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Iron Sucrose

Medically reviewed on Sep 10, 2018

Pronunciation

(EYE ern SOO krose)

Index Terms

  • Ferric Saccharate
  • Iron (III) Hydroxide Sucrose Complex
  • Iron Sucrose Complex, Inj

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Venofer: 20 mg/mL (2.5 mL, 5 mL, 10 mL)

Brand Names: U.S.

  • Venofer

Pharmacologic Category

  • Iron Salt

Pharmacology

Iron sucrose is dissociated by the reticuloendothelial system into iron and sucrose. The released iron increases serum iron concentrations and is incorporated into hemoglobin.

Distribution

Vdss: Healthy adults: 7.9 L

Metabolism

Dissociated into iron and sucrose by the reticuloendothelial system

Excretion

Healthy adults: Urine (5%) within 24 hours

Onset of Action

Onset of action: Hematologic response to either oral or parenteral iron salts is essentially the same; red blood cell form and color changes within 3 to 10 days

Maximum effect: Peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase within 2 to 4 weeks

Half-Life Elimination

Healthy adults: 6 hours; Nondialysis-dependent adolescents: 8 hours

Use: Labeled Indications

Iron-deficiency anemia: Treatment of iron-deficiency anemia in chronic kidney disease (CKD)

Off Label Uses

Chemotherapy-associated anemia

Data from two multicenter, open-label, prospective, randomized clinical trials support the use of iron sucrose in the management of patients with chemotherapy-associated anemia [Bastit 2008], [ Hedenus 2007].

Contraindications

Known hypersensitivity to iron sucrose or any component of the formulation

Documentation of allergenic cross-reactivity for iron is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Doses expressed in mg of elemental iron. Note: Test dose: Product labeling does not indicate need for a test dose in product-naive patients.

Per National Kidney Foundation KDOQI Guidelines, initiation of iron therapy, determination of dose, and duration of therapy should be guided by results of iron status tests combined with the Hb level and the dose of the erythropoietin stimulating agent. See Reference Range for target levels. There is insufficient evidence to recommend IV iron if ferritin level >500 ng/mL.

Iron-deficiency anemia in chronic kidney disease (CKD): IV:

Hemodialysis-dependent patient: 100 mg administered during consecutive dialysis sessions to a cumulative total dose of 1,000 mg (10 doses); may repeat treatment if clinically indicated.

Peritoneal dialysis-dependent patient: Two infusions of 300 mg administered 14 days apart, followed by a single 400 mg infusion 14 days later (total cumulative dose of 1,000 mg in 3 divided doses); may repeat treatment if clinically indicated.

Nondialysis-dependent patient: 200 mg administered on 5 different occasions within a 14-day period (total cumulative dose: 1,000 mg in 14-day period); may repeat treatment if clinically indicated. Note: Dosage has also been administered as 2 infusions of 500 mg on day 1 and day 14 (limited experience).

Chemotherapy-associated anemia (off-label use): IV: 200 mg once every 3 weeks for 5 doses (Bastit 2008) or 100 mg once weekly during weeks 0 to 6, followed by 100 mg every other week from weeks 8 to 14 (Hedenus 2007)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Doses expressed in mg of elemental iron. Note: Test dose: Product labeling does not indicate need for a test dose in product-naive patients.

Per National Kidney Foundation KDOQI Guidelines, initiation of iron therapy, determination of dose, and duration of therapy should be guided by results of iron status tests combined with the Hb level and the dose of the erythropoietin stimulating agent. See Reference Range for target levels. There is insufficient evidence to recommend IV iron if ferritin level >500 ng/mL.

Iron-deficiency anemia in chronic kidney disease (CKD): Children ≥2 years of age and Adolescents: IV: Note: Not indicated for iron replacement treatment in children and adolescents.

Hemodialysis-dependent patient: Maintenance therapy: 0.5 mg/kg/dose (maximum: 100 mg/dose) every 2 weeks for 12 weeks (6 doses); may repeat if clinically indicated.

Nondialysis-dependent patient (concurrent erythropoietin therapy): Maintenance therapy: 0.5 mg/kg/dose (maximum: 100 mg/dose) every 4 weeks for 12 weeks (3 doses); may repeat if clinically indicated

Peritoneal dialysis-dependent patient (concurrent erythropoietin therapy): Maintenance therapy: 0.5 mg/kg/dose (maximum: 100 mg/dose) every 4 weeks for 12 weeks (3 doses); may repeat if clinically indicated

Dosing: Renal Impairment

Chronic kidney disease, nondialysis-dependent: No dosage adjustment necessary (indicated for use in nondialysis-dependent CKD patients).

Hemodialysis: No dosage adjustment necessary (indicated for use in CKD patients on hemodialysis); not dialyzable.

Peritoneal dialysis: No dosage adjustment necessary (indicated for use in CKD patients on peritoneal dialysis).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Reconstitution

Children: May administer undiluted or diluted in NS to a concentration of 1 to 2 mg/mL. Do not dilute to concentrations <1 mg/mL.

Adults: Doses ≤200 mg may be administered undiluted or diluted in a maximum of 100 mL NS. Doses >200 mg should be diluted in a maximum of 250 mL NS. Do not dilute to concentrations <1 mg/mL.

Administration

IV: Administer intravenously as a slow IV injection (not for rapid IV injection) or as an IV infusion. Can be administered through dialysis line.

Children and Adolescents:

Slow IV injection: Administer undiluted over 5 minutes

Infusion: Infuse diluted solution over 5 to 60 minutes

Adults:

Slow IV injection: May administer doses ≤200 mg undiluted by slow IV injection over 2 to 5 minutes. When administering to hemodialysis-dependent patients, give iron sucrose early during the dialysis session (generally within the first hour).

