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Subcutaneous Immune Globulin: Alternative Therapeutic Pathway for Patients with Primary Immunodeficiency INTRODUCTIONPrimary immunodeficiencies (PIDs) were first identified and characterized in the middle of the 20 th century. The development of immunoglobulin (Ig) administration as a therapeutic option for PIDs has extended and improved the quality of life for many patients who lack life-sustaining antibody function.
Initially, Ig was only available in a preparation that could be administered via subcutaneous (SC) or intramuscular (IM) routes. This limited the use of Ig products for PIDs because many indications, primarily immunomodulatory disorders, required higher doses than could feasibly be administered SC or IM due to volume restrictions. Intravenous (IV) administration of Ig (IVIG) was introduced to the market in the 1970s, and its introduction expanded the use of Ig to other medical conditions while increasing the availability of treatment options for patient with PIDs.Marketed Ig products evolved substantially over the next several decades and they now give patients and clinicians additional therapeutic options with significantly improved safety and quality profiles.
For example, the most frequently used Ig products in the United States (U.S.) today have reduced overall reliance on sugars for antibody stabilization; the products are available in premixed, ready-to-use packages that contain Ig at physiologic osmolarity and osmolality. These enhancements compared to early Ig products have relegated the IM route to rare use and given patients and providers options for IV and SC administration that can be completed in ambulatory clinics or home-care settings, the latter of which facilitates patient self-administration of medications. 1-3PIDs are characterized by defects in either the innate immune system, such as complement deficiencies, or the adaptive immune system, such as T-cell defects. Patients who are untreated for PIDs experience increased susceptibility to infection: the spectrum of infections varies according to specific PID subtype and extent of the immunocompromised state. 4 Approximately 1 in 1200 persons in the U.S.
Have a clinically significant PID. 5More than 120 specific PIDs are characterized in the medical literature, but this review for pharmacy clinicians focuses on those in which Ig treatment is a mainstay of disease management, including:. Common variable immune deficiency (CVID), which is a heterogeneous group of disorders that is primarily characterized by a reduction in the serum levels of IgG, IgA, or IgM.
CVID is the most frequent and most symptomatic type of PID, with a prevalence estimated to be between 1 in 25,000 and 1 in 50,000. 6 The hallmark of CVID is primary hypogammaglobulinemia, which necessitates life-long Ig maintenance therapy. Severe combined immunodeficiency (SCID), which is another group of heterogeneous disorders. SCID is characterized by the inability of T-cells to differentiate. In contrast to CVID, patients with SCID present with severe infections early in life, usually younger than 1 year of age.
Without treatment, the majority of patients with SCID will experience mortality in the first year of life. 7 SCID is present in between 1 in 50,000 and 1 in 500,000 live births. Treatment with hematopoietic stem cell transplantation (HSCT) remains the treatment of choice for SCID, and Ig is used as a temporizing measure prior to HSCT.
8. Wiskott–Aldrich syndrome (WAS), which is linked to 1 of several defects in a single gene on the X chromosome that encodes the Wiskott–Aldrich syndrome protein (WASp).
WASp is a protein in the cytoplasm of hematopoietic cells; mutations in WASp lead to deficiencies in both B-cell and T-cell signaling and antigenic response. 9 The majority of patients with WAS have near-normal levels of IgG. However, despite these near-normal IgG levels, the antibodies do not function properly, which leads to an increased risk of infection, even in the setting of immunization. Many patients with WAS will ultimately require HSCT. Supportive measures for these patients include splenectomy, antibiotic prophylaxis, and Ig supplementation.
9Life-long Ig replacement, either intravenously (IVIG) or subcutaneously (SCIG), is a cornerstone of PID management for most patients. 10 For each Ig product, the clinician and patient must carefully consider product selection, dosage, route of administration, and monitoring characteristics. Appropriate replacement therapy will prevent serious, recurrent infections, which will improve overall morbidity and mortality (e.g., pulmonary complications leading to terminal lung disease) for these patients. 10 Importantly, developing a treatment plan that optimizes adherence can further enhance the health and quality of life for patients with PIDs.
11 OPTIMIZING IMMUNOGLOBULIN THERAPYA multitude of IgG formulations are currently commercially available in the U.S. 12-26 The formulations differ in several aspects: Ig concentration, stabilizing additives, trace non-IgG proteins, and manufacturing process. These differences may lead to variations in adverse reactions experienced by patients. 27,28 In addition, patients may have medical considerations such as heart failure, diabetes, or renal dysfunction that influence their abilities to tolerate the different potential routes of administration ( ). 27,28 Formulating, establishing, and maintaining an Ig treatment regimen is a complex process that is most effectively determined with the collaboration of the patient and health care providers (i.e., physicians, nurses, and pharmacists).
The route of administration, which should be chosen on the basis of a patient's overall clinical picture, is typically the first factor considered when selecting an Ig regimen. IgG formulation is chosen next on the basis of pharmaceutical suitability. Characteristics of Select Immunoglobulin Products 12-26Brand nameFormulation, concentrationStabilizerSodiumcontentIgA content (mcg/mL)Sugar contentpHOsmolarity/osmolality (mOsm/kg)Latex-freepackagingRoute of administrationBivigamLiquid, 10%Glycine0.100–0.140 M≤200None4.0–4.6≤510YesIVCarimune NFLyophilized,3%–12%Sucrose. Postgraduate Healthcare Education, LLC (PHE) is the source of Power-Pak C.E.® continuing education for health careprofessionals. Our accredited programs assist in meeting the requirements of licensure. PHE provides continuingeducation for the broad spectrum of health care professionals.
This site features a searchable database of accreditedPower-Pak C.E. ® courses on important topics for today's health care professionals.PHE customizes Power-Pak C.E. ® online for each visitor by creating a personal participant profile.
Registered participantsmay update their contact information, take an exam, receive instant grading, view their exam history, and print certificatesfor successfully completed programs at any time. Monthly notifications will be sent to participants notifying you of newcourses available on the site.