Thank you for your recent inquiry.
There is a significant body of literature on anaphylactic reactions to intravenous iron preparations. However, unfortunately, I was not able to find any published protocol regarding desensitization to any intravenous iron preparation. There is some debate as to the safest of the three preparations available, but the ferric gluconate preparation that you mentioned, or iron sucrose preparations clearly appear to be less likely to cause anaphylactic reactions than the iron dextran preparation.
Unfortunately, since I could find no published protocol for desensitization to any intravenous iron preparation, you would need to construct a protocol based on those used for other drugs.
The Ferrlecit (ferric gluconate complex in sucrose) is administered intravenously. It is usually given in a dose of 125 mg (10 ml) diluted in 100 ml of normal saline. Thus, you might consider starting with 1/10th (12.5 mg) or 1/100th (1.25 mg) of Ferrlecit diluted in smaller volumes, and progress slowly, increasing the dose gradually, from that point.
The abstracts copied below will offer you at least some information about previously reported cases. I have not looked at each of these articles completely, but even though I could not find any reference of desensitization on a literature search, it is possible that embedded in the bibliography of one of these there may be mention of a desensitization protocol.
Thank you again for your inquiry and we hope this response is helpful to you.
Int J Obstet Anesth. 2005 Oct;14(4):362-4.
Anaphylactoid reaction to intravenous sodium ferric gluconate complex during pregnancy.
Cuciti C, Mayer DC, Arnette R, Spielman FJ.
Department of Anesthesiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. email@example.com
Int J Obstet Anesth. 2006 Jul;15(3):264.
We report the first case of a severe anaphylactic or anaphylactoid reaction to sodium ferric gluconate complex in a pregnant patient. Sodium ferric gluconate complex is felt to be one of the safest forms of iron therapy during pregnancy. This case highlights the need for extreme caution and vigilance in pregnant patients receiving any type of parenteral iron therapy
Pharmacotherapy. 2007 Apr;27(4):613-5.
Safe administration of iron sucrose in a patient with a previous hypersensitivity reaction to ferric gluconate.
Sane R, Baribeault D, Rosenberg CL.
Department of Pharmacy, Boston Medical Center, Boston, Massachusetts 02118, USA. Radhika.Sane@BMC.org
A 67-year-old woman with iron deficiency anemia required parenteral iron therapy and was treated with intravenous ferric gluconate. She tolerated the first dose, but after the second dose, she developed a tingling feeling all over her body, along with swelling in her hands and feet, and a rash with hives over most of her body. It was thought that she had likely experienced a hypersensitivity reaction to ferric gluconate. The decision was made to continue therapy; however, two modifications were made. The patient was given dexamethasone, diphenhydramine, and ibuprofen 1 hour before administering the third dose, and the infusion time was prolonged by 1 hour. Approximately 45 minutes after the infusion was completed, the patient developed hives on her arms and legs. At the patient's next clinic visit, it was decided that continuation of parenteral iron repletion was necessary, and the decision was made to attempt a challenge with iron sucrose. The patient was given dexamethasone 8 mg to be taken the night before and the morning of treatment. She successfully completed the iron repletion therapy with iron sucrose. Three parenteral iron products are available in the United States: iron dextran, sodium ferric gluconate complex, and iron sucrose. Iron dextran, the oldest of these products, carries the highest risk for hypersensitivity reactions. Available data suggest that either iron sucrose or ferric gluconate can be safely administered to patients with known hypersensitivity to iron dextran. Our patient's experience implies that it may be possible to safely administer iron sucrose to a patient with hypersensitivity to ferric gluconate. This finding has clinical implications and warrants confirmation in a larger population
Ren Fail. 2008;30(6):629-38.
The comparative safety of various intravenous iron preparations in chronic kidney disease patients.
Anirban G, Kohli HS, Jha V, Gupta KL, Sakhuja V.
Department of Nephrology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
The relative safety of parenteral iron preparations is a controversial issue in the management of anemia in chronic kidney disease (CKD), as direct head-to-head comparative trials are lacking. In this study, patients of CKD were randomized to receive intravenous low molecular weight iron dextran (ID), sodium ferrigluconate complex (SFGC), and iron sucrose (IS) at doses and infusion rates recommended by the product manufacturer. One time test dose was used only for ID and SFGC. A total of 2,980 injections (n = 339) of i.v. iron was given, and 49 patients (14.45% per patient) and a total of 56 adverse events (1.88% per infusion) were noted. Odds ratios (OR) of serious adverse drug events (ADE; i.e., death, anaphylaxis, or suspected immuno-allergic events) per patient was not significant between ID vs. SFGC (3.566) and SFGC vs. IS (2.129), whereas that between ID vs. IS (7.594) was highly significant (p = 0.034). OR of serious ADE exposure was significantly higher in ID vs. SFGC (OR = 5.670, p = 0.0147) and ID vs. IS (OR = 7.799, p < 0.001). No significant difference was seen between the three groups in terms of non-serious ADEs. Drug discontinuation occurred significantly more often with ID. One patient who developed anaphylactoid reaction with SFGC and ID tolerated iron sucrose well.
Nephrol Dial Transplant. 2005 Jul;20(7):1443-9. Epub 2005 Apr 26.
Hypersensitivity reactions and deaths associated with intravenous iron preparations.
Bailie GR, Clark JA, Lane CE, Lane PL.
Albany Nephrology Pharmacy (ANephRx) Group, Albany, NY, USA. firstname.lastname@example.org
BACKGROUND: Parenteral iron therapy is an accepted adjunctive management of anaemia in kidney disease. Newer agents may have fewer severe hypersensitivity adverse events (AE) compared with iron dextrans (ID). The rate of type 1 AE to iron sucrose (IS) and sodium ferric gluconate (SFG) relative to ID is unclear. We used the US Food and Drug Administration's Freedom of Information (FOI) surveillance database to compare the type 1 AE profiles for the three intravenous iron preparations available in the United States. METHODS: We tabulated reports received by the FOI database between January 1997 and September 2002, and calculated 100 mg dose equivalents for the treated population for each agent. We developed four clinical categories describing hypersensitivity AE (anaphylaxis, anaphylactoid reaction, urticaria and angioedema) and an algorithm describing anaphylaxis, for specific analyses. RESULTS: All-event reporting rates were 29.2, 10.5 and 4.2 reports/million 100 mg dose equivalents, while all-fatal-event reporting rates were 1.4, 0.6 and 0.0 reports/million 100 mg dose equivalents for ID, SFG and IS, respectively. ID had the highest reporting rates in all four clinical categories and the anaphylaxis algorithm. SFG had intermediate reporting rates for urticaria, anaphylactoid reaction and the anaphylaxis algorithm, and a zero reporting rate for the anaphylaxis clinical category. IS had either the lowest or a zero reporting rate in all clinical categories/algorithm. CONCLUSIONS: These findings confirm a higher risk for AE, especially serious type 1 reactions, with ID therapy than with newer intravenous iron products and also suggest that IS carries the lowest risk for hypersensitivity reactions
Phil Lieberman, M.D.