Description

Ferlixit 62.5 mg/5 ml Solution

Composition

Each 5 ml ampoule of Ferlixit contains 62.5 mg of iron in the form of iron (III) hydroxide sucrose complex, which corresponds to 12.5 mg of elemental iron. Inactive ingredients include water for injections and sodium hydroxide for pH adjustment.

Description

Ferlixit is a parenteral iron preparation used to replenish iron stores in patients with iron deficiency anemia (IDA), especially when oral supplementation is ineffective or contraindicated. It ensures rapid restoration of iron levels and supports hemoglobin synthesis in various clinical settings.

Pharmacology

Ferlixit acts by providing bioavailable iron directly into systemic circulation. The iron (III) hydroxide sucrose complex is slowly dissociated in the body, releasing iron ions that bind to transferrin and are subsequently used for erythropoiesis. It bypasses gastrointestinal absorption, making it suitable for patients with malabsorption or severe deficiency.

See study: Safety and efficacy of intravenous iron sucrose in the treatment of iron deficiency anemia

Indications

• Treatment of iron deficiency anemia in patients who cannot tolerate or have not responded to oral iron therapy
• Anemia associated with chronic kidney disease, including dialysis-dependent and non-dialysis patients
• Iron-deficient states caused by blood loss, surgery, trauma, or increased physiological demands (e.g., pregnancy)

Dosage and Administration

• Route: Intravenous (IV) only, slow injection or infusion
• Adult dose: Typically 100–200 mg of iron per session, 1–3 times per week
• Children: Dosage is based on body weight (mg/kg), under strict medical supervision
• Important: Always perform a test dose before full administration due to risk of hypersensitivity reactions

Ferlixit must be administered by trained healthcare professionals in facilities equipped for managing anaphylactic reactions.

Contraindications

• Known hypersensitivity to Ferlixit or any of its components
• Iron overload syndromes (e.g., hemochromatosis, hemosiderosis)
• Anemias not caused by iron deficiency (e.g., hemolytic anemia)
• Severe liver disease or active infection

Precautions

• Use cautiously in patients with asthma, eczema, or allergies
• Monitor ferritin and transferrin saturation levels during prolonged use
• Pregnancy: Category B; use only if clearly needed
• Breastfeeding: No known risk, but consult a physician

Drug Interactions

• Do not co-administer with oral iron supplements — discontinue oral iron at least 5 days before starting Ferlixit
• May reduce absorption of tetracyclines if co-administered
• Monitor blood levels if patient is on erythropoiesis-stimulating agents

Side Effects

• Common: Nausea, vomiting, metallic taste, local pain or swelling at injection site
• Less common: Dizziness, headache, hypotension, flushing
• Rare but serious: Anaphylactic shock, bronchospasm, chest pain, dyspnea

Reference: Parenteral iron therapy: Indications and risks

Overdose

In the event of an overdose, symptoms may include hypotension, vomiting, abdominal pain, and signs of iron toxicity. Immediate medical intervention is necessary. Supportive care and chelation therapy (e.g., with deferoxamine) may be required in severe cases.

Storage

• Store at room temperature (15–25°C)
• Protect from light and freezing
• Keep in original packaging until use
• Keep out of reach of children