INFeD is a formulation of Iron Dextran that contains 50 mg per ml of elemental iron. It is used in the treatment of iron deficiency anemia.

Iron Dextran (Infed) Uses:

• Iron deficiency:

  • Treating iron deficiency in persons who cannot or do not want to take oral medication

Iron Dextran dose in adults:

Note:

• Before giving iron dextran, stop using oral iron supplements.

• Before beginning iron dextran therapy, a 25 mg test dose should be given.

• Watch the patient for at least an hour before administering the therapeutic dose (after the test dose).

Iron-deficiency anemia:

• IM (INFeD, Canadian product DexIron), IV (INFeD, Canadian product DexIron):

• The following formula is used to compute the total dosage (mL): LBW + 0.0442 (desired hemoglobin - observed hemoglobin) (0.26 x LBW)
  • Weight in Kilograms of Lean Body (LBW)
  • 14.8 g/dL of hemoglobin is considered normal.

• Total dose infusion (off label):

  • An hour-long total dosage infusion of 1 gm of iron dextran is safe and effective for people with iron deficiency anaemia, according to  data from a retrospective analysis.
  • For patients receiving IV iron for the first time, a test dosage of 40 mg was given over the course of five minutes, and then the remainder was given  after fifteen minutes of observation.

For patients who have lost blood, INFed (Iron Sucrose) is used as iron replacement therapy as:

• Replacement iron (mg) = blood loss (mL) x Hct, IM (INFeD, DexIron [Canadian product]), IV (INFeD, DexIron [Canadian product]).

  • Maximum daily dosage (manufacturer's labeling):

    • By administering a series of daily smaller incremental doses, it is possible to replace higher projected iron shortages (total dose).
    • Typically, daily doses should not exceed 100 mg of iron or 2 mL.

Iron Dextran (Infed) in Cancer or chemotherapy-associated anemia: IV:

Point to be noted:

• Use the iron-deficiency anemia equation to calculate the dose as necessary.

• Weekly administration (off-label dosing; INFeD):

  • From the 1st week to the third:

    • 75 mg (bolus) once a week after a test dose of 25 mg (over 1 to 2 minutes)

  • The fourth week and afterward:

    • 100 mg is administered once each week for 5 minutes until the prescribed amount is attained.

  • Total dose infusion (off-label dosing; INFeD):

    • After administering a test dose of 25 mg over 1 to 2 minutes, the remaining portion of the calculated total dose was combined with 500 mL of NS and infused at a rate of 175 mL per hour.

Iron Dextran dose in children:

Note:

• Close attention must be paid to the specific product when ordering and giving; improper selection or switching from one salt form to another (dextran vs. sucrose) without suitable dose modification may result in serious over- or underdosing.
• Multiple states of parenteral iron are found
• Before giving iron dextran, stop using oral iron supplements. 
• Dosing presented as both mg and mL
• Test doses are recommended before starting therapy.
• When ordering and distributing, pay attention.

Note: One millilitre of iron dextran contains 50 mg of elemental iron.

Patients with anemia and the dosage of INFed (Iron Dextran):

• Infants younger than or equal to 4 months, kids, and teenagers: IM, IV

  • Test dose:

    • The normal dosage is 10 to 25 mg (0.2 to 0.5 mL), administered an hour before the start of iron dextran treatment.

    • The manufacturer advises using a fixed test dosage of 25 mg (or 0.5 mL).

    • Lower dosages and a weight-based strategy, on the other hand, would be preferred. Some centers have employed the following:

      • Infants older than 4 months and less than 10 kg: 10 mg (0.2 mL).
      • Children between 10 to 20 kg: 15 mg (0.3 mL).
      • Children over 20 kg and Adolescents: 25 mg (0.5 mL).

• Calculating total replacement dosage of iron dextran:

  • Hb = desired haemoglobin (g/dL) = 12 g/dL if under 15 kg or 14.8 g/dL if above 15 kg.
  • Dose (mL) equals 0.0442 (Hb - Hb) x LBW plus (0.26 x LBW).
  • Lean body weight, in kilograms, is LBW. Use genuine body weight for patients weighing 5 to 15 kg.
  • Hemoglobin concentration (g/dL) = Hb.

