Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 11 January 2017

Indication(s)

INDICATIONS AND USAGE Dexferrum is indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.

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Advisory information

contraindications
CONTRAINDICATIONS Hypersensitivity to the product. All anemias not associated with iron deficiency.
Special warnings and precautions

PRECAUTIONS General: Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis.

Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.

Dexferrum should be used with caution in individuals with histories of significant allergies and/or asthma.

Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection.

Therefore, administer a test dose prior to the first administration of Dexferrum.

(See BOXED WARNING and DOSAGE AND ADMINISTRATION).

Epinephrine should be immediately available in the event of acute hypersensitivity reactions.

(Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.)

Note:

Patients using beta-blocking agents may not respond adequately to epinephrine.

Isoproterenol or similar beta-agonist agents may be required in these patients.

Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Dexferrum.

Information For Patients: Patients should be advised of the potential adverse reactions associated with the use of Dexferrum.

Drug/Laboratory Test Interactions: Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration.

The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium.

Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran.

Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Dexferrum and slowly returns to baseline after about 3 weeks.

Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells.

Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

Carcinogenesis, Mutagenesis, Impairment Of Fertility: See WARNINGS. Pregnancy: Teratogenic Effects, Pregnancy Category C: 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.

No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs and monkeys at doses of 50 mg iron/ kg or less.

Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/ kg over a 14 day period.

Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/ kg.

Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/ kg and higher.

The animals used in these tests were not iron deficient.

There are no adequate and well-controlled studies in pregnant women.

Dexferrum should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Placental Transfer: Various animal studies and studies in pregnant humans have demonstrated inconclusive results with respect to the placental transfer of iron dextran as iron dextran.

It appears that some iron does reach the fetus, but the form in which it crosses the placenta is not clear.

Nursing Mothers: Caution should be exercised when Dexferrum is administered to a nursing woman.

Traces of unmetabolized iron dextran are excreted in human milk.

Pediatric Use: Not recommended for use in infants under 4 months of age (See DOSAGE AND ADMINISTRATION).

Adverse reactions

ADVERSE REACTIONS Severe/Fatal: Anaphylactic reactions have been reported with the use of iron dextran injection; on occasions these reactions have been fatal.

Such reactions, which occur most often within the first several minutes of administration, have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse.

Because fatal anaphylactic reactions have been reported after administration of iron dextran injection, the drug should be given only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.

(See BOXED WARNING and PRECAUTIONS: General, pertaining to immediate availability of epinephrine.)

Cardiovascular: Chest pain, chest tightness, shock, cardiac arrest, hypotension, hypertension, tachycardia, bradycardia, flushing, arrhythmias.

(Flushing and hypotension may occur from too rapid injections by the intravenous route.)

Dermatologic: Urticaria, pruritus, purpura, rash, cyanosis.

Gastrointestinal: Abdominal pain, nausea, vomiting, diarrhea.

Hematologic/lymphatic: Leucocytosis, lymphadenopathy.

Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis -See PRECAUTIONS: General), myalgia; backache; sterile abscess; brown skin and/or underlying tissue discoloration (staining); cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site.

Neurologic: Convulsions, seizures, syncope, headache, weakness, unresponsiveness, paresthesia, febrile episodes, chills, dizziness, disorientation, numbness, unconsciousness.

Respiratory: Respiratory arrest, dyspnea, bronchospasm, wheezing.

Urologic: Hematuria.

Delayed reactions: Arthralgia, backache, chills, dizziness, fever, headache, malaise, myalgia, nausea, vomiting (See WARNINGS).

Miscellaneous: Febrile episodes, sweating, shivering, chills, malaise, altered taste.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Oral iron should be discontinued prior to administration of Dexferrum.

Dosage: I. Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy.

It should be recognized that iron storage may lag behind the appearance of normal blood morphology.

Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state.

After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count.

Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex.

Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required.

This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin.

It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted.

Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well.

Factors contributing to the formula are shown below.

mg blood iron = mL blood x g hemoglobin x mg iron lb body weight lb body weight mL blood g hemoglobin Blood volume...............

65 mL/kg of body weight Normal hemoglobin (males and females) over 15 kg (33 lbs)...............

14.8 g/dl 15 kg (33 lbs) or less........... 12 g/dl Iron content of hemoglobin...............

0.34 % Hemoglobin deficit Weight Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb).

Note:

The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss.

