Hemozaide 125 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medicine is recommended to begin 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 sachets with the closest available strength. The dose is 20mg/kg once daily. An initial 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. An initial 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 levels. For patients who have already responded well to deferoxamine therapy, the initial 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 begin treatment with this medicine at 20mg/kg/day.) 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, individually according to the patient's response and treatment goals (maintaining or reducing iron burden). For patients who are 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 to 40mg/kg may be considered. Experience with doses exceeding 40mg/kg/day is limited; therefore, 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. Use caution in patients whose serum creatinine is 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 medication use, dehydration, or severe infection. The recommended initial 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. For patients with moderate hepatic impairment (Child-Pugh B), the initial dose should be reduced by 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), efficacy and the occurrence of adverse reactions that may require dosage adjustment should be closely monitored. Liver function should be monitored in all patients before treatment, every 2 weeks during the first month of treatment, and monthly thereafter. The recommended dose for older patients is the same as that for adult patients. 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. This medicine should be taken once daily on an empty stomach, at the same time each day if possible, 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 to clear any residue. Do not take this medicine without water.

Child dose

Children aged 2 years to under 6 years: The initial dose of this medicine should be the same as that for adults and should subsequently be adjusted individually. Changes in 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 data on its efficacy and safety in this age group are insufficient.

This medication may affect kidney and liver function, so kidney and liver function should be regularly monitored before and during treatment. In particular, patients with impaired kidney function or liver dysfunction may require dose adjustment, and treatment should be discontinued if the condition worsens. This medication can irritate the gastrointestinal tract, and symptoms such as nausea, vomiting, diarrhea, and abdominal pain may occur. There is also a risk of gastrointestinal bleeding or ulcers, so caution is needed. Blood cell counts may decrease, so regular blood tests should be conducted to monitor blood cell levels, and if abnormalities are found, treatment should be adjusted or stopped. Hypersensitivity reactions may rarely occur; thus, immediate treatment is required if symptoms such as rash, difficulty breathing, or angioedema develop. Patients with a history of hypersensitivity to this medication should not be re-administered. This medication is not to be used in patients with aluminum accumulation, and concomitant use with other iron chelators is not recommended. Pregnant or breastfeeding women are advised to avoid this medication and should consult with a healthcare professional if necessary. In pediatric patients, growth and development should be regularly monitored during treatment. In case of overdose, symptoms such as nausea, vomiting, headache, and diarrhea may occur, requiring immediate treatment. This medication may be affected by food intake, so it is recommended to take it on an empty stomach at regular intervals. Additionally, this medication may interact with various drugs, so it is essential to inform the healthcare provider if other medications are being taken. Dizziness, vision, or hearing disturbances may occur, so these symptoms should lead to avoidance of driving or operating machinery. Finally, this medication should be stored out of the reach of children, and kept in a cool and dry place at temperatures below 30 degrees Celsius.

Renal failure, liver failure, gastrointestinal bleeding, non-progressive increase in serum creatinine, acute renal failure, tubular injury, diarrhea, vomiting, increase in liver transaminases, suggestive hepatitis, gastrointestinal irritation, gastrointestinal ulcer, gastrointestinal bleeding, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, severe allergic reaction, nausea, abdominal pain, skin rash, headache, dizziness, early cataract, macular disorder, optic neuritis, hearing loss, sore throat, diarrhea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia, gastrointestinal bleeding, gastrointestinal ulcer, duodenal ulcer, gastritis, esophagitis, increase in transaminases, hepatitis, cholelithiasis, rash, pruritus, pigmentation disorder, erythema multiforme, increased serum creatinine, proteinuria, tubulopathy, fever, edema, fatigue, renal tubular necrosis, interstitial nephritis, acute pancreatitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, allergic reaction, agranulocytosis, neutropenia, thrombocytopenia, exacerbation of anemia, hearing loss, decreased hearing, lens opacification, cataract, increased intraocular pressure, retinal abnormalities, nausea, increased ALT, increased AST, abdominal pain, dyspepsia, pruritus, gastrointestinal disturbance, azotemia, upper abdominal pain, loss of appetite, increased blood urea nitrogen, gastric ulcer, liver dysfunction, headache, urine protein/creatinine ratio increase, fever, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, increase in transaminases, dysphagia, cough, increased serum bilirubin, asthenia, proteinuria, dizziness, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, increased ALP, papules, skin disorders, sensory abnormalities, pain, hearing loss, renal dysfunction, upper abdominal discomfort, dry mouth, oral mucosa peeling, gastroesophageal reflux, dysphagia, gastric bleeding, pancreatitis, liver disease, neutropenia, folliculitis, acne, acneiform dermatitis, erythema, limb pain, hypokalemia, hypocalcemia, hyperkalemia, metabolic acidosis, weight loss, herpes simplex, otitis media, increased tendency to bruise, splenic disease, graft-versus-host disease, conjunctivitis, tonsillar hypertrophy, nausea, headache

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the drug's efficacy, it is important to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

White to pale yellow powder

Package unit

30 packets