Take IV Iron Therapy to a proven place: No dextrans. No bolded or black box warnings. No test dose!


Clinical Presentation
Patients at the earliest state of iron depletion may fail to exhibit any physiologic impairment. However, as iron deficiency progresses to anemia, signs and symptoms generally parallel severity.

Anemia:

  • Fatigue
  • Pallor
  • Decreased exercise capacity
  • Cold hands and feet
  • Tachycardia
  • Lightheadedness
  • Apnea

Severe iron deficiency:

  • Mouth soreness
  • Difficulty swallowing
  • Spooning (softening/curling of nails)
  • Pica (craving to ingest substances such as clay, ice or cornstarch)

Criteria for diagnosis
Anemia is diagnosed through lab determinations of Hb and Hct. For CKD patients, an anemia workup is recommended when values fall outside of the specified range for this population. Recognizing the important role of iron in the development of anemia in CKD, particularly during therapy with epoetin, the guidelines also recommend assessing iron status.

Table 1: 2006/2007 Anemia and Iron Indices Targets1



Differential Diagnosis
In addition to iron deficiency, there are several other causes of anemia.

Table 2: Causes of Anemia2,3



Two useful lab tests for differentiating anemias are mean corpuscular volume (MCV) and RBC distribution width (RDW).

MCV is a measure of the average red blood cell volume. In anemic patients, cells may be classified as microcytic (below normal range), normocytic (within normal range) or macrocytic (above normal range). In iron deficiency anemia, RBCs are microcytic.

RDW reflects the variation in RBC sizes. Normal RBCs fall within a definitive size range. However certain disorders, such as iron deficiency anemia, may cause variation. A RDW above 14%, along with other positive indicators, is indicative of iron deficiency anemia.

American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


Please see Full Prescribing Information.


References