Package insert / product label Elimination INFeD should not normally be given in the first four months of life. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. The https:// ensures that you are connecting to the The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). ~q`C34&rAd oG 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. 0000026302 00000 n 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. Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. (See Cautions.). Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. 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. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. 8600 Rockville Pike . ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. xref 0000026943 00000 n 5.2 Delayed Reactions Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000010118 00000 n 0000002986 00000 n Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Unauthorized use of these marks is strictly prohibited. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. . Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. 0000037333 00000 n Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. . Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Do not freeze. Accessibility II. . The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. All rights reserved. .65 mL/kg of body weight, b. MeSH Excretion P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 0000047340 00000 n Drug class: Iron Preparations 0000008504 00000 n Do not administer Infed to patients with evidence of iron overload. Dosage form: injection Dextran, a polyglucose, is either metabolized or excreted. An official website of the United States government. . Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet 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. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. 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/$ RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T (See Boxed Warning.) DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. Four of the seven dilute solutions were stable after two months of storage. 4. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. PubMed PMID: 23981803. xb```f``= @Q#3108-. 2 DOSAGE AND ADMINISTRATION This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. After slow IV injection (given over 30 seconds for INFeD or 5 minutes for Dexferrum) or IM injection (INFeD) of 25 mg of iron (0.5 mL), observe for 1 hour for sensitivity reactions (see Anaphylaxis under Cautions) before administering the remaining portion of the initial dose. 12.1 Mechanism of Action 0000036574 00000 n Do Not Copy, Distribute or otherwise Disseminate without express permission. Therefore, administration of subsequent test doses during therapy should be considered. J Pediatr Pharmacol Ther. . Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Oral iron should be discontinued prior to administration of INFeD. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , 0000010877 00000 n 0000013948 00000 n The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Copyright 1993-2021 In iron-deficient patients, reticulocytosis may begin by the 4th day following an IV infusion of the total calculated dose of iron dextran and reaches a maximum by about the 10th day. (Normal Hb for Children 15 kg or less is 12 g/dl). Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. 0000007617 00000 n 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 Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 0000009066 00000 n . 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. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 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. 0000018000 00000 n 0000026747 00000 n Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. 0000032198 00000 n FOIA Available for Android and iOS devices. Importance of informing patients of other important precautionary information. Animal Data Question patients regarding any prior history of reactions to parenteral iron products. After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. Corrections in compilation of information on stability of injectable medications after reconstitution. 0000003686 00000 n Dosage Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Patients with Renal Impairment 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 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)]. Watson Pharma, Inc. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. 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. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. Int J Pharm Compd. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. government site. 0000005019 00000 n (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! 0000030666 00000 n Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions. 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. 0000006734 00000 n endstream endobj 57 0 obj<> endobj 58 0 obj<>stream 0000024030 00000 n 0000005669 00000 n Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. Disclaimer. . 0000001168 00000 n endobj Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. 0000004233 00000 n David McAuley, Pharm.D. Risk of developing potentially life-threatening anaphylactic reactions. <> The half-life of free iron in the plasma circulation is approximately 5 hours. Risk Summary 5.4 Iron Overload Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Carcinogenesis For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet 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)]. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. 0000011042 00000 n Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. . 3. Normal hemoglobin (males and females) 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)]. 06\ zp#2j)kS \(nd+?5R Morristown, NJ 07962 USA. 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. Obstetric clinical pharmacy: A necessary birth of a new specialty, Sister Mary Louise Degenhart dies at 85 years, Infection risk and management strategies for patients with cirrhosis taking proton pump inhibitors, Cold chain experts look to future during latest ASHP forum, National trends in prescription drug expenditures and projections for 2023, ASHP National Surveys of Pharmacy Practice in Hospital Settings, Population Health Management Theme Issues, Practice Advancement Initiative Collection, Transitions of Care/Medication Reconciliation, Emergency Preparedness and Clinician Well-being, Author Instructions for Residents Edition, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 American Society of Health-System Pharmacists. Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. Available for Android and iOS devices. Fatal reactions have also occurred in situations where the test dose was tolerated. Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). Ferentino, Italy 03013, Distributed By: KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Infed is a registered trademark of Allergan Sales, LLC. 0000010567 00000 n The https:// ensures that you are connecting to the 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 circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. 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. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Medical Communications (See DOSAGE AND ADMINISTRATION: Administration. In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. 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). The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. [Progress in drug technology in the years 1968 and 1969]. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. government site. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? '* endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream 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). AHFS DI Essentials. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. The animals used in these tests were not iron deficient. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream The maximum daily dose of INFeD should not exceed 2 mL. Based on: Desired Hb = the target Hb in g/dl. PMC %PDF-1.3 % Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. Careers. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. 2009;23(3):223-30. doi: 10.1080/15360280903098382. 0000003347 00000 n 1 0 obj All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. There are two preparations of IV iron available; IV iron sucrose (Venofer) given as divided dosages, and low molecular weight iron dextran (CosmoFer) this can be given as divided dose or as a total dose infusion (CosmoFer may also be given intramuscularly). If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. 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. Medically reviewed by Drugs.com on Oct 25, 2022. The maximum daily dose of Infed should not exceed 2 mL. Protect from light. Y-site compatibility of medications with parenteral nutrition.
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