Fedulow Suspension (Deferasirox)

Adult dose

In patients receiving regular blood transfusions, treatment with this medicine is recommended after approximately 20 units of packed red blood cells (equivalent to 100mL/kg) have been transfused, or when clinical monitoring shows evidence of chronic iron accumulation (serum ferritin > 1000μg/L or liver iron concentration > 2mg Fe/g dry weight). Take the suspension using the dose calculated in mg/kg. 1) Initial dose The recommended initial dose of this medicine is 20mg/kg once daily. 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 need 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. For patients who have already responded well to deferoxamine treatment, the initial dose of this medicine should be considered at half the deferoxamine dose. (For example, treatment may be started at 20mg/kg/day in a patient who was receiving deferoxamine 40mg/kg/day or an equivalent dose for 5 days each week.) 2) Maintenance dose 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). In patients who are 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 to 40mg/kg may be considered. Since experience with doses exceeding 40mg/kg/day is limited, doses exceeding 40mg/kg/day are not recommended. Discontinue this medicine if serum ferritin is below 500μg/L on several consecutive measurements. Urinary iron excretion is not an appropriate parameter for monitoring treatment. 3) Patients with renal impairment Use this medicine with caution in patients whose serum creatinine level 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 medications, dehydration, or severe infection. The recommended initial dose for patients with renal impairment is the same as for adults in general. Serum creatinine should be monitored monthly in all patients, and the daily dose may be reduced to 10mg/kg if necessary. 4) Patients with hepatic impairment Reduce the initial dose by up to 50% in patients with moderate hepatic impairment (Child-Pugh B); 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), closely monitor efficacy and the occurrence of adverse reactions that may require dose adjustment. In all patients, liver function should be monitored before treatment, every 2 weeks during the first month of treatment, and monthly thereafter. 6) Elderly patients The recommended dose for elderly patients is the same as for adults. In clinical trials, adverse reactions occurred more frequently in elderly patients than in younger patients; therefore, closely monitor for adverse reactions that may require dose adjustment. 2. Administration Take this medicine once daily on an empty stomach, preferably at the same time each day, at least 30 minutes before food. After taking the suspension, add a small amount of water to the remaining residue, resuspend it, and take it. For single-dose packaging, take care to ensure that no medicine remains in the package.

Child dose

5) Pediatric and adolescent patients Exposure in children aged 2 to under 6 years is lower than in adults. Therefore, a higher dose than that required in adults may be needed. However, the initial dose should be the same as in adults and subsequently adjusted individually. Changes in body weight over time should be taken into account when calculating the dose for pediatric patients. Use of this medicine is not recommended in children under 2 years of age because there are insufficient data on its efficacy and safety in this age group.

This medication can affect kidney and liver function, so it is crucial to regularly monitor kidney and liver status through blood tests before and during treatment. Special caution is needed for patients with impaired kidney function, liver dysfunction, or low platelet counts. Gastrointestinal bleeding or ulcers may occur during the use of this medication, so patients with gastrointestinal issues or those taking gastrointestinal medications should consult their physician. Side effects that reduce blood cell counts might occur, hence it is important to regularly check blood cell levels through blood tests. Rarely, allergic reactions may occur; if allergy symptoms develop, treatment should be immediately discontinued, and healthcare personnel should be consulted. This medication should not be administered to patients with certain kidney diseases, children under the age of 2 years, or high-risk blood diseases. Women who are pregnant or breastfeeding should consult their physician before using this medication and decide whether to discontinue breastfeeding if necessary. This medication should not be used in conjunction with other iron chelators, and it may interact with certain medications, so it is essential to inform healthcare providers about any other medications being taken. It is recommended to take this medication on an empty stomach at a consistent time, as food may affect its absorption. Overdose may lead to symptoms such as nausea, vomiting, headache, and diarrhea, so it is important to adhere to the prescribed dosage. Dizziness or visual and auditory disturbances may occur, thus caution is required when driving or operating machinery. This medication should be stored out of the reach of children and care should be taken not to transfer it to other containers.

Renal failure, liver failure, gastrointestinal hemorrhage, non-progressive increase in serum creatinine, acute renal failure, tubular disease, diarrhea, vomiting, gastrointestinal irritation, gastrointestinal ulcer, gastrointestinal bleeding, gastrointestinal perforation, agranulocytosis, neutropenia, thrombocytopenia, severe hypersensitivity reaction (anaphylaxis, angioedema), gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain), skin rash, increased serum creatinine, elevated liver transaminases, hepatitis, liver failure, high-frequency hearing loss, lens opacification (early cataract), anxiety, sleep disorders, headache, dizziness, early cataract, macular disorders, optic neuritis, hearing loss, sore throat, constipation, abdominal distension, dyspepsia, duodenal ulcer, gastritis, esophagitis, cholelithiasis, pruritus, pigmentation disorders, erythema multiforme, increased serum creatinine, proteinuria, Fanconi syndrome, fever, edema, fatigue, renal tubular necrosis, interstitial nephritis, Stevens-Johnson syndrome, leukocytoclastic vasculitis, urticaria, alopecia, myasthenia, oropharyngeal pain, upper respiratory infection, dyspnea, hyperbilirubinemia, elevated alkaline phosphatase, papules, skin disorders, sensory disturbances, pain, hearing impairment, upper abdominal discomfort, dry mouth, mucosal peeling, gastroesophageal reflux, dysphagia, gastric hemorrhage, pancreatitis, liver disease, folliculitis, acne, acneiform dermatitis, erythema, limb pain, facial edema, generalized edema, insomnia, hypokalemia, hypocalcemia, hyperkalemia, metabolic acidosis, weight loss, herpes simplex, otitis media, increased tendency to bruise, spleen disease, graft-versus-host disease, conjunctivitis, tonsillar hypertrophy

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

A suspension that is an opaque white liquid with a melon and banana flavor, contained in a white plastic bottle or aluminum foil pouch.

Package unit

280mL/bottle, 10mL/sachets x 28, 20mL/sachets x 28