Ferinject
Ferinject: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Instructions for the use of Ferinjekt: method and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews Ferinjekte
- 18. Price of Ferinject in pharmacies
Latin name: Ferinject
ATX code: B03AC01
Active ingredient: iron carboxymaltosate (Ferric carboxymaltosate)
Manufacturer: BIPSO GmbH (Germany)
Description and photo update: 2018-24-10
Ferinject is an antianemic drug, a hematopoietic stimulator for parenteral administration.
Release form and composition
The dosage form of the drug Ferinject is a solution for intravenous (iv) administration: an opaque liquid of dark brown color (2 or 10 ml in transparent glass bottles, in a cardboard box 1 or 5 bottles of 2 ml, 1, 2 or 5 bottles of 10 ml).
1 ml of solution contains:
- active substance: iron - 50 mg (in the form of iron carboxymaltose - 156-208 mg);
- auxiliary components: hydrochloric acid / sodium hydroxide - up to pH 5.0–7.0, water for injection - up to 1 ml.
Pharmacological properties
Pharmacodynamics
Ferinject's active component is trivalent iron in a stable form, it is a complex consisting of a multinuclear iron-hydroxide core and a carbohydrate ligand. Due to the high stability of the complex, only a small amount of weakly bound iron, also called labile or free, is released. The purpose of the complex is to provide a controlled source of utilized iron for body proteins that transport iron (transferrin) and deposit it (ferritin). According to the results of clinical studies, it was found that the achievement of a hematological response and the filling of the iron depot is carried out faster as a result of intravenous administration of Ferinject solution than when taking analog drugs orally.
The rates of utilization by erythrocytes of 59 Fe and 52 Fe from the radioactively labeled iron of the Ferinject preparation were 61–99%; on day 24 in patients with iron deficiency anemia, this indicator varied within 91–99% and in patients with renal anemia - 61–84%.
Pharmacokinetics
Studies have shown that 59 Fe and 52 Fe in the Ferinject preparation are quickly removed from the blood and transferred to the bone marrow, as well as deposited in the spleen and liver.
As a result of a single intravenous injection of Ferinjekt at doses of 100-1000 mg of iron, its maximum concentration (C max) in the blood serum was 37-333 μg / ml, the time to reach the indicator (T Cmax) varied from 15 to 60-80 minutes from the moment administration of the solution. The volume of distribution (V d) of the central chamber is practically equal to the volume of blood plasma and is ~ 3 liters.
As a result of parenteral administration of the drug, iron is rapidly excreted from the plasma, the half-life (T 1/2) is 7–12 hours, the average residence time in the body is 11–18 hours. The elimination of iron by the kidneys was practically not observed.
Indications for use
According to the instructions, Ferinject is recommended for the treatment of iron deficiency anemia, when the use of oral iron preparations is ineffective or for a number of reasons is impossible.
Before starting parenteral iron administration, confirmation of the diagnosis by laboratory tests is required.
Contraindications
Absolute:
- non- megaloblastic anemia, hemolytic anemia caused by a lack of vitamin B 12;
- violation of iron utilization, signs of an excess of iron;
- children and adolescents up to 14 years old;
- hypersensitivity to a complex of iron carboxymaltose, a solution of iron carboxymaltose, or any of the components of the drug.
Relative (Ferinject should be used with caution): liver failure, bronchial asthma, acute / chronic infectious diseases (risk of inhibition of erythropoiesis), atopic allergy, eczema.
To avoid overloading the body with iron requires careful monitoring of its content in the blood.
Instructions for the use of Ferinjekt: method and dosage
Ferinject solution is injected intravenously (jet or drip), or by direct injection into the venous section of the dialysis system.
Ferinject should be administered in specially designed departments with the necessary equipment for first aid in the development of anaphylactic reactions. All patients should be monitored for the development of symptoms or signs of hypersensitivity reactions for half an hour or more after each administration of a solution of iron carboxymaltose.
Before using the solution, the vials should be inspected for damage and possible sediment. Only a homogeneous solution that does not contain inclusions and sediment is allowed for use.
