Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America

Journal of Clinical Immunology

Volumn 36, Issue 7, 2016, Pages 700-712

  Suez, Daniel ^a   Stein, Mark ^b   Gupta, Sudhir ^c   Hussain, Iftikhar ^d   Melamed, Isaac ^e   Paris, Kenneth ^f   Darter, Amy ^g   Bourgeois, Christelle ^h   Fritsch, Sandor ^h   Leibl, Heinz ^h   McCoy, Barbara ⁱ   Gelmont, David ^j   Yel, Leman ^c,i  

^a Asthma and Immunology Clinic P   (United States)

^b Allergy Associates of the Palm Beache   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Vital Prospects Clinical Research Institute PC   (United States)

^e IMMUNOe International Research Center   (United States)

^f LSU Health Science Center   (United States)

^g Oklahoma Allergy and Asthma Clinic   (United States)

^h Baxalta Innovations GmbH   (Austria)

ⁱ Baxalta US   (United States)

^j Baxalta US Inc   (United States)

more..

Author keywords

20 immunoglobulin; Immunoglobulin replacement therapy; Pharmacokinetics; Primary immunodeficiency diseases; Subcutaneous administration

Indexed keywords

ANTIBIOTIC AGENT; HAPTOGLOBIN; HEMOGLOBIN; HEMOSIDERIN; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN G; LACTATE DEHYDROGENASE; IMMUNOGLOBULIN;

ABDOMINAL PAIN; ABSCESS; ADOLESCENT; ADULT; AGAMMAGLOBULINEMIA; AGED; ANTIBIOTIC THERAPY; AREA UNDER THE CURVE; ARTICLE; AUTOSOMAL RECESSIVE DISORDER; BACKACHE; BACTEREMIA; BACTERIAL ARTHRITIS; BACTERIAL INFECTION; BACTERIAL MENINGITIS; BACTERIAL PNEUMONIA; BURNING SENSATION; CHILD; CHILL; CLINICAL EVALUATION; COMMON VARIABLE IMMUNODEFICIENCY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HEMOLYSIS; HUMAN; IMMUNE DEFICIENCY; IMMUNOGLOBULIN BLOOD LEVEL; INFUSION RATE; INFUSION RELATED REACTION; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE URTICARIA; LABORATORY TEST; LUNG ADENOCARCINOMA; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MIGRAINE; MINIMUM PLASMA CONCENTRATION; MYALGIA; NAUSEA; NORTH AMERICA; OPEN STUDY; OSTEOMYELITIS; PAIN; PATIENT COMPLIANCE; PATIENT SATISFACTION; PHARMACEUTICAL EQUIVALENCE; PHARMACOKINETIC PARAMETERS; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PRURITUS; SEPSIS; SIDE EFFECT; SOMNOLENCE; SUBCUTANEOUS IMMUNOTHERAPY; SYSTEMIC DISEASE; SYSTEMIC THERAPY; TREATMENT DURATION; URINE COLOR; URTICARIA; VALIDATION PROCESS; CLINICAL TRIAL; COMPLICATION; MIDDLE AGED; MULTICENTER STUDY; PRESCHOOL CHILD; QUALITY OF LIFE; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BACTERIAL INFECTIONS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC DEFICIENCY SYNDROMES; INFUSIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; QUALITY OF LIFE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84984856748     PISSN: 02719142     EISSN: 15732592     Source Type: Journal    
DOI: 10.1007/s10875-016-0327-9     Document Type: Article

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