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Venofer solution for intravenous administration 20 mg/ml ampoules of 5 ml 5 pcs.

The drug Venofer is administered only intravenously: by drip infusion, or slow injection, or directly into the venous section of the dialysis system. Before use, ampoules/vials should be inspected for sediment or damage. Only use ampoules/vials containing a homogeneous, sediment-free, brown solution. Each ampoule/vial of Venofer is intended for single use only. Any remaining unused medicinal product or waste should be disposed of in accordance with local requirements. The administration of the drug Venofer should be carried out under the supervision of medical personnel experienced in the diagnosis and treatment of anaphylactic reactions, in a specialized department. It should be possible to carry out anti-shock therapy, including a 0.1% solution of epinephrine (adrenaline), antihistamines and/or corticosteroids. The test dose is not a reliable predictor of the subsequent development of hypersensitivity reactions, and therefore its preliminary administration is not recommended. During the administration of the drug and immediately after administration, patients should be under medical supervision. When the first signs of anaphylactic reactions appear, the use of the drug should be stopped immediately. It is necessary to monitor each patient for at least 30 minutes after each administration of Venofer at a therapeutic dose to ensure the absence of adverse events. Intravenous drip infusion. Venofer is diluted only with sterile 0.9% (w/v) sodium chloride (NaCl) solution. The diluted solution should be transparent and brown in color. Dilution should be made immediately before infusion. Intravenous injection. Venofer can be administered by slow intravenous injection at a rate of 1 ml of undiluted solution per minute and its dose should not exceed 10 ml (200 mg of iron) per injection. Injection into the venous portion of the dialysis system. Venofer can be administered during a hemodialysis session directly into the venous section of the dialysis system under the same conditions as for intravenous injection. Doses. For each patient, the cumulative dose of Venofer should be individually calculated and should not be exceeded. Standard doses. Adult and elderly patients. 5-10 ml of Venofer (100-200 mg iron) 1-3 times a week. Children. There is only a moderate amount of research data on the use of the drug in children. In case of clinical need for use, it is not recommended to exceed a dose of 0.15 ml of Venofer (3 mg of iron) per kg of body weight no more than 3 times a week.

Venofer®

Application

The drug Venofer® is administered only intravenously: by drip infusion, or slow injection, or directly into the venous section of the dialysis system.

Before use, ampoules/vials should be inspected for sediment or damage. Only use ampoules/vials containing a homogeneous, sediment-free, brown solution.

Each ampoule/vial of Venofer® is intended for single use only. Any remaining unused medicinal product or waste should be disposed of in accordance with local requirements.

The administration of the drug Venofer® should be carried out under the supervision of medical personnel experienced in the diagnosis and treatment of anaphylactic reactions, in a specialized department. It should be possible to carry out anti-shock therapy, including a 0.1% solution of epinephrine (adrenaline), antihistamines and/or corticosteroids.

The test dose is not a reliable predictor of the subsequent development of hypersensitivity reactions, and therefore its preliminary administration is not recommended.

During the administration of the drug and immediately after administration, patients should be under medical supervision. When the first signs of anaphylactic reactions appear, the use of the drug should be stopped immediately.

It is necessary to monitor each patient for at least 30 minutes after each administration of Venofer® at a therapeutic dose to ensure the absence of adverse events.

Intravenous drip infusion

Venofer® is diluted only with sterile 0.9% (w/v) sodium chloride (NaCl) solution. The diluted solution should be transparent and brown in color. Dilution should be made immediately before infusion, and the resulting solution should be administered as follows:

Dose of Venofer® (mg iron)	Dose of the drug Venofer® (ml of the drug Venofer®)	Maximum dilution volume of sterile 0.9% (w/v) NaCl solution	Minimum infusion time
100 mg	5 ml	100 ml	15 minutes
200 mg	10 ml	200 ml	30 minutes
300 mg	15 ml	300 ml	1,5 hour
400 mg	20 ml	400 ml	2.5 hours
500 mg	25 ml	500 ml	3.5 hours

Dilution of the drug to lower concentrations of iron is unacceptable for reasons related to solution stability.

Intravenous injection

Venofer® can be administered by slow intravenous injection at a rate of 1 ml of undiluted solution per minute and its dose should not exceed 10 ml (200 mg of iron) per injection.

