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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:
Multifocal Motor Neuropathy (MMN)

Safety profile established in the largest controlled clinical trial for MMN to date1,2

The demonstrated tolerability profile of intravenous (IV) administration of GAMMAGARD LIQUID was established in a clinical study in adult patients with MMN (N=44).1

Safety profile and infusion experience1

Of non-serious ARs:

mild severe moderate 72 % 21 % 7 %

Adverse reactions (ARs) with GAMMAGARD LIQUID were mostly mild1

  • 72% (n=126/176) of non-serious ARs were considered mild,* 21% (n=37/176) moderate and 7% (n=13/176) severe1‡
  • Two serious ARs occurred, pulmonary embolism and blurred vision, both of which were judged to be treatment related1

* 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 patients1a

GAMMAGARD LIQUID Placebo
AR By infusion
(N=983) N (%)
By subject
(N=44) N (%)
By infusion
(N=129) N (%)
By subject
(N=43) N (%)
Headache 28 (2.85%) 14 (31.82%) 3 (2.33%) 2 (4.65%)
Nausea 28 (2.85%) 3 (6.82%) 2 (1.55%) 1 (2.33%)
Muscular
weakness
4 (0.41%) 3 (6.82%) 1 (0.78%) 1 (2.33%)
Pain in
extremity
4 (0.41%) 3 (6.82%) 1 (0.78%) 1 (2.33%)
Oropharyngeal pain 4 (0.41%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
Chest
discomfort
3 (0.31%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
Muscle
spasms
3 (0.31%) 3 (6.82%) 0 (0.00%) 0 (0.00%)
GAMMAGARD LIQUID Placebo
AR By subject
(N=44) N (%)
By subject
(N=43) N (%)
Headache 14 (31.82%) 2 (4.65%)
Nausea 3 (6.82%) 1 (2.33%)
Muscular
weakness
3 (6.82%) 1 (2.33%)
Pain in
extremity
3 (6.82%) 1 (2.33%)
Oropharyngeal pain 3 (6.82%) 0 (0.00%)
Chest
discomfort
3 (6.82%) 0 (0.00%)
Muscle
spasms
3 (6.82%) 0 (0.00%)
GAMMAGARD LIQUID Placebo
AR By infusion
(N=983) N (%)
By infusion
(N=129) N (%)
Headache 28 (2.85%) 3 (2.33%)
Nausea 28 (2.85%) 2 (1.55%)
Muscular
weakness
4 (0.41%) 1 (0.78%)
Pain in
extremity
4 (0.41%) 1 (0.78%)
Oropharyngeal pain 4 (0.41%) 0 (0.00%)
Chest
discomfort
3 (0.31%) 0 (0.00%)
Muscle
spasms
3 (0.31%) 0 (0.00%)

aDefined as adverse events occurring during or within 72 hours of infusion or any causally-related event occurring withing the study period.

Rate of headache compared to placebo1

The percentage of infusions for which patients on GAMMAGARD LIQUID experienced a headache was 2.85% (28/983) compared with 2.33% (3/129) of infusions for patients on placebo1

GAMMAGARD LIQUID Placebo 10 8 6 Infusions (%) 4 2 0 2.85% 2.33%

>98% of infusions occurred without rate reduction or discontinuation2

98.35 % without rate reduction or discontinuation required a reduction in rate or discontinuation 1.65%
  • 98.35% (n=4/242) of infusions with GAMMAGARD LIQUID were completed without the need for rate reduction or discontinuation for any reason2
  • 1.65% of infusions required a reduction in rate or discontinuation for any reason

§0.78% (n=1/129) of infusions with placebo required a reduction in rate or discontinuation for any reason.

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GAMMAGARD LIQUID is the first and only FDA-approved treatment for adults with MMN1

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