For intravenous infusion, Ferinject should be diluted with a sterile isotonic solution of 0.9% sodium chloride (NaCl), and then administered intravenously by drip (infusion); the maximum single dose is 1000 mg of iron or up to 20 mg / kg of body weight (in this dose, the drug cannot be administered more often than 1 time per week).
Dilution of Ferinject for infusion administration:
- 2-4 ml (iron content 100-200 mg) - in 50 ml of 0.9% NaCl solution;
- 4-10 ml (iron content 200-500 mg) - in 100 ml of 0.9% NaCl solution, the minimum administration time is 6 minutes;
- 10–20 ml (iron content 500–1000 mg) - in 250 ml of 0.9% NaCl solution, the minimum administration time is 15 minutes.
The drug remains stable up to a concentration of at least 2 mg / ml, further dilution of the drug is not allowed.
Ferinject can be injected intravenously, the maximum single dose is 4 ml (200 mg of iron) per day (at this dose, the drug cannot be administered more than 3 times a week).
Do not exceed the cumulative dose to replenish iron stores with iron carboxymaltose.
The cumulative dose of iron, determined based on the patient's body weight and hemoglobin (Hb) level:
- Hb (g / dl) <10: patients weighing 35–70 kg - 1500 mg; patients weighing ≥ 70 kg - 2000 mg;
- Hb (g / dl) ≥10: patients weighing 35–70 kg - 1000 mg; patients weighing ≥ 70 kg - 1500 mg.
For patients weighing <35 kg, the cumulative dose of iron should not exceed 500 mg.
In overweight patients, the need for iron should be determined based on the normal ratio of body weight to volume of circulating blood.
For Hb ≥ 14 g / dL, the initial dose of iron administered should be 500 mg, and the iron level in the body should be checked before subsequent administration.
To make sure that the iron concentration has returned to normal and is maintained at an adequate level, after filling its deficiency, regular assessments should be carried out.
In patients with chronic kidney disease requiring hemodialysis, the maximum daily dose of iron should not exceed 200 mg.
Side effects
Nausea was most often observed with Ferinject.
Other side effects according to clinical trials (in the pre- and post-registration periods, including in safety studies after drug registration), using a frequency scale: 0.1-0.01 - often; 0.01-0.001 - infrequently; 0.001-0.0001 - rarely:
- immune system: infrequently - increased individual sensitivity; rarely - anaphylactoid reactions;
- nervous system: often - dizziness, headache; infrequently - taste perversions, paresthesia;
- cardiovascular system: often - increased blood pressure (BP); infrequently - flushing of the face, tachycardia, lowering blood pressure;
- respiratory system: infrequently - shortness of breath;
- digestive system: often - nausea; infrequently - dyspepsia, vomiting, abdominal pain, diarrhea, constipation;
- skin and subcutaneous tissue: infrequently - itching, rash, urticaria, erythema; rarely - erythematous rash, macular, maculopapular itching, generalized;
- musculoskeletal system: infrequently - myalgia, back pain, joint pain, muscle cramps;
- metabolism: often - hypophosphatemia;
- laboratory data: often - an increase in the activity of alanine aminotransferase (ALT); infrequently - an increase in the activity of aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), lactate dehydrogenase (LDH) and alkaline phosphatase (ALP);
- general reactions: infrequently - weakness, fever, chest pain, peripheral edema, chills, pain; rarely - malaise, trembling;
- reactions at the injection site: infrequently - pain, burning sensation, discoloration, hematomas, extravasation, irritation; rarely - paresthesia.
Spontaneous post-marketing reports of side effects
As part of spontaneous post-marketing observations of the use of the drug Ferinject, the following serious negative side reactions were noted:
- nervous system: loss of consciousness and vertigo;
- mental disorders: anxiety;
- cardiovascular system: light-headedness, fainting;
- respiratory system: bronchospasm;
- skin and subcutaneous tissue: dermatitis, angioedema, pallor and edema of the face.
The frequency of these reactions has not been determined, since it is impossible to establish the exact total number of patients who took the drug in post-marketing research conditions.
Overdose
A symptom of an iron overdose is hemosiderosis, and serum ferritin and the percentage of transferrin saturation should be determined to facilitate its diagnosis.
