Hemoject 500 mg/10 ml (IV Injection or Infusion)

Indications

• Treatment of iron deficiency anaemia in adult patients with intolerance to oral iron
• Treatment of iron deficiency anaemia in adult patients with unsatisfactory response to oral iron
• Treatment of iron deficiency anaemia in adult patients with non-dialysis dependent chronic kidney disease

Description

• Colloidal iron (III) hydroxide in complex with Carboxymaltose, a Carbohydrate polymer that releases iron

Dosage & Administration

• Stepwise approach for determination, calculation, and administration of individual iron need
• Posology based on body weight and haemoglobin level
• Maximum individual iron dose limitations
• Post-iron repletion assessments

Interaction

• Formal drug interaction studies not performed

Contraindications

• Hypersensitivity to the active substance or any excipients
• Serious hypersensitivity to other parenteral iron products
• Anaemia not attributed to iron deficiency
• Evidence of iron overload or disturbances in iron utilization

Side Effects

• Infrequent and mild side effects
• Common side effects: nausea, headache, dizziness, hypertension, injection site reactions
• Uncommon side effects: dysgeusia, tachycardia, hypotension, dyspnoea, abdominal pain
• Rare side effects: anaphylactoid reactions, loss of consciousness, anxiety, phlebitis

Pregnancy & Lactation

• No adequate and well-controlled trials in pregnant women
• Animal data suggesting potential influence on fetal skeletal development
• Restricted use during second and third trimester if benefit outweighs potential risk
• Unlikely risk to breast-fed child based on limited data

Precautions & Warnings

• Risk of serious hypersensitivity reactions
• Monitoring for signs and symptoms of hypersensitivity during and after administration
• Potential transient elevations in systolic blood pressure
• Laboratory test alterations in the 24 hours following administration

Use in Special Populations

• Maximum daily injection dose limitations for patients with haemodialysis-dependent chronic kidney disease
• Not recommended in children under 14 years

Overdose Effects

• Potential accumulation of iron leading to hemosiderosis
• Monitoring of iron parameters such as serum ferritin and transferrin saturation
• Consideration of iron chelator use if iron accumulation has occurred

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in a cool and dry place below 30°C
• Keep away from light and do not freeze
• Keep out of the reach of children

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