|
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|
|
|
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|
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|
EPOETIN ONLY*
(n=66) |
Ferrlecit® + EPOETIN*
(n=66) |
|
Adverse events |
104 in 35 pts |
69 in 32 pts |
|
Related adverse events |
0 |
7 in 4 pts |
|
diarrhea, dyspepsia, dyspnea, dizziness, chest pain, back pain, and increased
sweating |
|
|
|
Serious adverse events (all unrelated) |
14 in 9 pts |
12 in 9 pts |
Cardiac adverse events
cardiac arrest, CHF, cardio-respiratory arrest, endocarditis, MIs, and arrhythmias |
4 in 4 pts |
4 in 4 pts |
Blood disorders
anemia and coagulation disorders |
6 in 4 pts |
1 in 1 pt |
Vascular disorders
arterial stenosis, gangrene, hematoma, hot flashes, hypertension, hypotension,
TIA |
21 in 13 pts |
5 in 5 pts |
|
Infections |
13 in 10 pts |
12 in 8 pts |
|
Bronchitis |
0 |
1 |
|
Cellulitis |
1 |
0 |
|
Viral conjunctivitis |
1 |
0 |
|
Fungal infections |
1 |
0 |
|
Furuncles |
0 |
3 |
|
Clostridial difficile |
1 (SAE)† |
0 |
|
Implant infections |
0 |
1 (SAE)
|
|
Pneumonia |
2 (1 SAE)
|
1 |
|
Nasopharyngitis |
0 |
1 |
|
Sepsis |
3 (2 SAE)
|
1 (SAE)
|
|
Skin infections including subcutaneous abscess |
1 |
2 (1 SAE)
|
|
Upper respiratory infections |
2 |
1 |
Urinary tract infections
 |
1
|
1
|
* Based on the safety population of randomized patients who received at least one
dose of study treatment.
† SAE = Serious Adverse Event: Any adverse event that results in any of the
following outcomes: a life-threatening experience, inpatient hospitalization or
prolongation of existing hospitalization, death, a persistent or significant disability/incapacity,
or a congenital anomaly/birth defect.
 REFERENCES
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Important Safety Information3
Ferrlecit® is indicated for the treatment of iron deficiency anemia in chronic
hemodialysis patients age 6 years and over receiving supplemental epoetin therapy
• Ferrlecit® is contraindicated in non iron-deficient anemias, in patients
hypersensitive to Ferrlecit® or its inactive components, or with evidence of
iron overload • Hypersensitivity reactions have been reported with injectable
iron products • Hypotension has been reported with rapid administration of
IV iron • In a single-dose, placebo-controlled safety study (n=1097), the most
frequent adverse events occurring after Ferrlecit® administration were hypotension,
nausea, and vomiting and/or diarrhea • In multiple-dose studies (n=126), the
most frequent adverse events, whether or not related to Ferrlecit® administration
were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps,
hypertension, dizziness, dyspnea, and chest pain
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