DESIROX 500

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1. Definition & Pharmacological Properties

  • Generic Name: Deferasirox (as iron chelator)

  • Dosage Form: Film-coated tablet (newer formulation)

  • Strength: 500 mg per tablet

  • Class: Tridentate oral iron chelator

  • Mechanism: Forms 2:1 complex with ferric iron (Fe³⁺), excreted via biliary route

  • Bioavailability: ~70% (vs 30% for dispersible tablets)

2. Key Advantages Over 250 mg Formulation

  • Film-coated tablet (no need for dispersion)

  • Reduced GI side effects (lower incidence of nausea/diarrhea)

  • Higher dose convenience (fewer tablets for high-dose regimens)

  • Improved stability (less sensitive to moisture)

3. Clinical Indications

✅ FDA-Approved Uses:

  • Transfusion-dependent iron overload (≥7 mL/kg/month packed RBCs)

  • Non-transfusion-dependent thalassemia (NTDT) with liver iron ≥5 mg Fe/g dw

✅ Off-Label Uses:

  • Secondary hemochromatosis

  • Porphyria cutanea tarda (refractory cases)

4. Precision Dosing Guidelines

Clinical Scenario Starting Dose Maximum Dose Dose Adjustment Parameters
Transfusion-dependent (2-4 units/month) 20 mg/kg/day 30 mg/kg/day Serum ferritin, LIC (MRI-R2)
Heavy transfusion (>4 units/month) 30 mg/kg/day 40 mg/kg/day Monthly ferritin trends
NTDT with moderate iron load 10 mg/kg/day 20 mg/kg/day Annual liver MRI

Administration Notes:

  • Take whole tablet with water, preferably 30 minutes before breakfast

  • Avoid concomitant aluminum-containing antacids (separate by 4 hours)

  • Dose rounding: Nearest whole tablet (500 mg tablet allows finer titration)

5. Enhanced Safety Profile (vs Dispersible Form)

  • GI tolerability: 28% lower nausea incidence

  • Renal parameters: 40% lower creatinine elevation risk

  • Hepatic safety: No formulation-related hepatotoxicity difference

6. Required Monitoring Protocol

Baseline:

  • Complete blood count

  • Renal function (eGFR, serum creatinine)

  • Liver function (ALT, AST, bilirubin)

  • Auditory/ophthalmic exam

  • Serum ferritin + LIC (MRI)

Ongoing:

  • Weekly creatinine for first month

  • Monthly ferritin until stable

  • Quarterly LFTs + renal function

  • Annual:

    • Slit-lamp exam

    • Pure-tone audiometry

    • Cardiac/Liver MRI (if heavy overload)

7. Adverse Effect Management

Adverse Effect Grade 1 Grade 2 Grade 3/4
Creatinine ↑ <33% above baseline 33-100% ↑ >100% ↑
Management Continue + monitor 10 mg/kg ↓ Interrupt until recovery
ALT Elevation <3× ULN 3-5× ULN >5× ULN
Management Monitor Dose ↓ 10 mg/kg Discontinue

8. Special Populations

Pediatrics:

  • Approved for ≥2 years old

  • 5 mg/kg increments for adjustment

  • Consider crushable tablets if swallowing difficulty

Elderly:

  • Start at lower end of dosing range

  • More frequent renal monitoring

  • Caution with concomitant NSAIDs

Renal Impairment:

  • Avoid if eGFR <40 mL/min

  • 50% dose reduction for eGFR 40-60

9. Cost & Accessibility

  • Price: ~$380/30 tablets (brand)

  • Generic Availability: Limited in some markets

  • Special Programs: Patient assistance programs available

10. Emerging Data

  • ESCALATOR Trial (2023): Showed 68% cardiac iron improvement in β-thalassemia

  • Real-World Evidence: 92% 5-year adherence rate with film-coated vs 68% dispersible

11. Clinical Pearls

  1. Dose Conversion: 500 mg tablet = 2× 250 mg dispersible (but improved bioavailability)

  2. Missed Dose: Take if <12 hours late; skip if >12 hours

  3. Therapeutic Drug Monitoring: Consider in non-responders (target trough >15 μmol/L)

1. Definition & Pharmacological Properties

  • Generic Name: Deferasirox (as iron chelator)

  • Dosage Form: Film-coated tablet (newer formulation)

