Ferinject® is an I.V. iron product indicated for the treatment of Iron Deficiency (ID) / Iron Deficiency Anemia (IDA) in adult patients in cases that oral iron is not effective, cannot be used or tolerated.

Each vial of Ferinject contains 500 mg iron in 10 ml.

Active ingredients of Ferinject is Ferric Carboxymaltose with pH 5.0 – 7.0 and normal physiological Osmolarity.

It is a non-dextran I.V. iron for adult patients with Iron Deficiency / Iron Deficiency Anemia of various etiologies.

IDA etiologies may include:

• Non-dialysis dependent chronic kidney disease
• Heavy Uterine Bleeding
• Postpartum
• GI Disorders (e.g. IBD, celiac disease, etc.)
• Post-gastric bypass
• Cancer
• Congestive heart failure

Ferinject® is contraindicated in patients with hypersensitivity to Ferinject® or any of its inactive components.

IMPORTANT SAFETY INFORMATION

Contraindication

The use of Ferinject is contraindicated in the following cases:

• Hypersensitivity to the active substance or one of the excipients of the composition;
• anemia without confirmed iron deficiency;
• evidence of iron overload
• first trimester of pregnancy

Pregnancy

There are no clinical data from controlled studies on the use of Ferinject in pregnant women.

A risk/benefit assessment is necessary before administration during pregnancy.

Breast-feeding

Clinical studies show that transfer of iron from Ferinject to human milk was negligible (≤1%). Based on limited data on nursing women it is unlikely that Ferinject represents a risk to the nursing child.

Fertility

There are no data on the effect of Ferinject to human fertility. Fertility was unaffected following Ferinject treatment in animal studies.