Discontinue administration of any iron-containing products prior to administration of Infed. 1995; 26(2):327-330. Cancer Chemother Pharmacol. Such reactions may be immediate or delayed. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. . 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. 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. 0 $]: . Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. 0000001797 00000 n 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` PLEASE READ THE. 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)]. Y-site compatibility of medications with parenteral nutrition. (See Boxed Warning.) The https:// ensures that you are connecting to the INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. 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: If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. 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. Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), 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. Cancer Chemother Pharmacol. . Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Dextran, a polyglucose, is either metabolized or excreted. 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. 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. J Pain Palliat Care Pharmacother. (5.1) Elimination 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. Protect from light. 0000011536 00000 n The https:// ensures that you are connecting to the 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. 2021 Allergan. HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> Infed is a registered trademark of Allergan Sales, LLC. Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). Observed Hb = the patients current hemoglobin in g/dl. 0000012898 00000 n In vitro studies have shown that removal of iron dextran by dialysis is negligible. CAREFULLY BEFORE ACCESSING OR USING THIS SITE. 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). Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. <> Copyright 1993-2021 ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Careers. Brand names: Dexferrum, 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. Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. 0000005917 00000 n @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Calculate recommended total iron dextran dosage for treatment of iron deficiency anemia or iron replacement for blood loss from appropriate dosage formulas; these formulas are specific for each indication and are not interchangeable. . The product should be further diluted in a suitable diluent prior to infusion. 2 DOSAGE AND ADMINISTRATION (See PRECAUTIONS: General.) Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: The pH of the solution is between 4.5 to 7.0. We comply with the HONcode standard for trustworthy health information. 0000007617 00000 n 5.2 Delayed Reactions . 12.1 Mechanism of Action Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. . Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. . Pregnancy For full access to this pdf, sign in to an existing account, or purchase an annual subscription. . Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. (See Iron, oral under Interactions.). Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. 0000002441 00000 n s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). 8600 Rockville Pike 0000006673 00000 n The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. 0000015331 00000 n PMC . David McAuley, Pharm.D. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. W = body weight in kg Administer the test dose at a gradual rate over at least 30 seconds. . V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= 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. 0000008494 00000 n The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 0000003746 00000 n Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. 0000002803 00000 n Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Each days dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. (See Anaphylaxis under Cautions.) HR0~ It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 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. 0000035692 00000 n 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. endstream endobj 46 0 obj<>stream Patheon Italia S.p.A. FOIA % . 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. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. Package insert / product label Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Drug class: Iron Preparations Br Med J (Clin Res Ed). . During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. This site needs JavaScript to work properly. Blood volume . CONTRAINDICATIONS 4. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Would you like email updates of new search results? No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V endobj Please enable it to take advantage of the complete set of features! To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. (5.3). This site complies with the HONcode standard for trust- worthy health information: verify here. The site is secure. These half-life values do not represent clearance of iron from the body. . endstream endobj 57 0 obj<> endobj 58 0 obj<>stream PMC [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK .14.8 g/dl 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. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. 0000036574 00000 n Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. The stability of Meropenemreconstituted in solution is influenced by the following factors: Storage temperature: The drug is stable for longer time in solutions stored at 4 to 5C than in solutions stored at 21 to 26C. INFeD should not normally be given in the first four months of life. 0000003913 00000 n Available for Android and iOS devices. 8.1 Pregnancy Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. Known hypersensitivity to iron dextran or any ingredient in the formulation. 2. *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). Discontinue oral iron therapy prior to initiation of iron dextran therapy. l Sm3G.E7=" r7/[^;q|= 0000004715 00000 n Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. 7.1 Drug/Laboratory Test Interactions Sv In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 0000002275 00000 n xref Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. 4GWVI~p`1x_7G|_Wz/ev5%b[~?w>ZG/*p%\/??w~=+ |O?~po>u|.@uM=Nvm_~~>\.%>?_mk+mp_{"ly"Y{JlqgIl#Y!Y@osLu]Mt=xx? 0000036781 00000 n Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. LBW = Lean body weight in kg. 1985;14(2):83-95. doi: 10.1007/BF00434343. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. II. 0000002909 00000 n 1989;23(4):197-207. doi: 10.1007/BF00451642. . $ 2.4 Administration (Normal Hb for Children 15 kg or less is 12 g/dl). 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 Removal of Iron Dextran by Hemodialysis: An In Vitro Study. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE the 6 time points after injection.15 A 94-subject rater-blinded randomized control study of EDP action potentials compared toxin used within 2 hours, 72 hours, 1, 2, 3, or 4 weeks after reconstitution; at 1 week after injection, the point of maximum effect, there was no difference in quantitative paralysis . Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). HHS Vulnerability Disclosure, Help This site needs JavaScript to work properly. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000006695 00000 n 0000035990 00000 n 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. . . Risk Summary Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. There are no data on the effects of iron dextran in breastfed infants or effects on milk production. INFeD belongs to a class of drugs called Iron Products. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. MeSH 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. 0000009066 00000 n Specific Populations Epinephrine should be immediately available. Thank you for submitting a comment on this article. Allergan USA, Inc. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. . Written by ASHP. <<7815BA97DDE94C498B4A3154474182CA>]>> KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Advise pregnant persons of the potential risk to the fetus. 3. Corrections in compilation of information on stability of injectable medications after reconstitution. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Generic name: iron dextran The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. official website and that any information you provide is encrypted Do not administer Infed to patients with evidence of iron overload. Medically reviewed by Drugs.com on Oct 25, 2022. 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. Risk Summary . Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. [Progress in drug technology in the years 1968 and 1969]. (See DOSAGE AND ADMINISTRATION: Administration. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. Fetal/Neonatal Adverse Reactions All rights reserved. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. Metabolism Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). For information on systemic interactions resulting from concomitant use, see Interactions. over 15 kg (33 lbs) . Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. . . %PDF-1.3 % 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. 1986 Jul-Aug;40(4):142-63. endobj Medically reviewed by Drugs.com. endstream endobj 47 0 obj<>stream . 0000018000 00000 n 0000001168 00000 n used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. Therefore, administration of subsequent test doses during therapy should be considered. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream 0000014709 00000 n This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. 0000003686 00000 n 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. Available for Android and iOS devices. Clinical Considerations Carcinogenesis 0000003708 00000 n INFeD may be used alone or with other medications. official website and that any information you provide is encrypted Last updated on Dec 1, 2022. Dilution not recommended by manufacturers, but there have been reports of the total calculated dose of iron dextran being diluted in 2501000 mL of 0.9% sodium chloride injection for IV infusion [off-label]. 1972;9:94-98. (See Cautions.). Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Oxford University Press is a department of the University of Oxford. Infusion should then be stopped for 1 hour. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). 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/$ Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). 0000010005 00000 n 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). Various studies involving intravenously administered 59Fe iron dextran to iron deficient subjects, some of whom had coexisting disease, have yielded half-life values ranging from 5 hours to more than 20 hours. 0000010877 00000 n Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. . Copyright 2021 GlobalRPH - Web Development by, The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. . Dosage 0000003224 00000 n (See Boxed Warning.). 0000011305 00000 n The animals used in these tests were not iron deficient. 0000004693 00000 n <> 0000010759 00000 n 0000009983 00000 n Bullock L, Parks RB, Lampasona V, Mullins RE. The stability of injectable medications after reconstitution is presented. David McAuley, Pharm.D. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron for increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route is preferred for iron administration in such patients.

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