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Ferric carboxymaltose injection with the brand name Injectafer is a parental iron replacement product which was approved by USFDA in July 2013, for the treatment of iron deficiency anemia in adults who have showed intolerance to oral iron or have had a poor response to oral iron. Injectafer is also indicated for iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease (NND-CKD). Injectafer was developed by Luitpold pharmaceutical Inc, a Daiichi Sankyo Group Company, headquartered in Shirley, New York. The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. Iron is a mineral that is very much needed by the body to produce red blood cells. When the body does not get enough iron, it cannot produce the required number of red blood cells and this condition is called iron deficiency anemia. Iron-deficiency can occur due to insufficient dietary intake and absorption of iron, and/or loss of iron as a result ofinternal bleeding which can originate from a range of sources such as the intestinal, uterine or urinary tract. Thus theoccurrence of iron deficiency anemia can be the result of our body not making enough red blood cells or due to bleeding that causes loss of red blood cells more quickly than they can be replaced. Iron deficiency anemia affect women more often than men.Iron deficiency anemia ischaracterized by the signs of pallor and/or symptoms of fatigue, light-headedness, and weakness that are usuallynon-specific. Pallor is a condition of the skin becoming pale as a result of reduced amounts of oxyhaemoglobin in the skin or mucous membrane. Injectafer with active ingredient ferric carboxymaltose is a dark brown, sterile, aqueous, isotonic colloidal solution for intravenous injection. The dosage of Injectafer is expressed as milligram of elemental iron.The recommended dose of Injectafer is 15 mg/kg with a total cumulative dose not exceeding 1500mg of elemental iron. Injectafer can be given in two separate doses for atleast 7 days. Each mL of Injectafer contains 50 mg of elemental iron. Injectafer is available in 15 mL single-use vials containing 750mg of elemental iron. Injectafer can be administered intravenously either as an undiluted slow intravenous push or by infusion. Injectafer treatment may be repeated if iron deficiency anemia reoccurs. The FDA approval of Injectafer was based on the safety and efficacy that was evaluated in two randomized, open label, comparator controlled clinical trials (Trial1 and Trial2).Trial1 included iron deficiency anemia patients who were intolerant to oral iron or have had unsatisfactory response to oral iron for a 14 day period. They were then randomised into two groups and given twice daily dose of 750 mg Injectafer for group 1 and thrice daily of 325 mg oral/IV ironfor group 2, for another 14 days. On day 35, the mean increase of haemoglobin from baseline was found to be 2.90 g/dL and 2.16 g/dL for Injectafer and oral/IV iron respectively. Trial2 was on iron deficiency anemia patients with non-dialysis dependent chronic kidney disease.Trial 2 compared thrice daily of 750 mg Injectafer to five daily doses of 200 mg venofer.On Day 56,the mean increase of haemoglobin from baseline was found to be 1.13 g/dL and 0.92 g/dL for Injectafer and venofer respectively. Venofer is an iron sucrose injection to treat iron deficiency anemia patients with chronic kidney disease in adults and paediatric children older than 2 years. Venofer is administered as a total cumulative dose of 1000 mg as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions. The major side effects reported for Injectafer are hypersensitivity reactions, injection site discoloration, hypertension, nausea, vomiting, dizziness, head ache, and constipation. Some of the adverse reactions reported are abdominal pain, diarrhoea, rash, paraesthesia, and sneezing. Transient decreases in blood phosphorus levels have also been reported.Also one should pay utmost caution during administration of IV Injectafer to avoid any extravasation of the drug since the brown discoloration at the extravasation site may be long lasting; extravasation is the leakage of intravenous drugs from the vein into the surrounding tissue. If extravasation occurs, one should discontinue the drug administration at that site. Injectafer is a newoption for adults who have intolerance to oral iron or have had a poor response to oral iron. It is also proved to be effective in patients with Non-Dialysis Dependent Chronic Kidney Disease. Clinical trials have also confirmed thatInjectafershowed a gradual increase in ferritin levels in the blood with no renal elimination of iron. Clinnovo is a clinical innovation company. It is pioneer CRO industry in India. Clinnovo offers professional Clinical Research Course, clinical data management course , SAS and imaging training. Clinnovo has been serving different bio-pharma industries across the world with excellence and high quality. For more information contact at +91 9912868928, 040 64635501
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new drug, iron deficiency, Luitpold, Injectafer, iron deficiency, Clinical Research, Clinical Data Management, SAS, Training, anemia, pharmaceutical,
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