Ferox^®

Ferox® is the preparation of Ferric Carboxymaltose which is a colloidal Iron (III) Hydroxide in complex with Carboxymaltose, a carbohydrate polymer that releases Iron.

No Data

Ferox® is indicated for the treatment of iron deficiency anemia in adult patients 

• Who have intolerance to oral iron or have had unsatisfactory response to oral iron.
• Who have non-dialysis dependent chronic kidney disease. 

Dose and administration
The individual iron need for repletion using Ferox® is determined based on the patient's body weight and haemoglobin (Hb) level. Refer to Table 1 for determination of the iron need-

Table-1: Dilution plan of Ferox® for intravenous infusion

Calculation and administration of the maximum individual iron dose
Based on the iron need determined above the appropriate dose of Ferox ® should be administered taking into consideration the following:
A single Ferox^® administration should not exceed:

-15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)

-1000 mg or 1 g of iron (20 ml of Ferox^®)

The maximum recommended cumulative dose of Ferox® is 20 ml (1000 mg or 1 g of iron) per week.

Intravenous injection
Ferox^® may be administered by intravenous injection using undiluted solution. The maximum single dose is 15 mg iron/kg body weight but should not exceed 1000 mg iron. The administration rates are as shown in Table 2-

Table 2: Administration rates for intravenous injection of Ferox^®

Intravenous infusion

Ferox^® may be administered by intravenous infusion, in which case it must be diluted. The maximum single dose is 20 mg iron/kg body weight, but should not exceed 1000 mg iron. For infusion, Ferox^® must only be diluted in sterile 0.9% w/v sodium chloride solution as shown in Table 3-

Table 3: Dilution plan of Ferox® for intravenous infusion

Note: Diluted solution is stable for 72 hours when stored at room temperature. For stability reasons, dilutions to concentrations less than 2 mg iron/ml are not permissible. Ferox^® must not be administered by the subcutaneous or intramuscular route. Discard unused portion.

Hemodialysis dependent chronic kidney disease: A single maximum daily injection dose of 200 mg iron should not be exceeded in hemodialysis dependent chronic kidney disease patients.

Pregnancy: There are no data for the use of ferric carboxymaltose in pregnant women. A careful risk/benefit evaluation is required before use during pregnancy and ferric carboxymaltose should not be used during pregnancy unless clearly necessary. If the benefit of ferric carboxymaltose treatment is judged to outweigh the potential risk to the fetus, it is recommended that treatment should be confined to the second and third trimester.

Lactation: Ferric carboxymaltose is excreted in human milk. So breastfed and infants should be monitored for gastrointestinal toxicity.

Use in children and adolescents
Safety and effectiveness of it in children and adolescents under 14 years age have not been established.

Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of each administration. Monitor serum phosphate levels in patients at risk for low serum phosphate who require a repeat course of treatment. Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose administration

The most common side effects of ferric carboxymaltose are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.

Ferric carboxymaltose is contraindicated in patients with known hypersensitivity to ferric carboxymaltose or any components of this product. It is also contraindicated in patients with known serious hypersensitivity in other parenteral iron products, anemia not attributed to iron deficiency (e.g., other microcytic anaemia), evidence of iron overload or disturbances in utilization of iron.

Formal drug interaction studies have not been performed with ferric carboxymaltose. 

Excessive dosages of ferric carboxymaltose may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. If iron accumulation has occurred, treatment should be done according to standard medical practice, e.g., consideration of the use of an iron chelator.

Ferox^® 2 ml IV injection/infusion: Each 2 ml vial contains Ferric Carboxymaltose INN equivalent to Elemental Iron 100 mg.
Ferox^® 10 ml IV injection/infusion: Each 10 ml vial contains Ferric Carboxymaltose INN equivalent to Elemental Iron 500 mg.
Ferox^® 15 ml IV injection/infusion: Each 15 ml vial contains Ferric Carboxymaltose INN equivalent to Elemental Iron 750 mg.
Ferox^® 20 ml IV injection/infusion: Each 20 ml vial contains Ferric Carboxymaltose INN equivalent to Elemental Iron 1 g.

Keep away from the reach of children. Store in a cool {below 30°C) and dry place protected from light. Do not freeze.

No Data

Ferox^® 2 ml IV injection/infusion: Each box contains one vial of 2 ml Ferric Carboxymaltose solution, one vial of 50 ml Salinor® (Sodium Chloride BP 0.9% w/v) as diluent, one infusion set, one disposable syringe (3 ml), one baby needle, one alcohol pad and one first aid bandage.

Ferox^® 10 ml IV injection/infusion: Each box contains one vial of 10 ml Ferric Carboxymaltose solution, one vial of 100 ml Salinor® (Sodium Chloride BP 0.9% w/v) as diluent, one infusion set, one disposable syringe (10 ml), one alcohol pad and one first aid bandage.

Ferox^® 15 ml IV injection/infusion: Each box contains one vial of 15 ml Ferric Carboxymaltose solution, one bag of 250 ml Normal Saline (Sodium Chloride BP 0.9% w/v) as diluent, one infusion set, one disposable syringe (20 ml), one alcohol pad and one first aid bandage.

Ferox^® 20 ml IV injection/infusion: Each box contains one vial of 20 ml Ferric Carboxymaltose solution, one bag of 250 ml Normal Saline (Sodium Chloride BP 0.9% w/v) as diluent, one infusion set, one disposable syringe (20 ml), one alcohol pad and one first aid bandage.