Hemosirox Diffusion Tablet 250 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medication is recommended to begin after transfusion of approximately 20 units of packed red blood cells (equivalent to 100mL/kg), or when clinical monitoring provides evidence of chronic iron accumulation (serum ferritin > 1000μg/L or hepatic iron concentration > 2mg Fe/g dry weight). Calculate the dose in mg/kg and use the whole tablet strength that is closest to the calculated dose. 1) Starting dose The recommended starting dose of this medication is 20mg/kg once daily. A starting dose of 30mg/kg/day may be considered for 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 for 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 medication should be considered to be half the deferoxamine dose. (For example, patients receiving deferoxamine 40mg/kg/day for 5 days each week or an equivalent dose may begin treatment with this medication at a dose of 20mg/kg/day.) 2) Maintenance dose Serum ferritin should be monitored monthly, and it is recommended that the dose of this medication 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 iron overload is not adequately controlled with a dose of 30mg/kg (for example, when serum ferritin levels consistently exceed 2500μg/L and show no downward trend over time), an increase in the dose to 40mg/kg may be considered. As experience with doses exceeding 40mg/kg/day is limited, doses exceeding 40mg/kg/day are not recommended. Treatment with this medication should be interrupted 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 medication should be used with caution in patients whose serum creatinine levels are above the age-appropriate upper limit of the normal range. Particular caution is warranted 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 general adult patients. 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 For patients with moderate hepatic impairment (Child-Pugh B), reduce the starting dose 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), closely monitor efficacy and the occurrence of adverse reactions that may require dosage adjustment. In all patients, liver function should be monitored before 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, elderly patients had a higher incidence of adverse reactions than younger patients; therefore, they should be closely monitored for adverse reactions that may require dosage adjustment. 2. Method of administration This medication 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 medication 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 medication or swallow the tablet whole.

Child dose

Children aged 2 to under 6 years: The recommended starting dose of this medication is 20mg/kg once daily. 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 subsequently adjusted for each individual. When calculating the dose, take into account changes in the pediatric patient's body weight over time. Children under 2 years: Use of this medication is not recommended in children under 2 years because data on its efficacy and safety in this age group are insufficient.

This medication can affect kidney and liver function; therefore, regular blood tests should be conducted before and during treatment to closely monitor kidney and liver status. Particularly, patients with impaired kidney function, reduced liver function, the elderly, and those with low platelet counts require careful observation. This medication may irritate the gastrointestinal tract, so if gastrointestinal bleeding or ulcer symptoms occur, the healthcare provider should be notified immediately. Since the number of cells in the blood may decrease, regular blood tests should be performed to check the blood cell status, and if abnormalities are found, the use of the medication may need to be discontinued. Allergic reactions may rarely occur, so if symptoms such as rash, shortness of breath, or facial swelling appear, notify the healthcare provider immediately and discontinue the use of the medication. During pregnancy or breastfeeding, it is advisable to avoid using this medication, and if necessary, a careful decision should be made after consulting a specialist. This medication should not be used in conjunction with other iron chelators, and interactions may occur with certain medications; hence, it is essential to inform the healthcare provider of any other medications being taken. In case of overdose, symptoms such as nausea, vomiting, headache, diarrhea may occur; thus, it is important to adhere to the prescribed dosage and consult healthcare providers immediately if any adverse symptoms arise. In children, growth and developmental status should be regularly monitored when deciding to administer this medication. It is recommended to undergo regular hearing and vision tests while taking this medication, and to avoid driving or operating machinery if experiencing symptoms like dizziness. This medication contains lactose, so patients with lactose intolerance should not use it. Finally, this medication should be stored in a cool and dry place, below 30 degrees Celsius, out of the reach of children.

Renal failure, liver failure, gastrointestinal bleeding, 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, maculopathy, optic neuritis, hearing loss, sore throat, gastrointestinal ulcer, duodenal ulcer, gastritis, esophagitis, liver failure, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, hypersensitivity reaction, agranulocytosis, neutropenia, thrombocytopenia, exacerbation of anemia, cholelithiasis, acute pancreatitis, increased blood creatinine, nausea, elevated ALT, elevated AST, abdominal pain, dyspepsia, pruritus, gastrointestinal disorders, azotemia, epigastric pain, loss of appetite, increased blood urea nitrogen, gastric ulcer, abnormal liver function, increased urine protein/creatinine ratio, fever, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, increased transaminases, dysphagia, cough, increased blood bilirubin, weakness, proteinuria, dizziness, oropharyngeal pain, upper respiratory infection, respiratory distress, hyperbilirubinemia, increased ALP, papules, skin disorders, sensory disturbances, pain, hearing impairment, renal impairment, epigastric discomfort, dry mouth, oral mucosal peeling, gastroesophageal reflux, dysphagia, gastric hemorrhage, pancreatitis, 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, increased tendency to bruise, splenic disease, graft-versus-host disease, conjunctivitis, tonsillar enlargement

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Moreover, it should be kept in a cool place, below 30 degrees Celsius, to maintain its effectiveness.

Appearance

Flat, round tablets that are white to pale yellow

Package unit

28 tablets (7 tablets/PTPx4)