2025C; excursions permitted to 1530C. 0000006734 00000 n
Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. Br Med J (Clin Res Ed). Four of the seven dilute solutions were stable after two months of storage. startxref
.65 mL/kg of body weight, b. Prior to the first intramuscular Infed therapeutic dose, administer an intramuscular test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. 88 0 obj<>stream
Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. 0000010759 00000 n
Fatal reactions have also occurred in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; 0000001168 00000 n
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. 0000001797 00000 n
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Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. 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. 0000010005 00000 n
Unauthorized use of these marks is strictly prohibited. Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including Infed. . During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. 2001;5(1):75-7. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. PubMed PMID: 23981803. 2. Known hypersensitivity to iron dextran or any ingredient in the formulation. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 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. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Drug class: Iron Preparations After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. x&q}2(33",Y
&HS4)
IE][5MA0A8eT?g_>^J37_/>O?'_koJ?DE>k/~fhFh-hiQv?}{spq8[vwVZinj4i
~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Last updated on Dec 1, 2022. Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* 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: 5. 0000035990 00000 n
MeSH V]{iXn L2 Tv]OXSe` a
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`qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Figure 1. Data [2:/T6*cz1"Jk&n#n[[TU Continue Infed until hemoglobin is within the normal range and iron stores are replete. The development and health benefits of breastfeeding should be considered along with the mothers clinical need for Infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. 2 DOSAGE AND ADMINISTRATION The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability of frozen antibiotics. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Risk Summary Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. To avoid injection or leakage into subcutaneous tissue, use Z-track injection technique (i.e., firmly push aside subcutaneous tissue over the site of injection before inserting the needle). Therefore, administration of subsequent test doses during therapy should be considered. It should be understood that these half-life values do not represent clearance of iron from the body. 0000004693 00000 n
0000015331 00000 n
The total amount of INFeD 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. Accessibility Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. Hb```f`` l,/`"`FOB/r7}UL 0000002986 00000 n
CAREFULLY BEFORE ACCESSING OR USING THIS SITE. and transmitted securely. 0000010567 00000 n
. . The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage). 0000008022 00000 n
Allergan USA, Inc. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Advise patients with history of significant allergies and/or asthma to inform their healthcare provider as the risk of hypersensitivity reactions may be increased [see Warnings and Precautions (5.3)]. 2.1 Important Pre-Treatment Information MeSH (See Boxed Warning.). Advise patients to consult their healthcare provider should they start to show symptoms of acute kidney infection as Infed should not be used [see Warnings and Precautions (5.3)]. 0000012318 00000 n
Use with extreme caution in patients with serious impairment of hepatic function. m$K~*&S)j5-Df"F
d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? A current package insert for the iron dextran product being used should always be reviewed, since these package inserts are periodically updated, and the product is currently made by more than one manufacturer. The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic III. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Factors contributing to the formula are shown below. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. . [See USP Controlled Room Temperature]. Elimination Please check for further notifications by email. <> 0000002918 00000 n
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. Curr Opin Clin Nutr Metab Care. 0000036781 00000 n
HdTr0+(R^ INFeD (IRON DEXTRAN COMPLEX) INJECTION SDS EFFECTIVE DATE: SEPTEMBER 24, 2018 PAGE 1 OF 8 SAFETY DATA SHEET Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS Standards, European Union CLP EC 1272/2008 and the Global Harmonization Standard 1. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Available for Android and iOS devices. ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Delayed Reactions 2.2 Recommended Dosage for Iron Deficiency Anemia Systemic exposure to iron dextran may be increased. J Pediatr Pharmacol Ther. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet endstream
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. endobj 5.1 Hypersensitivity Reactions 5 If reconstituted vaccine is not used immediately or comes in a multidose vial, be sure to clearly mark the vial with the date and time the vaccine was reconstituted, maintain the product at 2-8C (36-46F); do not freeze, and use only within the time indicated on chart above. 0000000016 00000 n
HHS Vulnerability Disclosure, Help Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. 0000006695 00000 n
For solution and drug compatibility information, see Compatibility under Stability. The pH of the solution is between 4.5 to 7.0. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. 0000027226 00000 n
INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02). (See DOSAGE AND ADMINISTRATION: Administration. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) J Parenter Sci Technol. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS over 15 kg (33 lbs) . A.YGtT~Ud!$8 d|Ey[9l]^Z.d,{Ah>=1LfC6=
Lc3I`hOf2!*sXk!dPz9.UZJe|6xsd_nMS]UYG4@GCj_'8m$7$U
|_6%$yf <<7815BA97DDE94C498B4A3154474182CA>]>>
Do not exceed a total daily dose of 2 mL undiluted Infed. 0000011042 00000 n
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. Dosage form: injection )U!$5X3/9 ($5EO1'G!X! Copyright 2021 GlobalRPH - Web Development by, IV Dilutions Medication Reference and Infusion Guidelines, Renal dosing for healthcare professionals, HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy. Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Total iron and free ferrous ion content of the preparations were measured for: (1) the dilute solutions at monthly intervals after up to three months of storage at room temperature and under refrigeration and (2) the parenteral nutrient solutions after 18 hours of storage at room temperature. (See Special Populations under Pharmacokinetics.). Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. 0000009371 00000 n
. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. (Normal Hb for Children 15 kg or less is 12 g/dl). This site needs JavaScript to work properly. The total volume of Infed required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed [see Dosage and Administration (2.2)]. All Rights Reserved. 0000013099 00000 n
rFsh4Js$[i
=I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Bonnie E. Kirschenbaum, M.S., Clifton J. Latiolais, Sc.D., Stability of injectable medications after reconstitution, American Journal of Hospital Pharmacy, Volume 33, Issue 8, 1 August 1976, Pages 767791, https://doi.org/10.1093/ajhp/33.8.767. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. The product should be further diluted in a suitable diluent prior to infusion. Nephron. Patheon Italia S.p.A. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of Infed. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. Calculate recommended total iron dextran dosage for treatment of iron deficiency anemia or iron replacement for blood loss from appropriate dosage formulas; these formulas are specific for each indication and are not interchangeable. 0000009538 00000 n
Iron storage parameters may improve prior to hematologic parameters. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. The stability of injectable medications after reconstitution is presented. Take precautions to be prepared to treat potential allergic reactions. 0000046285 00000 n
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The maximum daily dose of INFeD should not exceed 2 mL. 0000026943 00000 n
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Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Discontinue administration of any iron-containing products prior to administration of Infed. 0000040000 00000 n
May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). Observed Hb = the patients current hemoglobin in g/dl. Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. PMC Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. FOIA II. ~q`C34&rAd oG
2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. 0000010855 00000 n
Bookshelf Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. endobj Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. Sv . Oral iron should be discontinued prior to administration of INFeD. Oxford University Press is a department of the University of Oxford. . . 0000009088 00000 n
The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. Such reactions may be immediate or delayed. . Specific Populations 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. 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. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. The site is secure. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.487.4 hours) following IV administration of iron dextran. xref
The 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. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. Women's Bond NFT Collection For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o
=6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy, Parenteral iron treatment should be administered only when, Milliliter Requirement of INFeD Based On Observed. Discontinue oral iron therapy prior to initiation of iron dextran therapy.
Children weighing 515 kg (1133 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (12 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). The stability of injectable medications after reconstitution is presented. Careers. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). endobj Reticulocyte count will increase in 3-4 days and peak in 7-10 days. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. d. Hemoglobin deficit 0000003224 00000 n
Copyright 2023, Selected Revisions November 4, 2013. 0000030666 00000 n
Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. LBW = Lean body weight in kg [A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.] Ling J, Gupta VD. Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. endstream
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. 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. Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Disclaimer. 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. (See Anaphylaxis under Cautions.) <> After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. Hatton RC, Portales IT, Finlay A, Ross EA. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. 34 0 obj <>
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Risk of developing potentially life-threatening anaphylactic reactions. The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. Iron Overload Federal government websites often end in .gov or .mil. hO4,qv(8p]4SXs?_k^ '4["G!@` \
Pregnancy 0000026747 00000 n
. Disease-Associated Maternal and/or Embryo/Fetal Risk SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. l Sm3G.E7="
r7/[^;q|= 0000010118 00000 n
and transmitted securely. CONTRAINDICATIONS Initial U.S. Approval: 1974 equivalent to 50 mg of elemental iron per mL. General considerations, the nitrosoureas and alkylating agents. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. 0000003396 00000 n
3. INFeD (iron dextran injection), for intravenous or . Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. 12.3 Pharmacokinetics CAS number: 9004-66-4. Advise pregnant persons of the potential risk to the fetus. May increase risk for anaphylaxis with concomitant use, Bone scans using imaging agents labeled with technetium Tc 99m (diphosphonate), Dense, crescentic areas of activity along the contour of the iliac crest, visualized 16 days after IM administration of iron dextran, Possible reduced bone uptake, marked renal activity, and excessive blood pool and soft tissue accumulation, Therapeutic duplication; increased risk for iron toxicity, Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran, Serum ferritin concentrations peak approximately 79 days following an IV iron dextran dose and slowly return to baseline over a period of about 3 weeks, Bone marrow examination for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells, May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium, Prolonged partial thromboplastin time following IV administration of iron dextran when the blood sample for the test is mixed with anticoagulant citrate dextrose solution but not sodium citrate solution, Blood typing and cross-matching unaffected.