Maltofer 1 gm/20 ml Injection is a parenteral iron preparation containing ferric carboxymaltose, indicated for the treatment of iron deficiency anemia in adult patients. It is especially suitable for patients who are unable to tolerate oral iron therapy, have shown an inadequate response to oral iron, or are suffering from non-dialysis dependent chronic kidney disease (CKD).

Maltofer provides a controlled and effective replenishment of iron stores, helping to restore hemoglobin levels and improve oxygen transport in the body.

Therapeutic Class

Parenteral Iron Preparations

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Indications

Maltofer 1 gm/20 ml Injection is indicated for the treatment of iron deficiency anemia in adult patients:

• Who have intolerance to oral iron therapy

• Who have had an unsatisfactory response to oral iron

• Who have non-dialysis dependent chronic kidney disease

Pharmacology

Maltofer contains ferric carboxymaltose, a non-dextran intravenous iron formulation. It is a colloidal iron hydroxide complexed with carboxymaltose, a carbohydrate polymer that allows controlled release of iron. After intravenous administration, macrophages take up the complex and regulate iron release. The released iron binds to transferrin and is transported to target organs such as the liver, spleen, and bone marrow, where it is utilized for hemoglobin synthesis, myoglobin formation, and enzymatic processes involved in oxygen transport.

Mode of Action

Ferric carboxymaltose replenishes iron stores by delivering elemental iron directly into circulation. The iron is gradually released from the complex, taken up by transferrin, and incorporated into hemoglobin and other iron-containing proteins essential for oxygen delivery and cellular metabolism.

Dosage & Administration

Dosage is expressed in mg of elemental iron.
Each mL of Maltofer 1 gm/20 ml contains 50 mg of elemental iron.

Recommended Dosage:

• Patients weighing 50 kg or more:

  • Two doses of 750 mg each

  • Doses should be separated by at least 7 days

  • Maximum cumulative dose: 1500 mg per treatment course

• Patients weighing less than 50 kg:

  • Two doses of 15 mg/kg body weight

  • Doses should be separated by at least 7 days

  • Maximum cumulative dose: 1500 mg per treatment course

Treatment may be repeated if iron deficiency anemia reoccurs.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Administration:

• Administer intravenously either as:

  • Undiluted slow IV push:

    • Approximate rate: 100 mg (2 mL) per minute

  • IV infusion:

    • Dilute up to 750 mg of iron in a maximum of 250 mL of 0.9% Sodium Chloride Injection

    • Infusion concentration should not be less than 2 mg iron/mL

    • Administer over at least 15 minutes

When diluted in 0.9% Sodium Chloride at concentrations of 2–4 mg iron/mL, the solution remains stable for up to 72 hours at room temperature. Do not dilute below 2 mg iron/mL.

Inspect visually for particulate matter or discoloration before use. Each vial is for single use only. Discard any unused portion.

Avoid extravasation during administration, as it may cause long-lasting brown discoloration at the injection site. Discontinue infusion immediately if extravasation occurs.

Drug Interactions

No known or well-documented drug interactions have been reported.

Contraindications

• Hypersensitivity to ferric carboxymaltose or any component of the formulation

Side Effects

Possible side effects may include:

• Nausea, vomiting, constipation

• Hypertension or hypotension

• Flushing, dizziness, headache

• Decreased blood phosphorus

• Injection site discoloration

• Pruritus, rash, urticaria

• Wheezing

• Dysgeusia

• Increased alanine aminotransferase levels

• Serious anaphylactic or anaphylactoid reactions

Pregnancy & Lactation

Pregnancy Category C. Animal studies have shown adverse effects on the fetus, and adequate, well-controlled studies in pregnant women are lacking. Maltofer should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

Hypersensitivity Reactions:
Serious hypersensitivity reactions, including life-threatening anaphylactic-type reactions, have been reported. Monitor patients during and for at least 30 minutes after administration. Maltofer should only be administered where appropriate medical personnel and emergency treatments are immediately available.