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Oxyfer-500: Each 10 ml solution contains Ferric carboxymaltose INN equivalent to elemental Iron 500 mg.

Ferric carboxymaltose is an iron replacement product 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

The cumulative dose for repletion of iron using Ferric carboxymaltose is determined based on the patient's body weight and haemoglobin (Hb) level and must not be exceeded. The following table (Table 1) should be used to determine the cumulative iron dose: Hb (g/dL): <10 : Patients with body weight 35 kg to <70 kg 1,500 mg and Patients with body weight ≥70 kg 2,000 mg >10: Patients with body weight 35 kg to <70 kg 1,000 mg and Patients with body weight ≥70 kg 1,500 mg Note: A cumulative iron dose of 500 mg should not be exceeded for patients with a body weight <35 kg. For overweight patients, a normal body weight/blood volume relationship should be assumed when determining the iron requirement. For patients with a Hb value ≥14 g/dL, an initial dose of 500 mg iron should be given and iron parameters should be checked prior to repeat dosing. Post repletion, regular assessments should be completed to ensure that iron levels are corrected and maintained.

Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric carboxymaltose. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric carboxymaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Other serious adverse reactions associated with hypersensitivity which included, pruritus, rash, urticaria, wheezing, or hypotension may occur. Hypertension Transient elevations in systolic blood pressure, sometimes occurring with facial flushing, dizziness, or nausea were observed. These elevations generally occurred immediately after dosing and resolved within 30 minutes. Monitor patients for signs and symptoms of hypertension following each Ferric carboxymaltose administration. Laboratory Test Alterations In the 24 hours following administration of Ferric carboxymaltose, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Ferric carboxymaltose.

Pregnancy category: C. There are no adequate and well-controlled trials of ferric carboxymaltose in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and ferric carboxymaltose should not be used during pregnancy unless clearly necessary. Breast-feeding: Clinical studies showed that transfer of iron from ferric carboxymaltose to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that ferric carboxymaltose represents a risk to the breast-fed child. Fertility: There are no data on the effect of ferric carboxymaltose on human fertility. Fertility was unaffected following ferric carboxymaltose treatment in animal studies.

The most common adverse reactions (≥2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.

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

Administration of ferric carboxymaltose in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis. Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.

The use of ferric carboxymaltose is contraindicated in cases of- • hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients. • known serious hypersensitivity to other parenteral iron products. • anaemia not attributed to iron deficiency, e.g. other microcytic anaemia. • evidence of iron overload or disturbances in the utilization of iron. Special precautions for disposal and other handling • Inspect vial visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution. • Each vials of ferric carboxymaltose is intended for single use only. Any unused product or waste material should be disposed of in accordance with local requirements. • Ferric carboxymaltose must only be mixed with sterile 0.9% sodium chloride solution. No other intravenous dilution solutions and therapeutic agents should be used, as there is the potential for recipitation and/or interaction.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Do not freeze.

Oxyfer-500: Each box contains one vial of 10 ml Ferric carboxymaltose solution with one 100 ml normal saline, one infusion set, one alcohol pad, one first aid bandage, hanger & one 10 ml disposable syringe.