Unifer

This is indicated for the treatment of Unifer deficiency in the following indications:

Where there is a clinical need for a rapid Unifer supply

In patients who can not tolerate oral Unifer therapy or who are non-compliant

In active inflammatory bowel disease where oral Unifer preparations are ineffective

... Read more This is indicated for the treatment of Unifer deficiency in the following indications:

Where there is a clinical need for a rapid Unifer supply

In patients who can not tolerate oral Unifer therapy or who are non-compliant

In active inflammatory bowel disease where oral Unifer preparations are ineffective

Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin

Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin

Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin

Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin

It is also indicated in the treatment of Unifer deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.

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 for Intravenous use. The drug product contains approximately 30% Sucrose w/v (300 mg/ml) and has a pH of 10.5-11.1. Following intravenous administration, Iron Sucrose Injection is dissociated into Iron and Sucrose by the reticuloendothelial system, and Iron is transferred 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, from which Iron is easily available. Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply the tissues. The transferrin receptor, located in the cell, and the transferrin-receptor complex is returned to the cell membrane. Transferrin without Iron (apotransferrin) is then released to the plasma. The intracellular Iron becomes (mostly) haemoglobin in circulating red blood cells (RBCs). Transferrin synthesis is increased and ferritin production reduced in Iron deficiency. The converse is true when Iron is plentiful. Its elimination halflife 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. In Iron Sucrose, its Iron component 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 that the bone marrow is an Iron trapping compartment and not a reversible volume distribution. The sucrose component is eliminated mainly through urinary excretion.

Adults and Elderly : 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level. Children : There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Drug-drug interactions involving Unifer have not been studied. Unifer Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Unifer is reduced. Even oral Unifer therapy should not be given until 5 days after last injection.

The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anaemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.

Adverse reactions, whether or not related to Unifer injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron.

Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders

General: hypotension, chest pain, hypertension, hypervolemia.

Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.

Central and Peripheral Nervous System: dizziness.

Musculoskeletal System: cramps/leg cramps, musculoskeletal pain.

Respiratory System: dyspnea pneumonia, cough.

Skin and appendages: pruritus, application site reaction.

Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Unifer administration can occur. So, patients should be given a small test dose initially.

Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.

General : Because body Unifer excretion is limited and excess tissue Unifer can be hazardous, caution should be exercised to withhold Unifer administration in the presence of evidence of tissue Unifer overload. Patients receiving Unifer require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Unifer therapy should be withheld in patients with evidence of Unifer overload. Transferrin saturation values increase rapidly after IV administration of Unifer; thus, serum Unifer values may be reliably obtained 48 hours after IV dosing. Hypersensitivity Reactions : Serious hypersensitivity reactions have been rarely reported in patients receiving Unifer. Several cases of mild or moderate hypersensitivity reactions were observed in these studies. Hypotension : Hypotension has been reported frequently in hemodialysis patients receiving intravenous Unifer. Hypotension following administration of Unifer may be related to rate of administration and total dose administered. Caution should be taken to administer Unifer according to recommended guidelines.

Dosages of Unifer Injection in excess of Unifer needs may lead to accumulation of Unifer in storage sites leading to hemosiderosis. Periodic monitoring of Unifer parameters such as serum ferritin and transferrin saturation may assist in recognizing Unifer accumulation. Unifer should not be administered to patients with Unifer overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Unifer overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Unifer deficiency anaemia. Symptoms associated with overdosage or infusing Unifer too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.