OUR PRODUCTS
Each tablet for oral suspension contains 125 mg, 250 mg, or 500 mg deferasirox.
- Estimated glomerular filtration rate is less than 40 mL/min/1.73 m2
- Poor performance status
- High-risk myelodysplastic syndromes.
- advanced malignancies
- Platelet count less than 50 x 109/L
- Known hypersensitivity to deferasirox or any of the ingredients in deferasirox
- Aluminum-containing antacids: Coadministration with deferasirox is contraindicated due to the mechanism of action of deferasirox.
- Drugs Metabolized by CYP3A4: Deferasirox stimulates this yeast and thus reduces the concentration of the drugs used in combination.
- Drugs metabolized by CYP2C8: deferasirox inhibits this yeast and therefore the dose of the drugs used in combination (repaglinide, paclitaxel) should be reduced.
- Drugs metabolized by CYP1A2: deferasirox inhibits this yeast and thus increases the concentration of drugs metabolized in it when co-administered (melatonin, duloxetine, theophylline, tizanidine).
- Colestyramine, colesevelam, colestipol: Combined use should be avoided due to the possibility of a decrease in the concentration of deferasirox.
- Busulfan: Possible increase in exposure to busulfan and combined use should be closely monitored until dose adjustments are necessary.
- Treatment of chronic iron overload due to blood transfusions (transfusion iron overload): FerObalance Tablets for Oral Suspension is indicated for the treatment of chronic iron overload due to blood transfusions (transfusion hemosiderosis) in patients 2 years of age and older.
- Treatment of chronic iron overload in non-transfusion-dependent thalassemia syndromes: Ferobalance Tablets for Oral Suspension is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia syndrome (NTDT) with iron concentrations in Liver (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dry weight) and serum ferritin greater than 300 mcg/
Dosage:
-Transferred Iron Overload: The recommended initial dose of Ferobalance for patients 2 years of age and older with a GFR greater than 60 mL/min/1.73 m2 is 20 mg per kg of body weight orally, once daily.
- Iron overload in non-transfusion-dependent thalassemia syndromes: Treatment with Ferobalance should only be considered when a patient with NTDT syndrome has a low LIC of at least 5 mg iron/g body weight and serum ferritin greater than 300 mcg / Liter
- The recommended initial dose of Ferobalance for patients with a GFR greater than 60 mL/min/1.73 m2 is 10 mg per kg of body weight orally once daily.
- If baseline LIC is greater than 15 mg Fe/g dry weight, the dose should be increased to 20 mg/kg/day after 4 weeks.
-Re-start treatment when the LIC rises again to more than 5 mg iron/g dry weight.
- Patients with hepatic or renal insufficiency:
Mild hepatic impairment: No dose adjustment required
Moderate hepatic impairment: reduce dose by 50%.
Severe hepatic insufficiency: Avoid Ferobalance tablets.
-Do not use Ferobalance in adult or pediatric patients with an estimated GFR less than 40 mL/min/1.73 m2.
- For patients with renal impairment (eGFR 40 to 60 mL/min/1.73 m2), reduce the starting dose by 50%.
- How to use: Do not chew or swallow the tablets. Ferobalance is taken once daily on an empty stomach 30 minutes before the start of food, preferably daily at the same time.
Kidney failure, nephrotoxicity (Fanconi syndrome), hepatotoxicity, gastrointestinal bleeding, bone marrow depression, hypersensitivity, severe skin reactions, auditory and eye abnormalities, diarrhea, nausea, vomiting, myelodysplastic syndrome, increased creatinine
A carton box containing 3 blisters , and each one contains 10 tablets for oral suspension.