Injection into the venous site of the dialysis system

Venofer® can be administered during a hemodialysis session directly into the venous portion of the dialysis system under the same conditions as for intravenous injection.

Doses

For each patient, the cumulative dose of Venofer® should be individually calculated and should not be exceeded.

Dose calculation

The total cumulative dose of Venofer®, equivalent to total iron deficiency (mg), is determined based on hemoglobin (Hb) content and body weight (BW). The dose of Venofer® should be individually calculated for each patient in accordance with the total iron deficiency calculated using the Ganzoni formula below, for example:

Total iron deficiency [mg] = body weight [kg] x (target hemoglobin content - actual hemoglobin content) [g/l] x 0.24* + deposited iron [mg]

With body weight less than 35 kg:

target hemoglobin content = 130 g/l, and amount of deposited iron = 15 mg/kg body weight

With a body weight of 35 kg or more:

target hemoglobin content = 150 g/l, and amount of deposited iron = 500 mg

* Coefficient 0.24 = 0.0034 (iron content in hemoglobin = 0.34%) x 0.07 (blood mass ≈7% of body weight) x 1000 (conversion [g] to [mg])

Total amount of Venofer® to be administered (in ml) = Total iron deficiency [mg]/ 20 mg iron/ml

The total amount of Venofer® (ml) that should be administered, depending on body weight, actual hemoglobin content and target hemoglobin content*:

Body weight [kg]	Total amount of Venofer® (20 mg iron per ml) to be administered
	hemoglobin 60 g/l		hemoglobin 75 g/l		hemoglobin 90 g/l		hemoglobin 105 g/l
	mg Fe	ml	mg Fe	ml	mg Fe	ml	mg Fe	ml
5	160	8	140	7	120	6	100	5
10	320	16	280	14	240	12	220	11
15	480	24	420	21	380	19	320	16
20	640	32	560	28	500	25	420	21
25	800	40	700	35	620	31	520	26
30	960	48	840	42	740	37	640	32
35	1260	63	1140	57	1000	50	880	44
40	1360	68	1220	61	1080	54	940	47
45	1480	74	1320	66	1140	57	980	49
50	1580	79	1400	70	1220	61	1040	52
55	1680	84	1500	75	1300	65	1100	55
60	1800	90	1580	79	1360	68	1140	57
65	1900	95	1680	84	1440	72	1200	60
70	2020	101	1760	88	1500	75	1260	63
75	2120	106	1860	93	1580	79	1320	66
80	2220	111	1940	97	1660	83	1360	68
85	2340	117	2040	102	1720	86	1420	71
90	2440	122	2120	106	1800	90	1480	74

* With body weight less than 35 kg:

Target hemoglobin = 130 g/l

With a body weight of 35 kg or more:

Target hemoglobin = 150 g/l

To convert hemoglobin (mmol) to hemoglobin (g/l), multiply the first value by 16.

If the total dose required exceeds the maximum permitted single dose, it should be divided into several administrations.

If there is no response in hematological parameters after 1-2 weeks, the initial diagnosis should be reconsidered.

Calculation of the dose to replenish iron stores after blood loss or when donating autologous blood

The dose of Venofer® required to compensate for iron deficiency can be calculated using the following formulas:

If the amount of blood lost is known: the administration of 200 mg of iron (10 ml of Venofer®) should lead to approximately the same increase in hemoglobin concentration as a transfusion of 1 unit of blood (400 ml with a hemoglobin concentration = 150 g/l).

Amount of iron that needs to be replaced [mg] = number of units of lost blood x 200 mg

Required volume of Venofer® [ml] = number of units of lost blood x 10 ml

If the hemoglobin content is lower than desired: the formula assumes that the iron depot does not need to be replenished.

Amount of iron that needs to be replenished [mg] = body weight [kg] * 0.24 x (target hemoglobin content - actual hemoglobin content) [g/l]

Example:

With body weight = 60 kg and decreased hemoglobin content = 10 g/l

=> = 150 mg of iron must be replenished

=> 7.5 ml of Venofer® is required

The maximum tolerated single and weekly doses are listed below in the sections “Standard Doses” and “Maximum Tolerated Single and Weekly Doses.”

