Xoferon 100 mg/5 ml (IV Injection or Infusion)

Indications

• Treatment of Xoferon deficiency
• Rapid Xoferon supply
• Patients unable to tolerate oral therapy
• Active inflammatory bowel disease
• Non-dialysis dependent-chronic kidney disease patients
• Hemodialysis dependent-chronic kidney disease patients
• Peritoneal dialysis dependent-chronic kidney disease patients
• Treatment of Xoferon deficiency anaemia
• Patients undergoing surgical procedures
• Patients donating blood
• Postpartum patients

Pharmacology

• Therapeutic class: haematinic
• Iron Sucrose Injection USP is a brown, sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use
• Approximately 30% Sucrose w/v (300 mg/ml)
• pH of 10.5-11.1
• Dissociation into Iron and Sucrose by the reticuloendothelial system
• Iron transfer to liver and bone marrow
• Transferrin, an Iron storage protein
• Transferrin receptor and the intracellular Iron
• Elimination half-life: 6h
• Total clearance: 1.2 L/h
• Non-steady state apparent volume of distribution: 10.0 L
• Steady state apparent volume of distribution: 7.9 L
• Distribution in blood, liver, spleen, bone marrow
• Sucrose elimination through urinary excretion

Dosage

• Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
• Children: Not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week

Administration

• Intravenous injection
• Administration undiluted by slow intravenous injection
• Maximum of 10 ml Iron Sucrose Injection (200 mg Iron) per injection
• Test dose before therapeutic dose in new patients
• Infusion by drip infusion in a dilution of 1 ml Iron Sucrose Injection (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride
• Infusion time based on Iron dosage

Interaction

• Not studied for drug-drug interactions
• Should not be administered concomitantly with oral iron preparations
• Oral Xoferon therapy should not be given until 5 days after last injection

Contraindications

• Patients with evidence of Iron overload
• Known hypersensitivity to Iron Sucrose or its components
• Anaemia not caused by Iron deficiency
• History of allergic disorders, liver disease, infections

Side Effects

• Hypotension
• Cramps/leg cramps
• Nausea
• Headache
• Vomiting
• Diarrhea
• Fever
• Chest pain
• Hypertension
• Dizziness
• Musculoskeletal pain
• Dyspnea
• Pruritus
• Hypersensitivity reactions
• Anaphylactoid reactions

Pregnancy & Lactation

• Pregnancy Category-B
• Limited studies in pregnant women
• Caution in nursing women

Precautions & Warnings

• Periodic monitoring of hematologic and haematinic parameters
• Caution in the presence of evidence of tissue Iron overload
• Monitoring transferrin saturation values
• Caution for hypersensitivity reactions
• Hypotension precautions

Use in Special Populations

• Safety and effectiveness in pediatric patients not established
• No significant safety differences observed in elderly patients
• Injection into dialyser
• Administration guidelines for chronic kidney disease patients

Overdose Effects

• Accumulation of Iron in storage sites
• Monitoring of Iron parameters for recognizing accumulation
• Symptoms associated with overdosage
• Caution to avoid Iron overload
• Treatment for symptoms

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in a cool (15°C-30°C) & dry place
• Protected from light
• Do not freeze

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