Iron Sucrose

B03A - Iron preparations ATC B03AC02 Small molecule approved 2000 Parenteral

JFDA label: Feradeed

Mechanism of Action

— Supplement

Indications

Approved

Iron-deficiency anemia

Off-label

Chemotherapy-associated anemia

Contraindications

Source: Lexicomp

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 Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Cardiac disorders (6)

Very Common Hypotension

Common cardiac failure · chest pain · Hypertension · peripheral edema · thrombosis

Nervous system disorders (2)

Very Common Headache

Common Dizziness

Immune system disorders (1)

Common Graft complications

Metabolism and nutrition disorders (4)

Common gout · hyperglycemia · hypervolemia · Hypoglycemia

Gastrointestinal disorders (6)

Very Common Nausea

Common abdominal pain · diarrhea · dysgeusia · peritonitis · Vomiting

Skin and subcutaneous tissue disorders (1)

Common Pruritus

Musculoskeletal and connective tissue disorders (6)

Very Common Muscle cramps

Common arthralgia · back pain · Limb pain · myalgia · weakness

Eye disorders (1)

Common Conjunctivitis

Ear and labyrinth disorders (1)

Common Otalgia

Infections and infestations (1)

Common Sepsis

General disorders and administration site conditions (2)

Common Fever · Injection site reaction

Respiratory, thoracic and mediastinal disorders (7)

Very Common Nasopharyngitis · pharyngitis · sinusitis · upper respiratory tract infection

Common cough · Dyspnea · nasal congestion

Dosing

Source: Lexicomp

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)

(For additional information see "Iron sucrose: Pediatric drug information") 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

Refer to adult dosing.

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).

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

Warnings & Precautions

Source: Lexicomp

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.

Pregnancy & Lactation

Pregnancy

FDA category B

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).

Lactation

Iron is present in breast milk (IOM 2001). In one study, iron concentrations were not increased following a single infusion of iron sucrose 100 mg IV to 10 women (2 to 3 days postpartum) with iron-deficiency anemia; milk concentrations were evaluated for 4 days after the injection (Breymann 2007). Breast milk or iron fortified formulas generally provide enough iron to meet the recommended dietary requirements of infants (IOM 2001). The manufacturer recommends caution be used if iron sucrose is

Monitoring

Clinical pearl	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)

Clinical pearl

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)

Chemistry & Properties

Formula	C12H22FeO11
Molecular weight	398.14 g/mol

Biology & Pharmacokinetics

Pharmacokinetics

Half-life	7.0 h

Drug–drug interactions (42, DDInter)

Interacting drug	Severity	Management
Dimercaprol	major
Erdafitinib	major
Alendronic acid	moderate
Benazepril	moderate
Calcifediol	moderate
Captopril	moderate
Chloramphenicol	moderate
Cholecalciferol	moderate
Demeclocycline	moderate
Dihydrotachysterol	moderate
Doxercalciferol	moderate
Doxycycline	moderate
Enalapril	moderate
Ergocalciferol	moderate
Etidronic acid	moderate
Ferrous fumarate	moderate
Ferrous gluconate	moderate
Ferrous sulfate anhydrous	moderate
Fosinopril	moderate
Gallium chloride Ga-67	moderate
Ibandronate	moderate
Iron	moderate
Iron protein succinylate	moderate
Levothyroxine	moderate
Liothyronine	moderate
Liotrix	moderate
Lisinopril	moderate
Minocycline	moderate
Moexipril	moderate
Omadacycline	moderate
Oxytetracycline	moderate
Paricalcitol	moderate
Perindopril	moderate
Quinapril	moderate
Ramipril	moderate
Risedronic acid	moderate
Sarecycline	moderate
Tetracycline	moderate
Thyroid, porcine	moderate
Tiludronic acid	moderate

Showing 40 of 42.

Registered Products (1)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Feradeed	Vial 20 mg/ml	1 vial	MS PHARMA/JORDAN	4.830