Dosing and uses of Venofer (iron sucrose)
Adult dosage forms and strengths
injectable solution
- 20mg (Fe)/mL
Iron-deficiency Anemia in Chronic Kidney Disease
Hemodialysis-dependent CKD: 100 mg elemental iron IV (injection or infusion over 2-5 min) per dialysis session not to exceed total cumulative dose of 1000 mg divided in 3 doses/week
Non-dialysis-dependent CKD: 200 mg IV injection for 5 doses in over 14 days (cumulative 1000 mg in 14-day period)
Peritoneal dialysis-dependent CKD: 300 mg IV infusion (1.5 hr) for 2 doses 14 days apart, THEN 400 mg IV infusion (2.5 hr) 14 days later (cumulative 1000 mg divided in 3 doses/week)
Pediatric dosage forms and strengths
injectable solution
- 20mg (Fe)/mL
Iron-deficiency Anemia in Chronic Kidney Disease
Indicated for maintenance treatment of iron-deficient anemia associated with chronic kidney disease
<2 years: Safety and efficacy not established
Hemodialysis-dependent: 0.5 mg/kg IV q2weeks for 12 weeks; not to exceed 100 mg/dose
Non-dialysis dependent or peritoneal-dependent (on erythropoietin): 0.5 mg/kg IV q4weeks for 12 weeks; not to exceed 100 mg/dose
Venofer (iron sucrose) adverse (side) effects
>10%
Hypotension (36%)
Muscle cramps (23%)
Headache
Nausea
1-10%
Dizziness
Fatigue
Arthralgia
Back pain
Hypertension
Fluid overload
Peripheral edema
Cough
Vomiting
Diarrhea
Constipation
Pruritus
Frequency not defined
Potentially fatal anaphylaxis (rare)
Warnings
Contraindications
Hypersensitivity
Anemia not caused by iron deficiency
Iron overload
Cautions
Risk of hypotension
Withhold therapy in tissue iron overload
Hypersensitivity
- Serious hypersensitivity reactions reported, including anaphylactic-type reactions, some of which have been life-threatening and fatal
- Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse
- If hypersensitivity reactions or signs of intolerance occur during administration, stop infusion immediately
- Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes and until clinically stable following completion of the infusion
Pregnancy and lactation
Pregnancy category: B
Lactation: Not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Venofer (iron sucrose)
Mechanism of action
Replacement of iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin
Pharmacokinetics
Half-life elimination: 6 hr
Vd: 7.9-10 L
Clearance: 1.2 L/hr
Excretion: Urine (5%)
Administration
IV Incompatibilities
Do not mix with other medications or add to parenteral nutrition solutions for IV infusion
IV Compatibilities
Solution: Ns
IV Administration
HD-dependent CKd
- May be administered via dialysis line as the undiluted solution or by diluting 100 mg (5 mL) in 100 mL NS
- Administer either by slow IV injection over 2-5 min or IV infusion over at least 15 min
Non-dialysis-dependent CKd
- Administer undiluted by slow IV inj over 2-5 min
PD-dependent CKd
- Dilute dose in a maximum of 250 mL NS
- 300 mg doses: infuse IV over 1.5 hr
- 400 mg dose: infuse IV over 2.5 hr
Pediatric
- Undiluted: Administer by slow IV injection over 5 minutes
- Diluted in 25 mL of 0.9% NaCl: Administer IV over 5-60 minutes
Storage
Store vials at room temp; do not freeze
