Ferimax

The therapeutic class of Iron Sucrose is haematinic. Iron Sucrose Injection USP is a brown, sterile, aqueous complex of Polynuclear Iron (III) Hydroxide in Sucrose, made for intravenous use. The product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5 to 11.1.

After intravenous administration, the reticuloendothelial system dissociates Iron Sucrose Injection into Iron and Sucrose, and the Iron moves from the blood to a pool of Iron in the liver and bone marrow. Ferritin, an Iron storage protein, binds and sequesters Iron in a nontoxic form, and from there the Iron is easily available. Iron binds to plasma transferrin, which carries it within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor sits in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. Inside the cell, the Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). In Iron deficiency, transferrin synthesis increases and ferritin production falls. The converse is true when Iron is plentiful.

Its elimination half-life is 6 h, total clearance is 1.2 L/h, non-steady state apparent volume of distribution is 10.0 L and steady state apparent volume of distribution is 7.9 L. The Iron component of Iron Sucrose appears to distribute mainly in blood and to some extent in extravascular fluid. A significant amount of the administered Iron distributes in the liver, spleen and bone marrow, and the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.

Iron Sucrose is listed as Pregnancy Category-B. There are no adequate and well controlled studies in pregnant women, so it should be used during pregnancy only if clearly needed.

It isn't known whether Iron Sucrose passes into human milk. Many drugs do pass into milk, so caution should be exercised when it is given to a nursing woman.

For children, the safety and effectiveness of Iron Sucrose have not been established. In elderly patients, no overall differences in safety were seen between older and younger subjects. Other reported clinical experience hasn't found differences in response between elderly and younger patients either, but greater sensitivity in some older people cannot be ruled out. The injection can also be given directly into the venous limb of the dialyser, under the same conditions as for an intravenous injection. In hemodialysis dependent chronic kidney disease (HDD-CKD), Iron Sucrose Injection may be given undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes. Or it may be given as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCl, over at least 15 minutes. Either way it is given per consecutive hemodialysis session, for a total cumulative dose of 1,000 mg. In non-dialysis dependent chronic kidney disease (NDD-CKD), the total cumulative dose is 1000 mg over a 14 day period. It is given as a 200 mg slow IV injection, undiluted, over 2 to 5 minutes, on 5 different occasions within those 14 days.

Giving Iron Sucrose Injection in doses higher than the body needs can let iron build up in the storage sites and lead to hemosiderosis. Checking iron parameters from time to time, such as serum ferritin and transferrin saturation, may help to spot this build-up. Iron Sucrose should not be given to patients with iron overload, and it should be stopped when serum ferritin reaches or goes above the established guidelines. Take particular care to avoid iron overload where anaemia that does not respond to treatment has been wrongly diagnosed as iron deficiency anaemia. Symptoms linked with overdosage, or with infusing the injection too rapidly, included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema and cardiovascular collapse. Most of these symptoms have been treated successfully with IV fluids, hydrocortisone and/or antihistamines. Infusing the solution at the recommended rate, or more slowly, may also ease the symptoms.

Keep Iron Sucrose in a cool, dry place where the temperature stays between 15°C and 30°C, and protect it from light. Don't freeze it. Keep it out of the reach of children.