Venofer (Iron Sucrose) is used to treat patients with anemia caused by iron deficiency in patients with kidney disease. It is also used to treat iron-deficiency anemia in patients with gastrointestinal disorders and in whom a rapid rise in the hemoglobin is required.

Venofer (Iron Sucrose) Uses:

• Iron-deficiency anemia:
  • Treatment of iron-deficiency anemia in chronic kidney disease.

KDIGO guideline recommendations:

• For CKD patients with anemia and receiving dialysis, IV iron may be indicated if an increase in the hemoglobin concentration (without initiating or increasing the dose of an erythropoiesis-stimulating agent) is desired and the transferrin saturation (TSAT) is ≤30% and ferritin is ≤500 ng/mL;
• For CKD patients not on dialysis, a trial of oral iron is suggested, although the route of administration is selected based on iron deficiency severity, venous access, response to prior oral iron therapy, patient adherence, and cost.
• There is insufficient data to recommend IV iron if the ferritin level is >500 ng/mL or TSAT is >30% (KDIGO 2012).
• Off Label Use of Iron Sucrose in Adults:
  • Chemotherapy-associated anemia

 Doses expressed in mg of elemental iron.

Venofer (iron sucrose) Dose in Adults

• Note: Test dose: Product labeling does not indicate a test dose in product-naive patients.

Venofer (iron sucrose) Dose in the treatment of Iron-deficiency anemia in chronic kidney disease:

• Hemodialysis-dependent chronic kidney disease:
  • 100 mg administered during consecutive dialysis sessions;
  • the usual cumulative total dose is 1,000 mg (10 doses);
  • may repeat treatment if clinically indicated.
• Peritoneal dialysis-dependent chronic kidney disease:
  • 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.
• Non-dialysis-dependent chronic kidney disease:
  • 200 mg administered on 5 different occasions in the 14-day period (total cumulative dose: 1,000 mg in the 14-day period);
  • may repeat treatment if clinically indicated.
  • Note: Dosage has also been given as 2 infusions of 500 mg on day 1 and day 14 (limited experience).

Venofer (iron sucrose) dose in the treatment of Chemotherapy-associated anemia (off-label):

• • 200 mg IV once every 3 weeks for a total of 5 doses or
  • 100 mg once a week during weeks 0 to 6, followed by 100 mg every other week from weeks 8 to 14 or
  • 200 mg dose once a week after each platinum-based chemotherapy cycle for up to 6 doses or
  • 200 mg after each platinum-based chemotherapy cycle for 6 total cycles.
• Multiple forms for parenteral iron exist;
• close attention must be paid to the specific product when ordering and administering;
• incorrect selection or substitution of one dosage form for another form without proper dosage adjustment may result in serious over- or underdosing.
• Doses are expressed as mg of elemental iron.

Venofer (iron sucrose) Dose in Childrens

Note:

• Per National Kidney Foundation DOQI Guidelines, initiation of iron therapy, dose determination, and therapy duration should be guided by results of iron status tests combined with the Hb level and erythropoietin stimulating agent dose.
• There is no sufficient evidence to recommend IV iron if ferritin level >500 ng/mL.

Venofer (iron sucrose) Dose in the treatment of Iron deficiency anemia in CKD:

• Repletion treatment:
  • Children ≥2 years and Adolescents <15 years:
    • IV: 1 mg/kg/dialysis;
• Maintenance therapy:
  • Children ≥2 years and Adolescents:
    • Hemodialysis-dependent CKD:
      • IV: 0.5 mg/kg/dose
      • The maximum dose: 100 mg every 2 weeks for a total of 12 weeks (6 doses);
      • may repeat if clinically indicated
    • Peritoneal dialysis-dependent CKD with concurrent erythropoietin therapy:
      • IV: 0.5 mg/kg/dose
      • The maximum dose: 100 mg every 4 weeks for a  total of 12 weeks (3 doses);
      • may repeat if clinically indicated
    • Non-dialysis-dependent CKD with concurrent erythropoietin therapy:
      • IV: 0.5 mg/kg/dose
      • The maximum dose: 100 mg every 4 weeks for a total of 12 weeks (3 doses);
      • may repeat if clinically indicated

