Xefer 100 mg/2 ml (IV Injection or Infusion)

Indications

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

Therapeutic Class

• Parenteral Iron Preparations

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 iron dose(s)
• Calculation based on patient's body weight and haemoglobin level
• Maximum recommended cumulative dose of 1000 mg of iron per week

Interaction

• Formal drug interaction studies not performed

Contraindications

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

Hypertension

• Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea

Laboratory Test Alterations

• In the 24 hours following administration of Xefer, laboratory assays may overestimate serum iron and transferrin bound iron

Side Effects

• Infrequent, mild, and generally do not cause patients to stop treatment
• Common side effects include nausea, headache, dizziness, and hypertension
• Uncommon side effects such as hypersensitivity, dysgeusia, tachycardia, and gastrointestinal discomfort
• Rare side effects like anaphylactoid reactions, loss of consciousness, and respiratory symptoms

Pregnancy & Lactation

• No adequate and well-controlled trials in pregnant women
• Animal data suggest potential influence on fetal skeletal development
• Unlikely risk to breast-fed child based on limited data

Precautions & Warnings

• Serious hypersensitivity reactions reported
• Monitoring for signs and symptoms of hypersensitivity during and after administration
• Transient elevations in systolic blood pressure
• Laboratory test alterations in the 24 hours following administration

Use in Special Populations

• Single maximum daily injection dose of 200 mg iron in haemodialysis-dependent chronic kidney disease patients
• Not recommended in children under 14 years

Overdose Effects

• Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis
• Monitoring of iron parameters may assist in recognizing iron accumulation

Storage Conditions

• Store in a cool (below 30°C) & dry place, away from light
• Do not freeze
• Keep out of the reach of children

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