Strength
DEFRATAJ 250 mg - Deferasirox
Dispersible Tablet · Oral (after dispersion in water or juice)
DEFRATAJ 250 mg
Deferasirox Dispersible Tablet
| Product Name | Deferasirox Dispersible Tablet 250 mg |
|---|---|
| Brand Name | DEFRATAJ |
| Strength | 250 mg |
| Dosage Form | Dispersible Tablet |
| Route of Administration | Oral (after dispersion in water or juice) |
| Packing | 10 x 10 PVC/PVDC-Aluminium blisters; HDPE bottles available; custom pack sizes for tenders |
| Shelf Life | 24-36 months (market-specific) |
| Therapeutic Use | Iron chelator (ATC: V03AC03) for chronic transfusional iron overload |
| Indication | Treatment of chronic iron overload due to frequent blood transfusions in patients with beta-thalassemia major, sickle-cell disease and myelodysplastic syndromes; non-transfusional iron overload syndromes where locally approved. |
| Storage | Store below 30 degrees C. Protect from moisture. Keep in the original blister. |
| Composition | Each dispersible tablet contains: Deferasirox 250 mg. Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. |
| Tablet Description | Off-white to pale yellow, round, flat, uncoated tablet with break-line on one face; disperses in water or juice within ~3 minutes to form a fine suspension. |
Full Excipient Breakdown
| Excipient | Function |
|---|---|
| Lactose monohydrate | Diluent |
| Microcrystalline cellulose | Diluent / binder |
| Crospovidone | Disintegrant |
| Povidone K30 | Binder |
| Sodium lauryl sulfate | Wetting agent |
| Colloidal silicon dioxide | Glidant |
| Magnesium stearate | Lubricant |
| Purified water | Granulation solvent (removed during drying) |
Dosage Instructions
Disperse the tablet(s) in 100-200 ml of water, orange juice or apple juice; stir until fully dispersed; drink immediately. Rinse the glass with additional liquid and drink. Take on an empty stomach, 30 minutes before food, at the same time daily. Dose calculated per body weight; refer to locally approved prescribing information.
Caution & Warning
Schedule H drug. Sold by retail on the prescription of a Registered Medical Practitioner only.
Monitor renal and hepatic function before and during therapy.
Discontinue immediately if signs of severe cutaneous adverse reactions (SJS / TEN / DRESS), GI haemorrhage, renal failure or hepatic failure occur.
Not for use when creatinine clearance < 60 mL/min.
Monitor renal and hepatic function before and during therapy.
Discontinue immediately if signs of severe cutaneous adverse reactions (SJS / TEN / DRESS), GI haemorrhage, renal failure or hepatic failure occur.
Not for use when creatinine clearance < 60 mL/min.
Overdose
No specific antidote. Limited data; doses up to 80 mg/kg tolerated with GI side effects. Supportive management. Dialysis unlikely effective due to high protein binding.
Disposal
Dispose in accordance with local regulations for pharmaceutical waste. Do not dispose via wastewater or household refuse.
DEFRATAJ 250 mg is the most commonly used strength in adult and adolescent transfusion-dependent iron overload, allowing convenient titration in 5 mg/kg/day increments from typical starting doses around 20 mg/kg/day.
Schedule H: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Not all pack sizes may be marketed.