
Maltofer500 mg/10
Incepta Pharmaceuticals Ltd.
Ferric Carboxymaltose is an intravenous (IV) iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in the following settings: Established / Approved Uses Iron…
Ferric Carboxymaltose is an intravenous (IV) iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in the following settings:
Ferric Carboxymaltose is not indicated for anemias not caused by iron deficiency and should not be used when iron deficiency has not been confirmed.
Ferric Carboxymaltose is administered only by intravenous injection or infusion by a healthcare professional. Dosing is individualized by body weight and, in some indications, by hemoglobin level. See Dosage and Administration sections below for details. A summary of per-indication dosing is provided here:
| Indication | Population | Typical Dosing |
|---|---|---|
| Iron deficiency anemia (oral iron intolerant/inadequate response) | Adults and children ≥1 year, ≥50 kg | 750 mg IV per dose, in 2 doses at least 7 days apart (cumulative 1,500 mg per course); or up to 1,000 mg as a single dose in adults, depending on product labeling |
| Iron deficiency anemia | Patients <50 kg | 15 mg/kg IV per dose, in 2 doses at least 7 days apart |
| Non-dialysis-dependent CKD | Adults | Same weight-based dosing as above |
| Chronic heart failure (NYHA II/III) with iron deficiency | Adults | Dosing individualized by baseline hemoglobin and body weight, per approved dosing table; maintenance doses may be given at intervals if iron stores remain low |
Do not exceed the maximum single-dose or cumulative-dose limits specified in the approved product labeling. Repeat courses should only be given if iron deficiency recurs, and phosphate levels should be checked before repeat dosing (see Precautions and Warnings).
The most common side effects of Ferric Carboxymaltose include:
Less common effects include altered taste (dysgeusia), tachycardia, hypotension, dyspnea, rash, and myalgia.
Rare but serious effects include hypersensitivity reactions up to and including anaphylaxis (see Contraindications and Precautions and Warnings), and, with repeated high cumulative dosing, symptomatic hypophosphatemic osteomalacia.
Ferric Carboxymaltose is contraindicated in patients with:
Ferric Carboxymaltose should not be used in patients with anemia not caused by iron deficiency.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.