Ferinject solution for injection 50mg / ml, 10ml No. 1

• Iron deficiency anemia when oral iron supplements are ineffective or cannot be used.
  The diagnosis must be confirmed by laboratory tests.

The calculation of the dose of the FerinjectЃ drug is carried out on the basis of the following step-by-step approach: determination of the individual need for iron, calculation and prescription of the dose (doses) of iron, assessment of the saturation of the patient's body with iron after administration.

Step 1. Determining the individual need for iron

The individual need for iron to be replenished with FerinjectЃ is determined based on the patient's body weight and hemoglobin level. To determine the need for iron, you should use the table. (in the instructions attached to the preparation)

Iron deficiency must be confirmed by laboratory tests.

Determining the iron requirement in overweight patients should be based on the normal ratio of body weight to blood volume.

Step 2. Calculation and appointment of the maximum individual dose (s) of iron

Based on the need for iron, determined in the way described above, it is necessary to enter the appropriate dose (s) of FerinjectЃ, taking into account the following conditions:

• with a single administration of FerinjectЃ, the following levels should not be exceeded:

  • 15 mg iron / kg body weight (when administered as an intravenous injection) or 20 mg iron / kg body weight (when administered as an intravenous infusion);

  • 1000 mg of iron (20 ml of FerinjectЃ).

• the maximum recommended total dose of FerinjectЃ is 1000 mg of iron (20 ml of FerinjectЃ) per week.

Step 3. Assessment of the patient's body saturation with iron after administration

After iron levels have been replenished, regular assessments should be made to ensure that iron levels have returned to normal and are maintained at the proper level. Reassessment of iron levels should be performed by a clinical specialist based on the individual condition of the patient. The assessment of the hemoglobin level should be carried out no earlier than 4 weeks after the last use of the FerinjectЃ drug, in order to give sufficient time for erythropoiesis and the absorption of iron. If the patient needs further replenishment of iron stores in the body, then the iron requirement must be re-calculated using the data in the table above to determine the iron requirement.

The single maximum daily dose in hemodialysis patients with chronic kidney disease should not exceed 200 mg of iron.

Mode of application

The drug is administered intravenously - jet or drip (infusion) and by direct injection into the venous section of the dialysis system. FerinjectЃ should not be used subcutaneously or intramuscularly.

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

FerinjectЃ should be used in departments that have the necessary equipment to provide emergency medical care in the event of anaphylactic reactions. Each patient should be observed for the development of signs or symptoms of hypersensitivity reactions for at least 30 minutes after each administration of a solution of iron carboxymaltose (see section 'Special instructions').

IV jet injection

FerinjectЃ can be administered intravenously undiluted. The maximum single dose is 15 mg of iron / kg of body weight, but should not exceed 1000 mg of iron (20 ml of FerinjectЃ).

IV infusion

FerinjectЃ can be administered intravenously (infusion) in a maximum single dose of up to 1000 mg of iron (maximum 20 mg of iron / kg of body weight). Do not enter intravenously drip (infusion) 1000 mg of iron (20 ml of FerinjectЃ) more than 1 time per week.

Immediately before the infusion administration, the drug must be diluted with a sterile 0.9% sodium chloride solution for injection in the proportions indicated in the table.

1 ml of the preparation contains:
active substance:
iron carboxymaltose 156Ц208 mg;
equivalent to an iron content of 50 mg;
excipients: sodium hydroxide / hydrochloric acid to pH 5.0-7.0; water for injection up to 1 ml.

FerinjectЃ is supplied as a non-dextran / dextran-free formulation.

• Hypersensitivity to a complex of iron carboxymaltose, a solution of iron carboxymaltose, or to any of the components of the drug;

• Anemia not associated with iron deficiency, such as other microcytic anemia;

• Signs of iron overload or impaired iron utilization;

• Children under the age of 14.

