CONTENT:  Fe sucrose (ferric hydroxide in complex w/ sucrose)

INDICATION:  Treatment of Fe deficiency anemia in the following patients: Hemodialysis dependent chronic kidney disease (HDD-CKD), peritoneal dialysis dependent chronic kidney disease (PDD-CKD) & nondialysis dependent chronic kidney disease (NDD-CKD) receiving an erythropoietin or not.

DOSAGE:  HDD-CKD 100 mg (5 mL) by slow IV inj into the dialysis line over 2-5 min period 1-3 times/wk or by IV infusion into the dialysis line at a rate of 100 mg Fe in at least 15-min period. NDD-CKD 200 mg by slow IV inj undiluted over 2-5 min on 5 different occasions w/in 14-day period. PDD-CKD 1,000 mg by IV infusion during a 28-day period or 2 infusions of 300 mg over 1.5 hr 14 days apart, followed by one 400-mg infusion over 2.5 hr, 14 days later.

OVERDOSAGE: hemosiderosis. Periodic monitoring of iron parameters eg, serum ferritin and transferrin saturation may assist in recognizing iron accumulation. Iron sucrose should not be administered to patients with iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid iron overload where anemia unresponsive to treatment has been incorrectly diagnosed as iron deficiency anemia. Symptoms associated with overdosage or infusing iron sucrose too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema and cardiovascular collapse.

CONTRAINDICATION:  Patients with evidence of iron overload, in patients with known hypersensitivity to iron sucrose or any of its inactive components and in patients with anemia not caused by iron deficiency.

WARNING:  Hypersensitivity reactions have been reported with injectable iron products.

ADVERSE REACTION: Hypotension, chest pain, HTN, hypervolemia, CHF, cramps, musculoskeletal pain, diarrhea, nausea, vomiting, abdominal pain, elevated liver enzymes, skin irritation, pruritus, application site reaction, dizziness, dyspnea, pneumonia, cough, headache, fever, asthenia, malaise.

STORAGE:  Store at temperatures not exceeding 30°C. Do not freeze.

SPECIAL PRECAUTION: exercised to withhold iron administration in the presence of evidence of tissue iron overload. Patients receiving iron sucrose requires periodic monitoring of hematologic and hematinic parameters. Iron therapy should be withheld in patients with evidence of iron overload. Transferrin saturation values increase rapidly after IV administration of iron sucrose; thus, serum iron values may be reliably obtained 48 hrs after IV dosing. Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving iron sucrose. Hypotension: Hypotension has been reported in chronic kidney disease patients receiving IV iron. Hypotension following administration of iron sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer iron sucrose according to recommended guidelines.

USE IN PREGNANCY &  LACTATION:  Use in pregnancy: Pregnancy Category B. No adequate and well controlled studies in pregnant women have been reported. Because animal reproduction studies are not always predictive of human response, Encifer should be used during pregnancy only if clearly needed.  Use in lactation: It is not known whether Encifer is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when iron sucrose is administered to a nursing woman.

PACKING:  Inj 20 mg/mL (amp, brown, sterile, aqueous soln) x 5's.