• Intermittent dosing for replacement (multiple doses):

  • Calculate the total dose volume (iron dextran 50 mg/mL elemental iron) using the previous calculation. As long as you don't go over the maximum daily dose recommended for the route, you might want to consider splitting the total replacement dose and taking it more frequently if it is greater.

• Iron Dextran Usual maximum daily dosage:

  • IV:
    • 100 mg (2 mL)/day.
  • IM:
    • Children 5 to 10 kg and infants over 4 months old: 50 mg (1 mL)/day.
    • Adolescents and children above 10 kg: 100 mg (2 mL)/day.
    • Infants over 4 months old and under 5 kg: 25 mg (0.5 mL)/day.

• Total dose infusion:

  • Infants younger than 11 months, kids, and teenagers:

    • The entire dose, which shouldn't be more than 1,000 mg/dose, should be calculated using the previous method. The total dose should then be given as a single infusion over the course of an hour.

Iron replacement dosage for acute blood loss after ingestion of iron dextran:

Note:

• Calculate the total dose volume (elemental iron dextran 50 mg/mL).

• Assumption: 1 mg of elemental iron is present in 1 mL of normocytic, normochromic red blood cells.

• If the total replacement dose is considerable, think about splitting it up and using smaller incremental dosages to stay below the route's suggested maximum daily dosages.

• Infants under four months old, kids, and teenagers:

• IM, IV:

  • Hematocrit (hem) x blood loss (mL) = replacement iron (mg) (expressed as a decimal fraction).

  • Usual highest daily dosage:

    • IM:
      • Infants ≥4 months <5 kg: 25 mg (0.5 mL)/day.
      • Children 5 to 10 kg: 50 mg (1 mL)/day.
      • Children >10 kg and Adolescents: 100 mg (2 mL)/day.
    • IV:
      • 100 mg (2 mL)/day.

Patients with chronic renal failure and anemia should get an iron dextran dose infusion:

Note:

• For target levels, refer to Reference Range.
• Based on the KDOQI Anemia Guidelines from 2000 for dosing.
• The findings of the iron status tests, the Hb level, and the dose of the erythropoietin stimulating medicine should be used to determine the start of the iron treatment,  the dose, and the length of therapy.
• The KDIGO guidelines and more recent KDOQI guidelines no longer advocate precise doses or particular products for intravenous Fe supplementation.
• If the ferritin level is greater than 500 ng/mL, there is not enough data to warrant IV iron.

• Predialysis or peritoneal dialysis:

  • Infants and Children: as a single dosage given as often as is clinically required: IV:

    • Under 10 kg: 125 mg.
    • Over 20 kg: 500 mg.
    • Between 10 to 20 kg: 250 mg.

• Hemodialysis:

  • Infants, Children, and Adolescents:

    • Ten doses should be given, one for each dialysis: IV:

    • Under 10 kg: 25 mg.
    • Over 20 kg: 100 mg.
    • Between 10 to 20 kg: 50 mg.

Pregnancy Risk Category: D (First Trimester), C (2nd and 3rd Trimesters)

• Iron dextran could cross the placenta
• During pregnancy, maternal iron requirements rise.
• Affective iron levels can be maintained for the fetus regardless of maternal iron status, except in extreme cases of anemia.
• The treatment of iron deficiency (or IDA) in pregnancy is generally the same as for non-pregnant women.
• Most studies have shown that iron therapy can improve and optimize maternal hematologic parameters. However, there is not much information about the clinical outcomes for mothers and babies.
• Oral iron preparations are sufficient in most cases. However, patients who are unable to tolerate or won't take oral iron may need parenteral iron therapy in severe iron deficiency or malabsorption situations.
• Because of limited safety data, intravenous iron should not be given to a woman during early pregnancy.
• For the treatment of IDA during pregnancy, iron dextran has been investigated.
• Iron deficiency (IDA) and untreated iron deficiency in pregnant women can lead to adverse events such as low birth weight, preterm births, and increased perinatal mortality.

