GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). GAMMAGARD LIQUID for MMN is for intravenous use only.
![GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% logo.](/content/experience-fragments/takeda/gammagard/us/en/hcp/mmn/header---mmn/master/_jcr_content/root/container_1325140548/container_6852551/container/image.coreimg.svg/1755842420057/logo-gammagard-white.svg){kind=logo}
Safety & Tolerability
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 evaluated in a clinical study in adult patients with MMN (N=44).1 Patients received a total of 983 infusions.
In the study, among the 317 non-serious adverse reactions, 176 were considered ARs. Of these, 126 were mild (transient discomfort that resolves spontaneously or with minimal intervention), 37 were moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 13 were severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae).
MMN=Multifocal Motor Neuropathy.
Safety profile and infusion experience1
Adverse reactions (ARs) with GAMMAGARD LIQUID were mostly mild1
- 72% (n=126/176) of ARs were considered mild,* 21% (n=37/176) moderate,† and 7% (n=13/176) severe1‡
- Two serious ARs, pulmonary embolism and blurred vision, occurred1
*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.
Of non-serious ARs:
ARs* occurring in ≥5% of MMN patients1
| GAMMAGARD LIQUID | PLACEBO | |||
|---|---|---|---|---|
| EVENTS | Per Infusion (N=983) N (%) | Per Patient (N=44) N (%) | Per Infusion (N=129) N (%) | Per Patient (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%) |
*Defined as adverse events occurring or within 72 hours of infusion or any causally related event occurring within 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% (n=28/983) compared with 2.33% (n=3/129) of infusions for patients on placebo.1
98% of GAMMAGARD LIQUID infusions occurred without rate reduction or discontinuation2
- 98.35% (n=238/242) of infusions with GAMMAGARD LIQUID were completed without the need for rate reduction or discontinuation for any reason during double-blind period2
- 1.65% (n=4/242) of infusions with GAMMAGARD LIQUID required a reduction in rate or discontinuation for any reason2§
§0.78% (n=1/129) of infusions with placebo required a reduction in rate or discontinuation for any reason.
How is GAMMAGARD LIQUID manufactured?
Every step of the process, from collection to manufacturing and delivery, ensures reliable, well-controlled, and high safety margins.1
References:
- GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%. Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
- Hahn AF, Beydoun SR, Lawson V, et al. A controlled trial of intravenous immunoglobulin in multifocal motor neuropathy. J Peripher Nerv Syst. 2013;18(4):321-330.