Monofer - Instructions For The Use Of Ampoules, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Monofer

Monofer: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Monofer

ATX code: B03AC06

Active ingredient: iron (III) hydroxide oligoisomaltosate [Ferric (III) hydroxide olygoisomaltosate]

Manufacturer: Solupharm Pharmazeutische Erzeugnisse GmbH (Germany); Wasserburger Arzneimittelwerk GmbH (Germany)

Description and photo update: 2019-30-08

Prices in pharmacies: from 9000 rubles.

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Monofer - antianemic agent; iron preparation for parenteral use.

Release form and composition

The drug is produced in the form of a solution for intravenous (iv) administration: a dark brown liquid [1, 2, 5 or 10 ml in ampoules or vials (depending on the manufacturer) from transparent colorless glass, in a cardboard box 2 ampoules / vial of 5 or 10 ml, or 10 ampoules / vials of 1 or 2 ml, or 5 ampoules / vials of 1, 2, 5 or 10 ml and instructions for use of Monofer].

1 ml of solution contains:

• active substance: iron (III) hydroxide oligoisomaltosate - 417 mg, which is equivalent to iron in the amount of 100 mg;
• additional components: depending on the manufacturer - either 25% hydrochloric acid / sodium hydroxide solution 10 M, or 1 M hydrochloric acid solution / 1 M sodium hydroxide solution - up to pH 5.5; water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Monofer is a complex containing iron tightly bound to carbohydrate moieties. The iron located in the center of the complex is surrounded by an amorphous shell consisting of oligoisomaltosate molecules with a molecular weight of about 1000 Da. The oligoisomaltose complex of iron (III) hydroxide is structurally similar to ferritin (iron protein), which protects the body from the toxic effects of unbound iron (III) of an inorganic nature, since it provides a slow and controlled release of bioavailable iron against the background of a slight risk of free iron formation. Due to its low toxicity, Monofer can be used in high doses.

The Monofer effect is recorded already several days after the start of the course of treatment, as evidenced by an increase in the level of reticulocytes in the blood. After a single intravenous injection of the drug, on average, after 7–9 days, the maximum concentration (C _max) of ferritin is observed in the blood plasma, and then, over 3 weeks, the level of its content slowly returns to the initial one.

Pharmacokinetics

With a single intravenous administration of iron (III) Monofer, oligoisomaltosate hydroxide is vigorously captured by the cells of the reticuloendothelial system (RES), mainly the spleen and liver, which then slowly remove iron into the blood. The half-life (T _1/2) is 5 hours for iron circulating in the systemic circulation, and 20 hours in total for bound iron that has entered the systemic circulation.

Iron is utilized by the RES cells from the vascular bed through the cleavage of the oligoisomaltose complex of iron (III) hydroxide into its constituents, iron and oligoisomaltose. Iron immediately binds to endogenous proteins that transport (transferrin) and store it (hemosiderin and ferritin), which means that the metabolism of iron in the body is physiologically controlled. As a result of this process, the plasma concentration of hemoglobin (Hb) in the blood is restored, and the iron stores in the depot are replenished.

Due to the large size of the complex, Monofer is not excreted by the kidneys unchanged. Small amounts of iron are eliminated by the intestines and kidneys. Oligoisomaltosate also undergoes metabolic transformation and is excreted.

Indications for use

Monofer is recommended for the treatment of absolute or functional iron deficiency states in case of ineffective use of oral iron preparations or if rapid iron replacement is required.

Contraindications

Absolute:

• anemia not caused by iron deficiency (hemolytic anemia);
• existing signs of iron overload (hemosiderosis, hemochromatosis) or impaired iron utilization;
• rheumatoid arthritis with symptoms of an active inflammatory process;
• hepatitis and cirrhosis of the liver in the stage of decompensation;
• bacteremia;
• I trimester of pregnancy;
• age up to 18 years;
• hypersensitivity to any component of the product.

Relative (treatment with Monofer is required with caution due to the increased risk of allergic or anaphylactoid reactions, including anaphylactic shock):

• bronchial asthma;
• polyvalent allergy;
• eczema;
• II – III trimesters of pregnancy (provided that the expected benefit from drug therapy for the mother outweighs the possible threat to the health of the fetus);
• a history of allergic reactions to other parenteral iron preparations;
• immune system disorders such as systemic lupus erythematosus, rheumatoid arthritis, acute / chronic infections.

Monofer, instructions for use: method and dosage

Monofer is administered to adults, including elderly patients, intravenously: jet, or as an infusion of a full dose of the solution, or drip, as well as jet through the dialysis system.

The use of the drug is allowed only in a hospital setting, in the presence of personnel who are able to timely identify anaphylactic reactions and provide anti-shock therapy. Patients are required to be under close medical supervision during each injection of the drug and for 1 hour immediately after it.