TOTAL DEXFERRUM® REQUIREMENT FOR HEMOGLOBIN RESTORATION AND IRON STORES REPLACEMENT * Milliliter Requirement of Dexferrum Based On Observed Hemoglobin of PATIENT LEAN BODY WEIGHT 3 (g/dl) 4 (g/dl) 5 (g/dl) 6 (g/dl) 7 (g/dl) 8 (g/dl) 9 (g/dl) 10 (g/dl) kg lb * Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs).

5 11 3 3 3 3 2 2 2 2 10 22 7 6 6 5 5

4 4 3 15 33 10 9 9 8 7 7 6 5 20 44 16 15 14 13 12 11

10 9 25 55 20 18 17 16 15 14 13 12 30 66 23 22 21 19 18 17 15 14 35 77 27 26 24 23 21 20 18 17 40 88 31 29 28 26 24 22 21 19 45 99 35 33 31 29 27 25 23 21 50 110 39 37 35 32 30 28 26 24 55 121 43 41 38 36 33 31 28 26 60 132 47 44 42 39 36 34 31 28 65 143 51 48 45 42 39 36 34 31 70 154 55 52 49 45 42 39 36 33 75 165 59 55 52 49 45 42 39 35 80 176 63 59 55 52 48 45 41 38 85 187 66 63 59 55 51 48 44 40 90 198 70 66 62 58 54 50 46 42 95 209 74 70 66 62 57 53 49 45 100 220 78 74 69 65 60 56 52 47 105 231 82 77 73 68 63 59 54 50 110 242 86 81 76 71 67 62 57 52 115 253 90 85 80 75 70 64 59 54 120 264 94 88 83 78 73 67 62 57 The total amount of Dexferrum in mL required to treat the anemia and replenish iron stores may be approximated as follows:

Adults and Children over 15 kg (33 lbs): See Dosage Table.

Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: Desired Hb = the target Hb in 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: patient 's weight in pounds = weight in kilograms 2.2 Children 5 - 15 kg (11 - 33 lbs): See Dosage Table.

Dexferrum should not normally be given in the first four months of life.

(See PRECAUTIONS: Pediatric Use) Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W) Based on: Desired Hb = the target Hb in g/dl.

(Normal Hb for Children 15 kg or less is 12 g/dl) W = Weight in kg.

To calculate a patient 's weight in kg when lbs are known: patient 's weight in pounds = weight in kilograms 2.2 II.

Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis.

Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis.

Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss.

The table and formula described under I. Iron Deficiency Anemia are not applicable for simple iron replacement values.

Quantitative estimates of the individual 's periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose.

The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit Example: Blood loss of 500 mL with 20 % hematocrit Replacement Iron = 500 x 0.20 = 100 mg Dexferrum dose = 100 mg = 2 mL 50 Administration: The total amount of Dexferrum required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage).

Dexferrum is administered by intravenous injection.

PRIOR TO THE FIRST DEXFERRUM THERAPEUTIC DOSE, ADMINISTER A TEST DOSE OF 0.5 ML INTRAVENOUSLY (See BOXED WARNING and PRECAUTIONS).

ADMINISTER THE TEST DOSE AT A GRADUAL RATE OVER AT LEAST FIVE MINUTES.

Although anaphylactic reactions known to occur following Dexferrum administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given.

Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached.

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

If no adverse reactions are observed, Dexferrum can be given according to the following schedule until the calculated total amount required has been reached.

Each day 's dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients.

NOTE: Do not mix Dexferrum 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.

Pregnancy and lactation
Nursing Mothers: Caution should be exercised when Dexferrum is administered to a nursing woman. Traces of unmetabolized iron dextran are excreted in human milk.

Interactions

Drug/Laboratory Test Interactions: Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration.

The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium.

Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran.

Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Dexferrum and slowly returns to baseline after about 3 weeks.

Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells.

Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following iron dextran infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.

More information

Category Value
Authorisation number NDA040024
Orphan designation No
Product NDC 0517-0134,0517-0234
Date Last Revised 02-04-2014
Type HUMAN PRESCRIPTION DRUG
RXCUI 206215
Marketing authorisation holder American Regent, Inc.
Warnings

WARNING:

RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have followed 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 Dexferrum administration.

Administer a test Dexferrum dose prior to the first therapeutic dose.

If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Dexferrum dose.

During all Dexferrum administrations, observe for signs or symptoms of anaphylactic-type reactions.

Fatal reactions have followed the test dose of iron dextran injection.

Fatal reactions have also occurred in situations where the test dose was tolerated.

Use Dexferrum 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 Dexferrum.