Feofer DS 200 mg/10 ml (IV Injection or Infusion)

Indications

• Treatment of Feofer DS deficiency
• Rapid Feofer DS supply
• Patients unable to tolerate oral Feofer DS therapy
• Active inflammatory bowel disease treatment
• Non-dialysis dependent-chronic kidney disease treatment
• Hemodialysis dependent-chronic kidney disease treatment
• Peritoneal dialysis dependent-chronic kidney disease treatment
• Treatment of Feofer DS deficiency anaemia in surgical procedures
• Treatment of Feofer DS deficiency anaemia in blood donation
• Treatment of Feofer DS deficiency anaemia in postpartum patients

Pharmacology

• Therapeutic class: Haematinic
• Sterile, aqueous, complex of Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use
• Contains approximately 30% Sucrose w/v (300 mg/ml)
• pH of 10.5-11.1
• Dissociated into Iron and Sucrose by the reticuloendothelial system
• Iron transferred from blood to a pool of Iron in the liver and bone marrow
• Iron binds to plasma transferrin, carrying it to the tissues
• Increased transferrin synthesis in Iron deficiency

Dosage

• Adult dosage: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week
• Children dosage: Limited data, 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
• Undiluted slow intravenous injection at recommended rate
• Max 10 ml Iron Sucrose Injection (200 mg Iron) per injection
• Test dose before full therapeutic dose

Interaction

• Not studied for drug-drug interactions
• Not to be administered concomitantly with oral iron preparations

Contraindications

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

Side Effects

• Hypotension
• Cramps/leg cramps
• Nausea
• Headache
• Vomiting
• Diarrhea
• Fever
• Pain
• Asthenia
• Malaise
• Elevated liver enzymes
• Dizziness
• Pruritus
• Hypersensitivity reactions
• Anaphylactoid reactions

Pregnancy & Lactation

• Pregnancy Category-B
• Caution advised during nursing

Precautions & Warnings

• Caution in presence of evidence of tissue Feofer DS overload
• Periodic monitoring of hematologic and haematinic parameters
• Hypersensitivity reactions monitoring
• Hypotension monitoring
• Caution in pediatric use
• Caution in geriatric use

Use in Special Populations

• Safety and effectiveness in pediatric patients not established
• No notable differences in safety between elder and younger subjects

Overdose Effects

• Accumulation of Feofer DS in storage sites leading to hemosiderosis
• Monitoring of serum ferritin and transferrin saturation
• Avoidance of Feofer DS overload
• Symptoms associated with overdosage or rapid infusion

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Cool and dry place
• Protected from light
• Do not freeze

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