Substitution therapy in patients with chronic iron deficiency anemia

The dose of Monofer and the scheme of its administrations are selected for each patient individually, taking into account the determination of the general iron deficiency. The optimal target for Hb levels may differ from patient to patient group, so the official guidelines should be strictly followed.

The dose of Monofer is expressed in mg of elemental iron.

The total iron dose is calculated using the Ganzoni formula below: total iron deficiency (mg) = body weight ¹ (kg) × (patient's target Hb - Hb concentration) ² (g / L) × 0.24 ³ + deposited iron ⁴ (mg).

¹ It is recommended to use the patient's ideal body weight or pre-pregnancy weight.

² To convert Hb (mmol) to Hb (g / L), multiply Hb (mmol) by a factor of 1.611 45.

³ Coefficient 0.24 = 0.003 4 × 0.07 × 1000, where 0.003 4 is the iron content in Hb (is 0.34%); 0.07 - blood volume 70 ml / kg (approximately 7% of body weight); 1000 - conversion factor (1 g / l = 1000 mg / l).

⁴ For a patient weighing more than 35 kg, the iron depot is approximately 500 mg.

Treatment with Monofer should provide both an increase in the iron content in Hb and the replenishment of iron stores in the depot. After the general iron deficiency is corrected, patients may need further drug therapy in order to maintain the required plasma hemoglobin level in the blood, as well as the values of other indicators that indicate the concentration of iron.

Iron replacement for blood loss

After blood loss, the replacement of iron deficiency with iron supplements should be equivalent to the amount of lost iron. If the Hb level is lowered, the previous formula should be used, assuming that there is no need to restore the iron depot: total iron dose (mg) = body weight (kg) × (required Hb level - patient's current Hb level) (g / L) × 0, 24.

If the amount of blood loss is not established, the use of Monofer at a dose of 200 mg leads to an increase in Hb equivalent to 1 unit of blood loss. Iron content to be replenished (mg) = number of blood units lost x 200.

Dilute Monofer only in 0.9% sterile sodium chloride solution.

Recommended dosage regimen:

• IV jet injection: at a dose of 100-200 mg up to 3 times a week at a rate of up to 50 mg / min; dilute the product in 10–20 ml of solvent;
• infusion of the full dose of the drug: in the form of a single infusion, it is allowed to inject the entire dose; with a single intravenous drip infusion, Monofer can be used at a dose of up to 20 mg iron / kg; doses less than 10 mg / kg are administered for more than 30 minutes, doses of 11–20 mg / kg - more than 60 minutes; if the total dose of iron exceeds 20 mg / kg, it must be divided into 2 administration sessions with an interval of at least 7 days; the drug is mixed with 100–500 ml of solvent;
• intravenous drip: should be used once a week at doses of 200-1000 mg until the entire required (full) dose of iron is administered: at a dose of up to 5 mg / kg - for at least 15 minutes, at a dose of 6–10 mg / kg - at least 30 minutes, at a dose of 11–20 mg / kg - at least 60 minutes; Monofer is diluted in 100–500 ml of solvent;
• administration through the dialysis system: it is possible to inject the solution directly into the venous site of the dialyzer with strict adherence to the intravenous injection technique.

Side effects

Information on the side effects of Monofer is limited. Presumably, adverse events can be recorded in more than 1% of patients.

Against the background of parenteral administration of iron-containing agents, hypersensitivity reactions are possible. In the course of clinical trials of the drug, allergic reactions were not recorded.

Undesirable effects observed during treatment with Monofer:

• nervous system: infrequently (> 1/1000 - 1/10 000 - <1/1000) - increased fatigue, agitation, dizziness, tremors, decreased thinking ability, convulsions, loss of consciousness; extremely rare (<1/10 000) - paresthesia, headache;
• blood and lymphatic system: extremely rare - hemolysis;
• cardiovascular system: rarely - lowering blood pressure (BP), tachycardia, heart rhythm disturbances; extremely rarely - increased blood pressure, palpitations, fetal bradycardia;
• respiratory organs: infrequently - shortness of breath; rarely - chest pain;
• organ of vision: infrequently - impaired clarity of visual perception;
• organ of hearing: extremely rare - short-term hearing loss;
• digestive tract: often (> 1/100 - <1/10) - diarrhea; infrequently - nausea, abdominal pain, vomiting, constipation;
• skin: infrequently - rash, itching, hot flashes; rarely - increased sweating, edema;
• immune system: infrequently - anaphylactoid reactions; extremely rare - anaphylactic shock;
• musculoskeletal system: infrequently - muscle cramps; rarely - arthralgia, myalgia;
• general disorders and reactions at the injection site of Monofer: infrequently - chills, a feeling of heat, flushing of the skin, a feeling of malaise, swelling and pain at the injection site, thrombophlebitis.

