Treatment Administration

Q.  If a patient is feeling queasy or gets some flushing during administration, is the treatment stopped and restarted when the patient is feeling better?

A. Normally, 1000mg of Ferinject® is given at a rate of 100ml over 15 minutes. If a patient is feeling unwell, it has been practice to slow the rate to 100ml over 1 hour.

 

Q. Is there any risk of unblinding when administering the drug?

A. As the product is a black liquid the vein will go brown initially, but this is only temporary. To avoid unblinding if this occurs, a cover will be provided to place over the hand and arm. Also we suggest preparing the skin with an iodine swab so any discolouration will be harder to detect by the patient.

 

Q. Is there a risk if the venflon tissues?

A. All IV access should be appropriately tested with a saline flush to exclude extravasation. Therefore, subsequent extravasation, once excluded via saline flush, should not occur.

 

Q. What risk is there of sepsis with the use of iron?

A. Chronic iron overload may predispose to infections due to its toxic effects on cells and tissues. It may also be detrimental to the body’s response against infection as shown in Sub-Saharan Africa where iron supplementation has been associated with increased Malaria risk.  However, with an acute iron injection, there is no evidence of increased infection rates. The IV iron will be gone from circulation within 48 hours and therefore not have an effect in the following few weeks when the patient is undergoing surgery. There is no evidence of increased infections in patients with renal disease or IBD who routinely receive IV iron therapy.

 

Q. How do we avoid air bubbles when using the black giving sets?

A. You would run the solution through in advance and the normal protocols followed for IV administration. In other clinical trials where there has been product blinding this has not proved to be a problem.