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VENOFER
Anemias
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Drug Name:

VENOFER Rx

Generic Name and Formulations:
Iron (as sucrose) 20mg/mL; soln for IV inj or infusion; preservative-free.

Company:
American Regent, Inc.

Therapeutic Use:

Indications for VENOFER:

Iron deficiency anemia in chronic kidney disease.

Adult:

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.

Children:

<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.

Warnings/Precautions:

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 (Cat.B). Nursing mothers.

Pharmacological Class:

Hematinic.

Interactions:

May reduce absorption of concomitant oral iron preparations.

Adverse Reactions:

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.

How Supplied:

Single-dose vials (2.5mL)—10, 25; (5mL)—1, 10, 25; (10mL)—5,10

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