Subcutaneous immunoglobulin

Adalimumab (Humira) is a human immunoglobulin Gj monoclonal TNF-a antibody. The binding of adalimumab results in inactivation of the proinflammatory cytokine TNF-a. It is indicated for psoriatic arthritis and treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The recommended dose for psoriatic arthritis is 40 mg subcutaneously every other week. The recommended dose for adults with plaque psoriasis is an initial dose of 80 mg, followed by 40 mg every other week starting 1 week after the initial dose. The most common adverse reactions are infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. 

Q53 Before initiating treatment with omalizumab, body weight and immunoglobulin E concentration need to be determined. Omalizumab is a monoclonal antibody administered by subcutaneous injection for the prophylaxis of allergic asthma. 

Omalizumab is a monoclonal antibody that binds to immunoglobulin E. It is used as additional therapy in asthma patients who have a proven IgE-mediated sensitivity to inhaled allergens and who are presenting with severe, persistent, uncontrolled asthma. It is administered by subcutaneous injection and the dose is calculated based on the immunoglobulin E concentration and body weight. 

Etanercept is a recombinant fusion protein produced in Chinese hamster ovary cells. It consists of the intracellular ligand-binding portion of the human p75 TNF receptor linked to the Fc portion of human immunoglobulin (Ig) Gi. Two p75 molecules are attached to each Fc molecule. Etanercept binds to soluble TNF-a and TNF-(3 and forms inactive complexes, effectively lowering circulating levels of these cytokines. It is administered subcutaneously, generally twice weekly. 

Mechanism of Action A monoclonal antibody that selectively binds to human immunoglobulin E (IgE) preventing it from binding to the surface of mast cells and basophils. Therapeutic Effect Prevents or reduces the number of asthmatic attacks. Pharmacokinetics Absorbed slowly after subcutaneous administration, with peak concentration in 7-8 days. Excreted in the liver, reticuloendothelial system, and endothelial cells. Half-life 26 days. 

In patients with chronic idiopathic thrombocytopenia (UP) who failed to respond adequately to previous treatment with steroids, immunoglobulins, or splenectomy, romiplostim significantly increased platelet count in most patients. In a 6-week placebo-controlled study in which patients were treated weekly with 1 or 3 mcg/kg, 12 of 16 patients reached the targeted platelet range of 50,000-450,000 platelets/mL. Romiplostim does not appear to decrease the rate of platelet destruction in ITP as platelet counts returned to pretreatment levels after the drug s discontinuation. An open label trial found that many patients maintained a platelet count of 100,000 platelets/mL or higher over a 48-week period and that over half of the patients were able to discontinue other therapies. Romiplostim is initiated as a weekly subcutaneous dose of 1 mcg/kg and then continued at the lowest dose required to maintain a platelet count of at least 50,000 platelets/mL. 

Abbreviations. Ab, antibody SC, subcutaneous IV, intravenous CHO HSA, human serum albumin SC, subcutaneous USP, United States Pharmacopeia AHF IU, international unit NMT, not more than Ig, immunoglobulin BHK, baby hamster kidney PEG, polyethylene glycol hGH, human growth hoimone IM, intramuscular WFI, water for injection. 

Diabetes mellitus in a 36-year-old man with acute pancreatitis could not be controlled with continuous subcutaneous insulin infusion, even with doses up to 1800 U/ day, because of insulin resistance (168). Intravenous insulin by pump had to be stopped because of a catheter infection. The continuous subcutaneous infusion of freeze-dried insulin and the addition of aprotinin, a protease inhibitor, soluble dexamethasone or prednisolone, and intravenous immunoglobulin was ineffective. An implantable pump for intraperitoneal delivery established good regulation at a dosage of 30 U/day. 

Adverse effects associated with intramuscular or subcutaneous administration of immunoglobulin are extremely rare, and are usually related to IgA deficiency in the patient or to additives in the preparation (for example preservatives). Adverse effects associated with intravenous immunoglobulin are more frequently seen and may be either local or systemic (138,139). Local reactions are essentially attributable to the technique used and are not specific to the intravenous immunoglobulin. 

Similar systemic immunization experiments were carried out in monkeys. Monkeys fed candies and cookies and given water containing 2% sucrose developed many cavities after 3 4 years unless immunized with whole cells of. S. mutans. Various purified protein antigens given by subcutaneous vaccination induced a blood plasma immunoglobulin response that protected monkeys from caries, whereas the glucosyl transferases protected only if vaccination methods that promoted salivary IgA immunity Sect. 12.1.4 were used. 

Figure 2.2 Plasma IgG levels following i.m. or s.c. injection in humans. This graph, which is redrawn from Figure 1 in [2], shows the difference in IgG uptake following oral administration and subcutaneous, intramuscular, or intravenous injection. In this particular situation, anti-Rh immunoglobulin G (IgG) was injected into the deltoid or subcutaneously in the buttock. Uptake rates were higher for i.m. injection (0.43 0.11 day" ) than for s.c. injection (0.22 0.025 day" ). Peak concentrations, which occurred after 3 days, were higher for i.m. injection ( 40%) than s.c. injection ( 30%). Pharmacokinetic analysis was used to predict average concentrations and rates of equilibration between vascular and extravascular compartments.

Subcutaneous administration of immunoglobulins may have several advantages. Compared with intravenous immunoglobulin, the trough IgG concentrations obtained are more stable and more physiological Furthermore, subcutaneous administration is associated with fewer systemic adverse reactions than intravenous administration [63 ] and it benefits patients with poor venous access [48 , 62 ]. Moreover, the extreme IgG peaks after infusion of intravenous immunoglobulin that are... 

The most commonly reported adverse events are mild local injection reactions, such as erythema, edema, swelling, pruritus, and local heat [48 , 60, 63 ], whose incidence decreases over time [48 ]. The incidence of non-infusion-site reactions after subcutaneous administration (0.24 events per infusion) is similar to the total incidence of 0.25 events per infusion during treatment with intravenous immunoglobulin [48 ]. Non-infusion-site adverse events after subcutaneous administration include headache, diarrhea, fatigue, and nausea [48 "]. 

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