GAMMAGARD LIQUID Safety Profile:
Primary Immunodeficiency (PI)
An established intravenous immune globulin (IVIG) safety profile
The demonstrated tolerability of IV administration of GAMMAGARD LIQUID was established in a clinical trial for PI (N=61). During more than 1,800 infusions given for the IVIG trial, the most common systemic adverse reaction (AR) per infusion was headaches at a rate of 5.2% (94/1,812).1
rate of headache per infusion (94 of 1,812 infusions)1
ARs in patients in the IVIG clinical trial
In this clinical study, 15 ARs in 8 participants were serious. Of these, 2 serious reactions (2 episodes of aseptic meningitis in 1 patient) were deemed to be possibly related to the infusion of GAMMAGARD LIQUID.1
In the study, of the 400 non-serious ARs1:
217
were mild*
164
were moderate†
19
were severe‡
All of the severe non-serious adverse experiences were transient, did not lead to hospitalization, and resolved without complication. One subject withdrew from the study due to a non-serious adverse experience (papular rash).1
*Mild: transient discomfort that resolves spontaneously or with minimal intervention.
†Moderate: limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae.
‡Severe: marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae.
ARs occurring in ≥5% of patients in the IVIG clinical triala
| Events | Per Infusion N (%) (N=1,812 infusions) |
Per Patient N (%) (N=61 patients) |
|---|---|---|
| Headache | 94 (5.2%) | 29 (47.5%) |
| Fatigue | 33 (1.8%) | 14 (23.0%) |
| Pyrexia | 28 (1.5%) | 17 (27.9%) |
| Nausea | 17 (0.9%) | 11 (18.0%) |
| Chills | 14 (0.8%) | 8 (13.1%) |
| Rigors | 14 (0.8%) | 8 (13.1%) |
| Pain in extremity |
13 (0.7%) | 7 (11.5%) |
| Diarrhea | 12 (0.7%) | 9 (14.8%) |
| Migraine | 12 (0.7%) | 4 (6.6%) |
| Dizziness | 11 (0.6%) | 8 (13.1%) |
| Vomiting | 11 (0.6%) | 9 (14.8%) |
| Cough | 9 (0.5%) | 8 (13.1%) |
| Urticaria | 9 (0.5%) | 5 (8.2%) |
| Asthma | 7 (0.4%) | 6 (9.8%) |
| Pharyngolaryngeal pain | 7 (0.4%) | 5 (8.2%) |
| Rash | 6 (0.3%) | 4 (6.6%) |
| Arthralgia | 5 (0.3%) | 4 (6.6%) |
| Myalgia | 5 (0.3%) | 5 (8.2%) |
|
Oedema peripheral |
5 (0.3%) | 5 (8.2%) |
| Pruritus | 5 (0.3%) | 4 (6.6%) |
| Cardiac murmur |
4 (0.2%) | 4 (6.6%) |
aAR is defined as an adverse event occurring during or within 72 hours of infusion or any causally-related event occurring within the study period.
Short-term clinical studies were consistent with IVIG safety profile
Pooled analysis of 4 short-term clinical studies with 106 subjects (total of 854 infusions) showed no differences in the safety profile of GAMMAGARD LIQUID. These short-term studies were designed to stabilize the immune globulin treatment or as a safety follow-up study. They were not designed to study the safety, efficacy, and tolerability of GAMMAGARD LIQUID. No additional adverse reactions were reported during the study periods.1
An established subcutaneous IG (SCIG) safety profile
The demonstrated tolerability of SC administration of GAMMAGARD LIQUID was established in a clinical trial for PI (N=47). During more than 2,200 infusions for the SCIG trial, the rate of local ARs was 2.4% (55/2,294).1 In this clinical study, no severe local ARs occurred during the SC treatment periods.1
ARs in patients in the SCIG clinical trial
228
were mild§
112
were moderate‖
8
were severe¶
Neither of the severe adverse reactions required hospitalization or resulted in sequelae.
§Mild: transient discomfort that resolves spontaneously or with minimal intervention.
‖Moderate: limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae.
¶Severe: marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae.
ARs occurring in ≥5% of patients in the SCIG clinical trialb
| Events | Per Infusion N (%) (N=2,294 infusions) |
Per Patient N (%) (N=47 patients) |
|---|---|---|
|
Infusion site (local) event |
55 (2.4%) | 21 (44.7%) |
| Headache | 31 (1.4%) | 19 (40.4%) |
| Fatigue | 11 (0.5%) | 7 (14.9%) |
|
Heart rate increased |
11 (0.5%) | 3 (6.4%) |
| Pyrexia | 11 (0.5%) | 9 (19.1%) |
|
Abdominal pain upper |
9 (0.4%) | 5 (10.6%) |
| Nausea | 7 (0.3%) | 3 (6.4%) |
| Vomiting | 7 (0.3%) | 5 (10.6%) |
| Asthma | 6 (0.3%) | 4 (8.5%) |
| Blood pressure systolic increased |
6 (0.3%) | 3 (6.4%) |
| Diarrhea | 5 (0.2%) | 3 (6.4%) |
| Ear pain | 4 (0.2%) | 3 (6.4%) |
| Aphthous stomatitis |
3 (0.1%) | 3 (6.4%) |
| Migraine | 3 (0.1%) | 3 (6.4%) |
|
Oropharyngeal pain |
3 (0.1%) | 3 (6.4%) |
| Pain in extremity |
3 (0.1%) | 3 (6.4%) |
bAR is defined as an adverse event occurring during or within 72 hours of infusion or any causally-related event occurring within the study period.
Demonstrated tolerability#
In the SC administration of GAMMAGARD LIQUID PI clinical study, 99.8% of infusions were completed without a rate reduction, interruption, or discontinuation due to tolerability reasons (adult and pediatric patients).1**
- 17% (N=8) of study participants had a local AR at first infusion
- This decreased to 2.2% (N=1) of participants during subsequent infusions. This ranged from 0% to 8.7% (N=0 to 4) during the remainder of the first year of SC treatment
- No local ARs were reported for remainder of study (weeks 53 to 68)
#The safety of GAMMAGARD LIQUID in SC infusions was evaluated in 47 participants.
**During all SC treatment periods.
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