WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
NCCN Clinical Practice Guidelines® in Oncology (NCCN Guidelines®) for cancer- and chemotherapy-induced anemia* in adult patients1
Anemia awareness and identification are important because of the high prevalence of anemia and CKD in patients with cancer.
NCCN Guidelines® note that the etiology of anemia in patients with cancer is multifactorial and recommend evaluating underlying comorbidities, such as renal insufficiency, as potential causes of anemia
- Hb level of 11 g/dL or below should prompt an evaluation of anemia. Guidelines consider Hgb of between 10 g/dL and the lower limit of normal to be mild2
Initiation of ESA and iron therapy:
- Consider iron supplementation in patients with absolute iron deficiency (ferritin < 30 ng/mL AND TSAT < 20%)
- For select patients with ferritin 30-500 ng/mL AND TSAT <50%, consider IV iron with ESA
- For patients with ferritin 500-800 ng/mL AND TSAT <50%, no iron supplementation needed OR consider IV iron for select patients
- In select patients, consider ESAs by FDA dosing/dosing adjustments†
*Different guidelines use slightly different Hgb ranges.
†The hemoglobin threshold for treatment and dosing with ESAs is different for chemotherapy-induced anemia and chronic kidney disease. For more details on the use of ESAs in patients with cancer and chronic kidney disease, see the NCCN Guidelines.
CKD: chronic kidney disease; ESA: erythropoiesis-stimulating agent; Hb and Hgb: hemoglobin; NCCN: National Comprehensive Cancer Network®; FDA: Food and Drug Administration; TSAT: transferrin saturation.
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONSFatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
- Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
- Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:
- who have intolerance to oral iron or have had unsatisfactory response to oral iron or
- who have chronic kidney disease (CKD).