Anofer Iv Injection, Syrup, Tablet
Following intravenous administration, this 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.
This is used for the treatment of Iron deficiency in the following indications:
- Where there is a clinical need for a rapid Iron supply
- In patients who can not tolerate oral Iron therapy or who are non-compliant
- In active inflammatory bowel disease where oral Iron 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 used for the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Anofer is also used to associated treatment for these conditions: Hyperphosphataemia
|Other Names||Ferric hydroxide sucrose complex, Iron oxide saccharated, Iron saccharate, Iron sucrose, Iron sucrose complex, Iron sugar, Saccharated ferric oxide, Saccharated iron, Saccharated iron oxide, Sucroferric oxyhydroxide|
|Type||Iv Injection, Syrup, Tablet|
It binds with transferrin.
|Therapeutic Class||Parenteral Iron Preparations|
|Manufacturer||Monicopharma Limited, Sun Pharma|
|Available Country||Bangladesh, India|
|Last Updated:||June 23, 2021 at 11:21 am|
Table Of contents
Adults and Elderly: 5-10 ml (100-200 mg Iron) once to three times a week depending on the hemoglobin level.
Anofer has exclusively to be administered intravenously by slow injection or by drip infusion or directly into the venous limb of the dialyzer. Anofer must not be used for intramuscular injection.
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 (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
As injection: Anofer can also be administered undiluted by slow IV injection at a rate of 1 ml Anofer (20 mg Iron) in at least 1 minute a maximum of 10 ml Anofer (200 mg Iron) can be administered per injection in at least 10 minutes.
As infusion: Anofer should preferably be administered by drip infusion ( in order to reduce hypotensive episodes) in a dilution of 1 ml Anofer in maximum 20 ml 0.9% NaCl etc up to 25 ml Anofer in maximum 500 ml 0.9% NaCl. Dilution must take place immediately prior to infusion and solution must be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes ete. Normal posology is to use 5-10 ml Anofer 1-3 times a week depending on the Hemoglobin level. For the administration of the maximum tolerable dose of 7 mg Iron/kg body weight an infusion time of at least 3.5 hours has to be respected, independently of the total dose.
Anofer is generally well tolerated. However, occasionally metallic taste, headache, nausea, vomiting and hypotension may occur. Less frequently side-effects are paresthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactic (pseudoallergic) reactions and in the region of the punctured vein, phlebitis and venous spasm have been observed.
Anofer should be administered with caution in patients with asthma, eczema, other atopic allergies or allergic reaction to other parenteral Iron preparations, low binding capacity and/or folic acid deficiency, liver dysfunction, acute or chronic infection.
Baseline tests: Ensure Hgb, Hct, serum ferritin and transferrin saturation is determined before starting therapy and periodically during treatment. Note that serum Iron levels may be reliably obtained 48 hours after IV dosing.
Blood Pressure: Monitor Blood Pressure during infusion. If hypotension occurs, slow the rate of infusion. If hypotension continues, discontinue infusion and be prepared to treat appropriately.
Discontinue oral Iron preparations before administering parenteral Iron products. Co administration of parenteral Iron preparations may reduce absorption of oral Iron.The dose will be in terms of elemental Iron. For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration. Medication is administered 1 to 3 times/ week. Do not administer more than 3 times/week. Discard any unused diluted solution. Do not save unused solution for future use. Do not administer if particulate matter or discoloration noted.
Drug-drug interactions involving Anofer have not been studied. Anofer Injection should not be administered concomitantly with oral iron preparations since the absorption of oral Iron is reduced. Even oral Iron therapy should not be given until 5 days after last injection.
- Take with food. Take with meals to maximize phosphate binding capacity and reduce phosphate absorption.
Volume of Distribution
Vd is 7.3 L
Total body clearance is 20.5 ml/min.
Pregnancy & Breastfeeding use
Pregnant women: FDA pregnancy category B.
Lactating mothers: It is not known whether this drug is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Anofer is administered to a nursing woman.
The use of Anofer is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Anofer 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.
Overdosage can cause acute iron overloading wich may manifests itself as haemosiderosis. Symptoms associated with overdosage or infusing Anofer too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema, and cardiovascular collapse. Overdosage should be treated with supportive measures and, if required, an Iron chelating agent. 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 below 25° C. Do not freeze. Use immediately after dilution in saline.