Desifer 400 — Deferasirox 400 mg Dispersible Tablets, 30 Tablets

Desifer 400 is supplied as dispersible tablets for oral suspension.

Qualitative and Quantitative Composition per Tablet:

• Active Ingredient: Deferasirox — 400 mg.
• Excipients: Microcrystalline cellulose, crospovidone, povidone, lactose monohydrate, colloidal anhydrous silica, sodium lauryl sulphate, magnesium stearate, mango flavor.

Packaging and Presentation: White to off-white, round or oval, flat-faced beveled-edge tablets with debossing. 6 tablets per blister strip. 5 blister strips (total 30 tablets) are packaged in an outer carton displaying Desifer (Deferasirox Tablets for Oral Suspension) 400 mg along with Natco Pharma corporate graphics and official prescribing information.

Pharmacodynamics:
Deferasirox is an orally active chelator with high selectivity for trivalent iron ($Fe^{3+}$). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Deferasirox promotes excretion of excess iron, predominantly reducing liver iron concentration (LIC) and preventing tissue damage from free iron radicals. Its affinity for zinc and copper is low.

Pharmacokinetics:

• Absorption: Following oral intake, peak plasma concentration ($C_{max}$) is reached within 1.5 to 4 hours. Absolute bioavailability is approximately 70%. Food intake slightly increases bioavailability.
• Distribution: Plasma protein binding (primarily serum albumin) is approximately 99%. Volume of distribution is relatively large.
• Metabolism: Glucuronidation is the main metabolic pathway (primarily via UGT1A1 and UGT1A3) yielding inactive metabolites.
• Elimination: Excreted primarily via feces (~84% of dose) as glucuronide metabolites. Renal excretion accounts for approximately 8%. Elimination half-life ($T_{1/2}$) ranges from 8 to 16 hours.

Desifer 400 is indicated in adult and pediatric patients (aged 2 years and older) for:

• Transfusional Iron Overload: Treatment of chronic iron overload due to frequent blood transfusions (transfusions exceeding 14 ml/kg/year of red blood cells) in patients with beta-thalassemia major aged 2 years and older.
• Alternative Chelation Therapy: Treatment of chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with other anemias, myelodysplastic syndromes, or sickle cell disease.
• Non-Transfusion-Dependent Thalassemia: Treatment of chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients aged 10 years and older.

Desifer 400 is administered orally once daily, preferably at the same time each day, on an empty stomach or with a light meal (at least 30 minutes before food).

Preparation Instructions:
Tablets must not be chewed or swallowed whole. Place tablet(s) in a glass of water, orange juice, or apple juice (approx. 100–200 ml) and stir until a uniform turbid suspension is obtained. Drink the suspension, then rinse the glass with a small amount of water and drink the remainder. Do not dissolve in carbonated beverages or milk.

Dosing Regimen:
The recommended initial daily dose for transfusional iron overload is typically 20 mg/kg body weight. The 400 mg strength facilitates convenient dosing combinations. Dose is individualized by the attending physician based on serum ferritin trends every 3–6 months.

Administration of Desifer 400 is contraindicated in:

• Hypersensitivity: Known hypersensitivity to deferasirox or any inactive excipient.
• Severe Renal Impairment: Creatinine clearance < 60 ml/min.
• Severe Hepatic Impairment: Severe hepatic impairment (Child-Pugh Class C).
• High-Risk Myelodysplastic Syndromes: Patients with high-risk myelodysplastic syndromes or advanced malignancies.
• Pregnancy and Lactation: Strictly contraindicated in pregnant or breastfeeding women.
• Pediatric Population: Children under 2 years of age.

Evaluated drug interactions for Desifer include:

• Aluminum-Containing Antacids: Co-administration with aluminum-based antacids is not recommended as they bind the chelator.
• Glucuronidation Inducers (rifampicin, phenytoin, carbamazepine, phenobarbital): May decrease deferasirox plasma concentrations; monitor ferritin levels and adjust dose if needed.
• Cardiac Glycosides, Cyclosporin, Simvastatin: Deferasirox may moderately affect pharmacokinetics of certain drugs via transporter inhibition (CYP3A4, CYP2C8). Use with caution.
• NSAIDs and Nephrotoxic Agents: Increase the risk of renal toxicity.

Pregnancy:
Desifer 400 is contraindicated during pregnancy. Preclinical studies indicate teratogenic risks. Women of childbearing potential must use effective contraception during therapy.

Lactation:
Excretion into human breast milk has not been studied. Breastfeeding must be discontinued during treatment.

The most frequent and clinically significant adverse reactions associated with deferasirox include:

• Gastrointestinal Tract (Very Common): Nausea, vomiting, diarrhea, abdominal pain, dyspepsia, constipation, flatulence. Rare reports of GI hemorrhage.
• Renal System: Serum creatinine elevations, proteinuria, renal failure. Regular renal function monitoring is mandatory.
• Hepatic System: Transaminase elevations, hyperbilirubinemia, drug-induced hepatitis.
• Skin & Appendages: Rash, pruritus, urticaria.
• Special Senses: Rare reports of ocular disturbances (cataracts, corneal opacities) and hearing loss (tinnitus, hearing impairment).

Symptoms:
Overdose manifests as pronounced gastrointestinal adverse events (nausea, vomiting, diarrhea, abdominal pain) alongside hepatic and renal dysfunction.

Treatment:
No specific antidote exists. Supportive and symptomatic care should be initiated, including emesis or gastric lavage (if recent), and intensive monitoring of laboratory parameters and vital organ function.

Storage Requirements for Desifer 400:

• 🌡️ Temperature Range: Store in a dry, light-protected place at temperatures below 25–30 °C.
• 💧 Moisture Protection: Keep in original blister packaging to protect tablets from moisture.
• 👶 Safety Precautions: Keep strictly out of reach of children.
• ⏳ Shelf Life: Stated on carton and blisters. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of genuine Desifer 400 manufactured by Natco Pharma, inspect the following features:

• ✅ Corporate Logo: Distinctive blue-green Natco Pharma corporate logo printed on the outer carton and blister foil.
• ✅ Packaging Markings: Clear factory printing displaying Batch No., Mfg. Date, Exp. Date, and product designation Desifer 400 (Deferasirox Tablets for Oral Suspension).
• ✅ Blister Quantity: Standard box contains exactly 5 blister strips of 6 tablets each (total 30 tablets).
• ✅ Print Quality: High-grade packaging artwork without color fading or typography errors.