Iron dextran use during breastfeeding:

• Breast milk contains iron (IOM 2001). Breast milk also contains trace amounts of iron dextran.
• Iron levels in breast milk are maintained for women with mild to moderate iron deficiency (IDA). However, concentrations may drop if IDA becomes severe.
• The treatment of postpartum IDA has been tested using the iron dextran complex.
• It may be preferable to use agents other than the iron complex.
• Iron dextran is compatible with breastfeeding when it's used to treat anemia (WHO 2002).

Infed (Iron Dextran) Dose in Kidney Disease:

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

Hemodialysis:

• Dialysis removal of iron dextran is negligible.

Infed (Iron dextran) Dose in Liver disease:

• Use with extreme vigilance in people with severe impairment.
• There are no dosage adjustments provided in the drug manufacturer’s labeling;

Side effects of Iron Dextran (Infed):

• Central Nervous System:

  • Headache
  • Paresthesia
  • Chills
  • Disorientation
  • Dizziness
  • Seizure
  • Shivering
  • Unresponsive To Stimuli
  • Loss Of Consciousness
  • Malaise
  • Numbness

• Hypersensitivity:

  • Anaphylaxis
•  

• Gastrointestinal:

  • Vomiting
  • Diarrhea
  • Abdominal Pain
  • Nausea
  • Dysgeusia

• Cardiovascular:

  • Chest Tightness
  • Syncope
  • Cardiac Arrhythmia
  • Circulatory Shock
  • Chest Pain
  • Flushing
  • Bradycardia
  • Shock
  • Tachycardia
  • Hypertension

• Dermatologic:

  • Skin Rash
  • Urticaria
  • Diaphoresis
  • Pruritus
  • Skin Cyanosis

• Genitourinary:

  • Hematuria

• Infection:

  • Sterile Abscess

• Neuromuscular & Skeletal:

  • Exacerbation Of Arthritis
  • Myalgia
  • Arthritis
  • Arthralgia
  • Asthenia
  • Back Pain

• Hematologic & Oncologic:

  • Leukocytosis
  • Lymphadenopathy
  • Purpuric Rash

• Local:

  • Pain At Injection Site (IM)
  • Swelling At Injection Site
  • Injection Site Phlebitis (IV)
  • Local Skin Discoloration
  • Fibrosis At Injection Site (IM)
  • Inflammation At Injection Site
  • Local Soreness/Soreness At Injection Site (IM)
  • Atrophy At Injection Site (IM)
  • Cellulitis At Injection Site

• Miscellaneous:

  • Fever

• Respiratory:

  • Acute Respiratory Distress
  • Bronchospasm
  • Dyspnea
  • Wheezing

Contraindications to Infed (Iron dextran):

• Any anemia that is not related to iron deficiency
• Hypersensitivity to any of the formulation's ingredients, including iron dextran

Warnings and safeguards

• Hypersensitivity [US Boxed Warning]

  • Parenteral iron dextran administration can cause anaphylactic-type reactions, including fatalities.
  • Only administer if resuscitation equipment or trained personnel in the treatment and detection of hypersensitivity are available.
  • Patients who have already experienced several medication sensitivities or anaphylactic episodes may be at higher risk.
  • Before administering the first therapeutic dose, give a test dose.
  • Contrary to low molecular weight iron dextran, high molecular weight iron dextran exhibited a higher rate of adverse events, including life-threatening ones.
  • Follow the test dose if you don't experience any anaphylactic-type symptoms. If so, give the full therapeutic dose.
  • During infusion, be aware of signs and symptoms that could indicate hypersensitivity.
  • Patients who were able to tolerate the test dose have experienced fatal reactions.
  • Hypersensitivity risk may also be increased by concurrent use of ACE medications, which suppress the angiotensin-converting enzyme.

• Allergies and asthma

  • Patients with severe allergies or asthma should be cautious.
•  

• Infusion reaction

  • Infusion reaction delayed (1 to 2 days)
    • Chills
    • Dizziness
    • Fever
    • Headache
    • Back pain, arthralgia
    • Large doses of IV iron dextran may cause nausea, malaise, or vomiting.
  • Symptoms usually disappear within three to four days.

• Cardiovascular disease

  • Patients with pre-existing heart disease should be careful.
  • Cardiovascular issues might get worse with iron dextran.