For the treatment of the condition, the use of chelates is recommended to bind iron in the body.
special instructions
The drug should not be administered intramuscularly or subcutaneously.
Each bottle of Ferinject solution is intended for single use only.
1 ml of the drug contains up to 5.5 mg of sodium, this must be taken into account by patients following sodium-controlled diets.
1 ml of the drug contains up to 75 μg of aluminum, which must be taken into account by patients on prolonged dialysis.
Ferinject is prescribed only to patients with a diagnosis of anemia, confirmed by appropriate laboratory tests.
Due to parenteral administration of iron preparations, hypersensitivity reactions can develop, including potentially life-threatening anaphylactoid reactions. Therefore, the injection procedure should be performed only if drugs are available for cardiopulmonary resuscitation. When the first signs of allergic reactions appear, the administration of the drug should be interrupted immediately.
In connection with the available data on allergic reactions after previous uncomplicated parenteral administrations of any iron complexes, including iron carboxymaltose, each patient should be monitored for the development of adverse reactions for at least half an hour after any administration of iron carboxymaltose solution.
It is important to be careful when administering Ferinject intravenously in order to avoid the penetration of the solution into the peri-venous space, as this can cause irritation and likely long-term staining of the skin at the injection site in brown. In case of penetration of the drug into the peri-venous space, the procedure must be interrupted immediately.
Influence on the ability to drive vehicles and complex mechanisms
There are no data on the effect of Ferinjekt on the ability to drive vehicles and complex mechanisms, but some side effects (dizziness, lightheadedness, fainting) should be considered, which can affect the speed of psychomotor reactions and concentration. In this regard, patients should avoid performing potentially hazardous types of work until these symptoms disappear completely.
Application during pregnancy and lactation
There are no data on the use of Ferinject during pregnancy, and therefore a careful assessment of the ratio of the potential benefits of therapy for the mother to the risk for fetal development is necessary. It is recommended to avoid parenteral administration of iron in the first trimester of pregnancy and to limit its use in the second and third trimesters.
Data on the use of Ferinjekt during lactation (breastfeeding) are limited. In clinical studies, it was determined that the intake of iron from the drug in breast milk is minimal (<1%), so the likelihood that the drug poses a danger to children who are breastfed is extremely small.
Pediatric use
In pediatric practice, Ferinject is contraindicated for the treatment of children and adolescents under the age of 14 due to the lack of research data.
With impaired renal function
There is insufficient data on the efficacy and safety of Ferinject's use in chronic kidney disease in patients on hemodialysis and receiving single doses of> 200 mg of iron.
For violations of liver function
With caution Ferinject should be used in patients with hepatic impairment.
Parenteral iron preparations are used for liver diseases only after a comprehensive assessment of the benefit / risk ratio. If iron overload is capable of accelerating the course of the disease, especially in tardive cutaneous porphyria, treatment should be discontinued. To avoid iron overload, careful monitoring of its content in the body is necessary.
Drug interactions
Ferinject, used parenterally, inhibits the absorption of iron from the gastrointestinal tract when used simultaneously with oral iron preparations. Therefore, if necessary, therapy with iron preparations for oral administration, it is started no earlier than 5 days after the last administration of the Ferinject drug.
Ferinject is compatible exclusively with 0.9% sodium chloride solution. It is not allowed to be mixed with other solutions and medicinal substances for intravenous administration in order to avoid precipitation and / or other interaction.
Analogs
Ferinject's analogs are: Monofer, Dextrafer, Venofer, Ferinject, CosmoFer, etc.
Terms and conditions of storage
Store in original packaging at temperatures up to 30 ° C. Do not freeze. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ferinject
Most of the reviews about Ferinjekt are positive. The most significant advantages are: the ability to simultaneously administer a large dose of iron, which allows you to quickly restore its deficiency; the absence of strong negative side reactions, especially from the digestive system, as when taking iron preparations inside; the possibility of using for gastrointestinal diseases. There is a high efficiency of the drug when used in emergency cases, as well as to increase hemoglobin during pregnancy.
Price for Ferinject in pharmacies
The approximate price for Ferinject (solution for injection 50 mg / ml, 2 ml in vials, 5 vials per pack) is from 4500 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