Overdose

Monofer is characterized by low toxicity and good tolerance, the risk of drug overdose is minimal. Iron accumulation or acute iron overload can cause an overdose, manifested by symptoms of hemosiderosis. Iron levels in the body are monitored by measuring ferritin levels. Treatment is symptomatic and, if necessary, chelates are used - substances that bind iron.

special instructions

Monofer is required to be used only in those patients in whom the diagnosis of iron deficiency anemia was confirmed by the data of appropriate laboratory tests, such as serum ferritin, hemoglobin and hematocrit, the number of erythrocytes and their parameters - the average volume of erythrocytes, the average concentration of hemoglobin in the erythrocyte.

In one syringe, the drug can only be mixed with sterile saline. It is forbidden to add other solutions for intravenous administration and therapeutic drugs to the syringe, since there is a threat of a precipitation reaction and / or other pharmaceutical interaction.

The compatibility of the solution with containers made of materials other than polyethylene, polyvinyl chloride and glass has not been studied.

Iron preparations administered intravenously can provoke the appearance of allergic or anaphylactoid reactions that can be life-threatening.

It is necessary to strictly observe the rate of administration of the agent, since with too rapid administration, cases of a sudden pronounced decrease in blood pressure are possible. A higher frequency of occurrence of adverse events (especially a decrease in blood pressure), which can also be quite severe, is associated with an increase in dose. As a result, the duration of administration of the solution recommended in this instruction must be strictly observed, even in the case when the patient does not receive the agent in the maximum tolerated single dose.

It is necessary to beware of the introduction of the solution into the perineous space, since its ingress outside the vessel can cause brown staining of the skin and lead to tissue necrosis. If the solution nevertheless penetrates beyond the boundaries of the vessel, in order to accelerate the excretion of iron and prevent its subsequent penetration into the adjacent tissues, it is recommended to apply heparin-containing preparations - a gel or ointment to the injection site (apply with careful movements, without rubbing).

After mixing the drug with 0.9% sterile sodium chloride solution for injection, the prepared solution can be stored for no more than 24 hours at room temperature.

Influence on the ability to drive vehicles and complex mechanisms

There are no data on the effect of Monofer on the reaction rate when driving vehicles or working with other complex equipment. However, patients engaged in potentially hazardous activities should take into account the risk of impaired vision clarity, as well as undesirable phenomena from the nervous system, during treatment.

Application during pregnancy and lactation

In the course of studies on animals with the introduction of the drug in single doses exceeding 125 mg / kg, teratogenic and embryotoxic effects were revealed. Adequate and strictly controlled studies on the use of the drug in pregnant women have not been conducted. Treatment with Monofer during pregnancy is possible only when absolutely necessary after a careful assessment of the benefit / risk ratio. For clinical use, the maximum recommended dose should not exceed 20 mg / kg.

In cases where the expected benefit from drug therapy for the mother exceeds the possible threat to the health of the fetus, Monofer can be used only in the II – III trimesters of pregnancy. It is not recommended to use Monofer in the first trimester.

In view of the fact that the excretion of Monofer with breast milk has not been established, the antianemic agent is allowed to be used during breastfeeding.

Pediatric use

Drug therapy for patients under 18 years of age is contraindicated due to insufficient data on the safety and efficacy of its use in children and adolescents.

For violations of liver function

In the presence of hepatitis and decompensated cirrhosis of the liver, the use of Monofer is contraindicated.

Drug interactions

Monofer should not be used concurrently with oral dosage forms of iron, as their combination may reduce the absorption of iron from the digestive tract. Treatment with oral iron preparations can be started no earlier than 5 days after the last administration of Monofer.

Analogs

Monofer analogues are Maltofer, Fer-Rompharm, Ferrum LEK, etc.

Terms and conditions of storage

Keep out of the reach of children at a temperature not exceeding 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Monofer

Reviews of Monofer, left by patients on medical sites, are usually positive. Patients receiving drug therapy note that after 5-7 injections of the solution, their hemoglobin and ferritin levels significantly increased, which were initially quite low.

The disadvantages of Monofer in the reviews include its high price and sometimes its absence in the pharmacy chain.

Price for Monofer in pharmacies

The price of Monofer, solution for intravenous administration (100 mg / ml), per package containing 5 pcs., Can be: 1 ml ampoules - 8900-10 600 rubles, 2 ml - 9000-11000 rubles.

Monofer: prices in online pharmacies

Drug name Price Pharmacy

Monofer 100 mg / ml solution for intravenous administration 2 ml 5 pcs. RUB 9,000 Buy

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!