References

Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112(1):1-7.
Berger M. Subcutaneous administration of IgG. Immunol Allergy Clin North Am. 2008;28(4):779-802.
Kittner JM, Grimbacher B, Wulff W, Jäger B, Schmidt RE. Patients' attitude to subcutaneous immunoglobulin substitution as home therapy. J Clin Immunol. 2006;26(4):400-405.
Pleis JR, Lucas JW. Summary health statistics for U.S. adults: National Health Interview Survey, 2007. Vital Health Stat 10. 2009;240:1-159.
Immune Deficiency Foundation. IDF guide for nurses. http://www.primaryimmune.org/publications/book_nurse/book_nurse.htm. Accessed April 23, 2010.
CSL Behring. A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects with Primary Immunodeficiency (PID) [clinical study report]. February 2009.
Wasserman RL. Common infusion-related reactions to subcutaneous immunoglobulin therapy: managing patient expectations. Patient Prefer Adherence. 2008;2:163-166
Ochs HS, Gupta S, Kiessler P, et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26(3):265-273.
Berger M. Principles of and advances in immunoglobulin replacement therapy for primary immunodeficiency. Immunol Allergy Clin North Am. 2008;28(2):413-437.
Murphy E, Burton J, Riley P. Nursing approaches to a novel subcutaneous therapy: a look at 4 patients during transition from IVIg to SCIg. Infusion. 2007;13(4)(suppl):1-8.

Important Safety Information

Immune Globulin Subcutaneous (Human), Hizentra^®, is indicated as replacement therapy for patients with primary humoral immunodeficiency (PI), age 2 and older. This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or components of Hizentra, such as polysorbate 80. Because it contains the stabilizer L-proline, Hizentra is contraindicated in patients with hyperprolinemia. Hizentra is also contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.

Hizentra should be administered subcutaneously only. Do not administer intravenously.

IgA-deficient patients with anti-IgA antibodies may be at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration immediately and treat as medically appropriate.

Hizentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The most common drug-related adverse reactions (observed in 5% or more of study subjects receiving Hizentra) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, rash, pruritis, vomiting, upper abdominal pain, pain, and migraine.

Monitor patients for thrombotic events and aseptic meningitis (AMS), which have been reported with SCIg. Also look forreactions reported to occur with IVIg treatment that might also occur with Hizentra, including renal dysfunction/failure, hemolysis, and transfusion-related acute lung injury (TRALI).

Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing.