Exferid A 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 whole sachet with the closest available strength. The recommended starting dose of this medicine 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 need 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 levels. In patients who have already responded well to deferoxamine treatment, the starting dose of this medicine should be considered at half the dose of deferoxamine. (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.) 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, on an individual basis according to the patient's response and treatment goal (maintenance or reduction of iron burden). For patients whose condition is not adequately controlled with a dose of 30mg/kg (for example, when serum ferritin levels persistently exceed 2500μg/L and show no downward trend over time), an increase in the dose up to 40mg/kg may be considered. As experience with doses exceeding 40mg/kg/day is limited, 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. This medicine should be used with caution in patients whose serum creatinine level is above the age-appropriate upper limit of the 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 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); 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. In all patients, liver function should be monitored 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 for adult patients. In clinical trials, adverse reactions occurred more frequently in elderly patients than in younger patients; therefore, they 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 with a small amount of water and swallow to clear any residue from the mouth. Do not take this medicine without water.

Child dose

Children aged 2 to under 6 years: The starting dose should be the same as for adults and should then be adjusted individually. Children under 2 years of age: Use is not recommended.

This medication may affect kidney and liver functions, so patients with renal or hepatic issues should exercise special caution. During treatment, kidney function should be periodically monitored through blood tests, especially more frequently during the initial phase. Liver function abnormalities may occur; therefore, regular liver function tests are required. This medication should not be administered to patients with severe liver impairment. This medication may cause gastrointestinal irritation, which can lead to symptoms such as nausea, vomiting, and diarrhea. There is also a risk for severe gastrointestinal bleeding or ulcers, so caution is warranted. Adverse reactions may involve decreased blood cell counts, necessitating regular monitoring of blood cell levels through blood tests. There may be hypersensitivity reactions to this medication; if any allergic symptoms develop, use should be immediately discontinued and medical consultation should be sought. It should not be used concurrently with other iron chelators, and interactions may occur with certain drugs, so any medications being taken should be disclosed. Women who are pregnant or breastfeeding should consult a doctor before using this medication, and they may need to decide whether to discontinue breastfeeding if necessary. In pediatric patients, growth and development should be monitored regularly, and this medication is not recommended for patients under 2 years of age. In cases of overdose, symptoms may include nausea, vomiting, headache, and diarrhea, and medical personnel should be notified promptly for appropriate treatment. This medication should be stored in a sealed container to protect it from air and moisture. It should be kept in a cool and dry place, away from children's reach. Caution is advised when driving or operating machinery, as symptoms such as dizziness may occur.

• Kidney failure
• liver failure
• gastrointestinal bleeding
• non-progressive rise in serum creatinine
• acute kidney failure
• tubular nephropathy
• diarrhea
• vomiting
• transaminase increase
• implicit hepatitis

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This storage method will help to maintain the efficacy and safety of the medication.

Appearance

White to light yellow powder

Package unit

30 packets/case