Ferinzhekt - instructions for use, dose, side effects, contraindications

Active substanceIron carboxymethyltosateIron carboxymethyltosate

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Ferinzhect®

solution in / in

Vifor (International) Inc. Switzerland

Dosage form: & nbsp

Solution for intravenous administration.

Composition:

1 ml of the preparation contains:

active substance:

iron carboxymethyltosate 156-208 mg;

equivalent to the content of iron - 50 mg;

Excipients:

sodium hydroxide / hydrochloric acid to pH 5.0-7.0;

water for injection up to 1 ml.

Ferinzhect® is supplied as a non-dextran / dextran-free drug.

Description:

Opaque solution of dark brown color.

Pharmacotherapeutic group:The iron preparation.

ATX: & nbsp

B.03.A.C Preparations of iron for parenteral use

Pharmacodynamics:

Ferinzhect®, a solution for intravenous administration, contains trivalent iron in stable form as an iron complex consisting of multinucleated iron-hydroxide nucleus with a carbohydrate ligand. Because of the high stability of the complex, there is only a very small amount of loosely bound iron (also called labile or free iron). The complex is designed to provide a controlled source of recycled iron for iron-transporting and iron-depositing body proteins (transferrin and ferritin, respectively).Clinical studies have shown that the hematologic response and the filling of the iron depot occurs more rapidly after intravenous administration of the Ferinhect® preparation as compared to the ingested analogues.

Disposal of erythrocytes ⁵⁹Fe and ⁵²Fe from the radiolabeled Ferinhect® drug ranged from 61% to 99%. After 24 days, iron-labeled iron utilization was 91% to 99% in patients with iron deficiency, and in patients with anemia of renal genesis, the utilization of radio-labeled iron ranged from 61% to 84%.

Pharmacokinetics:

It was shown that ⁵⁹Fe and ⁵²Fe from the preparation Ferinzhekt® quickly removed from the blood and moved to the bone marrow, and also deposited in the liver and spleen.

After a single dose of 100-1000 mg of iron in patients with iron deficiency, the maximum serum iron concentration from 37 μg / ml to 333 μg / ml was reached after 15 minutes - 1.21 hours after injection, respectively. The volume distribution of the central chamber corresponds to the volume of the plasma (about 3 liters).

Iron after injection or infusion was rapidly excreted from the plasma, the half-life period varied from 7 to 12 hours, the average time of drug stay was 11 to 18 hours. Excretion of iron by the kidneys is insignificant.

Indications:

Iron deficiency anemia in the case when oral iron preparations are ineffective or can not be used.

The diagnosis should be confirmed by laboratory tests.

Contraindications:

Hypersensitivity to iron complex of carboxymethyltosate, iron solution of carboxymethyltosate or to any of the components of the preparation;
Anemia not related to iron deficiency, for example, other microcytic anemia;
Signs of iron overload or disruption of iron utilization;
Children under the age of 14 years.

Carefully:

In patients with impaired liver function, iron can be administered parenterally only after a thorough assessment of the benefit-risk ratio. It is necessary to avoid the parenteral use of iron in patients with impaired liver function, if overloading with iron can accelerate the course of the disease, especially with late cutaneous porphyria. To avoid overloading with iron, careful monitoring of the status of iron is recommended.

There are no data on safe use in patients with chronic kidney disease who are on hemodialysis and who receive single doses of more than 200 mg of iron.It is necessary to use parenteral iron with caution in acute and chronic infections, bronchial asthma, eczema and atopic allergy.

It is recommended to stop using the drug Firinzhekt® in patients with ongoing bacteremia. In patients with chronic infection, all risks and benefits of therapy need to be weighed, taking into account depressed erythropoiesis caused by chronic infection.

One milliliter of the drug contains up to 5.5 mg of sodium. This should be taken into account for patients with a sodium-controlled diet.

Application of the preparation Ferinzhekt® was not studied in children under 14 years old.

Pregnancy and lactation:

Pregnancy

Data on the use of the drug during pregnancy are absent. Use the drug during pregnancy should be only if the potential benefit to the mother exceeds the risk to the fetus. If the benefits of treatment with Ferinhect® are less than the potential risk to the fetus, it is recommended that the therapy be limited to the second and third trimester.

Breastfeeding period

There is only a small experience of using the drug in breast-feeding mothers.Clinical studies have shown that the intake of iron from the drug Ferinhect® in breast milk is negligible (less than 1%). Based on limited data on breastfeeding women, it is unlikely that the drug is a danger to children who are breastfeeding.

Dosing and Administration:

Intravenous - jet or drip (infusion) and by direct injection into the venous section of the dialysis system.

Before use, inspect the vials for possible sediment and damage. You can use only a homogeneous solution without sediment.

