Generic Name and Formulations:
Iron (as sucrose) 20mg/mL; soln for IV inj or infusion; preservative-free.
American Regent, Inc.
Indications for VENOFER:
Iron deficiency anemia in chronic kidney disease.
Give by slow IV inj (undiluted) or infusion (diluted). Usual total cumulative dose: 1000mg. Hemodialysis dependent (HDD): 100mg slow IV inj over 2–5 mins or infuse 100mg over at least 15 mins per consecutive session. Non-dialysis dependent (NDD): 200mg slow IV inj over 2–5 mins or infuse 200mg over at least 15 mins on 5 different occasions within a 14-day period (limited experience with 500mg infusion over 3.5–4hrs on Days 1 and 14). Peritoneal dialysis dependent (PDD): two infusions of 300mg over 1.5hrs 14 days apart, then one 400mg infusion over 2.5hrs 14 days later.
<2yrs: not established. Iron replacement: not established. ≥2yrs: Iron maintenance: give undiluted by slow IV inj over 5mins or diluted at a concentration of 1–2mg/mL over 5–60mins. HDD: 0.5mg/kg (max 100mg/dose) every 2 weeks for 12 weeks. NDD or PDD: 0.5mg/kg (max 100mg/dose) every 4 weeks for 12 weeks. May repeat treatment if needed.
Monitor for hypersensitivity reactions during and after administration for ≥30mins and until stable following infusion completion; discontinue if occur. Do not give to patients with evidence of iron overload. Monitor hemoglobin, hematocrit, serum ferritin, transferrin saturation. Avoid serum iron measurements for ≥48 hours after dosing. Pregnancy. Nursing mothers: monitor infants for GI toxicity.
May reduce absorption of concomitant oral iron preparations.
Diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, inj site reactions, chest pain, peripheral edema. Also in children: respiratory tract viral infection, peritonitis, pyrexia, cough, arteriovenous fistula thrombosis, hypertension; hypersensitivity, iron overload.
Single-dose vials (2.5mL)—10, 25; (5mL)—1, 10, 25; (10mL)—5,10
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