Maltofer 500

Indications

Maltofer is prescribed for treating iron deficiency anemia in adult patients who:

• Are intolerant to oral iron or have not responded adequately to it.
• Suffer from non-dialysis dependent chronic kidney disease.
  Always follow the guidance of a registered healthcare professional when using this medication.

Description

Maltofer contains Ferric Carboxymaltose, a complex of colloidal iron (III) hydroxide and a carbohydrate polymer, designed to release iron gradually.

Dosage & Administration

The dosing for Ferric Carboxymaltose follows a three-step process:

1. Determining the Iron Requirement: The iron need is based on the patient’s body weight and hemoglobin (Hb) levels.
   • Hb <10 g/dl
     • Below 35 kg: 500 mg
     • 35 kg to <70 kg: 1500 mg
     • 70 kg and above: 2000 mg
   • Hb 10 to 14 g/dl
     • Below 35 kg: 500 mg
     • 35 kg to <70 kg: 1000 mg
     • 70 kg and above: 1500 mg
   • Hb >14 g/dl
     • All weight ranges: 500 mg
2. Calculating and Administering the Iron Dose: Based on the determined iron requirement, Ferric Carboxymaltose is administered as follows:
   • Do not exceed 15 mg iron/kg body weight (for intravenous injection) or 20 mg iron/kg (for intravenous infusion).
   • Maximum single dose: 1000 mg (20 ml).
   • The recommended maximum cumulative weekly dose is 1000 mg.
3. Post-Iron Replenishment Assessments: Reevaluate the patient’s Hb levels no earlier than 4 weeks after the final dose to allow sufficient time for iron absorption and erythropoiesis. If more iron is needed, recalculate the dosage accordingly.
   Always follow the guidance of a registered healthcare professional when using this medication.

Interactions

There have been no formal drug interaction studies conducted with Maltofer.

Contraindications

Maltofer should not be used in patients who have:

• Hypersensitivity to Ferric Carboxymaltose or its ingredients.
• Severe allergic reactions to other intravenous iron treatments.
• Non-iron deficiency anemia (e.g., other microcytic anemia).
• Evidence of iron overload or issues with iron utilization.

Side Effects

Side effects are uncommon and generally mild. They rarely cause discontinuation of the treatment.

Common side effects:

• Nausea, headache, dizziness, hypertension, and reactions at the injection site.
  Uncommon:
• Hypersensitivity, taste disturbances, tachycardia, flushing, dyspnea, gastrointestinal discomfort, and rashes.
  Rare:
• Severe allergic reactions, loss of consciousness, anxiety, and phlebitis.

Pregnancy & Lactation

There is limited data on the safety of Ferric Carboxymaltose in pregnant women. It should be used during pregnancy only if clearly necessary and restricted to the second and third trimesters when the benefits outweigh the potential risks. Its use during breastfeeding is unlikely to pose a risk to the infant.

Precautions & Warnings

Serious allergic reactions, including anaphylactic shock, have been reported with Maltofer. Patients should be monitored for at least 30 minutes post-administration for signs of hypersensitivity. Treatment for such reactions should be readily available.

Other warnings:

• Hypertension: Blood pressure spikes may occur shortly after the dose, usually resolving within 30 minutes.
• Laboratory Test Changes: Following administration, iron assays may temporarily show elevated levels due to the presence of Maltofer.

Use in Special Populations

• Patients with Kidney Disease: A single dose should not exceed 200 mg of iron in dialysis-dependent patients.
• Pediatric Patients: Maltofer is not recommended for children under 14 years, as it hasn’t been studied in this group.

Overdose

Excessive iron intake may cause iron accumulation (hemosiderosis). Monitoring ferritin and transferrin levels can help detect this condition. In such cases, an iron chelator may be required for treatment.

Therapeutic Class

Parenteral Iron Supplements

Storage

Store below 30°C, away from direct light. Do not freeze. Keep out of the reach of children.