Kidifer100 mg/5 ml

Iron sucrose injection is an intravenous iron replacement product used for the treatment of iron deficiency anaemia, particularly:

• In patients with chronic kidney disease (CKD), including those on haemodialysis, peritoneal dialysis, or not yet on dialysis
• In patients who cannot tolerate or adequately respond to oral iron therapy, as determined by the treating physician

It is given only by the intravenous route, under medical supervision, and is not a substitute for oral iron in patients who can be adequately treated orally.

Contains iron sucrose (an iron (III)-hydroxide sucrose complex) for intravenous use. Common presentations provide 20 mg of elemental iron per mL, supplied as single-dose vials (for example, 50 mg/2.5 mL, 100 mg/5 mL, or 200 mg/10 mL). Exact strengths and vial sizes vary by product.

Iron sucrose injection is a form of intravenous iron used to treat iron deficiency anaemia, most often in patients with chronic kidney disease. It replenishes the body's iron stores directly into the bloodstream, bypassing the gut, which is useful when oral iron is poorly tolerated, ineffective, or when rapid iron repletion is needed. It is administered only in a healthcare setting, either as a slow intravenous injection or a diluted intravenous infusion, with monitoring for infusion reactions.

Therapeutic Class: Parenteral Iron Replacement Therapy

Iron sucrose is a complex of polynuclear iron (III)-hydroxide in sucrose, with a molecular weight of approximately 34,000-60,000 daltons, designed for controlled release of iron following intravenous administration. The iron is taken up by the reticuloendothelial system and used for haemoglobin synthesis. Because it bypasses intestinal absorption, iron sucrose provides more reliable iron delivery than oral iron in patients with impaired gut absorption or high iron requirements, such as those undergoing dialysis.

• Administered only by the intravenous route, either as a slow push injection or as a diluted infusion in 0.9% sodium chloride, per the specific product's instructions
• Must be given by, or under the direct supervision of, a healthcare professional in a setting equipped to manage hypersensitivity or hypotensive reactions
• Patients should be monitored for signs of hypersensitivity during administration and for at least 30 minutes after each dose, until clinically stable
• Do not administer iron sucrose to patients with evidence of iron overload
• Serum iron measurements should not be performed for at least 48 hours after an intravenous dose, since transferrin saturation rises rapidly after administration

Iron sucrose should generally not be administered together with oral iron preparations, since intravenous iron may reduce the absorption of orally administered iron; timing of oral iron relative to intravenous doses should be guided by the treating physician. Concomitant use with erythropoiesis-stimulating agents is common in chronic kidney disease and is generally coordinated as part of anaemia management, under medical supervision.

Common side effects

• Hypotension (low blood pressure), which may occur following administration
• Headache
• Nausea
• Muscle or joint aches
• Injection site discoloration, particularly if extravasation occurs

Serious side effects (seek urgent medical attention)

• Signs of a hypersensitivity reaction: rash, itching, swelling of the face or throat, difficulty breathing, chest tightness
• Severe hypotension, dizziness, or fainting
• Cardiovascular collapse (rare, but can occur with rapid infusion or excessive dosing)

These reactions can occur up to 30 minutes after administration and may occur after the first or any subsequent dose, so monitoring during and after each infusion is important.

Pregnancy

Iron sucrose may be used in pregnancy when iron deficiency anaemia cannot be adequately managed with oral iron and treatment is considered clinically necessary, under specialist supervision, weighing the benefits against any risks.

Breastfeeding

Use during breastfeeding should be guided by a healthcare professional based on the mother's clinical need for intravenous iron treatment.

• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported and can be life-threatening; administer only where personnel and treatments for serious reactions are immediately available.
• Hypotension: Iron sucrose can cause clinically significant hypotension; monitor patients following each administration, especially if given too rapidly or at high total doses.
• Iron overload: Excessive parenteral iron therapy can lead to iatrogenic haemosiderosis; periodic monitoring of haemoglobin, haematocrit, serum ferritin, and transferrin saturation is required in all patients receiving iron sucrose.
• Do not administer to patients with evidence of existing iron overload.

Excessive dosing or too-rapid administration of iron sucrose may cause hypotension, difficulty breathing, headache, vomiting, nausea, dizziness, joint aches, tingling sensations (paresthesia), abdominal and muscle pain, swelling, and, in severe cases, cardiovascular collapse. These reactions may occur up to 30 minutes after administration. Suspected overdose or a serious reaction during or after infusion requires immediate medical attention; treatment is supportive and provided by the healthcare team administering the infusion.

Store single-dose vials as directed on the product label, generally at controlled room temperature; do not freeze. Iron sucrose contains no preservative, so any unused portion in an opened vial should be discarded and not reused for another patient or a later dose, per the specific product's instructions.

• Chronic kidney disease patients (haemodialysis, peritoneal dialysis, or non-dialysis-dependent): This is the primary population for iron sucrose therapy; dosing regimens differ by dialysis status and are determined by the treating nephrologist.
• Elderly: Select dosage with care due to age-related decline in hepatic, renal, or cardiac function and any concomitant disease or drug therapy.
• Pediatric patients: Used for iron maintenance in children 2 years and older with CKD, under specialist supervision.

The treatment course and total cumulative dose depend on the calculated iron deficit and the patient's ongoing dialysis status and response to therapy, as determined by the treating physician; iron sucrose is often used as an ongoing maintenance therapy in patients with chronic kidney disease who continue to have increased iron needs, particularly if on erythropoiesis-stimulating agent therapy.

Drug Class: Intravenous iron product (iron-carbohydrate complex)

After intravenous administration, iron is released from the iron sucrose complex and taken up by cells of the reticuloendothelial system, particularly in the liver, spleen, and bone marrow. This iron is then incorporated into ferritin stores or used directly for haemoglobin production in developing red blood cells, correcting iron deficiency anaemia more directly than oral iron, which depends on intestinal absorption.

Iron sucrose is used for iron maintenance treatment in children 2 years of age and older with dialysis-dependent or non-dialysis-dependent chronic kidney disease, particularly those on erythropoietin therapy. Pediatric dosing is determined by a pediatric nephrology specialist and should not be extrapolated from adult regimens.