Standard doses

Adult and elderly patients

5-10 ml of Venofer® (100-200 mg iron) 1-3 times a week.

The time of administration of the drug and the method of dilution are indicated in the “Application” section.

Children

There is only a moderate amount of research data on the use of the drug in children. In case of clinical need for use, it is not recommended to exceed a dose of 0.15 ml of Venofer® (3 mg of iron) per kg of body weight no more than 3 times a week.

The time of administration of the drug and the method of dilution are indicated in the “Application” section.

Maximum tolerated single and weekly dose

Adult and elderly patients

The maximum tolerated dose per day, administered by injection no more than 3 times a week:

10 ml of Venofer® (200 mg iron), administered over at least 10 minutes.

The maximum tolerated dose per day, administered as an infusion no more than once a week:

Patients weighing more than 70 kg: 500 mg of iron (25 ml of Venofer®), administered over a minimum of 3.5 hours.
Patients weighing 70 kg or less: 7 mg iron/kg body weight administered over a minimum of 3.5 hours.

The infusion times specified in the Administration section should be strictly adhered to, even if the patient has not received the maximum tolerated single dose.

Venofer solution d/iv injected 20 mg 5 ml No. 5

Compound

Active substance: iron (III) hydroxide sucrose complex 540 mg, which corresponds to an iron content of 20 mg.
Excipients: sodium hydroxide, water for injection - up to 1 ml.

Pharmacokinetics

Distribution

After a single intravenous administration of the drug Venofer® containing 100 mg of iron, Cmax of iron, on average 538 μmol, is achieved 10 minutes after injection.

The Vd of the central chamber almost completely corresponds to the volume of the serum - about 3 liters.

Vd at steady state is approximately 8 L (which indicates a low distribution of iron in body fluids). Due to the low stability of iron saccharate compared to transferrin, competitive iron metabolism is observed in favor of transferrin. As a result, about 31 mg of iron (III) is transferred in 24 hours.

Removal

T1/2 - about 6 hours. In the first 4 hours, less than 5% of iron from the total clearance is excreted by the kidneys. After 24 hours, the serum iron level returns to its original (pre-administration) value, and approximately 75% of sucrose leaves the vascular bed.

Indications for use

Venofer® is used to treat iron deficiency conditions in the following cases:

with a clinical need for rapid replenishment of iron reserves;
in patients who cannot tolerate oral iron supplements or do not comply with treatment regimen;
in the presence of active inflammatory bowel disease, when oral iron supplements are ineffective.

Contraindications

Anemia not associated with iron deficiency;
signs of iron overload (hemosiderosis, hemochromatosis);
disruption of the iron utilization process;
I trimester of pregnancy;
hypersensitivity to the components of the drug.

The drug is prescribed with caution to patients with bronchial asthma, eczema, polyvalent allergies, allergic reactions to other parenteral iron preparations; patients with low serum iron-binding capacity and/or folic acid deficiency; patients with liver failure, with acute or chronic infectious diseases, with elevated serum ferritin levels due to the fact that parenteral iron may have an adverse effect in the presence of a bacterial or viral infection.

Directions for use and doses

Venofer is administered only intravenously (slowly drip or stream) or into the venous section of the dialysis system. Not intended for intramuscular administration. Simultaneous administration of the full therapeutic dose of the drug is unacceptable.

Before administering the first therapeutic dose, a test dose must be prescribed. If during the observation period phenomena of intolerance occur, administration of the drug should be stopped immediately. Before opening the ampoule, you should inspect it for possible sediment and damage. Only brown solution without sediment can be used.

Drip administration: Venofer® is preferably administered by drip infusion in order to reduce the risk of a pronounced decrease in blood pressure and the risk of the solution entering the perivenous space. Immediately before infusion, Venofer® should be diluted with 0.9% sodium chloride solution in a ratio of 1:20, for example, 1 ml (20 mg of iron) in 20 ml of 0.9% sodium chloride solution. The resulting solution should be administered at the following speed: 100 mg of iron - no less than 15 minutes; 200 mg of iron - within 30 minutes; 300 mg of iron - within 1.5 hours; 400 mg of iron - within 2.5 hours; 500 mg of iron - over 3.5 hours. The maximum tolerated single dose of 7 mg iron/kg should be administered over a minimum of 3.5 hours, regardless of the total dose of the drug.

