Venofer

/ CTS

Posology: The cumulative dose of Venofer must be calculated for each patient individually and must not be exceeded.
For calculation of dosage: See prescribing information for full details.
Adults: 5-10ml of of Venofer (100 – 200 mg iron) one to three times a week.
Paediatric population: The use of Venofer has not been adequately studied in children and, therefore, Venofer is not recommended for use in children.
Method of Administration: Venofer 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.

Venofer is indicated for the treatment of iron deficiency in the following indications:
– Where there is a clinical need for a rapid iron supply,
– In patients who cannot tolerate oral iron therapy or who are non-compliant,
– In active inflammatory bowel disease where oral iron preparations are ineffective,
– In chronic kidney disease when oral iron preparations are less effective.

Hypersensitivity to the active substance, 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. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction. In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product.
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).
Venofer 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 Venofer 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 Venofer 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 Venofer at the injection site can lead to pain, inflammation and brown discoloration of the skin.
See prescribing information for full details.

The most commonly reported adverse drug reaction in clinical trials with Venofer was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with Venofer 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, it is recommended that Venofer is not administered concomitantly with oral iron preparations since the absorption of oral iron may be reduced.

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 Venofer 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 Venofer 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 Venofer 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.
Lactation: There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. It cannot be excluded that newborns/infants may be exposed to iron derived from Venofer via the mother’s milk, therefore the risk/benefit should be assessed.
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.

Incompatibility: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. There is the potential for precipitation and/or interaction if mixed with other solutions or medicinal products. The compatibility with containers other than glass, polyethylene and PVC is not known.
Shelf life: Shelf life of the product as packaged for sale: 3 years.
Shelf life after first opening of the container: From a microbiological point of view, the product should be used immediately.
Shelf life after dilution with sterile 0.9% m/V sodium chloride (NaCl) solution:
From a microbiological point of view, the product should be used immediately after dilution with sterile 0.9% m/V sodium chloride solution.
Storage: Prescribed storage conditions: 4 –25 °C. Do not freeze. Store in the original package.