For I.V. use only
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10ml contains:
Ferric Carboxymaltose MS equivalent to Elemental Iron. 500mg
Solution for Injection / Infusion
Elinjec injection (Ferric Carboxymaltose)Uses:
Ferric carboxymaltose injection is primarily used to treat iron deficiency anemia in adults. Iron deficiency
anemia occurs when the body does not have enough iron to produce sufficient red blood cells. This can lead to symptoms such as fatigue, weakness, shortness of breath, and pale skin. Ferric carboxymaltose injection helps to replenish iron stores in the body and improve the symptoms of anemia.
is indicated for the treatment of iron deficiency when: Oral iron preparations are ineffective.
Oral iron preparations cannot be used. There is a clinical need to deliver iron rapidly.
The diagnosis of iron deficiency must be based on laboratory tests.
POSOLOGY AND METHOD OF ADMINISTRATION:
Posology: The posology follows a stepwise approach:
Step 1: Determination of the iron need: The individual iron need for repletion use is determined based on the patient’s body weight and hemoglobin (Hb) level.
Refer to the below table for a determination of the iron need:
Table: Determination of Iron need:
Hb Patient body weight
g/dL mmol/L below 35kg 35kg to <70kg 70kg and above
<10 <6.2 500mg 1,500mg 2,000mg
10 to <14 6.2 to <8.7 500mg 1,000mg 1,500mg
≥14 ≥8.7 500mg 500mg 500mg
The iron deficiency must be confirmed by laboratory tests.
Step 2: Calculation and administration of the maximum individual iron dose(s): Based on the iron need determined above the appropriate dose(s) of should be administered taking into consideration the following:
A single administration should not exceed:
15mg iron/kg body weight (for administration by intravenous injection) or 20mg iron/kg body weight (for administration by intravenous infusion).
The maximum recommended cumulative dose of is 1,000mg of iron (20mL ) per week.
Step 3: Post-iron repletion assessments:
Re-assessment should be performed by the clinician based on the individual patient’s condition.
The Hb level should be re-assessed no earlier than 4 weeks post-final administration to allow adequate time for erythropoiesis and iron utilization. In the event, the patient requires further iron repletion, the iron need should be recalculated.
Special Population–patients with hemodialysis-dependent chronic kidney disease: A single maximum daily dose of 200mg iron should not be exceeded in hemodialysis-dependent chronic kidney disease patients.
Pediatric population: The use of has not been studied in children, and therefore, is not recommended in children under 14 years.
Method of administration:
must only be administered by the intravenous route:
By injection or by infusion, or;
During a hemodialysis session undiluted directly into the venous limb of the dialyzer.
must not be administered by the subcutaneous or intramuscular route.
may be administered by intravenous injection using the undiluted solution. The maximum single dose is 15mg iron/kg body weight but should not exceed 1,000mg iron.
Administration rates for intravenous injection of.
The volume of required Equivalent iron dose Administration rate / Minimum administration time
2 to 4mL 100 to 200mg No minimal prescribed time
>4 to 10mL >200 to 500mg 100mg iron / min
>10 to 20mL >500 to 1,000mg 15 minutes
may be administered by intravenous infusion, in which case it must be diluted. The maximum single dose is 20mg iron/kg body weight, but should not exceed 1,000mg iron.
For infusion, must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in the below table.
Note: For stability reasons, should not be diluted to concentrations less than 2mg iron/mL (not including the volume of the ferric carboxymaltose solution). For further instructions on dilution of the medicinal product before administration, refer below table.
Dilution plan for intravenous infusion.
required Equivalent iron dose Maximum amount of sterile 0.9% m/V sodium chloride solution Minimum administration time
2 to 4mL 100 to 200mg 50mL No minimal prescribed time
>4 to 10mL >200 to 500mg 100mL 6 minutes
>10 to 20mL >500 to 1,000mg 250mL 15 minutes
Elinjec injection (Ferric Carboxymaltose)Side Effects:
The most commonly reported adverse drug reaction (ADR) is
Nausea, followed by injection/infusion site reactions,
dizziness, and hypertension.
Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare. The most serious ADR is anaphylactoid/anaphylactic reactions (rare); fatalities are known to be reported.
nausea, injection/infusion site reactions*.
Hypersensitivity, paraesthesia, dysgeusia, tachycardia, hypotension, dyspnoea, vomiting, dyspepsia, abdominal pain, constipation, diarrhea, pruritus, urticaria, erythema, rash**, myalgia, back pain, arthralgia, pain in extremity, muscle spasm, pyrexia, fatigue, chest pain, edema peripheral, chills, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased.
Anaphylactoid/anaphylactic reactions, anxiety, phlebitis, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, distant skin discoloration, malaise, influenza-like illness (whose onset may vary from a few hours to several days).
Frequency not known:
Loss of consciousness,
*Includes the following preferred terms: Rash (individual ADR determined to be uncommon) and rash erythematous, generalized, -macular, -maculo-papular, pruritic (all individual ADRs determined to be rare).
**Includes, but is not limited to, the following preferred terms: Injection/infusion site-pain, hematoma, discoloration, extravasation, irritation, reaction, (all individual ADRs determined to be uncommon) and paraesthesia (individual ADR determined to be rare).