Before the first drip administration of a therapeutic dose of Venofer®, it is necessary to administer a test dose: 20 mg of iron for adults and children weighing more than 14 kg, and half the daily dose (1.5 mg iron/kg) for children weighing less than 14 kg, for 15 minutes. In the absence of adverse events, the remainder of the solution should be administered at the recommended rate.

Injection: Venofer® can also be administered as an undiluted IV solution slowly, at a rate (norm) of 1 ml of Venofer® (20 mg iron) per minute; 5 ml of Venofer® (100 mg iron) should be administered at least 5 minutes before. The maximum volume of the drug should not exceed 10 ml of Venofer® (200 mg iron) per 1 injection.

Before the first jet injection of a therapeutic dose of Venofer®, a test dose should be prescribed: 1 ml of Venofer® (20 mg iron) for adults and children weighing more than 14 kg and half the daily dose (1.5 mg iron/kg) for children weighing less than 14 kg within 1-2 minutes. If there are no adverse events during the next 15 minutes of observation, the remaining part of the solution should be administered at the recommended rate. After the injection, the patient is recommended to fix his arm in an extended position for a while.

Introduction to Dialysis System

Venofer® can be administered directly into the venous portion of the dialysis system, strictly following the rules described for intravenous injection.

Dose calculation: the dose is calculated individually in accordance with the general iron deficiency in the body using the formula:

General iron deficiency (mg) = body weight (kg) × [normal Hb level - patient’s Hb level] (g/l) × 0.24* + deposited iron (mg).

For patients weighing less than 35 kg: normal Hb level = 130 g/l, amount of deposited iron = 15 mg/kg body weight.

For patients weighing more than 35 kg: normal Hb level = 150 g/l, amount of deposited iron = 500 mg.

*Coefficient 0.24 = 0.0034×0.07×1000 (iron content in Hb=0.34%; blood volume = 7% of body weight; coefficient 1000 = conversion from “g” to “mg”).

The total volume (ml) of Venofer® that must be administered = total iron deficiency (mg)/20 mg/ml (Tables 1 and 2).

Table 1

Body weight (kg)	Cumulative therapeutic dose of Venofer® for administration
	Hb 60 g/l		Hb 75 g/l
	mg Fe	ml	mg Fe	ml
5	160	8	140	7
10	320	16	280	14
15	480	24	420	21
20	640	32	560	28
25	800	40	700	35
30	960	48	840	42
35	1260	63	1140	57
40	1360	68	1220	61
45	1480	74	1320	66
50	1580	79	1400	70
55	1680	84	1500	75
60	1800	90	1580	79
65	1900	95	1680	84
70	2020	101	1760	88
75	2120	106	1860	93
80	2220	111	1940	97
85	2340	117	2040	102
90	2440	122	2120	106

table 2

Body weight (kg)	Cumulative therapeutic dose of Venofer® for administration
	Hb 90 g/l		Hb 105 g/l
	mg Fe	ml	mg Fe	ml
5	120	6	100	5
10	240	12	220	11
15	380	19	320	16
20	500	25	420	21
25	620	31	520	26
30	740	37	640	32
35	1000	50	880	44
40	1080	54	940	47
45	1140	57	980	49
50	1220	61	1040	52
55	1300	65	1100	55
60	1360	68	1140	57
65	1440	72	1200	60
70	1500	75	1260	63
75	1580	79	1320	66
80	1660	83	1360	68
85	1720	86	1420	71
90	1800	90	1480	74

In cases where the total therapeutic dose exceeds the maximum permissible single dose, split administration of the drug is recommended. If after 1–2 weeks. after starting treatment with Venofer®, there is no improvement in hematological parameters, it is necessary to reconsider the initial diagnosis.

Dose calculation for replenishing iron levels after blood loss or autologous blood donation

The dose of Venofer® is calculated using the following formula:

If the amount of blood lost is known: intravenous administration of 200 mg of iron (10 ml of Venofer®) leads to the same increase in Hb concentration as the transfusion of 1 unit of blood (= 400 ml with Hb concentration = 150 g/l).