Ferinzhekt® should be used in departments that have the necessary equipment for emergency medical care in the case of anaphylactic reactions. Each patient should be observed for signs or symptoms of hypersensitivity reactions for at least 30 minutes after each administration of the iron solution of carboxymethyltosate (see section "Specific guidance").

Intravenous infusion:

Ferinzhekt® can be administered intravenously drip (infusion) in the maximum single dose up to 1000 mg of iron (up to 20 mg of maximum iron / kg of body weight).You can not inject intravenously drip (infusion) 1000 mg of iron (20 ml Ferinzhekt®) more than 1 time a week. Immediately before the infusion introduction the preparation must be diluted with sterile 0.9% solution of sodium chloride for injection in the ratios indicated in the table:

Guidance for the dilution of the drug Ferinzhect® for infusion

Ferinzhect®	Iron	The amount of sterile 0.9% solution of sodium chloride for injection¹	Minimum time of administration
> 2 to 4 ml	> 100 to 200 mg	50 ml	-
> 4 to 10 ml	> 200 to 500 mg	100 ml	6 min.
> 10 to 20 ml	> 500 to 1000 mg	250 ml	15 minutes.

Note:

¹To maintain the stability of the drug, dilution to concentrations of less than 2 mg of iron / ml is not permitted (the volume of the drug solution of Ferinhect® not taken into account).

Injection Injection:

Ferinzhect® can be injected intravenously in a single dose up to 4 ml (200 mg of iron) per day, but not more than 3 times a week.

Determination of cumulative iron dose

The cumulative dose for replenishment of iron stores with iron carboxymethyltosate is determined based on the patient's body weight and hemoglobin level (Hb) and should not be exceeded. When determining the cumulative dose of iron, the table below should be used.

The cumulative dose of iron based on the patient's body weight and hemoglobin level (Hb)

Hb (g / dL)	Patients with a body weight of 35 to <70 kg	Patients with a body weight ≥ 70 kg
<10	1500 mg	2000 mg
≥10	1000 mg	1500 mg

Note: in patients with a body weight of less than 35 kg, a cumulative dose of 500 mg iron can not be exceeded.

In determining the need for iron in patients with excessive body weight should be based on the normal ratio of body weight and blood volume.

Patients with a value Hb ≥ 14 g / dl, an initial dose of 500 mg of iron should be administered and the iron content should be checked before further administration.

After replenishment, regular assessments should be made to make sure that the level of iron is normalized and maintained at the proper level.

Maximum tolerable single dose: A single dose of the drug should not exceed 1000 mg of iron (20 ml) per day or 20 mg of iron (0.4 ml) per kg of body weight. A dose of 1000 mg of iron (20 ml) can not be administered more than once a week.

The use of the drug in chronic kidney disease requiring hemodialysis

Do not exceed the maximum daily dose of 200 mg in patients with chronic kidney disease requiring hemodialysis.

Side effects:

Side effects from clinical trials (before and after drug registration, including safety studies after drug registration)

Side effects of the drug Ferinzhect®, observed in patients (n= 6755) according to clinical studies, are summarized in the table below. The most common side effect of the drug was nausea in patients who were observed with a frequency> 1/100, <1/10.

Side effects of the drug according to clinical studies

System or organ	Often (>1/100, <1/10)	Infrequently (> 1/1000, <1/100)	Rarely (>1/10000, <1/1000)
Immune system disorders	-	Hypersensitivity	Anaphylactoid reactions
Nervous system disorders	Headache, dizziness	Paresthesia, perversion of taste	-
Heart Dysfunction	-	Tachycardia	-
Vascular violations	Increase in blood pressure (BP)	Reduction of blood pressure, "tide" of blood to the face	-
Respiratory disorders, disorders in the thorax and mediastinum	-	Dyspnea	-
Disturbances of the gastrointestinal tract	Nausea	Vomiting, indigestion, abdominal pain, constipation, diarrhea	-
Disturbances from the skin and subcutaneous tissue	-	Itching, urticaria, erythema, rash¹	-
Disturbances in muscle tissue, skeleton and connective tissue	-	Myalgia, back pain, joint pain, muscle cramps	-
General disorders and complications at the site of drug administration	Reactions in the area of injection²	Fever, weakness, chest pain, peripheral swelling, pain, chills	Shiver, malaise
Research	Increased activity of alanine aminotransferase in the blood	An increase in the activity of aspartate-transferase in the blood, an increase in the activity of gamma-glutamyltransferase in the blood, an increase in lactate dehydrogenase activity in the blood, an increase in the activity of alkaline phosphatase in the blood	-
Metabolic and metabolic disorders	Hypophosphatemia	-	-

¹ Includes the following preferred terms: rash (the individual frequency of this unwanted drug reaction is estimated as infrequent) and erythematous rash, generalized, macular, maculopapular pruritus (the individual frequency of all unwanted drug reactions is estimated as rare).