Carefully

In patients with impaired liver function, iron can be used parenterally only after a careful assessment of the balance of benefits and risks. It is necessary to avoid parenteral administration of iron in patients with impaired liver function, if iron overload can accelerate the course of the disease, especially with tardive cutaneous porphyria. Careful monitoring of iron status is recommended to avoid iron overload.
There are no data on safe use in patients with chronic kidney disease who are on hemodialysis and receiving 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 allergies.
It is recommended to discontinue the use of FerinjectЃ in patients with ongoing bacteremia. In patients with chronic infection, the risks and benefits of therapy must be weighed against the inhibited erythropoiesis caused by chronic infection.
One milliliter of the drug contains up to 5.5 mg of sodium. This must be considered for patients on a sodium controlled diet.
The use of FerinjectЃ has not been studied in children under 14 years of age.

Tradename:

FerinjectЃ (FerinjectЃ)

International non-proprietary name or group name:

iron carboxymaltose

Dosage form:

intravenous solution

Composition

1 ml of the preparation contains:
active substance:
iron carboxymaltose 156Ц208 mg;
equivalent to an iron content of 50 mg;
excipients: sodium hydroxide / hydrochloric acid to pH 5.0-7.0; water for injection up to 1 ml.

FerinjectЃ is supplied as a non-dextran / dextran-free formulation.

Description

An opaque, dark brown solution.

Pharmacotherapeutic group

Iron preparation.

ATX code:

¬03ј—

Pharmacological properties

Pharmacodynamics
FerinjectЃ, solution for intravenous administration, contains trivalent iron in a stable form in the form of an iron complex, consisting of a multinucleated iron-hydroxide core with a carbohydrate ligand. Due to the high stability of the complex, only a very small amount of loosely bound iron (also called labile or free iron) exists. The complex is designed to provide a controlled source of utilizable iron for the body's iron-transporting and iron-depositing proteins (transferrin and ferritin, respectively).
Clinical studies have shown that the hematological response and filling of the iron depot occurs faster after intravenous administration of FerinjectЃ in comparison with oral analogues.
Utilization of 59Fe and 52Fe by erythrocytes from the radioactively labeled FerinjectЃ preparation varied from 61% to 99%. After 24 days, in patients with iron deficiency, the utilization of radioactively labeled iron was noted from 91% to 99%, and in patients with anemia of renal genesis, the utilization of radioactively labeled iron was from 61% to 84%.
Pharmacokinetics
It was shown that 59Fe and 52Fe from the FerinjectЃ preparation were rapidly excreted from the blood and moved to the bone marrow, as well as deposited in the liver and spleen.
After a single administration of the drug at a dose of 100 to 1000 mg of iron in patients with iron deficiency, the maximum concentration of serum iron from 37 ?g / ml to 333 ?g / ml was reached 15 minutes - 1.21 hours after injection, respectively.
The volume of distribution of the central chamber corresponds to the volume of plasma (about 3 liters).
After injection or infusion, iron was rapidly excreted from the blood plasma, the half-life varied from 7 to 12 hours, and the average residence time of the drug was from 11 to 18 hours. Excretion of iron by the kidneys is negligible.

Indications for use

• Iron deficiency anemia when oral iron supplements are ineffective or cannot be used.
  The diagnosis must be confirmed by laboratory tests.

Contraindications

• Hypersensitivity to a complex of iron carboxymaltose, a solution of iron carboxymaltose, or to any of the components of the drug;

• Anemia not associated with iron deficiency, such as other microcytic anemia;

• Signs of iron overload or impaired iron utilization;

• Children under the age of 14.

Carefully

In patients with impaired liver function, iron can be used parenterally only after a careful assessment of the balance of benefits and risks. It is necessary to avoid parenteral administration of iron in patients with impaired liver function, if iron overload can accelerate the course of the disease, especially with tardive cutaneous porphyria. Careful monitoring of iron status is recommended to avoid iron overload.
There are no data on safe use in patients with chronic kidney disease who are on hemodialysis and receiving 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 allergies.
It is recommended to discontinue the use of FerinjectЃ in patients with ongoing bacteremia. In patients with chronic infection, the risks and benefits of therapy must be weighed against the inhibited erythropoiesis caused by chronic infection.
One milliliter of the drug contains up to 5.5 mg of sodium. This must be considered for patients on a sodium controlled diet.
The use of FerinjectЃ has not been studied in children under 14 years of age.

