Hemosirlox Diffusion Tablet 125 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medicine is recommended after approximately 20 units of packed red blood cells have been transfused (equivalent to 100mL/kg), or when clinical monitoring shows clinical evidence of chronic iron overload (serum ferritin > 1000μg/L or liver iron concentration > 2mg Fe/g dry weight). Calculate the dose in mg/kg and use whole tablets at 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, a patient receiving deferoxamine 40mg/kg/day for 5 days each week, or an equivalent dose, may start this medicine at 20mg/kg/day.) 2) Maintenance dose 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 5-10mg/kg, individualized according to the patient's response and treatment goal (maintaining or reducing iron burden). For patients whose iron overload is not adequately controlled with a dose of 30mg/kg (e.g., serum ferritin levels remain above 2500μg/L and show no downward trend over time), an increase to 40mg/kg may be considered. Experience with doses above 40mg/kg/day is limited; therefore, 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 whose serum creatinine level is above the upper limit of the age-appropriate normal range. Particular caution should be exercised 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 for the general adult patient 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 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 adverse reactions that may require dose adjustment. In all patients, liver function should be monitored 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 for adults. In clinical trials, elderly patients experienced adverse reactions more frequently than younger patients; therefore, closely monitor for adverse reactions that may require dose adjustment. This medicine should be taken once daily, at the same time each day if possible, on an empty stomach at least 30 minutes before food. Mix and disperse this medicine in water, apple juice, or orange juice (100-200mL) until a uniform suspension is formed. After taking the suspension, resuspend any remaining medicine 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, with subsequent individual adjustment. Children under 2 years: Administration is not recommended in these children because data on efficacy and safety are insufficient.

This drug can affect kidney and liver function, so kidney and liver function tests must be conducted before starting treatment. During treatment, kidney function should be regularly monitored, and any abnormal signs should be reported to medical staff immediately. Particularly in elderly patients or those with kidney or liver diseases, careful observation is required. This medication may cause gastrointestinal bleeding or ulcers, so caution should be taken in patients with gastrointestinal problems or low platelet counts. Blood cell counts may decrease, necessitating regular blood tests, and if abnormalities are found, dosing should be stopped immediately. Allergic reactions may rarely occur, so be mindful of allergy symptoms at the beginning of treatment. This drug should not be used with other iron chelators, and it may interact with specific medications, so it is essential to inform about any other medications taken. Use should be avoided or consultations should be made with experts in case of pregnancy or breastfeeding. Particular caution is required for children and elderly patients, with regular checks on growth and developmental status. Overdose may lead to symptoms such as nausea, vomiting, headache, and diarrhea, so the specified dosage must be strictly followed. This medication may affect absorption when taken with food, so it is best taken on an empty stomach at a consistent time. Store in a cool, dry place below 30 degrees Celsius, and keep out of reach of children.

renal failure, hepatic failure, gastrointestinal hemorrhage, increased serum creatinine, tubular nephropathy, metabolic acidosis, nausea, vomiting, diarrhea, abdominal pain, skin rash, elevated liver transaminases, hepatitis, cholelithiasis, pigmentation disorders, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, proteinuria, diabetes, fever, edema, fatigue, anxiety, sleep disturbances, headache, dizziness, early cataract, macular disorders, optic neuritis, hearing loss, sore throat, gastrointestinal ulcer, duodenal ulcer, gastritis, esophagitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, agranulocytosis, neutropenia, thrombocytopenia, worsened anemia, cholelithiasis, liver function abnormalities, acute pancreatitis, increased blood urea nitrogen, gastric ulcer, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, increased transaminases, dysphagia, cough, increased blood bilirubin, asthenia, dizziness, oropharyngeal pain, upper respiratory tract infection, dyspnea, hyperbilirubinemia, increased alkaline phosphatase, papules, skin disorders, sensory disturbances, pain, hearing impairment, renal impairment, upper abdominal discomfort, dry mouth, oral mucosal shedding, gastroesophageal reflux, dysphagia, gastric hemorrhage, liver disease, neutropenia, folliculitis, acne, acneiform dermatitis, erythema, decreased glomerular filtration rate, edema, fatigue, limb pain, facial edema, generalized edema, insomnia, hypokalemia, hypocalcemia, hyperkalemia, metabolic acidosis, weight loss, herpes simplex, otitis media, thrombocytopenia, increased tendency to bruise, splenic disease, graft-versus-host disease, conjunctivitis, tonsillar hypertrophy

This drug is sensitive to air and moisture, so it should be stored in a sealed container. Moreover, it should be kept in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

White to light yellowish flat round tablets

Package unit

28 tablets (7 tablets/ PTP x 4 packs)