FerInject® [Iron carboxymaltose]
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Clinical Pharmacology
FERINJECT is an iron preparation in the form of a carboxymaltozate complex of a multicore iron (III) hydroxide. After parenteral administration, the macromolecular complex is captured by the reticuloendothelial system and decomposed into iron and carboxymaltose. Iron enters the bloodstream where it binds to transport protein transferrin. Iron in combination with transferrin is transferred to the cells of the body, where it is used to synthesize hemoglobin, myoglobin and a large number of enzymes or accumulates in the form of ferritin.
Indications
Iron deficiency anemia in the case when oral iron preparations are ineffective or cannot be used. The diagnosis must be confirmed by laboratory tests.
Composition
Active substance: Iron carboxymaltose
Excipients: sodium hydroxide / hydrochloric acid to pH 5.0–7.0; water for injection up to 1 ml.
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Dosage and Administration
IV - jet or drip and by introducing into the venous area dialysis system.
Before opening, the bottles should be inspected for possible sediment and damage. You can use only a homogeneous solution without sediment.
Drip introduction
You can not assign a drip of 20 ml of Ferinject more than 1 time per week.
May be administered intravenously in a drip in the maximum single dose of up to 20 ml of Ferinject (1000 mg of iron), which should not exceed 0.3 ml of Ferinject (15 mg of iron) per 1 kg of body weight or the calculated cumulative dose.
Jet injection
Ferinject can be administered intravenously, in a maximum single dose of up to 4 ml (200 mg of iron) per day, but not more than 3 times a week.
Dose calculation
The cumulative dose of the drug in mg of elemental iron, necessary to restore the level of hemoglobin (Hb) and replenish iron stores, is calculated individually in accordance with the general iron deficiency in the body using the formula:
Cumulative iron deficiency [mg] = body weight [kg] × (target Hb * - actual Hb) [g / dL] ** × 2.4 *** + iron storage depot [mg] ****
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* Target Hb with a body weight less than 35 kg = 13 g / dl (respectively 8.1 mmol / l). Target Hb with a body weight of 35 kg and more = 15 g / dl (respectively 9.3 mmol / l).
** To convert Hb [mM] to Hb [g / dl]: multiply Hb [mM] by a factor of 1.61145.
*** Coefficient 2.4 = 0.0034 × 0.07 × 10000, where:
0.0034 - hemoglobin iron content is approximately equal to 0.34%;
0.07 - blood volume is approximately equal to 7% of body weight;
10,000 - conversion factor: 1 g / dl = 10,000 mg / l.
**** Iron deposited with a body weight less than 35 kg = 15 mg / kg body weight; iron deposited with a body weight of 35 kg and more = 500 mg.
For patients ≤66 kg: the calculated cumulative dose of iron should be rounded down to the nearest 100 mg.
For patients> 66 kg: the calculated cumulative dose of iron should be rounded up to the nearest 100 mg.
With the subsequent need to maintain the target level of Hb and other laboratory indicators of iron reserves within acceptable limits, it is possible to continue treatment with the Ferinject drug in the minimum maintenance dose.
Maximum tolerated single dose
Adequate cumulative dose of the drug should be calculated for each patient individually and should not exceed the calculated one.
Contraindications
Hypersensitivity to any of the components of the drug.
Anemia not related to iron deficiency.
Symptoms of iron overload or iron disruption.
Pregnancy, I trimester.
Lactation period.
Children under 14 years old.
Drug interactions
Any parenteral iron preparations should not be administered simultaneously with oral dosage forms of iron, since This reduces the absorption of iron from the gastrointestinal tract.
- BLOOD MANAGEMENT: Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial
- Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial
- Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia
- Ferric carboxymaltose for the treatment of iron-deficiency anemia
- PCV65 HEALTH ECONOMIC ASSESSMENT OF FERRIC CARBOXYMALTOSE IN PATIENTS WITH IRON DEFICIENCY AND CHRONIC HEART FAILURE IN THE FAIR-HF TRIAL
- P301 Short-term effectiveness and impact on quality of life of iron carboxymaltose in the treatment of iron deficiency anemia associated with inflammatory bowel disease
- Comparative Review of the Safety and Efficacy of Ferric Carboxymaltose Versus Standard Medical Care for the Treatment of Iron Deficiency Anemia in Bariatric and Gastric Surgery Patients
- Ferric Carboxymaltose in Patients with Heart Failure and Iron Deficiency
- Intravenous ferric carboxymaltose versus standard medical care in the treatment of iron deficiency anemia in patients with chronic kidney disease: a randomized, active-controlled, multi-center study
- Pharmacoeconomic Evaluation of Intravenous Ferric Carboxymaltose and Iron Sucrose in Correction of Preoperative Anaemia in Patients Undergoing Major Elective Surgery
- Ferric carboxymaltose/iron sucrose
- Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial
- Determinants of quality of life of patients with heart failure and iron deficiency treated with ferric carboxymaltose: FAIR-HF sub-analysis
- Ferric carboxymaltose improves exercise capacity and quality of life in patients with pulmonary arterial hypertension and iron deficiency: A pilot study
- PSY6 Economic Efficiency of Ferric Carboxymaltose to Treat or Prevent Iron Deficiency Anemia: Value to the Portuguese Hospitals
- Su1087 Ferric Carboxymaltose: Efficacy and Safety in Patients With Gastrointestinal-Related Iron Deficiency Anemia: A Pooled Analysis
- P369 Rapid infusion, high dose ferric carboxymaltose in the treatment of iron deficiency in paediatric inflammatory bowel disease – a single centre experience
- W472 A SINGLE 1000 MG IRON DOSE OF FERRIC CARBOXYMALTOSE IMPROVES FATIGUE IN IRON DEFICIENT, NON-ANAEMIC PREMENOPAUSAL WOMEN – RESULTS OF THE RANDOMISED, PLACEBO-CONTROLLED PREFER STUDY
- P380 Safety and efficacy of bolus administered ferric carboxymaltose (500 mg) in the treatment of iron deficiency anaemia in IBD patients
- FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease
- Anemia and iron deficiency in inflammatory bowel disease: an open, prospective, observational study on diagnosis, treatment with ferric carboxymaltose and quality of life
- A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia
- Ferric carboxymaltose/iron sucrose
- Ferric carboxymaltose increases epoetin- response and prevents iron deficiency before elective orthopaedic surgery