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:
- 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
>98% of infusions occurred without rate reduction or discontinuation2
- 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 reason2§
§0.78% (n=1/129) of infusions with placebo required a reduction in rate or discontinuation for any reason.
Review safety information
Review important information, including contraindications and other specific warnings and precautions, to consider when initiating and monitoring treatment with GAMMAGARD LIQUID.
See safety information
GAMMAGARD LIQUID is the first and only FDA-approved treatment for adults with MMN1
Review clinical trial