GAMMAGARD LIQUID is indicated as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

LIMITATIONS OF USE:  GAMMAGARD LIQUID has not been studied in immunoglobulin-naive patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

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    Safety & Tolerability

    Demonstrated Safety Profile

    The safety profile of GAMMAGARD LIQUID in CIDP was evaluated in a 6-month open-label trial.1

    The safety of GAMMAGARD LIQUID was evaluated in a clinical study of 20 adult subjects with CIDP. A total of 389 infusions of GAMMAGARD LIQUID were administered during the study.

    Fourteen out of the 20 patients reported 60 adverse events; 9 experienced mild events (transient discomfort that resolves spontaneously or with minimal intervention), 3 had moderate events (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 2 experienced severe events (marked impairment of function or can lead to a temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae). There were 39 ARs in 13 patients (65%), and 31 related to GAMMAGARD LIQUID in 11 patients (55%). One patient (5%) experienced one severe AR (headache) related to GAMMAGARD LIQUID. No AR resulted in early discontinuation or death, and no serious AR was reported.

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    AR = adverse reaction; CIDP = chronic inflammatory demyelinating polyneuropathy.

    Adverse Reactions1

    ARs* occurring in ≥5% of patients with CIDP are shown below. 

    EVENTSPer Infusion N (%) (N=389 Infusions)Per Patient N (%) (N=20 patients)
    Headache20 (5.1%)8 (40.0%)
    Pyrexia3 (0.8%)2 (10.0%)
    Abdominal pain upper1 (0.3%)1 (5.0%)
    Anemia1 (0.3%)1 (5.0%)
    Blood creatinine increased1 (0.3%)1 (5.0%)
    Chills2 (0.5%)1 (5.0%)
    Dizziness1 (0.3%)1 (5.0%)
    Illness1 (0.3%)1 (5.0%)
    Leukopenia1 (0.3%)1 (5.0%)
    Migraine1 (0.3%)1 (5.0%)
    Nasal Dryness1 (0.3%)1 (5.0%)
    Nasopharyngitis1 (0.3%)1 (5.0%)
    Neutropenia1 (0.3%)1 (5.0%)
    Pain in extremity1 (0.3%)1 (5.0%)
    Somnolence1 (0.3%)1 (5.0%)
    Tremor1 (0.3%)1 (5.0%)
    Vomiting1 (0.3%)1 (5.0%)

    *Defined as adverse events occurring or within 72 hours of infusion or any causally related event occurring within the study period.

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    Reference:

    1. GAMMAGARD LIQUID. Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.