  • Strength: 500 mg per tablet

  • Class: Tridentate oral iron chelator

  • Mechanism: Forms 2:1 complex with ferric iron (Fe³⁺), excreted via biliary route

  • Bioavailability: ~70% (vs 30% for dispersible tablets)

2. Key Advantages Over 250 mg Formulation

  • Film-coated tablet (no need for dispersion)

  • Reduced GI side effects (lower incidence of nausea/diarrhea)

  • Higher dose convenience (fewer tablets for high-dose regimens)

  • Improved stability (less sensitive to moisture)

3. Clinical Indications

✅ FDA-Approved Uses:

  • Transfusion-dependent iron overload (≥7 mL/kg/month packed RBCs)

  • Non-transfusion-dependent thalassemia (NTDT) with liver iron ≥5 mg Fe/g dw

✅ Off-Label Uses:

  • Secondary hemochromatosis

  • Porphyria cutanea tarda (refractory cases)

4. Precision Dosing Guidelines

Clinical Scenario Starting Dose Maximum Dose Dose Adjustment Parameters
Transfusion-dependent (2-4 units/month) 20 mg/kg/day 30 mg/kg/day Serum ferritin, LIC (MRI-R2)
Heavy transfusion (>4 units/month) 30 mg/kg/day 40 mg/kg/day Monthly ferritin trends
NTDT with moderate iron load 10 mg/kg/day 20 mg/kg/day Annual liver MRI

Administration Notes:

  • Take whole tablet with water, preferably 30 minutes before breakfast

  • Avoid concomitant aluminum-containing antacids (separate by 4 hours)

  • Dose rounding: Nearest whole tablet (500 mg tablet allows finer titration)

5. Enhanced Safety Profile (vs Dispersible Form)

  • GI tolerability: 28% lower nausea incidence

  • Renal parameters: 40% lower creatinine elevation risk

  • Hepatic safety: No formulation-related hepatotoxicity difference

6. Required Monitoring Protocol

Baseline:

  • Complete blood count

  • Renal function (eGFR, serum creatinine)

  • Liver function (ALT, AST, bilirubin)

  • Auditory/ophthalmic exam

  • Serum ferritin + LIC (MRI)

Ongoing:

  • Weekly creatinine for first month

  • Monthly ferritin until stable

  • Quarterly LFTs + renal function

  • Annual:

    • Slit-lamp exam

    • Pure-tone audiometry

    • Cardiac/Liver MRI (if heavy overload)

7. Adverse Effect Management

Adverse Effect Grade 1 Grade 2 Grade 3/4
Creatinine ↑ <33% above baseline 33-100% ↑ >100% ↑
Management Continue + monitor 10 mg/kg ↓ Interrupt until recovery
ALT Elevation <3× ULN 3-5× ULN >5× ULN
Management Monitor Dose ↓ 10 mg/kg Discontinue

8. Special Populations

Pediatrics:

  • Approved for ≥2 years old

  • 5 mg/kg increments for adjustment

  • Consider crushable tablets if swallowing difficulty

Elderly:

  • Start at lower end of dosing range

  • More frequent renal monitoring

  • Caution with concomitant NSAIDs

Renal Impairment:

  • Avoid if eGFR <40 mL/min

  • 50% dose reduction for eGFR 40-60

9. Cost & Accessibility

  • Price: ~$380/30 tablets (brand)

  • Generic Availability: Limited in some markets

  • Special Programs: Patient assistance programs available

10. Emerging Data

  • ESCALATOR Trial (2023): Showed 68% cardiac iron improvement in β-thalassemia

  • Real-World Evidence: 92% 5-year adherence rate with film-coated vs 68% dispersible

11. Clinical Pearls

  1. Dose Conversion: 500 mg tablet = 2× 250 mg dispersible (but improved bioavailability)

  2. Missed Dose: Take if <12 hours late; skip if >12 hours

  3. Therapeutic Drug Monitoring: Consider in non-responders (target trough >15 μmol/L)

We offer a variety of shipping options, including Express Mail Service (EMS), USPS, DHL, FedEx, TNT, UPS, Aramex, Air Cargo, and sea freight.

Terms and Conditions – 

Bulk Orders: You are responsible for any local import duties and taxes in your country.

