Femorum Inj

Femorum Inj

iron sucrose

Manufacturer:

Myungmoon

Distributor:

Cosma Medical

Marketer:

Cosma Medical
Full Prescribing Info
Contents
Ferric hydroxide sucrose complex (equivalent to Fe 100 mg).
Description
Each ampoule (5 mL) contains Ferric hydroxide sucrose complex 2700 mg (100 mg as Fe).
Action
Pharmacology: Pharmacodynamics/Pharmacokinetics: The ferrokinetics of Femorum labelled with 59Fe and 52Fe were assessed in 5 patients with anaemia and chronic renal failure. Plasma clearance of 52Fe was in the range of 60 to 100 minutes. 52Fe was distributed to the liver, spleen and bone marrow. At two weeks after administration, the maximum red blood cell utilisation of 59Fe ranged from 62% to 97%.
Following intravenous injection of a single dose of Femorum containing 100 mg iron in healthy volunteers, maximum iron levels, averaging 538 µmol/1, were obtained 10 minutes after injection. The volume of distribution of the central compartment corresponded well to the volume of plasma (approximately 3 litres).
The iron injected was rapidly cleared from the plasma, the terminal half-life being approx. 6 hours. The volume of distribution at steady state was about 8 litres, indicating a low iron distribution in the body fluid. Due to the lower stability of iron sucrose in comparison to transferrin, a competitive exchange of iron to transferrin was observed. This resulted in iron transport of approximately 31 mg iron/24 h. Renal elimination of iron, occurring in the first 4 h after injection, corresponds to less than 5% of the total body clearance. After 24 h the plasma levels of iron were reduced to the pre-dose iron level and about 75% of the dosage of sucrose was excreted.
Indications/Uses
The treatment of iron deficiency in the following indications: Where there is a clinical need to deliver iron rapidly to iron stores; in patients who cannot tolerate oral iron therapy or who are non­ compliant; in active inflammatory bowel disease where oral iron preparations are ineffective.
The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, serum iron, etc.).
Dosage/Direction for Use
Adults and the Elderly: The total cumulative dose of medicine, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose for medicine must be individually determined for each patient according to the total iron deficit calculated with the following formula: See Equation 1.

Click on icon to see table/diagram/image

The total amount of Femorum lnjection required in mg is determined from Equation 1.
Alternatively, the total amount of Femorum lnjection required in mL is determined from Equation 2 or Table.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

To convert Hb (mM) to Hb (g/L), multiply the former by 16.1145.
Dosage: The total single dose must not exceed 200 mg of iron given not more than three times per week. If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split.
Children: The use of Femorum lnjection has not been adequately studied in children and, therefore, Femorum lnjection is not recommended for use in children.
Intravenous Drip Infusion: Femorum lnjection must be diluted only in sterile 0.9% w/v sodium chloride solution: in max. 100 mL sterile 0.9% w/v sodium chloride solution per 1 ampoule of Femorum lnjection (100 mg as Fe).
Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg iron (5 mL Femorum lnjection) in at least 15 minutes, 200 mg iron (10 mL Femorum lnjection) in at least 30 minutes.
The first 25 mg of iron (i.e. 25 mL of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 50 mL in 15 minutes.
Intravenous Injection: Femorum lnjection may be administered by slow intravenous injection at a rate of 1 mL undiluted Femorum solution per minute and not exceeding 10 mL Femorum lnjection (200 mg iron) per injection.
Before administering a slow intravenous injection, a test dose of 1 mL (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given.
lnjection into dialyser: Femorum lnjection may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.
Administration: The drug must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Before administering the first dose to a new patient, a test dose should be given, if allergic reaction or drug intolerance occurs, stop the treatment with this drug.
Femorum lnj. must not be used for intramuscular injection.
Overdosage
Overdosage can cause acute iron overloading which may manifest itself as haemosiderosis. Overdosage should be treated, if required, with an iron chelating agent.
Contraindications
The use of Femorum lnjection is contraindicated in cases of: Known hypersensitivity to Femorum lnjection or any of its excipients.
Anaemias not attributable to iron deficiency.
Iron overload or disturbances in utilisation of iron.
Patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions.
Pregnancy first trimester.
Special Precautions
Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which may be potentially fatal. Therefore, treatment for serious allergic reactions and facilities with the established cardio-pulmonary resuscitation procedures should be available.
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit 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.
Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis.
Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded.
Paravenous leakage must be avoided because leakage of Femorum lnjection at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin.
Use In Pregnancy & Lactation
Data on a limited number of exposed pregnancies indicated no adverse effects of Femorum lnj. on pregnancy or on the health of the foetus/newborn child. No well-controlled studies in pregnant women are available to date. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Nevertheless, risk/benefit evaluation is required.
Femorum lnjection should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.
Pregnancy first trimester: See Contraindications.
Non metabolised Femorum lnjection is unlikely to pass into the mother's milk. No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to the nursing child.
Adverse Reactions
Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000): Nervous System Disorders: Common: Transient taste perversions (in particular metallic taste).
Uncommon: Headache, dizziness.
Rare: Paraesthesia, syncope, loss of consciousness, burning sensation.
Cardio-Vascular Disorders: Uncommon: Hypotension and collapse, tachycardia and palpitations. Rare: Hypertension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Bronchospasm, dyspnoea.
Gastrointestinal Disorders: Uncommon: Nausea; vomiting, abdominal pain, diarrhoea.
Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, urticaria, rash, exanthema, erythema.
Musculoskeletal, Connective Tissue and Bone Disorders: Uncommon: Muscle cramps, myalgia.
General Disorders and Administration Site Disorders: Uncommon: Fever, shivering, flushing, chest pain and tightness.
Injection Site Disorders such as Superficial Phlebitis, Burning, Swelling: Rare: Arthralgia, peripheral oedema, fatigue, asthenia, malaise, feeling hot, oedema.
Immune System Disorders: Rare: Anaphylactoid reactions.
Drug Interactions
As with all parenteral iron preparations, Femorum lnjection should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Femorum lnjection.
Storage
Store in hermetic container below 30°C. Protect from light.
Shelf-Life: 3 years.
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Presentation/Packing
Inj (amp) 100 mg/5 mL (brown sterile solution) x 5's.
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