Medication info

Experid San 250mg (Deferasirox)

Prescription medicationOral
Ingredient · strength
Deferasirox›250mg / 1 packet
Manufacturer / importer
Gunil Pharmaceutical Co., Ltd.
Appearance
White or pale yellow powder
Packaging
30 packets/case
Approval status
Active

MFDS item code 201701838 · Approved 2017.04.13

Summary

Main use
Treatment of transfusion-dependent hemosiderosis
Who takes it
Adults · Children
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 indicates 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 sachet with the closest available strength whole. Once daily, 20mg/kg per dose An initial 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. An initial 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 their iron concentration. In patients who have already responded well to deferoxamine treatment, the initial dose of this medicine should be considered at one-half the deferoxamine dose. (For example, patients who have been receiving deferoxamine 40mg/kg/day for 5 days each week, or an equivalent dose, may start 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 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 to 40mg/kg may be considered. Experience with doses exceeding 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. The recommended initial dose for patients with renal impairment is the same as that for typical adult patients. 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 up to 50%; 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 should be closely monitored, as dose adjustment may be necessary. 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 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 the mouth with a small amount of water and swallow the rinse to clear any residue from the mouth. Do not take this medicine without water.
Child dose
Children aged 2 to under 6 years: The initial dose should be the same as in adults and adjusted individually thereafter. Higher doses than those used in adults may be required. Children under 2 years: Administration is not recommended.

Ingredients

Manufacturer
Gunil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of transfusion-dependent hemosiderosis

  • Transfusion-dependent hemosiderosis
View approved original text

Transfusion-dependent hemosiderosis is a condition characterized by excessive iron accumulation in the body due to repeated blood transfusions. Treatment in this condition focuses on reducing iron overload. Primarily, iron chelator drugs are used to remove excess iron from the body and prevent damage to organs such as the liver and heart. By doing so, it helps maintain the patient's iron levels within normal ranges and reduces the risk of complications. Therefore, this drug is used effectively to treat excess iron in this condition.

How to take

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 indicates 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 sachet with the closest available strength whole. Once daily, 20mg/kg per dose An initial 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. An initial 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 their iron concentration. In patients who have already responded well to deferoxamine treatment, the initial dose of this medicine should be considered at one-half the deferoxamine dose. (For example, patients who have been receiving deferoxamine 40mg/kg/day for 5 days each week, or an equivalent dose, may start 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 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 to 40mg/kg may be considered. Experience with doses exceeding 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. The recommended initial dose for patients with renal impairment is the same as that for typical adult patients. 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 up to 50%; 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 should be closely monitored, as dose adjustment may be necessary. 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 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 the mouth with a small amount of water and swallow the rinse to clear any residue from the mouth. Do not take this medicine without water.

Child dose

Children aged 2 to under 6 years: The initial dose should be the same as in adults and adjusted individually thereafter. Higher doses than those used in adults may be required. Children under 2 years: Administration is not recommended.

Precautions

This drug can affect kidney and liver function, so patients with renal or hepatic problems should be especially cautious. Regular blood tests should be conducted to monitor kidney function, both before and during treatment. Dosage adjustments are necessary in cases of liver dysfunction, and it should not be administered to patients with severe liver impairment. This drug may irritate the gastrointestinal tract, leading to symptoms such as nausea, vomiting, and diarrhea. In severe cases, gastrointestinal bleeding or ulcers may occur, so immediate consultation with a healthcare professional is advised if these symptoms appear. There may be side effects related to decreased blood cell counts, thus regular blood tests are necessary, and if a decrease in blood cells is suspected, administration may be halted. Rarely, serious allergic reactions may occur, so if any adverse reactions are experienced after administration, immediate medical attention is required. This drug is contraindicated in patients with certain genetic metabolic disorders and should not be used with other iron chelation medications. Pregnant or breastfeeding women are advised to avoid this medication and consult a healthcare professional if necessary. In children, regular monitoring of growth and development is also important. In case of overdose, symptoms such as nausea, vomiting, headache, and diarrhea may occur, and medical personnel should be notified immediately for appropriate treatment. This drug should be taken on an empty stomach, and the absorption may be affected if taken with food, so it is recommended to take it at the same time every day. Additionally, this drug can interact with various medications, so patients should inform their healthcare provider of any other medications they are taking. Care should be taken when driving or operating machinery as dizziness may occur. Finally, this drug should be kept out of the reach of children and stored in a cool, dry place below 30 degrees Celsius.

Side effects

Renal failure, liver failure, gastrointestinal bleeding, non-progressive elevation of serum creatinine, acute renal failure, tubulopathy, diarrhea, vomiting, elevated serum transaminases, suggestive hepatitis, liver failure, gastrointestinal irritation, upper gastrointestinal irritation, ulcers, bleeding, multiple ulcers, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, serious hypersensitivity reactions, anaphylaxis, angioedema, gastrointestinal disorder, nausea, abdominal pain, abdominal distension, dyspepsia, gastrointestinal bleeding, gastrointestinal ulcers, duodenal ulcers, gastritis, esophagitis, hepatitis, cholelithiasis, rash, pruritus, pigmentation disorder, erythema multiforme, increased blood creatinine, proteinuria, tubulopathy, fever, edema, fatigue, anxiety, sleep disorders, headache, dizziness, early cataracts, macular disorders, optic neuritis, hearing loss, sore throat, renal tubular necrosis, interstitial nephritis, acute pancreatitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, hypersensitivity reactions, cytopenia, worsening anemia, high-frequency hearing loss, lens opacification, hearing impairment, decreased hearing, gastrointestinal perforation, acute pancreatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, erythema multiforme, rash, hearing disability, visual impairment, growth delay, nausea, headache, diarrhea, nausea, rash, elevated ALT, elevated AST, abdominal pain, dyspepsia, pruritus, gastrointestinal disorder, azotemia, upper abdominal pain, loss of appetite, increased blood urea nitrogen, gastric ulcer, abnormal liver function, headache, increased protein/creatinine ratio, fever, urticaria, abdominal discomfort, gastritis, abnormal liver function tests, elevated transaminases, dysphagia, cough, increased serum bilirubin, weakness, proteinuria, dizziness, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, elevated ALP, papules, skin disorders, sensory disturbances, pain, hearing impairment, renal dysfunction, upper abdominal discomfort, dry mouth, peeling oral mucosa, gastroesophageal reflux, dysphagia, gastric hemorrhage, pancreatitis, liver disease, neutropenia, folliculitis, acne, acneiform dermatitis, pigmentation disorder, erythema, decreased glomerular filtration rate, edema, fatigue, limb pain, facial swelling, 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

Not everyone experiences these, and they can vary from person to person.

Storage

This drug should be stored in a tightly sealed container to protect it from air and moisture, ideally at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White or pale yellow powder

Package unit

30 packets/case

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.