Ferrovin

/ Lapidot

Posology: The cumulative dose of FERROVIN must be calculated for each patient individually and must not be exceeded.
Calculation of Dosage: The total cumulative dose of FERROVIN, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of FERROVIN must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example:
Total iron deficit [mg] = BW [kg] X (target Hb- actual Hb) [g/dl] X 2.4* + storage
iron [mg]
– Below 35 kg BW: Target Hb= 13g/dl and storage iron= 15mg/kg BW
– 35 kg BW and above: Target Hb= 15g/dl and storage iron= 500 mg
Total FERROVIN to be administered (in ml)= Total iron deficit [mg] / 20 mg iron/ml
See prescribing information for full details.
Adults: 5-10ml of FERROVIN (100-200 mg iron) one to three times a week.
Paediatric population: The use of iron sucrose has not been adequately studied in children and, therefore, FERROVIN is not recommended for use in children.
Method of Administration: FERROVIN must only be administered by the intravenous route. This may be by a slow intravenous injection, by an intravenous drip infusion or directly into the venous line of the dialysis machine.
See prescribing information for full details.

FERROVIN is indicated for the therapy of iron deficiency anaemia in the following cases:
Severe iron deficiency only when oral administration has been found impossible. In cases of gastro-intestinal malabsorption which rules our oral therapy, patients on dialysis treated with erythropoietin.

– Hypersensitivity to the active substance, to FERROVIN or any of its excipients.
– Known serious hypersensitivity to other parenteral iron products.
– Anaemia not caused by iron deficiency.
– Evidence of iron overload or hereditary disturbances in utilization of iron.

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 including iron sucrose. However, in several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, iron sucrose was shown to be well tolerated.
The risk of hypersensitivity reactions 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).
FERROVIN 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. Each patient should be observed for adverse effects for at least 30 minutes following each FERROVIN injection. 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.
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 should be used with caution in the case of acute or chronic infection.
It is recommended that the administration of FERROVIN is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed.
Paravenous leakage must be avoided because leakage of FERROVIN at the
injection site can lead to pain, inflammation and brown discoloration of the skin.

The most commonly reported adverse drug reaction in clinical trials with iron sucrose was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with iron sucrose are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials.
See prescribing information for full details.

As with all parenteral iron preparations, FERROVIN 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 FERROVIN.

Pregnancy: There is no data from the use of iron sucrose in pregnant women in the first trimester.
Data (303 pregnancy outcomes) from the use of iron sucrose in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.
A careful risk/benefit evaluation is required before use during pregnancy and
FERROVIN should not be used during pregnancy unless clearly necessary.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with FERROVIN should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the fetus.
Breast-feeding
There is limited information on the excretion of iron in human milk following
administration of intravenous iron sucrose. In one clinical study, 10 healthy Breastfeeding: mothers with iron deficiency received 100 mg iron in the form of iron sucrose. Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from FERROVIN via the mother’s milk, therefore the risk/benefit should be assessed.
Preclinical data do not indicate direct or indirect harmful effects to the nursing child.
See prescribing information for full details.

Overdose can cause iron overload which may manifest itself as haemosiderosis.
Overdose should be treated, as deemed necessary by the treating physician, with an iron chelating agent or according to standard medical practice.