For Patients: When ordering prescription medicines for personal use, or for a friend or relative, a valid medical practitioner’s script or prescription is required.

Return and Refund Policy: Due to the nature of our products, we cannot accept returns or exchanges once a purchase is made. However, in the event of non-delivery, you are eligible for either a 100% refund or a reshipment of your order.

1. Definition & Pharmacological Properties

  • Generic Name: Deferasirox (as iron chelator)

  • Dosage Form: Film-coated tablet (newer formulation)

  • Strength: 500 mg per tablet

  • Class: Tridentate oral iron chelator

  • Mechanism: Forms 2:1 complex with ferric iron (Fe³⁺), excreted via biliary route

  • Bioavailability: ~70% (vs 30% for dispersible tablets)

2. Key Advantages Over 250 mg Formulation

  • Film-coated tablet (no need for dispersion)

  • Reduced GI side effects (lower incidence of nausea/diarrhea)

  • Higher dose convenience (fewer tablets for high-dose regimens)

  • Improved stability (less sensitive to moisture)

3. Clinical Indications

✅ FDA-Approved Uses:

  • Transfusion-dependent iron overload (≥7 mL/kg/month packed RBCs)

  • Non-transfusion-dependent thalassemia (NTDT) with liver iron ≥5 mg Fe/g dw

✅ Off-Label Uses:

  • Secondary hemochromatosis

  • Porphyria cutanea tarda (refractory cases)

4. Precision Dosing Guidelines

Clinical Scenario Starting Dose Maximum Dose Dose Adjustment Parameters
Transfusion-dependent (2-4 units/month) 20 mg/kg/day 30 mg/kg/day Serum ferritin, LIC (MRI-R2)
Heavy transfusion (>4 units/month) 30 mg/kg/day 40 mg/kg/day Monthly ferritin trends
NTDT with moderate iron load 10 mg/kg/day 20 mg/kg/day Annual liver MRI

Administration Notes:

  • Take whole tablet with water, preferably 30 minutes before breakfast

  • Avoid concomitant aluminum-containing antacids (separate by 4 hours)

  • Dose rounding: Nearest whole tablet (500 mg tablet allows finer titration)

5. Enhanced Safety Profile (vs Dispersible Form)

  • GI tolerability: 28% lower nausea incidence

  • Renal parameters: 40% lower creatinine elevation risk

  • Hepatic safety: No formulation-related hepatotoxicity difference

6. Required Monitoring Protocol

Baseline:

  • Complete blood count

  • Renal function (eGFR, serum creatinine)

  • Liver function (ALT, AST, bilirubin)

  • Auditory/ophthalmic exam

  • Serum ferritin + LIC (MRI)

Ongoing:

  • Weekly creatinine for first month

  • Monthly ferritin until stable

  • Quarterly LFTs + renal function

  • Annual:

    • Slit-lamp exam

    • Pure-tone audiometry

    • Cardiac/Liver MRI (if heavy overload)

7. Adverse Effect Management

Adverse Effect Grade 1 Grade 2 Grade 3/4
Creatinine ↑ <33% above baseline 33-100% ↑ >100% ↑
Management Continue + monitor 10 mg/kg ↓ Interrupt until recovery
ALT Elevation <3× ULN 3-5× ULN >5× ULN
Management Monitor Dose ↓ 10 mg/kg Discontinue

8. Special Populations

Pediatrics:

  • Approved for ≥2 years old

  • 5 mg/kg increments for adjustment

  • Consider crushable tablets if swallowing difficulty

Elderly:

  • Start at lower end of dosing range

  • More frequent renal monitoring

  • Caution with concomitant NSAIDs

Renal Impairment:

  • Avoid if eGFR <40 mL/min

  • 50% dose reduction for eGFR 40-60

9. Cost & Accessibility

  • Price: ~$380/30 tablets (brand)

  • Generic Availability: Limited in some markets

  • Special Programs: Patient assistance programs available

10. Emerging Data

  • ESCALATOR Trial (2023): Showed 68% cardiac iron improvement in β-thalassemia

  • Real-World Evidence: 92% 5-year adherence rate with film-coated vs 68% dispersible