Application during pregnancy and during breastfeeding

Pregnancy There are no
data on the use of the drug during pregnancy. The drug should be used during pregnancy only if the potential benefit to the mother outweighs the risk to the fetus. If the benefits of treatment with FerinjectЃ are less than the potential risk to the fetus, it is recommended to limit therapy in the second and third trimester.
Breastfeeding period
There is little experience with the use of the drug in breastfeeding mothers. Clinical studies have shown that the intake of iron from FerinjectЃ in breast milk is insignificant (less than 1%). Based on the limited data on breastfeeding women, it is unlikely that the drug is harmful to breastfed babies.

Intravenous - jet or drip (infusion) and by direct injection into the venous section of the dialysis system.
Before use, the vials should be inspected for possible sediment and damage. You can only use a homogeneous solution without sediment.
FerinjectЃ should be used in departments that have the necessary equipment to provide emergency medical care in the event of anaphylactic reactions. Each patient should be observed for the development of signs or symptoms of hypersensitivity reactions for at least 30 minutes after each administration of a solution of iron carboxymaltose (see section 'Special instructions').

Intravenous infusion:
FerinjectЃ can be administered by intravenous drip (infusion) in a maximum single dose of up to 1000 mg of iron (maximum 20 mg of iron / kg of body weight). Do not inject 1000 mg of iron (20 ml FerinjectЃ) more than 1 time per week by intravenous drip (infusion). Immediately before the infusion administration, the drug must be diluted with a sterile 0.9% sodium chloride solution for injection in the proportions indicated in the table. (in the attached instructions for the preparation)

Determining the iron requirement in overweight patients should be based on the normal ratio of body weight to blood volume.
Patients with an Hb value of ?14 g / dL should receive an initial dose of 500 mg of iron, and iron levels should be checked before subsequent administration.
After replenishment, regular assessments should be performed to ensure that iron levels have returned to normal and are maintained at the proper level.
Maximum tolerated 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. The dose of 1000 mg iron (20 ml) should not be administered more than once a week.
Use of the drug for chronic kidney disease requiring hemodialysis
Do not exceed the maximum daily dose of 200 mg in patients with chronic kidney disease requiring hemodialysis

Side effect

The adverse reactions presented below are listed in accordance with the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10000 and <1 / 1000), very rare (<1/10000, including isolated cases), the frequency is unknown.

The following adverse reactions were reported, identified during clinical trials, in which the drug FerinjectЃ was taken by more than 8000 patients, as well as reactions that were reported in the post-marketing period.

From the immune system: infrequently - hypersensitivity; rarely - anaphylactic / anaphylactoid reactions.

From the side of metabolism: often - hypophosphatemia.

From the nervous system: often - headache, dizziness; infrequently - paresthesia, taste distortion; frequency unknown - loss of consciousness 1.

Mental disorders: rarely - anxiety 2.

From the side of the cardiovascular system: often - 'rush' of blood to the face, arterial hypertension; infrequently - tachycardia, arterial hypotension; rarely - phlebitis, fainting2, light-headedness2; frequency unknown - Kounis syndrome1.

From the respiratory system: infrequently - shortness of breath; rarely - bronchospasm 2.

From the digestive system: often - nausea; infrequently - vomiting, indigestion, abdominal pain, constipation, diarrhea; rarely - bloating.

On the part of the skin and subcutaneous tissues: infrequently - itching, urticaria, erythema, skin rash3; rarely - angioedema2, pallor2; frequency unknown - facial edema 1.

From the musculoskeletal system: infrequently - myalgia, back pain, joint pain, pain in the limbs, muscle cramps.

