Iron Dextran Complex

Iron Dextran Complex is a prescription medicine used for treating iron-deficiency anemia.

• Iron Dextran Complex is available under the following different brand names: INFeD, Dexferrum

Adult and pediatric dosage

Injectable solution

• 50mg (Fe)/mL

Iron-deficiency Anemia

Adult dosage

• 25-100 mg IV or deep IM every day or as needed
• Not to exceed 100 mg (2 mL)/day

Pediatric dosage

• Weight above 15 kg: 0.0442(Desired Hgb - Observed Hgb) x Lean BW(kg) + (0.26 × Lean BW)
• 5-15 kg
• Not to be given in first 4 months of life
• Dose = 0.0442(Desired Hgb - Observed Hgb) x BW(kg) + (0.26 × BW)
• Desired hemoglobin usually 12 g/dL

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Iron Dextran Complex include:

• flushing,
• tingling of the hands/feet,
• shivering, or
• dizziness,
• injection site reactions (tenderness, irritation, soreness, pain, swelling, redness, or brown discoloration),
• nausea,
• vomiting,
• diarrhea,
• fever,
• sweating,
• chills,
• muscle or joint pain or aches,
• metallic taste in the mouth, or
• headache.

Serious side effects of the Iron Dextran Complex include:

• back/joint/muscle aches,
• chills,
• moderate to high fever,
• headache,
• nausea, or
• vomiting.
• abdominal pain,
• fast/slow/irregular heartbeat,
• severe headache, or
• blurred vision.

Rare side effects of the Iron Dextran Complex include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Iron Dextran Complex has severe interactions with no other drugs.
• Iron Dextran Complex has serious interactions with the following drugs:
  • baloxavir marboxil
  • benazepril
  • captopril
  • demeclocycline
  • doxycycline
  • eltrombopag
  • fleroxacin
  • gemifloxacin
  • levofloxacin
  • minocycline
  • moxifloxacin
  • mycophenolate
  • ofloxacin
  • oxytetracycline
  • tetracycline
• Iron Dextran Complex has moderate interactions with at least 31 other drugs.
• Iron Dextran Complex has minor interactions with the following drugs:
  • calcium acetate
  • calcium carbonate
  • calcium chloride
  • calcium citrate
  • calcium gluconate
  • carbidopa
  • gymnema
  • manganese
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of hypersensitivity to product or excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Iron Dextran Complex?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Iron Dextran Complex?”

Cautions

Iron overload

• Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis
• All adult and pediatric patients receiving drugs require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin, and transferrin saturation); do not administer drugs to patients with evidence of iron overload

Risk of toxicity in patients with underlying conditions

• Monitor for iron toxicity when the drug is used in patients with serious impairment of liver function
• May increase pathogenicity of certain microorganisms; product should not be used during the acute phase of infectious kidney disease
• Adverse reactions experienced following administration of the drug may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease
• Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of iron dextran
• Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions

Delayed reactions

• Large intravenous doses, such as those used with total dose infusions (TDI), associated with an increased incidence of adverse reactions
• Adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting
• The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days; etiology of reactions is not known; do not exceed a total daily dose of 2 mL undiluted iron dextran

Hypersensitivity reactions

• Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, were reported following parenteral administration of iron dextran products
• Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse; fatal reactions were reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated
• Administer only in a setting where resuscitation equipment and medications are available; administer test dose before first therapeutic dose; observe patients for at least one hour after test dose before administering remainder of initial therapeutic dose
• During all product administrations, observe patients for signs or symptoms of anaphylactic-type reactions
• Use the drug only in patients in whom clinical and laboratory investigations have established an iron-deficient state not amenable to oral iron therapy
• Factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies; additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product
• The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among products; if hypersensitivity reactions occur during administration, stop infusion immediately and manage reaction medically
• If hypersensitivity reactions occur during administration, stop administration immediately and manage the reaction medically

Pregnancy and Lactation

• There are no adequate and well-controlled studies on pregnant women; should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products, which may cause fetal bradycardia, especially during the second and third trimester
• Lactation
  • Exercise caution when the product is administered to a nursing woman; traces of unmetabolized iron dextran are excreted in human milk