Maltofer 1G

Indications

Maltofer is prescribed for treating iron deficiency anemia in adults:

• Patients who experience intolerance to oral iron or inadequate response to it.
• Patients with chronic kidney disease who are not dependent on dialysis.

Always consult a registered physician before use.

Description

Maltofer is an innovative formulation of colloidal iron (III) hydroxide, complexed with Carboxymaltose. This carbohydrate-based polymer gradually releases iron to the body.

Dosage & Administration

Ferric Carboxymaltose dosage follows a structured three-step process:

1. Determine Iron Requirements
   The required iron dosage is based on the patient’s 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:

   • Below 35 kg: 500 mg
   • 35 kg to <70 kg: 500 mg
   • 70 kg and above: 500 mg
2. Administering Iron Dosage
   Administer Ferric Carboxymaltose doses based on the determined need. Take note:
   • Do not exceed 15 mg iron/kg body weight via IV injection or 20 mg iron/kg via IV infusion.
   • A single dose should not exceed 1000 mg of iron (20 ml Ferric Carboxymaltose).
   • The weekly maximum dose is 1000 mg of iron.
3. Post-treatment Evaluation
   Reassess the patient’s hemoglobin levels no earlier than 4 weeks after the final Ferric Carboxymaltose dose. Further iron requirements should be calculated if additional treatment is needed.

Always consult a registered physician before use.

Interactions

No formal studies have been conducted to evaluate drug interactions with Maltofer.

Contraindications

Maltofer should not be used in patients with:

• Known hypersensitivity to Ferric Carboxymaltose or its ingredients.
• Severe allergic reactions to other intravenous iron treatments.
• Non-iron deficiency anemia, such as other types of microcytic anemia.
• Signs of iron overload or improper iron absorption.

Side Effects

Maltofer’s side effects are generally mild and infrequent, allowing most patients to continue treatment. Common reactions include nausea, headache, dizziness, and hypertension.

Less Common Reactions:

• Hypersensitivity, taste alterations, increased blood pressure, abdominal discomfort, and muscle pain.

Rare Reactions:

• Anaphylactic reactions, fainting, anxiety, and facial swelling.

Pregnancy & Lactation

Limited studies suggest that Ferric Carboxymaltose should only be used during pregnancy when clearly necessary. Iron released by the compound may cross the placenta and affect fetal development. The drug is recommended only during the second and third trimesters, where benefits outweigh potential risks. Minimal risk to breastfeeding infants has been noted based on available data.

Precautions & Warnings

• Severe Allergic Reactions: Life-threatening hypersensitivity has been reported in some patients. Monitor patients during and after Maltofer administration for at least 30 minutes, and ensure that appropriate emergency treatments are available.
• Hypertension: Temporary increases in blood pressure, sometimes accompanied by dizziness or facial flushing, can occur immediately after dosing but generally resolve within 30 minutes. Monitor patients accordingly.
• Laboratory Test Interference: Following Maltofer administration, iron levels in lab tests may be artificially elevated for up to 24 hours.

Special Populations

• Chronic Kidney Disease Patients on Dialysis: Do not exceed a daily maximum dose of 200 mg iron.
• Pediatric Use: Maltofer is not recommended for children under 14 years as no studies have been conducted in this age group.

Overdose Effects

Excessive doses of Maltofer may lead to iron accumulation, resulting in hemosiderosis. Monitoring iron parameters such as serum ferritin and transferrin saturation can help detect iron overload. Treatment may involve using iron chelators.

Therapeutic Class

Parenteral Iron Preparations.

Storage Conditions

Store below 30°C, in a dry, cool place, away from light. Do not freeze. Keep out of reach of children.