Infusion: Infuse diluted doses ≤200 mg over at least 15 minutes; infuse diluted 300 mg dose over 1.5 hours; infuse diluted 400 mg dose over 2.5 hours; infuse diluted 500 mg dose over 3.5 to 4 hours (limited experience). When administering to hemodialysis-dependent patients, give iron sucrose early during the dialysis session.

Storage

Store intact vials in original carton at controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Iron sucrose is stable for 7 days at room temperature (23°C to 27°C [73°F to 81°F]) or under refrigeration (2°C to 6°C [36°F to 43°F]) when undiluted in a plastic syringe or following dilution in normal saline in a plastic syringe (concentration 2 to 10 mg/mL) or for 7 days at room temperature (23°C to 27°C [73°F to 81°F]) following dilution in normal saline in an IV bag (concentration 1 to 2 mg/mL).

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Avoid combination

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Avoid combination

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Adverse Reactions

Events and incidences are associated with use in adults unless otherwise specified.

>10%:

Cardiovascular: Hypotension (2% to 3%; children: 2%; hemodialysis patients: 39%; may be related to total dose or rate of administration)

Central nervous system: Headache (3% to 13%; children: 6%)

Gastrointestinal: Nausea (5% to 15%; children: 3%)

Neuromuscular & skeletal: Muscle cramps (1% to 3%; hemodialysis patients: 29%)

Respiratory: Nasopharyngitis (2% to 16%), pharyngitis (2% to 16%), sinusitis (2% to 16%), upper respiratory tract infection (2% to 16%; children: 4%)

1% to 10%:

Cardiovascular: Hypertension (7% to 8%; children: 2%), peripheral edema (3% to 7%), chest pain (1% to 6%), thrombosis (children: 2%; arteriovenous fistula), cardiac failure (>1%)

Central nervous system: Dizziness (1% to 7%; children: 4%)

Dermatologic: Pruritus (2% to 4%)

Endocrine & metabolic: Hypoglycemia (≤4%), hypervolemia (1% to 3%), gout (≤3%), hyperglycemia (≤3%)

Gastrointestinal: Vomiting (5% to 9%; children: 4%), diarrhea (5% to 8%), dysgeusia (≤8%), peritonitis (children: 4%), abdominal pain (1% to 4%)

Immunologic: Graft complications (≤10%)

Infection: Sepsis (>1%)

Local: Injection site reaction (≤6%)

Neuromuscular & skeletal: Limb pain (3% to 6%), arthralgia (1% to 4%), myalgia (≤4%), weakness (1% to 3%), back pain (1% to 2%)

Ophthalmic: Conjunctivitis (≤3%)

Otic: Otalgia (≤2%)

Respiratory: Dyspnea (1% to 6%), cough (1% to 3%; children: 4%), nasal congestion (≤1%)

Miscellaneous: Fever (1% to 3%; children: 4%)

<1%, postmarketing, and/or case reports: Anaphylactic shock, anaphylactoid reaction, angioedema, bradycardia, bronchospasm, circulatory shock, confusion, facial rash, hyperhidrosis, hypersensitivity reaction (including wheezing), hypoesthesia, joint swelling, local discoloration (at injection site following extravasation), loss of consciousness, necrotizing enterocolitis (reported in premature infants; no causal relationship established), paresthesia, seizure, shock, urine discoloration, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Cases of hypersensitivity reactions, including anaphylactic and anaphylactoid reactions (some fatal), have been reported. Monitor patients during and for ≥30 minutes postadministration; discontinue immediately for signs/symptoms of a hypersensitivity reaction (shock, hypotension, loss of consciousness) or if signs of intolerance occur. Equipment for resuscitation and trained personnel experienced in handling medical emergencies should always be immediately available.

• Hypotension: Significant hypotension has been reported frequently in hemodialysis-dependent patients. Has also been reported in peritoneal dialysis and nondialysis patients. Hypotension may be related to total dose or rate of administration (avoid rapid IV injection), follow recommended guidelines.

Other warnings/precautions:

• Appropriate use: Withhold iron in the presence of tissue iron overload; periodic monitoring of hemoglobin, hematocrit, serum ferritin, and transferrin saturation is recommended.

Monitoring Parameters

CKD patients: Hematocrit, hemoglobin, serum ferritin, serum iron, transferrin, percent transferrin saturation (TSAT), TIBC (takes ~4 weeks of treatment to see increased serum iron and ferritin, and decreased TIBC); iron status should be assessed ≥48 hours after last dose (due to rapid increase in values following administration); signs/symptoms of hypersensitivity reactions (during and ≥30 minutes following infusion); hypotension (during and following infusion)

Chemotherapy-associated anemia (off-label use): Iron, total iron-binding capacity, transferrin saturation, or ferritin levels at baseline and periodically (Rizzo, 2011)

Pregnancy Risk Factor

B

Pregnancy Considerations

Iron can be detected in the fetus and cord blood; concentrations may be influenced by maternal iron status (IOM 2001). iron-deficiency anemia in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; IOM 2001).

Iron requirements increase during pregnancy. All females should be screened for iron deficiency during pregnancy; if iron-deficiency anemia is present, supplemental iron (in addition to prenatal vitamins) should be administered. Oral preparations are generally sufficient, however parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, muscle cramps, nausea, vomiting, back pain, joint pain, rhinitis, pharyngitis, or change in taste. Have patient report immediately to prescriber angina, severe dizziness, passing out, vision changes, severe headache, shortness of breath, swelling of arms or legs, or injection site irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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