General disorders and disorders at the injection site: often - reactions in the area of ??injection / infusion4; infrequently - fever, weakness, chest pain, peripheral edema, chills; rarely - malaise, flu-like condition (may occur over a period of time ranging from several hours to several days) 2.

Laboratory and instrumental data: infrequently - an increase in the activity of ALT in the blood, an increase in the activity of AST in the blood, an increase in the activity of GGT in the blood, an increase in the activity of LDH in the blood, an increase in the activity of ALP in the blood.

The most common adverse reaction is nausea, occurring in 2.9% of patients, followed by injection / infusion site reactions, hypophosphatemia, headache, flushing, dizziness, and hypertension. Injection / infusion site reactions include several adverse reactions that are individually infrequent or rare.

For participants in clinical trials who showed a decrease in serum phosphorus levels, troughs were obtained after about 2 weeks, and in most cases returned to baseline values ??12 weeks after treatment with FerinjectЃ. The most serious adverse reactions are anaphylactoid / anaphylactic reactions, the frequency of which is estimated to be rare (see section 'Special instructions').

1 Adverse reactions that were observed exclusively in the post-marketing period: the frequency of occurrence is assessed as rare.
2 Adverse reactions that were noted both in the post-marketing period and in clinical studies.
3 Including adverse reactions indicated by the following preferred terms: skin rash (the individual frequency of this adverse reaction is estimated as infrequent) and erythematous rash, generalized, macular, maculopapular, itching (the individual frequency of all adverse reactions is estimated as rare).
4 Including, but not limited to, adverse reactions denoted by the following preferred terms: pain at the injection site, hematoma, discoloration of the skin, extravasation, irritation, reaction at the injection site (an individual frequency of all adverse reactions is assessed as infrequent) and paresthesia (an individual frequency of an adverse reaction estimated as rare).

special instructions

The drug is not intended for intramuscular or subcutaneous administration.

Each bottle of FerinjectЃ is intended for single use only.

FerinjectЃ should be prescribed only to those patients in whom the diagnosis of anemia is confirmed by appropriate laboratory data.

Hypersensitivity reactions

Parenterally administered iron preparations can cause hypersensitivity reactions, including anaphylactoid reactions, which can be fatal, therefore appropriate means for cardiopulmonary resuscitation should be available. If during the use of the drug there are hypersensitivity reactions or signs of intolerance, you must immediately stop treatment.

The risk of hypersensitivity reactions to FerinjectЃ is increased in patients with allergic reactions, including allergic reactions to drugs, as well as a history of severe asthma, eczema or other atopic allergic reaction.

“акже существует повышенный риск реакций гиперчувствительности на парентеральные комплексы железа у пациентов с иммунными или воспалительными состо¤ни¤ми (например, системна¤ красна¤ волчанка, ревматоидный артрит).

—ообщалось о реакци¤х гиперчувствительности после предшествующих неосложненных введений любых комплексов парентерального железа, в т.ч. железа карбоксимальтозата.  аждого пациента следует наблюдать на предмет развити¤ нежелательных реакций в течение как минимум 30 мин после каждого введени¤ препарата ‘еринжектЃ.

vипофосфатеми¤

¬водимые парентерально препараты железа могут вызывать гипофосфатемию, котора¤ в большинстве случаев ¤вл¤етс¤ кратковременной и протекает без клинических симптомов. Ѕыли отмечены отдельные случаи гипофосфатемии, при которых требовалось медицинское вмешательство, главным образом у пациентов с наличием факторов риска и после продолжительного лечени¤ железом, вводимым в/в в высоких дозах.

ѕеченочна¤ и почечна¤ недостаточность

” пациентов с дисфункцией печени парентеральные препараты железа следует примен¤ть только после тщательной оценки пользы/риска. —ледует избегать введени¤ парентеральных препаратов железа у пациентов с дисфункцией печени, когда перегрузка железом ¤вл¤етс¤ провоцирующим фактором возникновени¤ поздней кожной порфирии (ѕ ѕ). “щательный мониторинг статуса железа позволит избежать перегрузки железом.

ќтсутствуют данные по безопасному применению у пациентов с хроническим заболеванием почек, наход¤щихс¤ на гемодиализе и получающих однократные дозы более 200 мг железа.

»нфекции

ѕарентеральное железо необходимо примен¤ть с осторожностью в случае острой или хронической инфекции, астмы, экземы или атопических аллергий. –екомендуетс¤ прекратить терапию препаратом ‘еринжектЃ у пациентов с продолжающейс¤ бактериемией. ” пациентов с хроническими инфекци¤ми необходимо выполнить тщательную оценку пользы/риска, принима¤ во внимание возможность угнетени¤ эритропоэза (вследствие хронической инфекции).

Ќеобходимо соблюдать осторожность при в/в введении препарата ‘еринжектЃ, чтобы не допустить проникновение препарата в околовенозное пространство, т.к. это может вызвать раздражение кожи и возможное длительное окрашивание тканей в месте введени¤ в коричневый цвет. ѕри проникновении препарата в околовенозное пространство введение препарата ‘еринжектЃ следует немедленно прекратить.

ќдин миллилитр неразведенного препарата ‘еринжектЃ содержит до 5.5 мг (0.24 ммоль) натри¤. Ёто необходимо учитывать в отношении пациентов, наход¤щихс¤ на диете с контролируемым употреблением натри¤.

»спользование в педиатрии

ѕрименение препарата ‘еринжектЃ не исследовалось у детей в возрасте до 14 лет.

¬ли¤ние на способность к управлению транспортными средствами и механизмами

ќтсутствуют данные о вли¤нии препарата на способность управл¤ть транспортными средствами и механизмами. ќднако некоторые побочные действи¤ (такие, как головокружение, обморок, предобморочное состо¤ние и другие (см. раздел 'ѕобочное действие')) могут вли¤ть на способность управл¤ть транспортными средствами и механизмами. ѕациентам, отмечающим у себ¤ данные побочные действи¤, следует рекомендовать не управл¤ть транспортными средствами и механизмами до полного исчезновени¤ указанных симптомов.

ѕередозировка

?елеза карбоксимальтозат в препарате ‘еринжектЃ обладает низкой токсичностью. ѕрепарат хорошо переноситс¤; риск случайной передозировки минимален.

—имптомы: введение препарата ‘еринжектЃ в количестве, превышающем потребности организма, может привести к накоплению железа в местах его хранени¤ (депо), что, в конечном итоге, приводит к гемосидерозу. ћониторинг таких показателей обмена железа, как сывороточный ферритин и процент насыщени¤ трансферрина, может помочь в диагностике чрезмерного накоплени¤ железа в организме.

Ћечение: в случае накоплени¤ железа, необходимо проводить лечение в соответствии со стандартами медицинской практики, например, рассмотреть возможность применени¤ хелатных средств дл¤ св¤зывани¤ железа.

Ћекарственное взаимодействие

“акже как и любые другие парентеральные препараты железа, ‘еринжектЃ уменьшает всасывание железа из ? “ при одновременном применении с препаратами железа дл¤ приема внутрь. ѕоэтому, при необходимости, терапию пероральными препаратами железа следует начинать не ранее чем через 5 дней после последней инъекции препарата ‘еринжектЃ.

‘армацевтическа¤ совместимость

‘еринжектЃ совместим только с 0.9% раствором натри¤ хлорида. Ќикакие другие в/в растворы и лекарственные вещества не следует вводить, поскольку существует потенциальный риск выпадени¤ осадка и/или взаимодействи¤.

”слови¤ хранени¤

ѕрепарат следует хранить в оригинальной упаковке в недоступном дл¤ детей месте при температуре не выше 30?C. Ќе замораживать.

—рок годности

—рок годности - 3 года. Ќе примен¤ть по истечении срока годности, указанного на упаковке.

”слови¤ реализации

The drug is available with a prescription.

Contacts for inquiries

VIFOR (INTERNATIONAL) INC.