Revofer Injection 500mg/10ml

Revofer Injection 500mg/10ml

Revofer is a colloidal iron (III) hydroxide in complex with Carboxymaltose, a Carbohydrate polymer that releases iron.

Indications

Revofer injection 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.

Interaction

Formal drug interaction studies have not been performed with Revofer.

Contraindications

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 productsan
• aemia not attributed to iron deficiency, e.g. other microcytic anaemia
• evidence of iron overload or disturbances in the utilisation of iron

Side Effects

The side effects of Revofer are infrequent, usually mild & generally do not cause patients to stop treatment.

Pregnancy & Lactation

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.

Precautions & Warnings

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Revofer. Patients may present with shock, clinically significant hypotension, loss of consciousness and collapse. 

Use in Special Populations

Patients with haemodialysis-dependent chronic kidney disease: A single maximum daily injection dose of 200 mg iron should not be exceeded in haemodialysis-dependent chronic kidney disease patients.Paediatric population: The use of Revofer has not been studied in children, and therefore is not recommended in children under 14 years.

Overdose Effects

Excessive dosages of Revofer 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 recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.

Therapeutic Class

Parenteral Iron Preparations

Storage Conditions

Store in a cool (below 30°C) & dry place, away from light. Do not freeze. Keep out of the reach of children.