Venofer Dose in the treatment of Iron deficiency anemia in patients refractory to oral therapy (eg, long-term TPN, GI malabsorption):

• Infants, Children, and Adolescents:
  • Calculate Iron Deficit:
    • Total replacement dose (mg of iron) = 0.6 x weight (kg) x ;
    • Note: In this equation, 12 is the desired target Hgb concentration; in some patients, a different target may be required.
  • Initial dose:
    • IV: at 5 to 7 mg/kg/dose;
    • maximum initial dose: 100 mg/dose
  • Maintenance dose:
    • IV: at 5 to 7 mg/kg/dose every 1 to 7 days until total replacement dose achieved;
    • maximum single dose: 300 mg/dose

Venofer in Pregnancy - Risk Category B

• During pregnancy, maternal iron requirements rise.
• Affective iron levels can be maintained at a normal level regardless of maternal iron status.
• Iron deficiency (IDA) and iron deficiency in pregnancy that are not treated may cause adverse effects such as low birth weight, preterm births, and increased perinatal mortality.
• The treatment of IDA during pregnancy is generally the same as for non-pregnant women.
• Most studies suggest that iron therapy can improve maternal hematologic parameters.
• However, there is not much information on clinical outcomes for the mother or her newborn.
• Oral iron preparations are sufficient in most cases.
• However, parenteral iron therapy can be used for patients who have severe iron deficiency or are unable or unwilling to take oral iron.
• Because of limited safety data, IV iron should not be used in the first trimester.

Use iron sucrose during breastfeeding

• Breast milk contains iron.
• Iron levels in breast milk are maintained for women with mild to moderate iron deficiency (IDA). However, concentrations may drop if IDA becomes severe.
• Multiple studies have evaluated iron sucrose for postpartum IDA treatment.
• Manufacturer recommends that breastfed infants be monitored for GI toxicity (eg constipation, diarrhea).

Venofer Dose in Kidney Disease:

• Chronic kidney disease, non-dialysis-dependent:
  • No dosage adjustment necessary (indicated for use in non-dialysis-dependent chronic kidney disease [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).

Venofer Dose in Liver disease:

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

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

Common Side Effects of Venofer (Iron sucrose):

• Cardiovascular:
  • Hypotension
• Central Nervous System:
  • Headache
• Gastrointestinal:
  • Nausea
• Neuromuscular & Skeletal:
  • Muscle Cramps
• Respiratory:
  • Nasopharyngitis
  • Pharyngitis
  • Sinusitis
  • Upper Respiratory Tract Infection

Less Common Side Effects of Venofer (Iron sucrose):

• Cardiovascular:
  • Hypertension
  • Peripheral Edema
  • Chest Pain
  • Thrombosis
  • Cardiac Failure
• Central Nervous System:
  • Dizziness
• Dermatologic:
  • Pruritus
• Endocrine & Metabolic:
  • Hypoglycemia
  • Hypervolemia
  • Gout
  • Hyperglycemia
• Gastrointestinal:
  • Vomiting
  • Diarrhea
  • Dysgeusia
  • Peritonitis
  • Abdominal Pain
• Immunologic:
  • Graft Complications
• Infection:
  • Sepsis
• Local:
  • Injection Site Reaction
• Neuromuscular & Skeletal:
  • Limb Pain
  • Arthralgia
  • Myalgia
  • Weakness
  • Back Pain
• Ophthalmic:
  • Conjunctivitis
• Otic:
  • Otalgia
• Respiratory:
  • Dyspnea
  • Cough
  • Nasal Congestion
• Miscellaneous:
  • Fever

Contraindications to Venofer (Iron sucrose):

• Hypersensitivity to iron sucrose, or any other component of the formulation
• There is not much documentation of iron-allergic cross-reactivity.
• Cross-sensitivity is possible due to the same chemical structure or pharmacologic actions.

