Venofer
Venofer: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Venofer
ATX code: B03AC02
Active ingredient: iron (III) hydroxide sucrose complex [ferric (III) hydroxide sacharose complex], or iron-sucrose complex (iron sucrose)
Manufacturer: Inc. Vifor (Switzerland)
Description and photo update: 2019-14-08
Prices in pharmacies: from 2570 rubles.
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Venofer is an anti-anemic drug intended for parenteral use.
Release form and composition
The drug is available in the form of a solution for intravenous administration (in ampoules of 2 and 5 ml, 5 ampoules in blisters, 1 package in a cardboard box).
Venofer's active ingredient is iron (III) hydroxide sucrose complex - 540 mg / ml, which corresponds to an iron content of 20 mg / ml.
The preparation contains water for injection and sodium hydroxide as auxiliary components.
Pharmacological properties
Pharmacodynamics
The active component of Venofer is the iron-sucrose complex, which is the core of the multinuclear iron (III) hydroxide, which is surrounded by a large number of non-covalently bound sucrose molecules. The average molecular weight of this complex is about 43 kDa. In structure, the multinucleated iron-containing nucleus is similar to the structure of the ferritin protein nucleus, which performs the function of a physiological iron depot.
The complex allows you to create a controlled source of utilized iron for ferritin and transferrin, which are responsible for the storage and transport of iron in the body.
After intravenous administration of the complex, its multinucleated iron-containing nucleus is predominantly captured by the reticuloendothelial system of the liver, bone marrow and spleen. At the next stage, iron is spent on the synthesis of hemoglobin, myoglobin, and other iron-containing enzymes, or is stored in the form of ferritin in the liver.
Pharmacokinetics
In a study involving patients with chronic renal failure and anemia, the ferrokinetics of the 59 Fe and 52 Fe labeled iron-sucrose complex was studied. It was shown that the 52 Fe complex was captured by the spleen, bone marrow and liver for 6–8 hours. The process of uptake by the macrophage-rich spleen of the radioactive label is believed to be typical of the uptake of iron by the reticuloendothelial system.
Healthy volunteers received a single intravenous dose of Venofer containing 100 mg of iron. In this case, at an average concentration of 538 µmol / L, the time to reach the maximum total concentration of iron in the blood serum was 10 minutes after administration. The volume of distribution of the central chamber corresponded to the volume of plasma (approximately 3 liters).
Most of the sucrose breaks down after injection. The multinucleated iron-containing nucleus is predominantly captured by the reticuloendothelial system of the spleen, bone marrow and liver. After 4 weeks, 59–97% of iron is utilized by erythrocytes.
The average molecular weight of the iron-sucrose complex is approximately 43 kDa, which is sufficient to prevent its excretion by the kidneys.
The excretion of iron through the kidneys during the first 4 hours after intravenous injection of an equivalent 100 mg of iron dose of Venofer was up to 5% of the administered dose. After 1 day, the total iron content in the blood serum decreased to the level recorded before the injection. Excretion of sucrose by the kidneys is about 75% of the initial dose.
Indications for use
According to the instructions, Venofer is used for iron deficiency states:
- Intolerance to iron preparations intended for oral administration, or non-compliance with the therapy regimen;
- The presence of active inflammatory bowel disease, when the effectiveness of oral iron preparations is limited;
- The need to quickly replenish iron;
- Disruption of the iron utilization process;
- Iron overload symptoms (hemochromatosis, hemosiderosis);
- Anemia not associated with iron deficiency;
- Hypersensitivity of the patient to the components of the drug;
- I trimester of pregnancy.
Contraindications
Venofer is prescribed with caution if the patient has bronchial asthma, eczema, liver failure, chronic and acute infectious diseases, polyvalent allergies, allergic reactions to other parenteral iron preparations, as well as with an increased content of ferritin in the serum and with a low iron-binding capacity of serum and / or folic acid deficiency.
Instructions for the use of Venofer: method and dosage
Venofer is intended only for intravenous administration (slow jet or drip) or for introduction into the venous section of the dialysis system.
