Pharmacokinetics and safety of a novel anti-HBs-enriched immunoglobulin in healthy volunteers after subcutaneous and intramuscular administration

European Journal of Clinical Pharmacology

Volumn 62, Issue 7, 2006, Pages 511-512

  Thürmann, Petra A ^a   Szymanski, Jacek ^a   Haffner, Steffen ^a   Tenter, Ute ^a   Grieger, Frank ^b   Sonnenburg, C ^c  

^a UNIVERSITY OF WITTEN HERDECKE   (Germany)

^b Institute for Research and Development IFE   (Germany)

^c BIOTEST AG   (Germany)

Author keywords

Anti HBs; Healthy volunteers; Immunoglobulin; Liver transplantation; Pharmacokinetics; Subcutaneous

Indexed keywords

BT 088; HEPATITIS B SURFACE ANTIBODY; LAMIVUDINE;

AREA UNDER THE CURVE; ARTICLE; CHRONIC LEUKEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG HALF LIFE; DRUG SAFETY; DRUG SELF ADMINISTRATION; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; HEPATITIS B; HUMAN; HUMAN EXPERIMENT; INDIVIDUALIZATION; INJECTION SITE REACTION; LIVER TRANSPLANTATION; MALE; MEAN RESIDENCE TIME; MULTIPLE MYELOMA; NORMAL HUMAN; OPEN STUDY; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; VOLUNTEER;

DRUG TOXICITY; FEMALE; HEPATITIS B ANTIBODIES; HUMANS; IMMUNOLOGIC FACTORS; INJECTIONS, INTRAMUSCULAR; INJECTIONS, SUBCUTANEOUS; MALE;

EID: 33745713136     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-006-0137-8     Document Type: Article

References (10)

1. Biotest AG (2004) Hepatect SC/IM. Investigator's brochure. Biotest AG, Dreieich, Germany
2. Burbach GJ, Bienzle U, Neuhaus R, Hopf U, Metzger WG, Pratschke J, Neuhaus P (1997) Intravenous or intamuscular anti-HBs immunoglobulin for the prevention of hepatitis B reinfection after orthotopic liver transplantation. Transplantation 63:478-480
3. Gardulf A, Andersen V, Björkander J, Ericson D, Frøland SS, Gustafson R et al (1995) Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet 345:365-369
4. Glöckner WM (1984) Kinetik von Immunglobulin G nach intravenöser und intra-muskulärer Applikation. In: Kornhuber B (ed) Patient-infektion-immunglobulin. Springer, Berlin Heidelberg New York, pp 33-38
5. Hammarström L, Smith CIE (1990) The use of intravenous IgG as prophylaxis and for treatment of infections. Infection 18:314-324
6. Han S-H, Martin P, Edelstein M, Hu R, Kunder G, Holt C et al (2003) Conversion from intravenous to intramuscular hepatitis B immune globulin in combination with lamivudine is safe and cost-effective in patients receiving long-term prophylaxis to prevent hepatitis B recurrence after liver transplantation. Liver Transplant 9:182-187
7. Markowitz JS, Martin P, Conrad AJ, Markmann JF, Seu P, Yersiz H et al (1998) Prophylaxis against hepatitis B recurrence following liver transplantation using combination lamivudine and hepatitis B immune globulin. Hepatology 28:585-589
8. Partovi N, Guy MW, Ensom MHH, Noble MA, Yoshida EM (2001) A study of the pharmacokinetic profile of low-dose hepatitis B immune globulin in long-term liver transplant recipients for chronic hepatitis B infection. Am J Transplant 1:51-54
9. Thürmann PA, Sonnenburg-Chatzopoulos C, Lissner R (1995) Pharmacokinetic characteristics and tolerability of a novel intravenous immunoglobulin preparation. Eur J Clin Pharmacol 49:237-247
10. Thürmann PA, Sonnenburg C, Valentova K, Gregora E, Freischläger F, Lissner R (2001) Pharmacokinetics of viral antibodies after administration of intravenous immunoglobulin in patients with chronic lymphocytic leukaemia or multiple myeloma. Eur J Clin Pharmacol 57:235-241