ASH Clinical News October 2016 | Page 48

Less time

More time

infusing.

living.

*

Only Injectafer® (ferric
carboxymaltose injection)
provides up to
1500 mg of iron in
just 2 administrations
While some intravenous irons require lengthy infusions or
multiple office visits, Injectafer delivers a high dose of iron
(750 mg) in a short period of time. For patients weighing at
least 50 kg (110 lb), this means Injectafer can be administered
at the rate of 100 mg/2 mL per minute (slow IV push) or over at
least 15 minutes (IV infusion) in as few as 2 doses separated by
at least 7 days.

*

INDICATIONS
Injectafer is an iron replacement product indicated for the
treatment of iron deficiency anemia in adult patients who have
intolerance to oral iron or have had unsatisfactory response
to oral iron, and in adult patients with non-dialysis dependent
chronic kidney disease.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Injectafer is c ontraindicated in patients with hypersensitivity to
Injectafer or any of its inactive components.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic-type
reactions, some of which have been life-threatening and fatal,
have been reported in patients receiving Injectafer. Patients
may present with shock, clinically significant hypotension, loss
of consciousness, and/or collapse. Monitor patients for signs
and symptoms of hypersensitivity during and after Injectafer
administration for at least 30 minutes and until clinically stable
following completion of the infusion. Only administer Injectafer
when personnel and therapies are immediately available for the
treatment of serious hypersensitivity reactions. In clinical trials,
serious anaphylactic/anaphylactoid reactions were reported in 0.1%
(2/1775) of subjects receiving Injectafer. Other serious or severe
adverse reactions potentially associated with hypersensitivity which
included, but were not limited to, pruritus, rash, urticaria, wheezing,
or hypotension were reported in 1.5% (26/1775) of these subjects.
In clinical studies, hypertension was reported in 3.8% (67/1775) of
subjects. Transient elevations in systolic blood pressure, sometimes
occurring with facial flushing, dizziness, or nausea were observed
in 6% (106/1775) of subjects. These elevations generally occurred
immediately after dosing and resolved within 30 minutes. Monitor
patients for signs and symptoms of hypertension following each
Injectafer administration.

In the 24 hours following administration of Injectafer, laboratory
assays may overestimate serum iron and transferrin bound iron by
also measuring the iron in Injectafer.
ADVERSE REACTIONS
In two randomized clinical studies, a total of 1775 patients were
exposed to Injectafer, 15 mg/kg of body weight, up to a single
maximum dose of 750 mg of iron on two occasions, separated by at
least 7 days, up to a cumulative dose of 1500 mg of iron. Adverse
reactions reported by ≥2% of Injectafer-treated patients were
nausea (7.2%); hypertension (3.8%); flushing/hot flush (3.6%); blood
phosphorus decrease (2.1%); and dizziness (2.0%).
The following serious adverse reactions have been most commonly
reported from the post-marketing spontaneous reports: urticaria,
dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort,
chills, angioedema, back pain, arthralgia, and syncope.
To report adverse events, please contact American Regent at
1-800-734-9236. You may also contact the FDA at
www.fda.gov/medwatch or 1-800-FDA-1088.
Please see Brief Summary on the following page.

For more information, please visit Injectafer.com

American Regent ® is a registered trademark of Luitpold
Pharmaceuticals, Inc. Injectafer ® and the Injectafer ® logo are
trademarks of Vifor (International), Inc., Switzerland. Injectafer ® is
manufactured under license from Vifor (International), Inc., Switzerland.
©2016 American Regent, Inc.

FCM294

Iss. 4/2016