Home' The Source : Third Quarter 2013 Contents For Intravenous (IV) Use
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
INDICATIONS AND USAGE
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic
kidney disease (CKD).
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its
ARNINGS AND PRECAUTIONS
ersensitivit Rea tions
Serious ersensitivit rea tions, in lu in ana la ti -t e rea tions, some of w i
ave been life-t reatenin an fatal, ave been re orte in atients re eivin Fera eme.
Observe atients for si ns an s m toms of ersensitivit urin an after Fera eme
a ministration for at least 30 minutes an until lini all stable followin om letion
of ea a ministration. Onl a minister t e ru w en ersonnel an t era ies are
imme iatel available for t e treatment of ana laxis an ot er ersensitivit
rea tions [see Adverse Reactions]. Ana la ti t e rea tions resentin wit ar ia /
ar iores irator arrest, lini all si nifi ant otension, s n o e, an unres onsive-
ness ave been re orte in t e ost-marketin ex erien e [see Adverse Reactions from
Post-marketing Spontaneous Reports]. In clinical studies, serious hypersensitivity reactions
were reported in . (3 ,7 6) of su ects receiving Feraheme. Other adverse reactions
potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were
reported in 3.7 (63 ,7 6) of these su ects.
Severe a verse rea tions of lini all si nifi ant otension ave been re orte . In
clinical studies, hypotension was reported in .9 (33 ,7 6) of su ects, including three
patients with serious hypotensive reactions. Hypotension has also een reported in
the post-marketing experience [see Adverse Reactions from Post-marketing Spontaneous
Reports]. Monitor patients for signs and symptoms of hypotension following each Feraheme
administration [see Dosage and Administration in the full prescri ing information and
Warnings and Precautions].
Excessive therapy with parenteral iron can lead to excess storage of iron with the possi ility
of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral
iron therapy [see Dosage and Administration in the full prescri ing information]. Do not
administer Feraheme to patients with iron overload. In the 4 hours following administration
of Feraheme, la oratory assays may overestimate serum iron and transferrin ound iron y
also measuring the iron in the Feraheme complex.
Ma neti Resonan e (MR) Ima in
Administration of Feraheme may transiently affect the diagnostic a ility of MR imaging.
Anticipated MR imaging studies should e conducted prior to the administration of Feraheme.
Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme
dose. If MR imaging is required within 3 months after Feraheme administration, use T - or
proton density-weighted MR pulse sequences to minimize the Feraheme effects; MR imaging
using T -weighted pulse sequences should not e performed earlier than 4 weeks after the
administration of Feraheme. Maximum alteration of vascular MR imaging is anticipated to
e evident for -- days following Feraheme administration [see Clinical Pharmacology in
the full prescri ing information]. Feraheme will not interfere with X-ray, computed tomography
(CT), positron emission tomography ( ET), single photon emission computed tomography
( ECT), ultrasound or nuclear medicine imaging.
Feraheme in ection may cause serious hypersensitivity reactions and hypotension [see Warnings
and Precautions]. In clinical studies, ,7 6 su ects were exposed to Feraheme; ,56 of these
had CKD and 64 did not have CKD. Of these su ects 46 were male and the median age was
63 years (range of 8 to 96 years). ecause clinical trials are conducted under widely varying
conditions, adverse reaction rates o served in the clinical trials of a drug may not reflect the rates
o served in practice.
A verse Rea tions in Clini al Stu ies
Across the three randomized clinical trials [Trial , , and 3, see Clinical Studies in the full
prescri ing information], a total of 6 5 patients were exposed to two in ections of 5 mg of
Feraheme and a total of 8 patients were exposed to mg day of oral iron for days.
Most patients received their second Feraheme in ection 3 to 8 days after the first in ection.
Adverse reactions related to Feraheme and reported y ≥ of Feraheme-treated patients in
the randomized clinical trials are listed in Ta le . Diarrhea (4. ), constipation ( . ) and
hypertension ( . ) have also een reported in Feraheme-treated patients.