• Hepatic impairment

  • Patients with severe hepatic impairment should be cautious.

• Renal disease, renal impairment

  • Patients with CKD (on hemodialysis), who require iron supplementation, can use the IV route.
  • Non-dialysis patients may use IV iron or oral iron. However, a trial period of 1 to 3 months is recommended for oral iron treatment.
  • If you have a severe kidney infection, avoid using it.

• Rheumatoid arthritis:

  • Rheumatoid arthritis patients may experience acute swelling and joint pain.

Iron dextran: Drug Interaction

Monitoring parameters:

• Hematocrit, reticulocyte count
• Serum ferritin
• Be on the lookout for an adverse response (the test dose, for an hour following the test dose, and the therapeutic dose)
• Serum iron
• Monitor hemoglobin,
• TIBC

• Cancer patients with anemia:

  • Keep track of your ferritin, transferrin saturation, total iron-binding capacity, and iron levels over time.

• Chronic kidney disease:

  • After an IV iron course, transferrin saturation should be checked more often.

How to administer Iron dextran (Infed)?

Point to be noted:

• A successful test dosage does not guarantee that a therapeutic dose won't cause an anaphylactic-type response.
• Give gradually for at least 30 seconds, then watch for an allergic reaction for at least an hour before giving the balance of the day's therapeutic dose (dose minus test dose).
• There should be access to resuscitation tools, medications, and qualified staff.
• On the first day of therapy, a test dosage ought to be administered.

IM (INFeD, DexIron [Canadian product]):

• Alternate buttocks with subsequent injections.
• The injection should go deep into the upper quadrant of the buttock.
• Use the Z-track technique
• Administer the test dose at the identical suggested site using this technique.

IV:

• Undiluted doses may be delivered in the future at a modest, escalating rate not to exceed 50 mg/minute (maximum: 100 mg).
• For INFeD, the test dosage must be given gradually over at least 30 seconds, for DexIron (a Canadian medication), over 5 minutes, or for anaemia brought on by chemotherapy or cancer, over 1 to 2 minutes.
• Avoid dilutions with dextrose since they increased the risk of phlebitis and localized discomfort.

Complete dose Iron dextran infusion (off-label administration):

• Whole dosage infusions may be linked to a higher frequency of negative effects 24 to 48 hours following the infusion.
• A total dosage infusion of 1gm (diluted in 250 mL of NS) given over the course of an hour to patients with iron deficiency anemia, according to a retrospective review, is thought to be both safe and efficacious (after an initial test dose).
• Patients with cancer/chemotherapy-related anaemia should receive the remaining dose 1 hour after the test dose, diluted in 500 mL of NS, and infused  at a rate of 175 mL/hour.
• Another retrospective study gave the whole dosage (after the initial test dose) over a period of 4 to 6 hours to individuals with CKD and iron deficient anemia.

   

  Mechanism of action of Infed (Iron dextran):

  • Plasma releases iron which replenishes bone marrow's iron stores. Hemoglobin is then incorporated into it.

  The onset of action:

  • Parenteral or oral iron salts have the same effect on the hematopoietic system. The color and shape of red blood cells can change in as little as 3 to 10 days.

  Maximum effect:

  • Parenteral or oral iron salts both produce the same hematologic response. In as little as 3 to 10 days, red blood cells' color and shape might change.

  Absorption:

  • IV:
    • At 10 to 20 mg/hour, the reticuloendothelial system appears to be steady in its iron intake.
  • IM:
    • 90% almost after 1 to 3 weeks,
    • 60% absorption seen after 3 days
    • The balance is gradually absorbed over months

  Half-life elimination:

  • 48 hours

  Excretion:

  • Through the reticuloendothelial system, excrete urine and feces

   

  International Brands of Iron dextran:

  • Infed
  • Dexiron
  • Infufer
  • Cosmofer
  • Desman
  • Driken
  • Fercayl
  • Ferrolecum
  • Fexibron
  • Fexiron
  • Imferon
  • Intrafer
  • Supral

   

  Iron Dextran Brand Names in Pakistan:

  Iron Dextran Injection 100 mg
  Cosmofer	Mission Pharmaceuticals