Simultaneous administration of a full therapeutic dose of Venofer is unacceptable. Before the introduction of the first therapeutic dose, the appointment of a test dose is recommended. If any manifestations of intolerance occur during the observation period, the drug should be stopped immediately.
Before use, the ampoule should be inspected for damage; a brown solution without precipitation is suitable for use.
The most preferred variant of Venofer's administration is drip infusion, since this method reduces the risk of a pronounced decrease in blood pressure and the possibility of getting the drug into the peri-venous space. Before the introduction, it is necessary to dilute Venofer with a solution of sodium chloride 0.9% in a ratio of 1:20. The amount of iron in the solution determines the time required for drug administration:
- 500 mg - 3.5 hours;
- 400 mg - 2.5 hours;
- 300 mg - 1.5 hours;
- 200 mg - 30 minutes;
- 100 mg - not less than 15 minutes.
The maximum tolerated single dose of Venofer is 7 mg of iron per 1 kg of body weight, it should be administered for at least 3.5 hours, regardless of the total dose of the drug.
The first drip of a therapeutic dose of Venofer is preceded by the introduction of a test dose, which for adult patients and children whose body weight is more than 14 kg is 20 mg of iron, and for children weighing less than 14 kg - half the daily dose (1.5 mg of iron per 1 kg of body weight). The test dose should be administered within 15 minutes. If there are no undesirable effects, the remainder of the drug is administered at the recommended rate.
Jet injection: when the drug is administered intravenously slowly, Venofer is used undiluted, the rate being 1 ml of the drug per minute. The maximum permissible dose of the drug per injection is 10 ml (200 mg of iron).
Before the first jet injection, a test dose is administered to the patient within 1-2 minutes: 1 ml of the drug for children weighing more than 14 kg and adult patients, half of the daily dose (1.5 mg per 1 kg of body weight) - for children whose body weight less than 14 kg. If after 15 minutes after the administration of the test dose, there are no undesirable reactions, the remaining solution is injected at the recommended rate. After the procedure, the patient is recommended to fix the arm in an extended position for a while.
When injecting the drug into the venous section of the dialysis system, it is necessary to strictly follow the recommendations described for intravenous injection.
The dose is determined individually according to a special formula and depends on the general iron deficiency in the patient's body.
The standard dose of Venofer for the elderly and adult patients is 5-10 ml of the drug 1-3 times a week (depending on the hemoglobin level). Data on the use of the drug in children under 3 years of age are limited. In this case, no more than 0.15 ml of Venofer is injected per 1 kg of body weight 1-3 times a week (depending on the level of hemoglobin).
The maximum tolerated single dose for the elderly and adult patients:
- Jet - 10 ml (200 mg of iron); injection time - at least 10 minutes;
- Drip - up to 500 mg of iron (7 mg per 1 kg of body weight), administered once a week.
Side effects
Side effects arising from the use of Venofer were very rare.
- From the side of the cardiovascular system: lowering blood pressure, tachycardia, palpitations, feeling of heat, collaptoid conditions, "hot flushes" of blood to the face;
- On the part of the digestive system: pain in the epigastric region, diffuse abdominal pain, nausea, vomiting, diarrhea, impaired taste;
- From the musculoskeletal system: back pain, limb pain, arthralgia, myalgia, joint edema;
- From the nervous system: headaches and dizziness, paresthesia, loss of consciousness;
- From the respiratory system: shortness of breath, bronchospasm;
- On the part of the skin: rash, itching, pigmentation disorders, excessive sweating, erythema;
- Allergic reactions: facial edema, laryngeal edema, anaphylactoid reactions;
- General disorders: chest pains, a feeling of heaviness in the chest, peripheral edema, fever, chills, weakness, asthenia, feeling unwell, pallor;
- Local reactions: swelling and pain at the injection site.
Overdose
An overdose of Venofer can lead to iron overload, as a result of which symptoms of hemosiderosis may appear. Treatment should be with a chelating agent to bind iron or according to standard medical practice.
special instructions
The drug is recommended for administration only to those patients whose diagnosis of anemia has been reliably confirmed by appropriate laboratory tests.
