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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:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® 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 the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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References