GAMMAGARD S/D (immune globulin) is not indicated in patients with selective IgA deficiency where
the IgA deficiency is the only abnormality of concern (see WARNINGS).
Primary Immunodeficiency Diseases
GAMMAGARD S/D (immune globulin) is indicated for the treatment of primary immunodeficient states,
such as: congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich
syndrome, and severe combined immunodeficiencies.6,7 This indication
was supported by a clinical trial of 17 patients with primary immunodeficiency
who received a total of 341 infusions. GAMMAGARD S/D (immune globulin) is especially useful when
high levels or rapid elevation of circulating IgG are desired or when intramuscular
injections are contraindicated (e.g., small muscle mass).
B-cell Chronic Lymphocytic Leukemia (CLL)
GAMMAGARD S/D (immune globulin) is indicated for prevention of bacterial infections in patients
with hypogammaglobulinemia and/or recurrent bacterial infections associated
with B-cell Chronic Lymphocytic Leukemia (CLL). In a study of 81 patients, 41
of whom were treated with GAMMAGARD, Immune Globulin Intravenous (Human), bacterial
infections were significantly reduced in the treatment group.8,9
In this study, the placebo group had approximately twice as many bacterial infections
as the IGIV group. The median time to first bacterial infection for the IGIV
group was greater than 365 days. By contrast, the time to first bacterial infection
in the placebo group was 192 days. The number of viral and fungal infections,
which were for the most part minor, was not statistically different between
the two groups.
Idiopathic Thrombocytopenic Purpura (ITP)
When a rapid rise in platelet count is needed to prevent and/or to control
bleeding in a patient with Idiopathic Thrombocytopenic Purpura, the administration
of GAMMAGARD S/D (immune globulin) , should be considered.
The efficacy of GAMMAGARD (immune globulin) has been demonstrated in a clinical study involving
16 patients. Of these 16 patients, 13 had chronic ITP (11 adults, 2 children),
and 3 patients had acute ITP (one adult, 2 children). All 16 patients (100%)
demonstrated a clinically significant rise in platelet count to a level greater
than 40,000/mm3 following the administration of GAMMAGARD (immune globulin) . Ten of
the 16 patients (62.5%) exhibited a significant rise to greater than 80,000
platelets/ mm3. Of these 10 patients, 7 had chronic ITP (5 adults,
2 children), and 3 patients had acute ITP (one adult, 2 children).
The rise in platelet count to greater than 40,000/mm3 occurred after
a single 1 g/kg infusion of GAMMAGARD (immune globulin) in 8 patients with chronic ITP (6 adults,
2 children), and in 2 patients with acute ITP (one adult, one child). A similar
response was observed after two 1 g/kg infusions in 3 adult patients with chronic
ITP, and one child with acute ITP. The remaining 2 adult patients with chronic
ITP received more than two 1 g/kg infusions before achieving a platelet count
greater than 40,000/mm3. The rise in platelet count was generally rapid, occurring
within 5 days. However, this rise was transient and not considered curative.
Platelet count rises lasted 2 to 3 weeks, with a range of 12 days to 6 months.
It should be noted that childhood ITP may resolve spontaneously without treatment.
GAMMAGARD S/D (immune globulin) , is indicated for the prevention of coronary artery aneurysms
associated with Kawasaki syndrome. The percentage incidence of coronary artery
aneurysm in patients with Kawasaki syndrome receiving GAMMAGARD (immune globulin) either at a
single dose of 1 g/kg (n=22) or at a dose of 400 mg/kg for four consecutive
days (n=22), beginning within seven days of onset of fever, was 3/44 (6.8%).
This was significantly different (p=0.008) from a comparable group of patients
that received aspirin only in previous trials and of whom 42/185 (22.7%) experienced
coronary artery aneurysms.10,11,12 All patients in the GAMMAGARD (immune globulin)
trial received concomitant aspirin therapy and none experienced hypersensitivity-type
reactions (urticaria, bronchospasm or generalized anaphylaxis).13
Several studies have documented the efficacy of intravenous gammaglobulin in
reducing the incidence of coronary artery abnormalities resulting from Kawasaki