Ferriprox Deferiprone Film-coated Tablets

1. Indications and Usage
Chronic Iron Overload:
Treatment of transfusion-dependent anemias (e.g., beta-thalassemia syndromes) with chronic iron overload when current chelation therapy is contraindicated or inadequate.
Specific Use: It is particularly effective in reducing iron accumulation in the heart (myocardial iron).
2. Dosage and Administration
Route of Administration:
Oral administration.
Recommended Dosage:
Standard Dose: 75 mg/kg/day, administered in 3 divided doses (e.g., 25 mg/kg three times daily).
Maximum Dose: Generally should not exceed 100 mg/kg/day.
Critical Administration Instructions:
Food: Can be taken with or without food.
Swallowing: The film-coated tablet should be swallowed whole with water.
Avoid Antacids: Do not take aluminum-containing antacids concomitantly.
3. Mechanism of Action
Iron Chelation:
Deferiprone is a bidentate ligand, meaning it binds to iron with two points of attachment.
Binding:
It binds to ferric iron (Fe³⁺) in a 3:1 ratio.
Therapeutic Result: It removes excess iron from the body primarily through urine excretion, reducing iron load in the liver and heart.
4. Safety and Warnings
Neutropenia and Agranulocytosis (Black Box Warning):
Neutropenia (ANC < 1.5 × 10⁹/L): Occurs in ~3-6.5% of patients.
Agranulocytosis (ANC < 0.5 × 10⁹/L): Occurs in ~0.5-2% of patients.
Action: Mandatory Monitoring: Absolute Neutrophil Count (ANC) must be monitored weeklyfor life.
Management: If neutropenia (ANC < 1.0–1.5) occurs, the drug must be stopped or neutrophil growth factors (G-CSF) used. If agranulocytosis occurs, the drug is permanently contraindicated.
Hepatic Impairment:
Monitor liver function tests (ALT, AST) before initiation and monthly thereafter.
Contraindications:
History of recurrent neutropenia or agranulocytosis.
Severe renal or hepatic impairment.
Pregnancy and breastfeeding.
5.Adverse Reactions
Most Common:
GI: Nausea, vomiting, abdominal pain, diarrhea.
Musculoskeletal: Joint pain (arthralgia) or arthritis.
Other: Orange/Brown Discoloration of Urine (harmless, due to iron-drug complex), elevated liver enzymes, decreased zinc levels.
6.Drug Interactions
NSAIDs:
Use with caution with non-steroidal anti-inflammatory drugs (NSAIDs) due to potential additive risk of neutropenia and GI toxicity.
Iron-Containing Supplements:
Avoid concurrent use as it may reduce efficacy and increase toxicity.
Vitamin C:
Concomitant use should be undertaken with caution (may increase iron toxicity or GI side effects).
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Deferiprone.
Appearance: Film-coated tablets (e.g., 500 mg).
Storage: Store below 30°C in a dry place.