Adverse Effects of Human Immunoglobulin Therapy

The range of diseases in which intravenous immunoglobulin (IVIG) is effective has expanded significantly since its initial use in primary antibody deficiency. There are at present at least 17 preparations of IVIG in use worldwide with similar profiles of adverse effects. Infusion-related effects range in severity. Mild adverse reactions (headache, flushing, low backache, nausea, wheezing) are often associated with a fast infusion rate, and respond rapidly on slowing the infusion. Very rare episodes of life-threatening anaphylaxis may occur, particularly in those IgA-deficient patients with anti-IgA antibodies; such patients should receive an IgA-depleted preparation of IVIG.

https://rd.springer.com/content/pdf/10.2165%2F00002018-199309040-00003.pdf

Adverse Effects of Intravenous Immunoglobulin

Background High-dose intravenous immunoglobulins (IVIGs) are increasingly used to treat inflammatory and/or autoimmune disorders In dermatology, they provide therapeutic benefit in Kawasaki disease and certain cases of dermatomyositis While most adverse effects following IVIG treatment are not severe, occasionally more severe adverse effects occur, including anaphylactic reactions and acute, usually transient, renal failure Observations We report 4 cases of a characteristic severe extensive eczematous reaction that occurred approximately 10 days after IVIG infusion for polyradiculoneuritis In all cases, onset was characterized by dyshidrotic lesions on the palms, rapidly followed by pruriginous maculopapular lesions involving the whole body All patients were treated with topical and/or systemic steroids, and complete resolution of skin lesions was observed within 1 month To date, 33 cases of cutaneous rash following IVIG infusion have been reported in the literature, mostly in neurology journals, and the features are identical to those reported herein Conclusions Severe eczematous skin reaction with a characteristic initial localization to the palms and/or soles that then extends to the rest of the body is a rare but characteristic adverse effect of high-dose IVIG therapy Although the precise mechanism of this cutaneous eruption remains to be elucidated, its occurrence within days of IVIG infusion, its characteristic distribution at onset, and its clinical course should be recognized by dermatologists

https://jamanetwork.com/journals/jamadermatology/articlepdf/402868/DOB50160.pdf

Severe eczematous skin reaction after high-dose intravenous immunoglobulin infusion: report of 4 cases and review of the literature.

Intravenous gammaglobulin (IVIG) is currently one of the major expenditures at many hospital pharmacies, especially in tertiary care centers. Its use was once the exclusive province of immunologists caring for patients with rare disorders of humoral and cellular immunity. However, the development of preparations of IgG that could be infused in very large quantities led to the discovery that IVIG can have an immunomodulating effect on the immune system. IVIG is being used to treat an ever increasing list of autoimmune and inflammatory diseases, though few controlled trials are available to prove the efficacy of such therapy. In addition, infectious diseases such as CMV that can not be treated effectively with low doses of gammaglobulin are being treated with some success with very high doses. Thus, IVIG is being used to treat and prevent infections in patients undergoing chemotherapy and bone marrow transplantation. The usefulness of IVIG in the treatment of primary immunodeficiency diseases is unquestioned, and studies have established the ability of high doses of IVIG to ameliorate ITP and Kawasaki Disease. The efficacy of gammaglobulin in other conditions is suggested but unproven. The clinician is faced with several publications each month that report the use of IVIG in yet another clinical condition. The decision of how and when to use this very expensive and scarce product is difficult, but should be based on an understanding of the mechanisms of action of IgG, the limitations of therapy, and an assessment of the literature related to the use of IVIG in various disease states. History of therapy with gammaglobulin

Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action

The intravenous immune globulin (IGIV) preparations are reviewed with respect to method of preparation, pharmacokinetics, clinical uses (with emphasis on the labeled indications), and adverse reactions; a brief review of the immune system also is provided. IGIV preparations are approved for the treatment of hypogammaglobulinemia, recurrent bacterial infections due to B-cell chronic lymphocytic leukemia, and idiopathic thrombocytopenic purpura (ITP). The mechanism of action in the first two indications is passive replacement of antibodies, but in ITP the mechanism is not clearly established. The clinical literature on the use of IGIV for these indications is summarized. In patients with ITP, platelet counts return to safe levels and the number of infections is reduced in patients with primary humoral immunodeficiency treated with IGIV. The use of IGIV in pregnant women and premature infants is controversial. Adverse reactions are primarily related to infusion rate, activation of complement, and anaphylactic reactions to a component of the product. There is minimal to no risk of viral transmission with IGIV therapy. IGIV also has been administered safely on an outpatient or homecare basis. This has led to a feeling of greater control by patients over their chronic illness. Other uses of IGIV are under investigation. As our understanding of the immune system and the pharmacology of immune globulin increases, the uses of IGIV will expand.

Use of intravenous immune globulin therapy: an overview.

Adverse effects to intravenous immunoglobulin (IVIg) are uncommon. We report a case of severe erythema multiforme (EM) developing during this treatment. A woman (aged 27) with idiopathic thrombocytopenic purpura (ITP) not responsive to corticosteroids was infused with 400 mg/Kg/day of pH 4/pepsin-treated immunoglobulin (Sandoglobulin, Sandoz) for 5 days with rapid normalization of platelet count. On the 4th day of treatment the patient complained of fever (37.5 °-38 °C) and itching urticaria-like skin lesions. After another 4 days a full-blown picture of EM developed over 24 hours extending to more than 80% of body surface including face, pahns and soles and consisting of iris lesions, vescicles and bullae with epidermal necrosis. Mucosal lesions were minimal and visceral involvement absent. Treatment with prednisone and erythromicin lead to a rapid disappearance of the fever and subsiding of cutaneous lesions within 3 weeks. The patient had been transfused with 2 units of platelets 1 year before. She had not been taking any drug during the month preceding immunoglobulin treatment. Routine laboratory parameters were normal and no evidence of underlying collagen disorder was obtained. Extensive serological investigations performed immediately and during 1 year follow-up failed to show seroconversion against herpes simplex, hepatitis B, Epstein-Barr, influenza, adeno, echo, coxackie, entero, cytomegalo and human immunodeficiency viruses and against mycoplasma pneumoniae and toxoplasma. At present the patient is in good health with a platelet count of about 50,000 platelets//A, without any treatment. The cause of this severe episode of EM remains obscure and, even if a previous sensitization to some blood component cannot be ruled out, its occurrence in strict concomitance with immunoglobulin infusion strongly suggests this treatment as the precipitating event. Our report adds to the reports of others who have recently described important adverse effects to IVIg. Alopecia has been reported in three cases after IVIg [1] and fatal thrombotic events in elderly people have been described by Woodruff et al. [4], although the relationship between IVIg and thrombosis in this report remains uncertain and not confirmed by other studies [2]. On the basis of the available data, a more cautious use of this treatment, of which the ultimate effect in the treatment of ITP is still undefined [3], seems advisable.

Erythema multiforme after intravenous immunoglobulin.

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Erythema multiforme after intravenous immunoglobulin.