Outline 02

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 Ferris Injection 30

● Ferris injection is an aqueous complex of iron (III)

hydroxide with sucrose
● Ferris is a dark brown, non transparent aqueous
solution
● Ferris is available in 5 ml plastic ampoules and pack of
5s
● Each 5 ml ampoule of Ferris contains 100 mg iron as
iron sucrose
● Ferris can ONLY be administered as IV.
● Ferris MUST ONLY be mixed with 0.9% w/v NaCl
solution, otherwise there is a potential for
precipitation and/or interaction.

Venofer Monograph
Module 4 | Ferris (Iron Sucrose Injection) Ferris Leaflet
 Blow Fill Seal Technology 31
What is BFS?
The blow fill seal process is the sterile and pyrogen-free moulding of bottles/ampoules from
extruded polyethylene in water cooled blow moulds with an immediate sterile filling of the
product.

How does it works BFS?

● Inside BFS machine FDA approved medical grade plastic is used for making plastic ampoules.
● Plastic ampoule is prepared through extruding & moulding and the product is filled in
ampoule then it’s sealed and final product is available
● This whole process take place under sterile filling chamber where no human interaction take
place.
● Final product comes with aseptic filling and greater sterility.

Module 4 | Ferris (Iron Sucrose Injection)

 Blow Fill Seal Technology
32
No Human Interaction

Module 4 | Ferris (Iron Sucrose Injection)

 Advantages of BFS
GLASS AMPOULES
● Product is filled through conventional method,
due to more human interaction, the probability
of contamination is higher
● Inaccurate dosing due to greater chances of
spillage
● Greater chances of thumb injuries during
administration
● The breakage of ampoule at the time of
administration increases the chances of glass
shards that can contaminate the treatment
Module 4 | Ferris (Iron Sucrose Injection)
33
BFS AMPOULES
● For products that must be aseptically filled
such as Iron Sucrose the US FDA classify BFS
as a superior filling process
● Increased dosing accuracy due to lower
spillage
● Convenient twist off caps reduces
paramedical injuries & saves times
● Greater assurance of sterility by eliminating
glass shards that can contaminate the
treatment
 Product Information 34
INDICATIONS

● Intolerance to oral iron therapy

● Clinical need for a rapid iron supply
● Iron deficiency anaemia in chronic kidney disease (CKD)

CONTRAINDICATIONS

● Hypersensitivity to the active substance

Module 4 | Ferris (Iron Sucrose Injection)

 Product Information 35
DOSAGE

● Adults: 5 - 10 ml of Ferris (100 - 200 mg iron) 1 to 3 times a week.

● Children (>2 years of age): The dosing for iron replacement treatment in pediatric patients with HDD-CKD*
has not been established.
○ For iron maintenance: Administer at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks
for 12 weeks

● Test Dose: Two Ferris ampoules may be diluted in 100 ml 0.9% NaCl.
○ First 25 ml should be infused as a test dose over a period of 30 minutes at the rate of 12 drops/min.
○ If no adverse reaction occurs during this time then remaining portion of the infusion i.e. 75 ml, should be
given at the rate of 36 drops/min.

*Hemodialysis Dependent Chronic Kidney Disease

Module 4 | Ferris (Iron Sucrose Injection)

 Product Information 36

PHARMACOKINETICS

● Distribution is mainly in blood and to some extent in extravascular fluid

● Iron core is mainly stored by the liver, spleen, and bone marrow

● Elimination half-life: 6 hours

● The sucrose component is eliminated mainly by urinary excretion

● About 5% of the iron is eliminated by renal excretion over 24 hours

Module 4 | Ferris (Iron Sucrose Injection)

 Product Information 37
PRECAUTIONS

● Observe for signs and symptoms of hypersensitivity during and after Ferris administration for
at least 30 minutes and until clinically stable following completion of each administration.

● Ferris should be given with caution in anaemia other than iron deficiency

● Ferris may cause hypotension. Monitor for signs and symptoms of hypotension during and
following each administration of Ferris.

● Do not administer Ferris to patients with iron overload or hereditary disturbances in

utilization of iron.

● Not recommended in 1st trimester of pregnancy

Module 4 | Ferris (Iron Sucrose Injection)

 Product Information 38

INTERACTIONS

● Iron sucrose should not be administered concomitantly with oral iron preparations since the
absorption of oral iron is reduced

B PREGNANCY CATEGORY: B

● Administer with caution during the 2nd and 3rd trimester

Module 4 | Ferris (Iron Sucrose Injection)

 Pregnancy Categories 39
CATEGORY A Controlled studies show no risk or find no evidence of harm.

CATEGORY B Animal studies show no risks, but there are no controlled studies on pregnant women.

CATEGORY C Animal studies have shown risk to the fetus, there are no controlled studies in women,
or studies in women and animals are not available.

CATEGORY D There is positive evidence of potential fetal risk, but the benefits from use in pregnant
women may be acceptable despite the risk (i.e. life threatening condition to mother).

CATEGORY X Studies in animals or human beings have demonstrated fetal abnormalities, or there
is evidence of fetal risk. The drug is contraindicated in women
who are or may become pregnant.

Module 4 | Ferris (Iron Sucrose Injection) http://americanpregnancy.org/medication/medication-and-pregnancy/