so it is crucial to adhere to the prescribed dose. In children, growth and development should be monitored regularly, and caution is needed for the elderly due to a higher risk of adverse reactions. While taking this medication, changes in hearing and vision may occur, so regular check-ups are recommended. If dizziness or any other abnormal symptoms occur during treatment, driving or operating machinery should be avoided. This medication contains lactose, so patients with lactose intolerance should consult a physician before taking it. The appropriate dosage and duration of treatment should be determined individually based on the therapeutic effect and the risk of side effects.

• Renal failure
• liver failure
• gastrointestinal bleeding
• increased serum creatinine
• tubulopathy
• metabolic acidosis
• nausea
• vomiting
• diarrhea
• abdominal pain

This medication is sensitive to air and moisture, so it should be stored in a well-sealed container. It is important to maintain a storage temperature of below 30 degrees Celsius. This will help preserve the effectiveness of the medication for a longer duration.

Appearance

Flat round tablets that are white to light yellowish beige

Package unit

28 tablets (7 tablets/PTP x 4)