title: Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases.
abstract: Subjects with primary immune deficiency diseases treated with intravenous immunoglobulin (n=42) received intravenous infusions of Carimune NF Liquid every 3-4 weeks for 6 months without routine premedication. The mean dose/patient/infusion was 278.5-800.7 mg/kg. Also, 80.4% of infusions achieved maximum rates of >or=3.5 mg/kg/min; 32% of infusions were associated with adverse events during or within 48 h of their end (upper 95% confidence interval was 39.4%, meeting the Food and Drug Administration (FDA) criterion for acceptable tolerability), and 54.8% of subjects had at least one temporally associated adverse event considered at least possibly drug-related (headache: 35.7% of subjects, 12.4% of infusions; nausea: 14.3%, 3.5%; myalgia: 14.3%, 3.2%; fatigue: 11.9%, 5.7%). The frequencies of these were highest after the first infusion. There were no serious drug-related adverse events or acute serious bacterial infections. Serum IgG trough levels were unchanged from baseline. Carimune NF Liquid, a ready-to-use, high-concentration, liquid immunoglobulin preparation is safe and effective.
authors.affiliation: Rainbow Babies and Children's Hospital, Division of Allergy/Immunology, 111100 Euclid Avenue, Cleveland, Ohio 44106, USA. melvin.berger@uhhospitals.org
authors.forename: Melvin
authors.initials: M
authors.lastname: Berger
authors.forename: Charlotte
authors.initials: C
authors.lastname: Cunningham-Rundles
authors.forename: Francisco A
authors.initials: FA
authors.lastname: Bonilla
authors.forename: Isaac
authors.initials: I
authors.lastname: Melamed
authors.forename: Johann
authors.initials: J
authors.lastname: Bichler
authors.forename: Othmar
authors.initials: O
authors.lastname: Zenker
authors.forename: Mark
authors.initials: M
authors.lastname: Ballow
mesh_terms: D000328:Adult; D000361:Agammaglobulinemia / Q000097:blood / Q000276:immunology / Q000628:therapy*; D002648:Child; D017074:Common Variable Immunodeficiency / Q000097:blood / Q000276:immunology / Q000628:therapy*; D004306:Dose-Response Relationship, Immunologic; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous