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

Indications

• Treatment of Hemofer deficiency
• Rapid Hemofer supply
• Patients intolerant to oral Hemofer therapy
• Active inflammatory bowel disease
• Patients with non-dialysis dependent-chronic kidney disease (NDD-CKD)
• Patients with dialysis dependent-chronic kidney disease (HDD-CKD)
• Patients with peritoneal dialysis dependent-chronic kidney disease (PDD-CKD)
• Patients undergoing surgical procedures
• Blood donors
• Postpartum patients

Pharmacology

• Therapeutic class: haematinic
• Aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose
• Approximately 30% Sucrose w/v
• pH of 10.5-11.1
• Transferred from blood to liver and bone marrow
• Binding to plasma transferrin
• Increased transferrin synthesis in Iron deficiency
• Elimination half-life: 6 hours
• Total clearance: 1.2 L/h
• Apparent volume of distribution: 10.0 L non-steady state, 7.9 L steady state

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
• Slow intravenous injection at recommended rate
• Maximum 10 ml Iron Sucrose Injection (200 mg Iron) per injection
• Test dose before therapeutic dose
• Infusion via drip infusion in dilution with sodium chloride

Interaction

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

Contraindications

• Patients with evidence of Iron overload
• Patients with known hypersensitivity to Iron Sucrose
• Patients with anaemia not caused by Iron deficiency
• Patients with history of allergic disorders, liver disease, infections

Side Effects

• Hypotension
• Leg cramps
• Nausea
• Headache
• Vomiting
• Diarrhea
• Fever
• Pain
• Asthenia
• Malaise
• Elevated liver enzymes
• Dyspnea
• Pneumonia
• Cough
• Pruritus
• Hypersensitivity reactions
• Anaphylactoid reactions

Pregnancy & Lactation

• Pregnancy Category-B
• Use during pregnancy only if clearly needed
• Unknown excretion in human milk

Precautions & Warnings

• Periodic monitoring of hematologic and haematinic parameters
• Hypersensitivity reactions
• Hypotension
• Safety and effectiveness in pediatric patients not established
• No overall differences in safety observed in elderly
• Injection into dialyser
• Administration guidelines for specific patient groups

Use in Special Populations

• Safety and effectiveness not established in pediatric patients
• No overall differences in safety for geriatric use
• Specific administration guidelines for chronic kidney disease patients

Overdose Effects

• Accumulation leading to hemosiderosis
• Periodic monitoring of Hemofer parameters
• Symptoms associated with overdosage
• Treatment with IV fluids, hydrocortisone, antihistamines

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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