Hemoside 250mg (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. 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 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.) 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 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. 3) Patients with renal impairment 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. 4) Patients with hepatic impairment 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. 6) Elderly patients 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. 2. Administration 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: Exposure in children aged 2 to under 6 years is lower than in adults. Therefore, a higher dose than that required in adults may be needed. However, the starting dose should be the same as in adults, and should then be adjusted individually. Changes in the child's body weight over time should be taken into account when calculating the dose. Children under 2 years: Use of this medicine is not recommended in children under 2 years because there are insufficient data on its efficacy and safety in this age group.

This medication may affect kidney and liver function, so kidney and liver function tests must be performed before administration. In particular, patients with compromised kidney function or liver dysfunction may require dose adjustment and should regularly check their condition with blood tests during treatment. This medication can cause gastrointestinal bleeding or ulcers, so patients with gastrointestinal issues or low platelet counts should exercise extra caution. Conditions such as blood cell count reduction (cytopenia) can occur, making regular blood testing essential. Allergic reactions may occur rarely, so if any allergy symptoms develop during administration, promptly inform healthcare professionals. This medication should not be used in conjunction with other iron chelators and should be avoided in combination with aluminum-containing antacids. Pregnant or breastfeeding women should consult a doctor before using this medication, and breastfeeding mothers should carefully consider whether to continue breastfeeding after drug administration. For pediatric patients, it is important to regularly monitor growth and development. In case of overdose, symptoms such as nausea, vomiting, headache, and diarrhea may occur, so strict adherence to the prescribed dosage is necessary. This medication should be stored in a cool, dry place below 30 degrees Celsius, out of reach of children. Additionally, this medication may cause dizziness, so caution is needed when driving or operating machinery.

Renal failure, liver failure, gastrointestinal hemorrhage, non-progressive increase in serum creatinine, acute renal failure, tubular nephropathy, diarrhea, vomiting, elevated liver transaminases, suggestive hepatitis, liver failure, gastrointestinal irritation, upper gastrointestinal irritation, ulcers, hemorrhage, multiple ulcers, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, severe allergic reactions, anaphylaxis, angioedema, gastrointestinal disorders, skin rash, high-frequency hearing loss, cataracts, anxiety, sleep disturbances, headache, dizziness, early cataract, macular disorders, optic neuritis, hearing loss, sore throat, diarrhea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, gastrointestinal hemorrhage, gastrointestinal ulcer, duodenal ulcer, gastritis, esophagitis, increased transaminases, hepatitis, cholelithiasis, rash, pruritus, pigmentation disorders, erythema multiforme, increased serum creatinine, proteinuria, tubular nephropathy, fever, edema, fatigue, renal tubular necrosis, interstitial nephritis, acute pancreatitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, hypersensitivity, agranulocytosis, neutropenia, thrombocytopenia, worsening anemia, hearing reduction, increased intraocular pressure, retinal abnormalities, otitis media, nausea, increased ALT, increased AST, abdominal pain, pruritus, gastrointestinal disturbances, azotemia, epigastric pain, anorexia, increased blood urea nitrogen, gastric ulcer, abnormal liver function, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, increased transaminases, dysphagia, cough, increased serum bilirubin, fatigue, proteinuria, dizziness, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, increased ALP, papules, skin disorders, sensory disturbances, pain, hearing loss, renal dysfunction, epigastric discomfort, dry mouth, oral mucosa peeling, gastroesophageal reflux, dysphagia, gastric hemorrhage, pancreatitis, liver disease, neutropenia, folliculitis, acne, acneiform dermatitis, erythema, limb pain, hypokalemia, hypocalcemia, hyperkalemia, metabolic acidosis, weight loss, herpes simplex, increased tendency for bruising, splenic disease, graft-versus-host disease, conjunctivitis, tonsillar hypertrophy

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is also advisable to avoid storing in excessively hot or cold places, keeping it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

White to pale yellow powder

Package unit

30 packets