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  • Ferinject
    / CTS


    Active Ingredient
    Ferric Carboxymaltose 1,800 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 10 ml

    partial basket chart 25671 6475

    Dosage

    Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Ferinject.
    Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Ferinject administration.
    The posology of Ferinject follows a stepwise approach: [1] determination of the individual iron need, [2] calculation and administration of the iron dose(s), and [3] post-iron repletion assessments. These steps are outlined below:
    Step 1: Determination of the iron need: The individual iron need for repletion using Ferinject is determined based on the patient’s body weight and haemoglobin (Hb) level. Refer to Table 1 at the attached doctor’s leaflet for determination of the iron need.
    Step 2: Calculation and administration of the maximum individual iron dose(s): Based on the iron need determined above the appropriate dose(s) of Ferinject should be administered taking into consideration the following:
    A single Ferinject administration should not exceed:
    • 15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
    • 1,000 mg of iron (20 mL Ferinject)
    The maximum recommended cumulative dose of Ferinject is 1,000 mg of iron (20 mL Ferinject) 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 Ferinject administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using Table 1 at the attached doctor’s leaflet.
    Patients with haemodialysis-dependent chronic kidney disease: A single maximum daily dose of 200 mg iron should not be exceeded in haemodialysisdependent chronic kidney disease patients.
    Paediatric population: The use of Ferinject has not been studied in children, and therefore is not recommended in children under 14 years.
    Method of administration:
    Ferinject must only be administered by the intravenous route:
    • by injection, or
    • by infusion, or
    • during a haemodialysis session undiluted directly into the venous limb of the dialyser.
    Ferinject must not be administered by the subcutaneous or intramuscular route.
    Intravenous injection Ferinject may be administered by intravenous injection using undiluted solution. The maximum single dose is 15 mg iron/kg body weight but should not exceed 1,000 mg iron. The administration rates are as shown in Table at the attached doctor’s leaflet.
    Intravenous infusion: Ferinject may be administered by intravenous infusion, in which case it must be diluted. The maximum single dose is 20 mg iron/kg body weight, but should not exceed 1,000 mg iron.
    For infusion, Ferinject must only be diluted in sterile 0.9% m/V sodium chloride solution as shown in Table 3 at the attached doctor’s leaflet.
    Note: for stability reasons, Ferinject should not be diluted to concentrations less than 2 mg iron/mL (not including the volume of the ferric carboxymaltose solution).


    Indications

    Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.
    The diagnosis of iron deficiency must be based on laboratory tests.


    Contra-Indications

    The use of Ferinject is contraindicated in cases of:
    Hypersensitivity to the active substance, to Ferinject or any of its excipients.
    Known serious hypersensitivity to other parenteral iron products.
    Anaemia not attributed to iron deficiency, e.g. other microcytic anaemia.
    Evidence of iron overload or disturbances in the utilisation of iron.


    Special Precautions

    Hypersensitivity reactions: Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
    The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other 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).
    There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction.
    Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each Ferinject administration. If hypersensitivity reactions or signs of intolerance occur during
    administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
    Hypophosphataemia: Hypophosphataemic osteomalacia
    Symptomatic hypophosphataemia leading to osteomalacia and fractures requiring clinical intervention including surgery has been 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 re-evaluated.
    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 200 mg iron are available.
    Infection: 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 Ferinject 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.
    Extravasation: Caution should be exercised to avoid paravenous leakage when administering Ferinject.
    Paravenous leakage of Ferinject 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 Ferinject must be stopped immediately.
    Excipients: One mL of undiluted Ferinject contains up to 5.5 mg (0.24 mmol) of sodium. This has to be taken into account in patients on a sodium-controlled diet.
    Paediatric population: The use of Ferinject has not been studied in children.


    Side Effects

    The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion site reactions, hypophosphatemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.
    See prescribing information for full details.


    Drug interactions

    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 administrationof Ferinject.


    Pregnancy and Lactation

    Pregnancy:
    There are limited data from the use of Ferinject in pregnant women. A careful benefit/risk evaluation is required before use during pregnancy and Ferinject 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 Ferinject 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 fetus.
    Fetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother.

    Animal data suggest that iron released from Ferinject can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus.
    Lactation: Clinical studies showed that transfer of iron from Ferinject to human milk was negligible (≤ 1%).
    Based on limited data on breast-feeding women it is unlikely that Ferinject represents a risk to the breast-fed child.


    Overdose

    Administration of Ferinject in quantities exceeding the amount needed to correct iron deficit at the time of administration may lead to accumulation of iron in storage sites eventually leading to haemosiderosis.
    Monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognising iron accumulation. If iron accumulation has occurred, treat according to standard medical practice, e.g. consider the use of an iron chelator.


    Important notes

    Storage: Do not store above 30 °C. Do not freeze.


    Manufacturer
    Vifor
    Licence holder
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