The amount of iron that needs to be replenished (mg) = the number of units of blood lost × 200 or the required volume of Venofer® (ml) = the number of units of blood lost × 10.

If Hb levels decrease: the previous formula should be used, provided that the iron depot does not need to be replenished.

The amount of iron (mg) that needs to be replenished = body weight (kg) × 0.24 × [normal Hb level - patient Hb level] (g/l).

For example: body weight 60 kg, Hb deficiency = 10 g/l: the required amount of iron is approximately 150 mg, and the required volume of Venofer® = 7.5 ml.

Standard dose

Adults and elderly patients are prescribed 5-10 ml of Venofer® (100-200 mg iron) 1-3 times a week, depending on the hemoglobin level.

There are only limited data on the use of the drug in children under 3 years of age. If necessary, it is recommended to administer no more than 0.15 ml of Venofer® (3 mg iron) per kg of body weight 1-3 times a week, depending on the hemoglobin level.

Maximum tolerated single dose

Adults and elderly patients: for jet administration - 10 ml of Venofer® (200 mg iron), duration of administration of at least 10 minutes; for drip administration, depending on the indications, a single dose can reach 500 mg of iron. The maximum permissible single dose is 7 mg/kg and is administered once a week, but it should not exceed 500 mg of iron. The time of administration of the drug and the method of dilution are as indicated above.

Storage conditions

The drug should be stored out of the reach of children, in its original packaging, at a temperature of 4° to 25°C; do not freeze.

Best before date

3 years.
Do not use after the expiration date. Shelf life after dilution with saline: chemical and physical stability after dilution at room temperature is 12 hours. From a microbiological point of view, the drug should be used immediately. If the drug is not used immediately after dilution, the user is responsible for the conditions and storage time, which in any case should not exceed 3 hours at room temperature if the dilution was carried out under controlled and guaranteed aseptic conditions.

special instructions

Venofer® should be prescribed only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data (for example, the results of determining serum ferritin or hemoglobin and hematocrit levels, the number of erythrocytes and their parameters - the average volume of an erythrocyte, the average hemoglobin content in an erythrocyte).

IV iron supplements may cause allergic or anaphylactoid reactions, which can be potentially life-threatening.

The rate of administration of Venofer® should be strictly observed (with rapid administration of the drug, blood pressure may decrease). A higher incidence of undesirable side effects (especially decreased blood pressure), which can also be severe, is associated with an increase in dose. Therefore, the recommended dosing time should be strictly followed, even if the patient is not receiving the drug at the maximum tolerated single dose.

Studies conducted in patients with hypersensitivity reactions to iron dextran showed no complications during treatment with Venofer®.

Penetration of the drug into the perivenous space should be avoided, because Venofer entering outside the vessel leads to tissue necrosis and brown discoloration of the skin. If this complication develops, to accelerate the removal of iron and prevent its further penetration into surrounding tissues, it is recommended to apply heparin-containing drugs to the injection site (gel or ointment is applied with light movements, without rubbing).

From a microbiological point of view, the drug should be used immediately.

Description

Hematopoiesis stimulating iron drug.

Pharmacodynamics

Iron supplement. The polynuclear iron(III) hydroxide centers are surrounded on the outside by many non-covalently bound sucrose molecules. As a result, a complex is formed, the molecular weight of which is approximately 43 kDa, as a result of which it is impossible to excrete it unchanged by the kidneys. This complex is stable and does not release iron ions under physiological conditions. The iron in this complex is bound to structures similar to natural ferritin.

Side effects

Side effects likely related to the administration of Venofer® were observed very rarely (<0.01% and ≥0.001%).

From the nervous system: dizziness, headache, loss of consciousness, paresthesia.

From the cardiovascular system: palpitations, tachycardia, decreased blood pressure, collapsed states, feeling of heat, “flushes” of blood to the face.

From the respiratory system: bronchospasm, shortness of breath.

From the digestive system: diffuse abdominal pain, pain in the epigastric region, diarrhea, taste disturbance, nausea, vomiting.

From the skin: erythema, itching, rash, pigmentation disorders, increased sweating.

From the musculoskeletal system: arthralgia, back pain, joint swelling, myalgia, pain in the extremities.