² Includes the following preferred terms: burning sensation at the site of injection, pain, bruises, discoloration, extravasation, irritation,reaction (the individual frequency of all unwanted drug reactions is estimated as infrequent) and paresthesia (the individual frequency of the unwanted drug reaction is estimated as rare).

Spontaneous post-marketing reports of side effects

As part of the post-marketing control of the use of the drug Firinzhektk, the following serious side effects were observed:

Spontaneous post-marketing messages

System or organ	The most common symptoms¹
Nervous system disorders	Loss of consciousness and vertigo
Mental disorders	Anxiety
Cardiovascular disorders	Fainting, pre-fainting condition
Disturbances from the skin and subcutaneous tissue	Angioedema, dermatitis, pallor and swelling of the face
Respiratory disorders, disorders in the thorax and mediastinum	Bronchospasm

¹ The frequency is not defined, since the total number of patients taking the drug in postmarketing studies can not be accurately established.

Overdose:

The introduction of the drug Ferinhect in an amount exceeding the body's requirements, can cause an overload with iron, which manifests itself as symptoms of hemosiderosis.Determining such indicators of iron metabolism as serum ferritin and the percentage of transferrin saturation can help in the diagnosis of excessive deposition of iron in the body. If iron accumulation occurs, treatment should be performed in accordance with standard medical practice, for example, the use of a chelating agent for iron binding can be considered.

Interaction:

As well as any other parenteral preparations of iron, preparation Ferinzhekt® reduces absorption of iron from a gastroenteric path at simultaneous application with preparations of iron for intake.

Therefore, if necessary, oral iron therapy should begin no earlier than 5 days after the last injection of the drug Firinject.

Pharmaceutical compatibility: Firinzhekt® is compatible only with 0.9% sodium chloride solution. No other intravenous solutions and medicinal substances should be administered, since there is a potential risk of precipitation and / or interaction.

Special instructions:

The drug should not be used for intramuscular or subcutaneous administration.

Each vial of Ferinhect® is intended for single use only.

Firinzhect ® should be given only to patients who are diagnosed with anemia with appropriate laboratory data.

Parenterally administered iron preparations may cause hypersensitivity reactions, including anaphylactoid reactions, which can be fatal, and appropriate means should be available for cardiopulmonary resuscitation. If hypersensitivity reactions or signs of intolerance occur during the use of the drug, it is necessary to immediately stop treatment.

Also, hypersensitivity reactions have been reported after previous uncomplicated injections of any parenteral iron complexes, including iron carboxymethyltosate. Each patient should be monitored for the development of adverse reactions for a minimum of 30 minutes after each administration of the ferric iron carboxymethylate solution.

Care should be taken with intravenous administration of the drug to prevent penetration of the drug into the circumveneal area, as this can cause skin irritation and possible long-term staining of the tissues at the point of introduction into the brown color.When the drug penetrates into the circumveneous area, the drug should be discontinued immediately.

Effect on the ability to drive transp. cf. and fur:

There are no data on the effect of the drug on the ability to drive vehicles and mechanisms. However, some side effects (such as dizziness, fainting, anticipation, and others (see "Side Effects")) can affect the ability to drive vehicles and mechanisms. Patients who report these side effects should not be advised not to drive vehicles and mechanisms until the symptoms disappear completely.

Form release / dosage:

Solution for intravenous administration 50 mg / ml.

By 2 ml or 10 ml of the drug in bottles of clear, colorless glass type I (Ph.Eur.), Sealed with brombutyl rubber stoppers and crimped with aluminum caps with plastic inserts such as "Flip off".

1 bottle of 2 ml or 10 ml with instructions for use in a cardboard pack.

2 bottles of 10 ml in a plastic pallet holder together with instructions for use in a cardboard bundle.

5 vials of 2 ml or 10 ml in a plastic holder holder together with instructions for use in a cardboard bundle.

Packaging:

By 2 ml or 10 ml of the drug in bottles of clear, colorless glass type I (Ph.Eur.), Sealed with brombutyl rubber stoppers and crimped with aluminum caps with plastic inserts such as "Flip off".

1 bottle of 2 ml or 10 ml with instructions for use in a cardboard pack.

2 bottles of 10 ml in a plastic pallet holder together with instructions for use in a cardboard bundle.

5 vials of 2 ml or 10 ml in a plastic holder holder together with instructions for use in a cardboard bundle.

Storage conditions:

Store in the original packaging at a temperature not exceeding 30 ° C.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008848/10

Date of registration:30.08.2010

The owner of the registration certificate:Vifor (International) Inc.Vifor (International) Inc. Switzerland

Manufacturer: & nbsp

VIFOR (International), Inc. Switzerland

Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.

Information update date: & nbsp09.07.2014

Illustrated instructions

Instructions

Ferinzhect® (Ferinject®)