HemoMax
Cheaper & Alternative Brands
Same generic (Iron Sucrose), same form (IV Injection or Infusion)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
This is indicated for the treatment of Anefer deficiency in the following indications:
Where there is a clinical need for a rapid Anefer supply
In patients who can not tolerate oral Anefer therapy or who are non-compliant
In active inflammatory bowel disease where oral Anefer preparations are ineffective
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This is indicated for the treatment of Anefer deficiency in the following indications:
Where there is a clinical need for a rapid Anefer supply
In patients who can not tolerate oral Anefer therapy or who are non-compliant
In active inflammatory bowel disease where oral Anefer 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 Anefer deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Contraindications
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.
Side Effects & Adverse Reactions
Adverse reactions, whether or not related to Anefer 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 Anefer administration can occur. So, patients should be given a small test dose initially.
Warnings & Precautions
General
: Because body Anefer excretion is limited and excess tissue Anefer can be hazardous, caution should be exercised to withhold Anefer administration in the presence of evidence of tissue Anefer overload. Patients receiving Anefer require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Anefer therapy should be withheld in patients with evidence of Anefer overload. Transferrin saturation values increase rapidly after IV administration of Anefer; thus, serum Anefer values may be reliably obtained 48 hours after IV dosing.
Hypersensitivity Reactions
: Serious hypersensitivity reactions have been rarely reported in patients receiving Anefer. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.
Hypotension
: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Anefer. Hypotension following administration of Anefer may be related to rate of administration and total dose administered. Caution should be taken to administer Anefer according to recommended guidelines.
Pharmacology & Mechanism of Action
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.