Medication info

Experid 125 mg (Deferasirox)

Prescription medicationOral
Ingredient · strength
Deferasirox›125mg / 1 packet
Manufacturer / importer
Gunil Pharmaceutical Co., Ltd.
Appearance
White or yellowish powder
Packaging
30 packets/case
Approval status
Active

MFDS item code 201701837 · 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 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. 20mg/kg per dose, 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. 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. The recommended dose for elderly patients is the same as for adult patients. 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. A higher dose than that required in adults may be needed. Children under 2 years of age: Use 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 of excessive iron accumulation in the body, which can primarily occur due to recurrent blood transfusions. This medication helps remove the accumulated iron from the body and prevents organ damage. Therefore, this drug is used for the treatment of transfusion-dependent hemosiderosis.

How to take

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. 20mg/kg per dose, 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. 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. The recommended dose for elderly patients is the same as for adult patients. 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. A higher dose than that required in adults may be needed. Children under 2 years of age: Use is not recommended.

Precautions

This drug may affect kidney and liver function, so kidney and liver function tests must be conducted before starting treatment. Patients with impaired kidney function, the elderly, and those with low platelet counts should be monitored more closely. During the course of this medication, blood tests should be conducted monthly to regularly check kidney and liver function, and if abnormalities are detected, dosage adjustment or discontinuation should be considered. There is a risk of gastrointestinal bleeding or ulcer, hence patients with a history of gastrointestinal disorders or high risk of gastrointestinal bleeding should be cautious when using this drug. Blood cell counts may decrease, thus white blood cell and platelet counts should be monitored regularly through blood tests, and if any issues arise, immediate consultation with a physician is necessary. This drug may cause hypersensitivity reactions, so patients who have previously experienced allergic reactions to this drug should not use it. Pregnant or breastfeeding women are advised to avoid the use of this drug and should consult with a physician if necessary. Children and the elderly should use this medication with special caution, and it is important to regularly check their growth and development status. This drug may interact with certain specific medications; therefore, if taking any other medications, it is essential to inform the physician or pharmacist. In case of overdose, symptoms such as vomiting, diarrhea, headache, etc., may occur, and if any abnormal symptoms arise, immediate contact with medical professionals is required. This medication should be kept out of the reach of children and stored in a dry place below 30 degrees Celsius. It is recommended to take this medication at the same time each day on an empty stomach; taking it with food may alter its effectiveness. Caution is advised when driving or operating machinery, as dizziness may occur.

Side effects

Renal failure, liver failure, gastrointestinal bleeding, non-progressive increase in serum creatinine, acute renal failure, tubular nephropathy, proteinuria, transaminase elevation, suggestive hepatitis, gastrointestinal irritation, upper gastrointestinal irritation, ulcer, bleeding, multiple ulcers, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, severe hypersensitivity reaction, anaphylaxis, angioedema, nausea, vomiting, diarrhea, abdominal pain, skin rash, headache, dizziness, early cataract, macular disorder, optic neuritis, hearing loss, sore throat, constipation, abdominal distension, dyspepsia, gastrointestinal bleeding, gastrointestinal ulcer, duodenal ulcer, gastritis, esophagitis, hepatitis, cholelithiasis, pigmentation disorder, erythema multiforme, fever, edema, fatigue, renal tubular necrosis, interstitial nephritis, acute pancreatitis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, toxic epidermal necrolysis, agranulocytosis, exacerbation of anemia, high-frequency hearing loss, lens opacification, increased serum creatinine, increased serum bilirubin, malaise, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, increased ALP, papules, skin disorders, sensory abnormalities, pain, hearing impairment, discomfort in the upper abdomen, dry mouth, oral mucosal peeling, gastroesophageal reflux, dysphagia, gastric bleeding, liver disease, 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

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

Storage

This drug should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 to 30 degrees Celsius. Storing in this manner helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

White or yellowish powder

Package unit

30 packets/case

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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.