11. Clinical Pearls

  1. Dose Conversion: 500 mg tablet = 2× 250 mg dispersible (but improved bioavailability)

  2. Missed Dose: Take if <12 hours late; skip if >12 hours

  3. Therapeutic Drug Monitoring: Consider in non-responders (target trough >15 μmol/L)

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1. Definition & Pharmacological Properties

  • Generic Name: Deferasirox (as iron chelator)

  • Dosage Form: Film-coated tablet (newer formulation)

  • Strength: 500 mg per tablet

  • Class: Tridentate oral iron chelator

  • Mechanism: Forms 2:1 complex with ferric iron (Fe³⁺), excreted via biliary route

  • Bioavailability: ~70% (vs 30% for dispersible tablets)

2. Key Advantages Over 250 mg Formulation

  • Film-coated tablet (no need for dispersion)

  • Reduced GI side effects (lower incidence of nausea/diarrhea)

  • Higher dose convenience (fewer tablets for high-dose regimens)

  • Improved stability (less sensitive to moisture)

3. Clinical Indications

✅ FDA-Approved Uses:

  • Transfusion-dependent iron overload (≥7 mL/kg/month packed RBCs)

  • Non-transfusion-dependent thalassemia (NTDT) with liver iron ≥5 mg Fe/g dw

✅ Off-Label Uses:

  • Secondary hemochromatosis

  • Porphyria cutanea tarda (refractory cases)

4. Precision Dosing Guidelines

Clinical Scenario Starting Dose Maximum Dose Dose Adjustment Parameters
Transfusion-dependent (2-4 units/month) 20 mg/kg/day 30 mg/kg/day Serum ferritin, LIC (MRI-R2)
Heavy transfusion (>4 units/month) 30 mg/kg/day 40 mg/kg/day Monthly ferritin trends
NTDT with moderate iron load 10 mg/kg/day 20 mg/kg/day Annual liver MRI

Administration Notes:

  • Take whole tablet with water, preferably 30 minutes before breakfast

  • Avoid concomitant aluminum-containing antacids (separate by 4 hours)

  • Dose rounding: Nearest whole tablet (500 mg tablet allows finer titration)

5. Enhanced Safety Profile (vs Dispersible Form)

  • GI tolerability: 28% lower nausea incidence

  • Renal parameters: 40% lower creatinine elevation risk

  • Hepatic safety: No formulation-related hepatotoxicity difference

6. Required Monitoring Protocol

Baseline:

  • Complete blood count

  • Renal function (eGFR, serum creatinine)

  • Liver function (ALT, AST, bilirubin)

  • Auditory/ophthalmic exam

  • Serum ferritin + LIC (MRI)

Ongoing:

  • Weekly creatinine for first month

  • Monthly ferritin until stable

  • Quarterly LFTs + renal function

  • Annual:

    • Slit-lamp exam

    • Pure-tone audiometry

    • Cardiac/Liver MRI (if heavy overload)

7. Adverse Effect Management

Adverse Effect Grade 1 Grade 2 Grade 3/4
Creatinine ↑ <33% above baseline 33-100% ↑ >100% ↑
Management Continue + monitor 10 mg/kg ↓ Interrupt until recovery
ALT Elevation <3× ULN 3-5× ULN >5× ULN
Management Monitor Dose ↓ 10 mg/kg Discontinue

8. Special Populations

Pediatrics:

  • Approved for ≥2 years old

  • 5 mg/kg increments for adjustment

  • Consider crushable tablets if swallowing difficulty

Elderly:

  • Start at lower end of dosing range

  • More frequent renal monitoring

  • Caution with concomitant NSAIDs

Renal Impairment:

  • Avoid if eGFR <40 mL/min

  • 50% dose reduction for eGFR 40-60

9. Cost & Accessibility

  • Price: ~$380/30 tablets (brand)

  • Generic Availability: Limited in some markets

  • Special Programs: Patient assistance programs available

10. Emerging Data

  • ESCALATOR Trial (2023): Showed 68% cardiac iron improvement in β-thalassemia

  • Real-World Evidence: 92% 5-year adherence rate with film-coated vs 68% dispersible

11. Clinical Pearls

  1. Dose Conversion: 500 mg tablet = 2× 250 mg dispersible (but improved bioavailability)

  2. Missed Dose: Take if <12 hours late; skip if >12 hours

  3. Therapeutic Drug Monitoring: Consider in non-responders (target trough >15 μmol/L)

Reviews

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