Please see Important Safety Information for Vivaglobin below.
Please see Important Safety Information for Hizentra below.
Important Safety Information for Vivaglobin
Immune Globulin Subcutaneous (Human), Vivaglobin®, is indicated for the treatment of patients with primary immunodeficiency (PI).
Vivaglobin is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations and in persons with selective immunoglobulin A deficiency who have known antibody against IgA. If anaphylactic or anaphylactoid reactions are suspected, discontinue administration immediately and treat as medically appropriate.
Vivaglobin 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.
In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash.
Patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients should be monitored in a clinical setting during the initial administration.
Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella.
In clinical studies, administration of Vivaglobin has been shown to be safe and well tolerated in both adult and pediatric subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Safety and efficacy were not studied in pediatric subjects under two years of age.
Please see full prescribing information.
Important Safety Information for Hizentra
Immune Globulin Subcutaneous (Human), Hizentra™, is
indicated as replacement therapy for patients with primary humoral
immunodeficiency (PI). 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 known antibody against IgA and a
history of hypersensitivity.
All IgA-deficient patients with anti-IgA antibodies are at greater risk
of developing potentially severe hypersensitivity and anaphylactic
reactions. 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 subjects in the clinical trial) were local reactions (ie, swelling,
redness, heat, pain, and itching at the injection site), headache,
vomiting, pain, and fatigue.
Monitor patients for reactions reported to occur with IVIg treatment
that might also occur with Hizentra, including renal
dysfunction/failure, thrombotic events, aseptic meningitis syndrome
(AMS), 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.
No overall differences in safety or efficacy were observed in patients
over 65 or in pediatric patients. In the clinical study, desired serum
IgG levels were achieved in pediatric patients without
pediatric-specific dose requirements.
Please read full Prescribing Information
and Patient Product Information for Hizentra.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.