Buy Ferinject (Injectafer)

The following adverse reactions have been reported from clinical trials in which more than 8,000 patients took Ferinject, as well as reactions reported in the post-marketing period.

The frequency of occurrence is defined 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 rarely (<1/10000, including individual cases), the frequency is unknown.

 

• From the digestive system: often - nausea; infrequently - vomiting, dyspepsia, abdominal pain, constipation, diarrhea; rarely - bloating.
• From the side of metabolism: often - hypophosphatemia.
• From the nervous system: often - headache, dizziness; infrequently - paresthesia, taste distortion; frequency unknown - loss of consciousness.
• From the side of the immune system: infrequently - hypersensitivity; rarely - anaphylactic / anaphylactoid reactions.
• Mental disorders: rarely - anxiety.
• From the side of the cardiovascular system: often - a "rush" of blood to the face, arterial hypertension; infrequently - tachycardia, arterial hypotension; rarely - phlebitis, syncope, pre-syncope state; frequency unknown - Kounis syndrome.
• From the respiratory system: infrequently - shortness of breath; rarely - bronchospasm.
• From the side of the skin and subcutaneous tissues: infrequently - pruritus, urticaria, erythema, skin rash; rarely - angioedema, pallor; frequency unknown - swelling of the face.
• From the musculoskeletal system: infrequently - myalgia, back pain, joint pain, pain in the extremities, muscle cramps.
• General disorders and disorders at the injection site: often - reactions at the injection / infusion site; infrequently - fever, weakness, chest pain, peripheral edema, chills; rarely - malaise, flu-like condition (may occur after a period of time ranging from several hours to several days).
• 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 alkaline phosphatase in the blood.

Overdose

The iron carboxymaltose in Ferinject has low toxicity. The drug is well tolerated; the risk of accidental overdose is minimal.

Symptoms: the introduction of the drug Ferinject in an amount exceeding the needs of the body can lead to the accumulation of iron in places of its storage (depot), which ultimately leads to hemosiderosis. Monitoring of indicators of iron metabolism, such as serum ferritin and percentage of transferrin saturation, can help in the diagnosis of excessive accumulation of iron in the body. Treatment: In case of iron accumulation, treatment should be carried out in accordance with standard medical practice, for example, consideration should be given to the use of chelating agents to bind iron.

• Hypersensitivity to iron carboxymaltose complex, iron carboxymaltose solution, or 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 14 years of age.

Carefully

The drug should be used with caution in patients with hepatic and renal insufficiency, acute or chronic infection, asthma, eczema or atopic dermatitis (see section "Special Instructions").

It is recommended to control the use of the drug Ferinject in pregnant women (II-III trimesters).

The calculation of the dose of the drug Ferinject is carried out on the basis of the following step-by-step approach: determining the individual need for iron, calculating and prescribing the dose (doses) of iron, assessing the saturation of the patient's body with iron after administration.

Step 1: Determining Your Individual Iron Need The individual iron requirement for replenishment with Ferinject is determined based on the patient's body weight and hemoglobin level. Use the table below to determine your iron requirement.

Table 1. Determination of iron requirements.

Hemoglobin	Patient's body weight

g/dl	mmol/l	< 35 kg	35 to 70 kg	≥70 kg
<10	<6.2	500 mg	1500 mg	2000 mg
10 to <14	6.2 to <8.7	500 mg	1000 mg	1500 mg
≥14	≥8.7	500 mg	500 mg	500 mg

Iron deficiency must be confirmed by laboratory tests.

When determining the need for iron in overweight patients, it should be based on the normal ratio of body weight and blood volume.

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

Based on the iron requirement determined as described above, the appropriate dose(s) of Ferinject should be administered, taking into account the following conditions:

• with a single administration of Ferinject, the following levels should not be exceeded: ​​​​​​​1.15 mg iron/kg body weight (when administered as an intravenous injection) or 20 mg iron/kg body weight (when administered as an intravenous infusion); 2.1000 mg of iron (20 ml of Ferinject).
• The maximum recommended total dose of Ferinject is 1000 mg of iron (20 ml of Ferinject) per week.

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

Once iron levels are replenished, regular evaluations 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 patient's condition. Assessment of hemoglobin levels should be carried out no earlier than 4 weeks after the last use of the drug Ferinject, to allow sufficient time for erythropoiesis and iron absorption. If the patient needs further replenishment of the body's iron stores, then the iron requirement must be recalculated using the data from the above table to determine the need for iron.

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

Mode of application

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

Vials should be inspected for possible sediment and damage prior to use. Only a homogeneous solution without sediment can be used.

Ferinject should be used in departments that have the necessary equipment to provide emergency medical care in the event of an anaphylactic reaction. 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 jet injection

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

Table 2. The rate of administration of intravenous injection of the drug Ferinject.

Ferinject	Iron Equivalent Dose	Infusion Rate
>2 to 4 ml	>100 to 200 mg	No min administration time prescribed
>4 to 10 ml	>200 to 500 mg	100 mg iron/min
>10 to 20 ml	>500 to 1000 mg	1000 mg 15 min

Intravenous infusion

Ferinject can be administered by intravenous drip (infusion) at a maximum single dose of up to 1000 mg iron (maximum 20 mg iron/kg body weight). It is impossible to inject 1000 mg of iron (20 ml of Ferinject) intravenously (by infusion) more than 1 time per week. Immediately before infusion administration, the drug must be diluted with a sterile 0.9% sodium chloride solution for injection in the ratios indicated in the table below.

Table 3. Guidelines for the dilution of Ferinject for infusion.

Ferinject	Iron	Amount of 0.9% NaCl*	Min Time of Adm
>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 min

*To maintain the stability of the drug, dilution to concentrations of less than 2 mg iron / ml is not allowed (the volume of the Ferinject solution is not taken into account).

The drug is not intended for intramuscular or subcutaneous administration.

Each vial of Ferinject is for single use only one time.

Ferinject should only be used in patients in whom the diagnosis of anemia has been confirmed by appropriate laboratory data.

Hypersensitivity reactions

Parenteral iron preparations can cause hypersensitivity reactions, including anaphylactoid reactions, which can be fatal, so appropriate facilities for cardiopulmonary resuscitation must be available. If during the use of the drug there are hypersensitivity reactions or signs of intolerance, treatment should be stopped immediately.

The risk of hypersensitivity reactions to Ferinject 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.

There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis).

Hypersensitivity reactions have been reported after previous uncomplicated administration of any parenteral iron complexes, incl. iron carboxymaltose. Each patient should be observed for the development of adverse reactions for at least 30 minutes after each administration of Ferinject.

Hypophosphatemia

Parenteral iron preparations can cause hypophosphatemia, which in most cases is transient and occurs without clinical symptoms. There have been isolated cases of hypophosphatemia requiring medical intervention, mainly in patients with risk factors and after prolonged treatment with high-dose intravenous iron.

Liver and kidney failure

In patients with hepatic dysfunction, parenteral iron preparations should only be used after a careful benefit/risk assessment. Parenteral iron preparations should be avoided in patients with hepatic dysfunction when iron overload is a precipitating factor in cutaneous porphyria tardive (PKP). Careful monitoring of iron status will help avoid iron overload.

There are no data on safe use in patients with chronic kidney disease on hemodialysis and receiving single doses of more than 200 mg of iron.

Infections

Parenteral iron should be used with caution in cases of acute or chronic infection, asthma, eczema, or atopic allergies. It is recommended that Ferinject therapy be discontinued in patients with ongoing bacteremia. In patients with chronic infections, a careful benefit/risk assessment should be performed, taking into account the possibility of inhibition of erythropoiesis (due to chronic infection).

Care must be taken when administering Ferinject intravenously to prevent penetration of the drug into the perivenous space, because this may cause skin irritation and possible permanent brown discoloration of the tissues at the injection site. If the drug enters the perivenous space, the administration of Ferinject should be stopped immediately.

One milliliter of undiluted Ferinject contains up to 5.5 mg (0.24 mmol) sodium. This should be considered in patients on a controlled sodium diet.

Influence on the ability to drive vehicles and mechanisms

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, fainting, and others (see section "Side effects")) may affect the ability to drive vehicles and mechanisms. Patients experiencing these side effects should be advised not to drive vehicles and mechanisms until the symptoms disappear completely.

Pregnancy and lactation

There are limited data on the use of Ferinject in pregnant women. Treatment with the drug should be limited to the II and III trimester of pregnancy and only if the potential benefit to the mother outweighs the risk to the fetus. Iron deficiency in the first trimester of pregnancy in most cases can be treated with oral iron preparations. Animal studies have shown that parenteral iron can cross the placental barrier and affect fetal skeletal development. 

There is limited clinical experience with the drug during lactation. Clinical studies have shown that the intake of iron from the drug Ferinject in breast milk is negligible (less than 1%). Based on limited data on breastfeeding women, it is unlikely that the drug is dangerous for children who are breastfed.

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Due to Quarantine, delivery time may increase slightly, but still delivery remains within reasonable limits and does not exceed the delivery time during Christmas sales.

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You can legally buy Ferinject (Injectafer) our website without prescription! 

As well as any other parenteral iron preparations, Ferinject reduces the absorption of iron from the gastrointestinal tract when used simultaneously with iron preparations for oral administration. Therefore, if necessary, oral iron therapy should be started no earlier than 5 days after the last injection of Ferinject.

Pharmaceutical compatibility

Ferinject is only compatible with 0.9% sodium chloride solution. No other IV solutions or drugs should be administered as there is a potential risk of precipitation and/or interaction.