Asunra 100 mg (Dispersible Tablet)

Indications

• Treatment of chronic iron overload in adult and pediatric patients with thalassaemia, sickle cell disease, and myelodysplastic syndrome

Pharmacology

• Highly selective for iron
• Binds iron with high affinity in a 2:1 ratio
• Promotes excretion of iron primarily in the faeces

Dosage

• 20-40 mg/kg body weight per day
• Administered on empty stomach
• Initial dose after transfusion of approximately 20 units of packed red blood cells or evidence of chronic iron overload
• Regular monitoring of serum ferritin level

Administration

• Taken once daily on an empty stomach at least 30 minutes before food
• Tablets are dispersed in water or juice until a fine suspension is obtained
• Dispersion in carbonated drinks or milk is not recommended

Interaction

• Not to be taken with aluminium-containing antacids
• Caution with drugs metabolized through CYP3A4
• Possible dose adjustments with concomitant use of specific medications
• Caution with drugs with ulcerogenic potential or anticoagulants

Contraindications

• Hypersensitivity to the active substance or excipients
• Creatinine clearance less than 40 ml/min or serum creatinine >2 times the upper limit of normal

Side Effects

• Cytopenias
• Gastrointestinal issues
• Headache and dizziness
• Elevation of hepatic transaminases
• Rare cases of Stevens-Johnson syndrome and skin rash
• Auditory and ocular disturbances

Pregnancy & Lactation

• Pregnancy Category C
• Potential risk to the fetus
• Not known if excreted in human milk

Precautions & Warnings

• Fatal and non-fatal gastrointestinal bleeding, ulceration, and irritation may occur
• Use caution when combining with drugs with ulcerogenic or hemorrhagic potential
• Monitor blood counts
• Severe hypersensitivity reactions reported

Use in Special Populations

• Similar safety and efficacy for pediatric and adult patients
• Increased risk for geriatric patients
• Not studied in patients with renal or hepatic impairment

Overdose Effects

• Maximal dose is 40 mg/kg body weight
• No information about overdose available

Therapeutic Class

• Antidote preparations

Storage Conditions

• Store in a dry place below 25°C
• Protect from light
• Keep out of the reach of children

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