Table 1 A verse Rea tions to Fera eme Re orte in ≥1% of Patients wit C D
(n = 605)
(n = 280)
A dominal ain
In clinical trials, adverse reactions leading to treatment discontinuation and occurring in
≥ Feraheme-treated patients included hypotension, infusion site swelling, increased serum
ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and
urticaria. Following completion of the controlled phase of the trials, 69 patients received two
additional 5 mg intravenous in ections of Feraheme (for a total cumulative dose of . 4 g).
Adverse reactions following this repeat Feraheme dosing were similar in character and
frequency to those o served following the first two intravenous in ections. In a place o-
controlled, cross-over trial, 7 3 patients with CKD received a single 5 mg dose of Feraheme.
Adverse reactions reported y these patients were similar in character and frequency to those
o served in other clinical trials.
A verse Rea tions from Post-marketin S ontaneous Re orts
The following adverse reactions have een identified during post-approval use of Feraheme.
ecause these reactions are reported voluntarily from a population of uncertain size, it is
not always possi le to relia ly estimate their frequency or esta lish a causal relationship
to drug exposure. The following serious adverse reactions have een 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 a normalities, angioedema,
ischemic myocardial events, congestive heart failure, pulse a sent, and cyanosis. These
adverse reactions have occurred up to 3 minutes after the administration of Feraheme
in ection. Reactions have occurred following the first dose or su sequent doses of Feraheme.
Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the
a sorption of concomitantly administered oral iron preparations.
USE IN SPECIFIC POPULATIONS
regnancy Category C. There are no studies of Feraheme in pregnant women. In animal
studies, ferumoxytol caused fetal malformations and decreased fetal weights at maternally
toxic doses of 6 times the estimated human daily dose. Use Feraheme during pregnancy only
if the potential enefit ustifies the potential risk to the fetus. Administration of ferumoxytol
during organogenesis, at doses of 3 .6 mg Fe kg day in rats and 6.5 mg Fe kg day in ra its,
did not result in maternal or fetal effects. These doses are approximately times the estimated
human daily dose ased on ody surface area. In rats, administration of ferumoxytol during
organogenesis at a maternally toxic dose of mg Fe kg day, approximately 6 times the
estimated human daily dose ased on ody surface area, caused a decrease in fetal weights.
In ra its, administration of ferumoxytol during organogenesis at a maternally toxic dose of
45 mg Fe kg day, approximately 6 times the estimated human daily dose ased on ody
surface area, was associated with external and or soft tissue fetal malformations and
decreased fetal weights.
Nursin Mot ers
It is not known whether Feraheme is present in human milk. ecause many drugs are excreted
in human milk and ecause of the potential for adverse reactions in nursing infants, a decision
should e made whether to discontinue nursing or to avoid Feraheme, taking into account
the importance of Feraheme to the mother and the known enefits of nursing.
Pe iatri Use
The safety and effectiveness of Feraheme in pediatric patients have not een esta lished.
In controlled clinical trials, 33 patients ≥ 65 years of age were treated with Feraheme. No
overall differences in safety and efficacy were o served etween older and younger patients
in these trials, ut greater sensitivity of older individuals cannot e ruled out. In general, dose
administration to an elderly patient should e cautious, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy
[see Dosage and Administration and Clinical Studies in the full prescri ing information].
No data are availa le regarding overdosage of Feraheme in humans. Excessive dosages of
Feraheme may lead to accumulation of iron in storage sites potentially leading to hemosiderosis.
Do not administer Feraheme to patients with iron overload [see Warnings and Precautions].
ee full prescri ing information for Feraheme availa le at www.feraheme.com.
AMAG harmaceuticals, Feraheme, and the logo designs presented in this material are trademarks of AMAG harmaceuticals, Inc.
© 3 AMAG harmaceuticals, Inc. DR- 49 - 5 3
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