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THE ONLY IG WITH TWO NEUROMUSCULAR INDICATIONS

US-GGL-0670v1.0 07/24

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% is indicated as a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older, as maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). Click here to learn more about an additional neuromuscular indication.

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

5.2% of patients reported headache.

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

In the study, of the 348 non-serious ARs1:

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**

99.8 %
  • 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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GAMMAGARD LIQUID offers a history of clinical use for patients with PI1

Clinical trial data