SOROMALT FCM

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml for Injection or infusion)

PRESENTATION

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml)

DESCRIPTION

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml) contains iron in a stable ferric state as a complex with a carbohydrate polymer designed to release utilizable iron to iron transport and storage proteins in the body. Clinical studies showed that the haematological response and filling of iron stores were faster after IV administration of FCM injection than with orally administered comparators.

INDICATIONS AND USAGE

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml) is indicated for treatment of iron deficiency when oral preparation are ineffective or cannot be used and where there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests.

DOSAGE AND ADMINISTRATION

Depending on patient iron requirement, patient weight and HB levels dose is decided and titrated accordingly.

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml) can be given as slow IV push or by infusion.

Iron Deficiency Anemia

Indicated as iron replacement for treatment of iron deficiency anemia (IDA) in adults who have intolerance or an unsatisfactory response to oral iron; also indicated for IDA in adults with non-dialysis dependent chronic kidney disease

≥50 kg

• 750 mg IV in 2 doses separated by at least 7 days; not to exceed cumulative dose of 1500 mg per course
• Alternatively, may administer 15 mg/kg IV as a single dose; not to exceed 1000 mg

<50 kg

• 15 mg/kg IV in 2 doses separated by at least 7 days

Iron Deficiency

Indicated as iron replacement for treatment of iron deficiency in adults with heart failure and New York Heart Association class II/III to improve exercise capacity

Day 1

• Hb ≤14 g/dL: 1,000 mg IV
• Hb >14 to <15 g/dL: 500 mg IV

Week 6

5. ≥70 kg
   • Hb <10 g/dL: 1,000 mg IV
   • Hb 10-14 g/dL: 500 mg IV
   • Hb >14 to <15 g/dL: No dose
5. <70 kg
   • Hb <10 g/dL: 500 mg IV
   • Hb 10-14 g/dL: No dose
   • Hb >14 to <15 g/dL: No dose

Maintenance

5. 500 mg at 12, 24, and 36 weeks if serum ferritin <100 ng/mL or serum ferritin 100-300 ng/mL with transferrin saturation <20%
5. There are no data available to guide dosing beyond 36 weeks or with Hb ≥15 g/dL

CONTRAINDICATION

SOROMALT FCM (Ferric Carboxymaltose Injection 500 mg/10 ml) should not be given to patients with evidence of iron overload, known hypersensitivity to Ferric Carboxymaltose or any ingredients of the formulation and in patients with anemia not caused by iron deficiency.