Agency for Therapeutic Products
authorization in
therapy to treat iron deficiency anemia (IDA) in adult patients with
chronic kidney disease (CKD). Ferumoxytol was approved for the same
indication in the
and
2011
AMAG’s partner,
for commercialization of ferumoxytol in
among other territories. Takeda plans to launch ferumoxytol in
tiered, double-digit royalties on product sales in the licensed
territories. AMAG has sole commercial rights for Feraheme in
States
“International expansion is one of four key areas of opportunity for
Feraheme/Rienso, and Swiss approval marks continued progress on this
front,” said
AMAG. “Through Takeda’s commercial efforts, Feraheme/Rienso will soon be
available to CKD patients in several countries around the world as a new
treatment option for their iron deficiency anemia. We believe that these
international launches, coupled with continued market penetration in
United States
market expansion, provide multiple avenues of growth for Feraheme.”
Iron deficiency is a common cause of anemia in CKD patients, and is very
common in the later stages of CKD as renal function deteriorates and
erythropoiesis (red blood cell production) declines. IDA can have a
profound impact on patients’ lives, causing fatigue, shortness of breath
and an increase in the risk of cardiovascular complications including
congestive heart failure.1 IV iron is recommended for use to
increase hemoglobin levels in CKD patients with IDA. 1
About
manufactures and markets ferumoxytol under the brand name Feraheme®
in
About Feraheme (ferumoxytol)/Rienso
In
Intravenous (IV) use is indicated for the treatment of iron deficiency
anemia in adult chronic kidney disease (CKD) patients. Feraheme received
marketing approval from the
2009
Ferumoxytol received marketing approval in
2011
in the
it will be marketed by Takeda as Rienso®. For additional
product information, please visit www.feraheme.com.
Rienso is a registered trademark of
Limited
1
guidelines and clinical practice recommendations for anemia in chronic
kidney disease. Am J Kidney Dis 2006;47(suppl 3):11–1458
The important safety information below is based on
prescribing information.
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in
adult patients with chronic kidney disease. Feraheme is contraindicated
in patients with known hypersensitivity to Feraheme or any of its
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 Feraheme. Observe patients for
signs and symptoms of hypersensitivity during and after Feraheme
administration for at least 30 minutes and until clinically stable
following completion of each administration. Only administer the
drug when personnel and therapies are immediately available for the
treatment of anaphylaxis and other hypersensitivity reactions.
Anaphylactic type reactions, presenting with cardiac/cardiorespiratory
arrest, clinically significant hypotension, syncope, and
unresponsiveness have been reported in the post-marketing experience.
In clinical studies, serious hypersensitivity reactions were reported in
0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions
potentially associated with hypersensitivity (e.g., pruritus, rash,
urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects.
Severe adverse reactions of clinically significant hypotension have
been reported in the post-marketing experience. In clinical studies,
hypotension was reported in 1.9% (33/1,726) of subjects, including three
patients with serious hypotensive reactions. Monitor for signs and
symptoms of hypotension following each Feraheme injection. Excessive
therapy with parenteral iron can lead to excess storage of iron with the
possibility of iatrogenic hemosiderosis. Patients should be regularly
monitored for hematologic response during parenteral iron therapy,
noting that lab assays may overestimate serum iron and transferrin bound
iron values in the 24 hours following administration of Feraheme. As a
superparamagnetic iron oxide, Feraheme may transiently affect magnetic
resonance diagnostic imaging studies for up to 3 months following the
last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT,
ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in
Feraheme treated patients versus oral iron treated patients reported in
≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%),
nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs.
0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs.
3.2%). In clinical trials, adverse reactions leading to treatment
discontinuation and occurring in 2 or more Feraheme treated patients
included hypotension, infusion site swelling, increased serum ferritin
level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic
renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during
post-approval use of Feraheme. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
The following serious adverse reactions have been reported from the
post-marketing spontaneous reports with Feraheme: life-threatening
anaphylactic-type reactions, cardiac/cardiorespiratory arrest,
clinically significant hypotension, syncope, unresponsiveness, loss of
consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic
myocardial events, congestive heart failure, pulse absent, and cyanosis.
These adverse reactions have occurred up to 30 minutes after the
administration of Feraheme injection. Reactions have occurred following
the first dose or subsequent doses of Feraheme.
For full prescribing information, please visit www.feraheme.com.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 and
other federal securities laws. Any statements contained herein which do
not describe historical facts, including but not limited to statements
regarding: the areas of significant growth opportunities for Feraheme,
Takeda’s expected launch of ferumoxytol in
royalties we may receive following such launch are forward-looking
statements which involve risks and uncertainties that could cause actual
results to differ materially from those discussed in such
forward-looking statements.
Such risks and uncertainties include: (1) uncertainties regarding our
and Takeda’s ability to successfully compete in the intravenous iron
replacement market both in the US and outside the US, including the EU
and
and timely complete our clinical development programs and obtain
regulatory approval for Feraheme/Rienso in the broader IDA
indication both in the US and in territories outside of the US,
including the EU, (3) the fact that significant safety or drug
interaction problems could arise with respect to Feraheme/Rienso,
(4) uncertainties regarding our ability to manufacture Feraheme/Rienso,
(5) uncertainties relating to our patents and proprietary rights, and
(6) other risks identified in our Securities and Exchange
Commission filings, including our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2012. We caution you not to place undue reliance
on any forward-looking statements, which speak only as of the date they
are made.
We disclaim any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be based,
or that may affect the likelihood that actual results will differ from
those set forth in the forward-looking statements.
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
