Hemozaid 1000 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). Calculate the dose in mg/kg and use the sachet with the closest strength intact. 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 need 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 their iron concentration. 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, a patient who has been receiving deferoxamine 40mg/kg/day for 5 days each week, or an equivalent dose, may begin treatment with this medicine at 20mg/kg/day.) 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 and should be individualized according to the patient's response and treatment goals (maintenance or reduction of iron burden). In patients whose iron overload is not adequately controlled with a dose of 30mg/kg (for example, when serum ferritin levels remain above 2500μg/L with no downward trend over time), an increase in the dose to 40mg/kg may be considered. Since experience with doses exceeding 40mg/kg/day is limited, doses exceeding 40mg/kg/day are not recommended. Treatment with this medicine should be discontinued if serum ferritin is below 500μg/L on several consecutive measurements. Urinary iron excretion is not an appropriate parameter for monitoring treatment. This medicine should be used with caution in patients whose serum creatinine is above the upper limit of the appropriate age-related normal range. Particular caution is required in patients with additional risk factors that may impair renal function, such as concomitant medication use, dehydration, or severe infection. The recommended starting dose for patients with renal impairment is the same as that for the general adult population. Serum creatinine should be monitored monthly in all patients, and the daily dose may be reduced to 10mg/kg if necessary. The starting dose should be reduced by approximately 50% in patients with moderate hepatic impairment (Child-Pugh B), and this medicine should not be administered 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. Liver function should be monitored in all patients before starting treatment, every 2 weeks during the first month of treatment, and monthly thereafter. The recommended dose for elderly patients is the same as that for adult patients. In clinical trials, adverse reactions occurred more frequently in elderly patients than in younger patients; therefore, patients should be closely monitored for adverse reactions that may require dose adjustment. This medicine should be taken once daily on an empty stomach, preferably at the same time each day, at least 30 minutes before food. Swallow this medicine with water (100-200mL), then rinse the mouth with a small amount of water and swallow any residue remaining in the mouth. Do not take this medicine without water.

Child dose

Children aged 2 to under 6 years: The starting dose is the same as in adults and should then be adjusted individually. A higher dose than that required in adults may be needed. Changes in the child's body weight over time should be taken into account when calculating the dose. Children under 2 years: Use is not recommended because there are insufficient data on efficacy and safety.

This medication may affect kidney and liver function; therefore, regular kidney and liver function tests should be conducted before and during administration. Special caution is needed for patients with compromised kidney function, the elderly, and those with low platelet counts. This medication can irritate the gastrointestinal tract and, in severe cases, can cause gastrointestinal bleeding or ulcers, so immediate consultation with medical personnel is necessary if symptoms occur. Decreased blood cell counts have been reported as a side effect, necessitating regular blood tests, and discontinuation may be required if abnormal symptoms appear. Allergic reactions may occur infrequently, so if allergy symptoms arise, administration should be stopped immediately, and treatment should be sought. It is advisable to avoid this medication during pregnancy or breastfeeding; especially during pregnancy, careful consideration with a physician is advisable. This medication should not be used in conjunction with other iron chelators, and potential interactions with specific medications necessitate informing the prescriber of any other medications being taken. Food can affect absorption, so it is recommended to take this medication on an empty stomach at a consistent time. Extra caution is needed for children and the elderly, and regular monitoring of weight and growth status is required. In case of overdose, symptoms such as nausea, vomiting, headache, and diarrhea may occur, requiring prompt medical attention. This medication should be stored in a cool, dry place below 30 degrees Celsius and kept out of reach of children.

• Renal failure
• liver failure
• gastrointestinal bleeding
• elevated serum creatinine
• tubulopathy
• diarrhea
• vomiting
• elevated liver transaminases
• hepatitis
• liver failure

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is advisable to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance

White to light yellow powder

Package unit

30 sachets