Allergic reactions: anaphylactoid reactions, facial swelling, laryngeal swelling.

Local reactions: pain and swelling at the injection site (especially if the drug enters extravasally).

General disorders: asthenia, chest pain, feeling of heaviness in the chest, weakness, peripheral edema, feeling of malaise, pallor, fever, chills.

Use during pregnancy and breastfeeding

Contraindicated in the first trimester of pregnancy.

Limited experience with the use of Venofer® in pregnant patients has shown the absence of undesirable effects of iron sucrose on the course of pregnancy and the health of the fetus/newborn. To date, there have been no well-controlled studies in pregnant women. Experimental studies of the effect on reproduction in animals did not reveal direct or indirect harmful effects on the development of the embryo/fetus, childbirth or postnatal development. However, further study of the relationship between the expected benefit of therapy for the mother and the possible risk for the fetus is required.

It is unlikely that unmetabolized iron sucrose passes into breast milk. Thus, Venofer® does not pose a danger to breastfed infants.

Interaction

The drug should not be prescribed simultaneously with dosage forms of iron for oral administration, because absorption of iron from the gastrointestinal tract decreases. Treatment with oral iron supplements can be started no earlier than 5 days after the last injection.

Pharmaceutical interactions

Venofer® can be mixed in one syringe only with saline solution. No other IV solutions or therapeutic agents may be added due to the risk of precipitation and/or other pharmaceutical interactions. Compatibility with containers made of materials other than glass, polyethylene and polyvinyl chloride has not been studied.

Overdose

Symptoms: hemosiderosis due to acute overload.

Treatment: symptomatic therapy is recommended and, if necessary, the use of drugs that bind iron (chelates), for example, intravenous deferoxamine.

Impact on the ability to drive vehicles and operate machinery

It is unlikely that the drug Venofer® may have an undesirable effect on the ability to drive vehicles and operate machinery.

Venofer

Venofer is a drug for the treatment of iron deficiency anemia and preanemic conditions. Intended for intravenous administration. Used:

• if it is necessary to quickly compensate for iron deficiency;

• in patients who poorly tolerate tablet forms of iron, as well as with poor adherence to treatment;

• in cases where the patient has an acute inflammatory process in the gastrointestinal tract, when tablet forms of iron are ineffective.

The production process of Venofer (the drug is produced in Switzerland by Vifor International Inc.) is so complex that reproducing its pharmacotherapeutic characteristics and safety profile is currently not possible. In other words, there are no generics (pharmaceutical copies) of Venofer - this is the only drug of its kind. On the outside, the polynuclear centers of ferric hydroxide are surrounded by molecules of the disaccharide sucrose. The molecular weight of this complex is so large that in this form its elimination by the kidneys is impossible. The complex is characterized by high stability and does not release iron ions under physiological (as opposed to artificial, laboratory) conditions. The retention of iron in this complex is ensured by structures similar to ferritin, a complex protein complex that functions as the main intracellular iron depot in the human body. The peak concentration of iron in the blood is reached 10 minutes after intravenous injection.

The half-life of the drug is 6 hours. Venofer is contraindicated in cases of non-iron deficiency anemia, excessive iron deposits in organs and tissues of various etiologies, individual intolerance to the drug, and in the first trimester of pregnancy. Intramuscular administration of Venofer is unacceptable. Before using the drug for the first time, it is necessary to check its tolerance to the body, for which the so-called drug is administered. test dose. If there are no reactions of individual intolerance during the monitoring period, the drug can be prescribed for further use. Before administration, it is necessary to ensure that there are no mechanical damage or sediment at the bottom of the ampoule. The presence of sediment is unacceptable; such a solution cannot be used. If there is no clinical improvement after 7-14 days of using the drug, it is necessary to re-diagnose the possible causes of iron deficiency. The prescription of Venofer is justified only when the diagnosis of iron deficiency anemia is based on appropriate laboratory parameters. The drug is administered slowly, because otherwise, you can provoke a sharp increase in blood pressure. Too high a dose of the drug, on the contrary, can cause a decrease in blood pressure. The drug should be injected directly into a vein, because its entry into the perivenous space can cause tissue necrosis.