It is necessary to strictly observe the recommended rate of administration of the drug in order to avoid the development of undesirable side reactions (especially a decrease in blood pressure).
Penetration of Venofer outside the vessel can lead to tissue necrosis and brown skin staining; therefore, it is necessary to avoid getting the drug into the peri-venous space. If such a complication occurs, heparin-containing preparations should be applied to the injection site, which helps to accelerate the excretion of iron and prevent its further penetration into the surrounding tissues.
The use of intravenous iron supplements can contribute to the development of potentially life-threatening allergic or anaphylactoid reactions.
Among patients with hypersensitivity to iron dextran, studies were conducted that showed no complications during therapy with Venofer.
The physical and chemical stability of the drug after dilution with saline is maintained at room temperature for 12 hours, but from a microbiological point of view, the drug is recommended to be used immediately. If the solution was not used immediately after preparation, all responsibility for the conditions and storage time (which in any case should not exceed 3 hours at room temperature and if the dilution was carried out under guaranteed and controlled aseptic conditions) rests with the user.
An undesirable effect of Venofer on the ability to drive a car and use machinery is unlikely.
Application during pregnancy and lactation
Venofer is contraindicated for use in the first trimester of pregnancy.
A moderate amount of data on the use of the drug in the II and III trimesters of pregnancy did not show the presence of a risk to the newborn or the mother. However, Venofer is recommended for use during this period only in cases where the perceived risk to the fetus is lower than the potential benefit to the mother.
Animal studies have not identified direct or indirect adverse effects on pregnancy, embryo / fetal health, labor, or postnatal development.
The amount of information on the excretion of iron in human breast milk as a result of intravenous administration of the drug is limited. In a small clinical study involving breastfeeding healthy mothers with iron deficiency who received a dose of an iron-sucrose complex equivalent to 100 mg of iron, the concentration of iron in milk remained the same 4 days after the start of therapy. There were no differences relative to the control group (n = 5). Since the possibility of iron intake from the drug into the mother's milk cannot be excluded, Venofer should be prescribed during breastfeeding only after assessing the balance of benefits and risks.
Pediatric use
There is a moderate amount of research data on the use of Venofer in children. If it is necessary to use the drug, it is not recommended to prescribe doses exceeding 0.15 ml per 1 kg of the patient's body weight. In this case, the introduction of Venofer should be made up to 3 times a week.
For violations of liver function
In hepatic insufficiency, Venofer should be used with caution.
Use in the elderly
When treating elderly patients, dose adjustment is not required.
Drug interactions
The simultaneous administration of Venofer and oral iron preparations is not recommended. Iron preparations intended for oral administration can be used at least 5 days after the last parenteral administration.
In one bottle, the drug can only be mixed with saline. The addition of other therapeutic drugs and solutions for intravenous administration is not allowed. The compatibility of Venofer with containers made of materials other than polyethylene, polyvinyl chloride and glass has not been studied.
Analogs
Venofer analogs are: Argeferr, Likferr 100, Iron (III) hydroxide sucrose complex, Dextrafer, Sufer, Maltofer, Ferrum Lek, FerMed, Ferinjekt, Ferrolek-Zdorovye.
Terms and conditions of storage
Store in its original packaging at a temperature of 4-25 ° C out of reach of children. Do not allow the drug to freeze.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Venofer
Reviews about Venofer are quite rare. Reports indicate the effectiveness of the drug in the treatment of iron deficiency anemia in a hospital setting. Also in the reviews there is information about side effects (dizziness, nausea, swelling in the legs), which disappear some time after the injection.
Price for Venofer in pharmacies
The approximate price for Venofer is 3040 rubles (for 5 vials of a solution of 20 mg / 1 ml, 5 ml each).
Venofer: prices in online pharmacies
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Drug name Price Pharmacy |
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Venofer 20 mg / ml solution for intravenous administration 5 ml 5 pcs. 2570 RUB Buy |
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Venofer solution for intravenous administration 20 mg / ml vial 5 ml 5pcs 4342 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
