INFeD (iron dextran injection USP)

INFED (iron dextran injection USP)

INFeD (iron dextran injection USP)

INFeD (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.

Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 4.5 to 7.0.

INDICATIONS AND USAGE

INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron.

Mechanism of Action

The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores.

Dosage and administration

Important Pre-Treatment Information

Discontinue administration of any iron-containing products prior to administration of INFeD.

Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy.

Administer a test dose of INFeD prior to administration of therapeutic dose.

Recommended Dosage for Iron Deficiency Anemia

Calculate the INFeD dose based upon Table 1 and formulas below. Continue INFeD until hemoglobin is within the normal range and iron stores are replete.

Administer daily doses of no more than 2 mL of INFeD until the total required dose is administered. Monitorresponse to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storageparameters (serum iron, total iron binding capacity, and percent saturation of transferrin). Iron storageparameters may improve prior to hematologic parameters. Serum ferritin may not be an accurate measure ofbody iron stores in patients on chronic dialysis.

Table 1

PATIENT LEAN BODY WEIGHTRecommended Volume (mL) of INFeD Based on Observed Hemoglobin
kglb3 (g/dL)4 (g/dL)5 (g/dL)6 (g/dL)7 (g/dL)8 (g/dL)9 (g/dL)10 (g/dL) 
51133332222 
102276655443 
1533109987765 
2044161514131211109 
25552018171615141312 
30662322211918171514 
35772726242321201817 
40883129282624222119 
45993533312927252321 
501103937353230282624 
551214341383633312826 
601324744423936343128 
651435148454239363431 
701545552494542393633 
751655955524945423935 
801766359555248454138 
851876663595551484440 
901987066625854504642 
952097470666257534945 
1002207874696560565247 
1052318277736863595450 
1102428681767167625752 
1152539085807570645954 
1202649488837873676257 

*Table values were calculated based on a normal adult hemoglobin of 14.8 g/dL for patients with body weights greater than 15 kg (33 lbs) and a hemoglobin of 12 g/dL for patients with body weights less than or equal to 15 kg (33 lbs).

Alternatively, the total dose may be calculated using the formulas below:

Adults and Children over 15 kg (33 lbs)

Dose (mL) = 0.0442 (Desired Hb -Observed Hb) x LBW + (0.26 x LBW)

Based on:

• Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL.]

• Observed Hb = the patient’s current hemoglobin in g/dL

• LBW = Lean body weight in kg [A patient’s lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.]

  • For males: LBW = 50 kg + 2.3 kg for each inch of patient’s height over 5 feet
  • For females: LBW = 45.5 kg + 2.3 kg for each inch of patient’s height over 5 feet
  • To calculate a patient’s weight in kg when lbs are known:

Weight in lbs/22 = weight in kg

Children 5 to 15 kg (11 to 33 lbs)

Otherwise, the total dose may be calculated using the formula below:

Dose (mL) = 0.0442 (Desired Hb -Observed Hb) x W + (0.26 x W)

Based on:

  • Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]
  • W = body weight in kg
  • To calculate a patient’s weight in kg when lbs are known:

weight in lbs/22 = weight in kg

Recommended Dosage of Iron Replacement for Blood Loss

Calculate the INFeD dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit.

The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron.

INFeD Dose (in mL) = [Blood loss (in mL) x hematocrit] ÷ 50 mg/mL

Example: Blood loss of 500 mL with 20% hematocrit

Replacement Iron = 500 x 0.20 = 100 mg

INFeD dose volume= 100mg/500mg/ml =2ml

Administration

The total volume of INFeD required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed.

The total volume of INFeD required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)].

NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Intravenous Injection

Test Dose: Prior to the first intravenous INFeD therapeutic dose, administer an intravenous test dose of 0.5 mL. Administer the test dose at a gradual rate over at least 30 seconds. Delay administration of the initial therapeutic INFeD dose until 1 hour or more after the test dose. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of INFeD.

INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute.

The maximum daily dose of INFeD should not exceed 2 mL.

Intramuscular Injection

Test Dose: Prior to the first intramuscular INFeD therapeutic dose, administer an intramuscular test dose of 0.5 mL. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Delay administration of the initial therapeutic INFeD dose until 1 hour or more after the test dose. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of INFeD.

If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total required dose has been reached. Each day’s dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients.

The maximum daily dose of INFeD should not exceed 2 mL.

INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock -never into the arm or other exposed areas -and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended.

CONTRAINDICATIONS

INFeD is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran.

Warnings and precautions

• Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection.

• Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.

• Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose.

• During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have been reported following the test dose of iron dextran injection. Fatal reactions have also occurred in situations where the test dose was tolerated.

• Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.

• Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD.

Adverse reactions

  • Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy.
  • Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias.
  • Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea.
  • General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation.
  • Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis, myalgia, backache.
  • Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste.
  • Psychiatric disorders: Disorientation
  • Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing.
  • Renal and urinary disorders: Hematuria.
  • Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating.
  • Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site.
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USE IN SPECIFIC POPULATIONS

Pregnancy: Parenteral iron administration may be associated with hypersensitivity reactions, which may have serious consequences, such as fetal bradycardia. Advise pregnant persons of the potential risk to the fetus. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose.

Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Fetal/Neonatal Adverse Reactions: Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context ofanaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as INFeD) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester, and lead to preterm birth and stillbirth.

Lactation: Trace amounts of unmetabolized iron dextran are present in human milk. There are no data on the effects of iron dextran in breastfed infants or effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for INFeD in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Pediatric Use: INFeD is not recommended for use in infants under 4 months of age.

OVERDOSAGE

Excessive dosages of INFeD may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer INFeD to patients with iron overload. INFeD is not removed by hemodialysis.

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