Like any medication, ferric carboxymaltose injection can cause side effects. Common side effects include headache, dizziness, nausea, vomiting, diarrhea, constipation, and injection site reactions such as pain, swelling, or redness. These side effects are usually mild and go away on their own. However, if they persist or worsen, it is important to consult a healthcare professional.
In rare cases, ferric carboxymaltose injection can cause serious side effects such as allergic reactions. Symptoms of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. If any of these symptoms occur, immediate medical attention should be sought.
Elinjec injection (Ferric Carboxymaltose)Dosage:
The dosage of ferric carboxymaltose injection is determined by a healthcare professional based on the individual’s iron deficiency and response to treatment. The medication is administered intravenously, usually as a slow infusion over a period of time. The total dose and frequency of administration will depend on the severity of the anemia and the patient’s iron needs.
Elinjec injection (Ferric Carboxymaltose)Contraindications:
Contraindicated in cases of:
Hypersensitivity to the active substance.
Known serious hypersensitivity to other parenteral iron products. Anaemia not attributed to iron deficiency, e.g. other microcytic anemia. Evidence of iron overload or disturbances in the utilization of iron.
Elinjec injection (Ferric Carboxymaltose)SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Hypersensitivity reactions: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. There are known reports of hypersensitivity reactions that progressed to Kounis syndrome (acute allergic coronary artery spasm that can result in myocardial infarction).
The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema, or another atopic allergy.
There is also an increased risk of
hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Ferric carboxymaltose injection should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available. Each patient should be observed for adverse effects for at least 30 minutes following each ferric carboxymaltose injection administration.
Ferric carboxymaltose injection
is contraindicated in individuals with known hypersensitivity to the medication or any of its components. It should also be avoided in patients with certain medical conditions such as active infection, liver disease, or a history of allergic reactions to other intravenous iron products. It is important to inform the healthcare provider about any existing medical conditions or allergies before starting treatment with ferric carboxymaltose injection.
If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately and consult the doctor immediately.
Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery are known to be reported in the post marketing setting. Patients should be asked to seek medical advice if they experience worsening fatigue with myalgias or bone pain.
Serum phosphate should be monitored in patients who receive multiple administrations at higher doses or long-term treatment, and those with existing risk factors for hypophosphataemia. In case of persisting hypophosphataemia, treatment with ferric carboxymaltose should be
Hepatic or renal impairment:
In patients with liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).
Careful monitoring of iron status
is recommended to avoid iron overload. No safety data on haemodialysis-dependent chronic kidney disease patients receiving single doses of more than 200mg iron are available.
Parenteral iron must be used with caution in case of acute or chronic infection, asthma, eczema or atopic allergies.
It is recommended that the treatment with ferric carboxymaltose injection is stopped in patients with ongoing bacteraemia.
Therefore, in patients with chronic infection a benefit/risk evaluation has to be performed, taking into account the suppression of erythropoiesis.
Caution should be exercised to avoid paravenous leakage when administering ferric carboxymaltose injection.
Paravenous leakage of ferric carboxymaltose injection at the administration site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of administration. In case of paravenous leakage, the administration of ferric carboxymaltose injection must be stopped immediately.
Iron carboxymaltose injection contains up to 5.5mg (0.24mmol) sodium per mL of undiluted solution, equivalent to 0.3% of the WHO recommended maximum daily intake of 2g sodium for an adult.
Paediatric population: The use of ferric carboxymaltose injection has not been studied in children.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:
The absorption of oral iron is reduced when administered concomitantly with parenteral iron preparations. Therefore, if required, oral iron therapy should not be started for at least 5 days after the last administration of ferric carboxymaltose injection.
FERTILITY, PREGNANCY AND LACTATION:
Pregnancy: There are limited data from the use of ferric carboxymaltose injection in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and ferric carboxymaltose injection should not be used during pregnancy unless clearly necessary. Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron.
Treatment with ferric carboxymaltose injection
should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus. Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.
Clinical studies showed that transfer of iron from ferric carboxymaltose injection to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that ferric carboxymaltose injection represents a risk to the breast-fed child.
There are no data on the effect of ferric carboxymaltose injection on human fertility. Fertility was unaffected following ferric carboxymaltose injection treatment in animal studies.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Ferric carboxymaltose injection is unlikely to impair the ability to drive and use machines.
Ferric carboxymaltose injection may interact with other medications, potentially affecting their efficacy or increasing the risk of side effects. It is important to inform the healthcare provider about all the medications, supplements, and herbal products being taken before starting treatment with ferric carboxymaltose injection. Certain medications, such as antacids, proton pump inhibitors, or tetracycline antibiotics, may reduce the absorption of iron from the gastrointestinal tract and should be taken at least two hours before or after ferric carboxymaltose injection.
ferric carboxymaltose injection is a medication used to treat iron deficiency anemia in adults. It is administered intravenously and helps replenish iron stores in the body. While generally well-tolerated, it can cause side effects such as headache, nausea, and injection site reactions. It is contraindicated in individuals with hypersensitivity to the medication and may interact with certain medications. The dosage and administration of ferric carboxymaltose injection should be determined by a healthcare professional based on the individual’s needs and response to treatment.