2.1 Important Pre-Treatment Information 1986;17(1):1-10. doi: 10.1007/BF00299858. The 5 hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin bound 59Fe. 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. 0000009371 00000 n 0000003224 00000 n Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. J Pediatr Pharmacol Ther. Infusion should then be stopped for 1 hour. These half-life values do not represent clearance of iron from the body. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. Am J Kid Dis. Discontinue oral iron therapy prior to initiation of iron dextran therapy. xb```f``= @Q#3108-. 5.2 Delayed Reactions Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. sharing sensitive information, make sure youre on a federal . TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE DOSAGE AND ADMINISTRATION Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Therefore, administration of subsequent test doses during therapy should be considered. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Distribution It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 218 0 obj << /Linearized 1 /O 220 /H [ 1168 873 ] /L 336009 /E 11783 /N 28 /T 331530 >> endobj xref 218 36 0000000016 00000 n 0000039715 00000 n Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Iron dextran is a 0000008504 00000 n 5.1 Hypersensitivity Reactions equivalent to 50 mg of elemental iron per mL. Federal government websites often end in .gov or .mil. . Importance of informing patients of other important precautionary information. "3#$-Irc8x=B_}>_W@HqAP!I`H9+.@F.ix;i1E]"EOQ4E7M9$PB em$ Ie2} %+}hIIU}E+rS_OENx(tF_)@nRAtZn#JHg221^m+U|"vy ]yakuU Drug class: Iron Preparations Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Oxford University Press is a department of the University of Oxford. . Fatal reactions have been reported following the test dose of iron dextran injection. The site is secure. . 0000011042 00000 n Careers. Blood volume . Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. Please enable it to take advantage of the complete set of features! . INFeD belongs to a class of drugs called Iron Products. 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. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. 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). 2.4 Administration Fatal anaphylactic reactions are possible. .65 mL/kg of body weight, b. 0000027226 00000 n Administer a test Infed dose prior to the first therapeutic dose. J Pediatr Pharmacol Ther. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. 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. The etiology of these reactions is not known. 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. official website and that any information you provide is encrypted . Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 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. The animals used in these tests were not iron deficient. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Isoproterenol or similar beta-agonist agents may be required in these patients. After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. 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. What are the possible side effects of INFeD? This site needs JavaScript to work properly. Specific Populations endobj INFeD (iron dextran injection), for intravenous or . a. trailer << /Size 254 /Info 216 0 R /Root 219 0 R /Prev 331519 /ID[<618a70ff49b482af49be42cc5de1ac5d><4f4e9802b6496a1513efa6cfdffb7212>] >> startxref 0 %%EOF 219 0 obj << /Type /Catalog /Pages 213 0 R /Metadata 217 0 R /PageLabels 211 0 R >> endobj 252 0 obj << /S 769 /T 901 /L 982 /Filter /FlateDecode /Length 253 0 R >> stream If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. Use with caution in patients with a history of clinically important allergies and/or asthma. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 0000003913 00000 n Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. CONTRAINDICATIONS Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. (See Cautions.). 5.4 Iron Overload III. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. 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. Accessibility . J Parenter Sci Technol. The product should be further diluted in a suitable diluent prior to infusion. Infed (iron dextran injection), for intravenous or intramuscular use Brand names: Dexferrum, INFeD Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Disclaimer. 0000011305 00000 n 0000009538 00000 n %PDF-1.3 % Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. 0000010855 00000 n Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' PMC Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. 0000037133 00000 n (See PRECAUTIONS: General.) HdTr0+(R^ 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. ],kI#tp. 3 0 obj Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. 0000003708 00000 n 0000013099 00000 n Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. This site complies with the HONcode standard for trust- worthy health information: verify here. Although anaphylactic reactions known to occur following INFeD 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. . The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. FLeQI!/r5=J aJp0s bEl$6uwK6).d>)bdJ6z!oGUayaZ`Z5$+=6mF2xzh[*'_L'T+Rbs VJlJ-2RSJrJIRSJxJ O))%Rs9PSJ~h]@?:4O~AQ@%{Ik@Ks1y,u?%s O))%\cy c ::y[%6b;+.:.=.7WKEbWd? (See Boxed Warning.) (See Sensitivity Testing under Dosage and Administration.) Delayed Reactions 12.3 Pharmacokinetics 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. . 0000026302 00000 n 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. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Risk Summary David McAuley, Pharm.D. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 0000001877 00000 n If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). 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. PMC N}F( 9N(i{:%NISD;%NIS*T1 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. 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. Anemias not associated with iron deficiency. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. 16.1 How Supplied Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. Anemia Associated with Chronic Renal Failure, Hypersensitivity Reactions [see Warnings and Precautions (5.1)], Delayed Reactions [see Warnings and Precautions (5.2)], Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)], Iron Overload [see Warnings and Precautions (5.4)], Fetal bradycardia [see Use in Specific Populations (8.1)]. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). All Rights Reserved. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5. All rights reserved. 2025C; excursions permitted to 1530C. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T Advise patients with pre-existing cardiovascular disease and rheumatoid arthritis that Infed administration may exacerbate symptoms and to contact their healthcare provider if any symptoms occur [see Warnings and Precautions (5.3)]. Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. 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. Do not exceed a total daily dose of 2 mL undiluted Infed. Nephron. Administer the test dose at a gradual rate over at least 30 seconds. 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)]. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 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. 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.] Br Med J (Clin Res Ed). INFeD may be used alone or with other medications. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. . Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. (See Boxed Warning.). Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. 0000008617 00000 n Figure 1. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Morristown, NJ 07962 USA. This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. 0000009066 00000 n The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. . A subsidiary of Watson Pharmaceuticals, Inc. Each monograph contains stability data, administration guidelines, and methods of preparation. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. For information on systemic interactions resulting from concomitant use, see Interactions. Take precautions to be prepared to treat potential allergic reactions. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. 0 Drug interactions involving Infed have not been studied. Would you like email updates of new search results? Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 0000002909 00000 n 1 0 obj 0000026943 00000 n Int J Pharm Compd. *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). 0000002696 00000 n Advise pregnant persons of the potential risk to the fetus. 0000010759 00000 n The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. The study suggests that addition of recommended daily doses of iron dextran to parenteral nutrient solutions creates no stability problems; however, further study of the effects of temperature, pH, light, and storage time are recommended. Abstract. 1989;23(4):197-207. doi: 10.1007/BF00451642. 3. . 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: . Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. 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. Parenteral iron dextran therapy: a review. endobj Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. d. Hemoglobin deficit American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. The pH of the solution is between 4.5 to 7.0. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 0000005561 00000 n 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@> Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream 0000015331 00000 n This site complies with the HONcode standard for trust- worthy health information: verify here. 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). 0000026747 00000 n 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. Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following Infed infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation. INFeD preparation: Administer by deep IM injection using a 2- or 3-inch, 19- or 20-gauge needle into the upper outer quadrant of the buttock only. . 0000007617 00000 n Iron storage parameters may improve prior to hematologic parameters. . Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. The half-life of free iron in the plasma circulation is approximately 5 hours. 34 0 obj <> endobj LBW = Lean body weight in kg. Absorption 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 .

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