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.
Summary of Clinical Information – adult IDA patients with CKD
A flexible infusion schedule1A full 1-g dose of Feraheme can be delivered in 2 IV infusions.1 Duration of delivery for diluted IV infusion is at least 15 minutes2
- Only administer Feraheme when personnel and therapies are immediately available for treatment of anaphylaxis and other hypersensitivity reactions
- Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion
Feraheme raised mean Hgb 1 g/dL with 1 g of IV iron in 35 days1In clinical trials of adult patients with CKD who were NDD1
- Two 510-mg doses of Feraheme raised mean Hgb by 1.2 g/dL (± 1.3, standard deviation [SD]; P >e; 0.001) in clinical trial 1 and by 0.8 g/dL (± 1.2, SD; P >e; 0.001) in clinical trial 2 vs baseline at day 351
- Following completion of the controlled phase of the trials, 69 patients received 2 additional 510-mg IV injections of Feraheme for a total cumulative dose of 2.04 g. On day 35 following the additional injections, 70% of these patients experienced an increase in Hgb and iron parameters (TSAT and ferritin)1
- Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
- The following serious adverse reactions have been reported from the postmarketing experience with Feraheme: fatal, life-threatening, and serious anaphylactic-type reactions; cardiac/cardiorespiratory arrest; clinically significant hypotension; syncope; unresponsiveness; loss of consciousness; tachycardia/rhythm abnormalities; angioedema; ischemic myocardial events; congestive heart failure; pulse absent; and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme
*As of August 2016.
CKD: chronic kidney disease; Hgb: hemoglobin; IV: intravenous; NDD: nondialysis dependent
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).