Canadian labeling: Additional contraindications not in the US labeling

• Iron overload
• Anemia is not caused by iron deficiency

Warnings and precautions

• Hypersensitivity
  • There have been reports of cases of hypersensitivity reactions including anaphylactic and/or anaphylactoid reactions (some even fatal).
  • Monitor patients throughout administration and for at most 30 minutes after infusion has been completed.
  • If there are signs or symptoms of hypersensitivity (eg shock, hypotension loss of consciousness, collapse, or signs of intolerance, discontinue immediately.
  • Always have equipment for resuscitation available and personnel who are trained in handling medical emergencies.
  • The majority of reactions happen within 30 minutes of the infusion.
• Hypotension
  • Hypotension can be clinically significant. Monitor for hypotension signs and symptoms.
  • Hypotension can occur depending on the dose and rate of administration. Avoid rapid IV injections.
• Infection
  • Patients with systemic active infection should not be given IV iron.

Iron sucrose: Drug Interaction

Monitoring parameters:

• CKD patients:
  • Hematocrit, hemoglobin,
  • Serum ferritin, serum iron, transferrin, percent transferrin saturation (T-Sat), total iron-binding capacity (TIBC) (takes about 4 weeks of treatment to see increased serum iron and ferritin, and decreased TIBC);
  • Iron status should be assessed ≥48 hours after the last dose (due to the rapid increase in values following administration);
  • Signs/symptoms of hypersensitivity reactions (during and ≥30 minutes following infusion);
  • hypotension (during and following infusion).
• Evaluate iron status (T-Sat and ferritin) when deciding to start or continue iron therapy, and at least every 3 months in patients also receiving erythropoietin-stimulating agent (ESA) therapy.
• Monitor ferritin and T-Sat more frequently when monitoring response to IV iron therapy, when initiating or increasing ESA dose, when there is blood loss, and in any other situations where iron stores may become depleted.

Chemotherapy-associated anemia (off-label use):

• • Monitor Iron, total iron-binding capacity, transferrin saturation, or ferritin levels at baseline and also periodically.

How to administer Venofer (Iron sucrose)?

• IV:
  • Administer intravenously in slow IV injection (not for rapid IV injection) or as an IV infusion.
  • It can be administered through the dialysis line.
• Slow IV injection:
  • May administer doses ≤200 mg undiluted by slow IV injection over 2 to 5 minutes.
  • When giving to hemodialysis-dependent patients, give iron sucrose early during the dialysis session (generally within the first hour).
• Infusion:
  • Infuse diluted doses ≤200 mg over 15 minutes at least;
  • infuse diluted 300 mg dose over 1.5 hours time;
  • infuse diluted 400 mg dose over 2.5 hours;
  • infuse diluted 500 mg dose over 3.5 to 4 hours time(limited experience).
  • When giving to hemodialysis-dependent patients, give iron sucrose early during the dialysis session.

Mechanism of action of Venofer (Iron sucrose):

• The reticuloendothelial systems disintegrates iron sucrose into sucrose and iron.
• The iron is then absorbed into hemoglobin and increases serum iron levels.

Pharmacodynamics, Pharmacokinetics -

Onset of action

• The hemologic response to parenteral or oral iron salts is the same. Red blood cell color and form change within three to 10 days.

Maximum effect:

• Peak reticulocytosis occurs in 5 to 10 days time, and hemoglobin values increase within 2 to 4 weeks.

Metabolism:

• Dissociated into iron and sucrose by the reticuloendothelial system of the body

Half-life elimination:

• Healthy adults: 6 hours; Non-dialysis-dependent adolescents: 8 hours

Excretion:

• Healthy adults: Urine (5%) within 24 hours

International Brands of Iron sucrose:

• Venofer
• Anerrum
• Avofer
• Biorose
• Dialifer
• Encifer
• Femax
• Femorum
• Feofer
• Ferogen
• Feromax
• Ferriscript
• Ferrofer
• Ferrovin
• Incros
• Innofer
• Itoferrose
• Maxifer
• Medofer
• Nefrofer
• Rafofer
• Referis
• Rinofer
• Sucrox
• Sufer
• Venofer
• Venoferrum
• Xenofer

Iron Sucrose Brand Names in Pakistan: