Experid 500 mg (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medicine is recommended to be initiated after transfusion of approximately 20 units of packed red blood cells (equivalent to 100mL/kg), or when clinical monitoring indicates clinical evidence of chronic iron accumulation (serum ferritin > 1000μg/L or liver iron concentration > 2mg Fe/g dry weight). The dose should be calculated in mg/kg, and whole sachets of the strength closest to the calculated dose should be used. 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 4units monthly 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 2units monthly in adults) who need to maintain their iron levels. In patients already responding well to deferoxamine treatment, the starting dose of this medicine should be considered at a dose equivalent to 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 a dose of 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, individualized according to the patient's response and treatment goal (maintenance or reduction of iron burden). In patients not adequately controlled with a dose of 30mg/kg (for example, when serum ferritin levels remain above 2500μg/L and show 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 interrupted if serum ferritin is below 500μg/L on several consecutive measurements. Urinary iron excretion is not an appropriate parameter for monitoring treatment. 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. The starting dose should be reduced by up to 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. The recommended dose for elderly patients is the same as for adult patients. In clinical trials, elderly patients had a higher frequency of adverse reactions than younger patients; therefore, they should be closely monitored for adverse reactions that may require dose adjustment. This medicine should be taken once daily, preferably at the same time each day, on an empty stomach at least 30 minutes before food. Swallow this medicine with water (100-200mL), then rinse with a small amount of water and swallow the rinse to take any residue remaining in the mouth. This medicine should not be taken without water.

Child dose

Children aged 2 to under 6 years: The recommended starting dose of this medicine is 20mg/kg once daily. The starting dose should be the same as in adults and should be adjusted individually thereafter. Children under 2 years: This medicine is not recommended for children in this age group because there are insufficient data on its efficacy and safety in children under 2 years.

This medication may affect kidney and liver function, and kidney and liver function tests must be performed before starting treatment. Particularly, patients with poor kidney function or liver dysfunction should be monitored closely with regular blood tests. Also, there is a risk of gastrointestinal bleeding or ulcers, so patients with gastrointestinal issues or low platelet counts need to be cautious. Blood-related side effects such as cytopenia have also been reported, making regular blood tests essential. Hypersensitivity reactions may occur, so special attention should be paid to allergic symptoms in the initial administration. This medication should not be given to patients with certain genetic disorders or those with severely impaired kidney function. Pregnant or breastfeeding women should avoid this medication or consult a physician, and the growth and development status of children should be regularly checked. During treatment, regular checks for liver and kidney function, blood tests, and hearing and vision tests are necessary, and any abnormal symptoms should be reported to the medical staff immediately. Furthermore, there may be interactions with other medications, so inform the medical staff about all medications being taken and manage them carefully. This medication must be used strictly according to prescribed dosages, and in case of overdose, it is essential to visit the hospital immediately for appropriate treatment. When storing this medication, keep it in a cool place away from direct sunlight and moisture, and out of reach of children.

Renal failure, liver failure, gastrointestinal bleeding, non-progressive serum creatinine elevation, acute renal failure, tubular nephropathy, diarrhea, vomiting, serum transaminase elevation, covert hepatitis, liver failure, gastrointestinal irritation, gastrointestinal ulcer, gastrointestinal bleeding, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, serious hypersensitivity reaction, anaphylaxis, angioedema, nausea, abdominal pain, skin rash, hearing loss, lens opacification, 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, transaminase increase, hepatitis, cholelithiasis, rash, pruritus, pigmentation disorder, erythema multiforme, increase in serum creatinine, proteinuria, tubular nephropathy, fever, edema, fatigue, renal tubular necrosis, interstitial nephritis, acute pancreatitis, Stevens-Johnson syndrome, leukocyte destructive vasculitis, urticaria, alopecia, toxic epidermal necrolysis, hypersensitivity reaction, agranulocytosis, neutropenia, thrombocytopenia, worsening anemia, hearing loss, decreased hearing, lens opacification, cataract, increased intraocular pressure, retinal abnormalities, nausea, headache, increase in serum creatinine, nausea, rash, ALT increase, AST increase, diarrhea, vomiting, abdominal pain, dyspepsia, pruritus, gastrointestinal disturbance, azotemia, epigastric pain, anorexia, increase in blood urea nitrogen, gastric ulcer, liver dysfunction, headache, increased urine protein/creatinine ratio, fever, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, transaminase increase, dysphagia, cough, increase in serum bilirubin, asthenia, proteinuria, dizziness, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, ALP increase, papule, skin disorders, sensory abnormalities, pain, hearing impairment, renal dysfunction, epigastric discomfort, dry mouth, oral mucosal peeling, gastroesophageal reflux, dysphagia, gastric hemorrhage, pancreatitis, liver disease, neutropenia, folliculitis, acne, acne dermatitis, pigmentation disorder, erythema, reduced 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 for bruising, splenic disease, graft-versus-host disease, conjunctivitis, tonsillar hypertrophy

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain room temperature between 1 degree and 30 degrees Celsius for storage. Proper storage can help maintain the drug's effectiveness and safety.

Appearance

White or yellowish powder

Package unit

30 sachets/case