BookGiuseppe Tridente.
Summary: This monograph gathers and evaluates data on adverse events (AEs) associated specifically with those 'biomedicines' - monoclonal antibodies, fusion proteins, and cytokines - that have recently entered therapeutic use in humans. All AEs observed when using each member of this new drug class are covered, with a view to improving understanding of pathogenesis, facilitating prevention, monitoring, and control, and contributing to the development of better drugs that provide benefits while minimizing risk. Further aspects here examined include the role of drug mechanisms of action and immunogenicity in relation to AEs outcome and induction of systemic syndromes. Additional data on AEs in off-label treatments are also considered. Electronic data sheets, downloadable from the Springer Extra Materials platform, include more detailed safety data as well as additional basic information on product characteristics, pre- and post-marketing AEs classified according to frequency, and system/organ targeting. Data on excipients and selected information on drug interactions and associations are also provided. Adverse Events with Biomedicines: Prevention Through Understanding will serve as a detailed, practical guideline to this important new area, which demands the attention of clinicians, immunologists, oncologists, allergologists, public health professionals, and drug companies.
Contents:
Part I. General Aspects: 1 Introduction
2 Adverse drug events to biomedicines
3 Systemic syndromes caused by biomedicines
Part II. Monoclonal antibodies: 4 Monoclonal antibodies
5 Abciximab
6 Adalimumab
7 Alemtuzumab
8 Basiliximab
9 Belimumab
10 Bevacizumab
11 Brentuximab
12 Canakinumab
13 Catumaxomab
14. Certolizumab
15 Cetuximab
16 Daclizumab
17 Denosumab
18 Eculizumab
19 Edrecolomab
20 Efalizumab
21 Gemtuzumab
22 Golimumab
23 Ibritumomab
24 Infliximab
25 Ipilimumab
26 Muromonab
27 Natalizumab
28 Nimotuzumab
29 Ofatumumab
30 Omalizumab
31 Palivizumab
32 Panitumumab
33 Pertuzumab
34 Ranibizumab
35 Rituximab
36 Tocilizumab
37 Tositumomab
38 Trastuzumab
39 Ustekinumab
Part III Fusion proteins: 40 Fusion proteins
41 Abatacept
42 Aflibercept
43 Alefacept
44 Belatacept
45 Etanercept
46 Rilonacept
47 Romiplostim
Part IV Cytokines : 48 Cytokines
49 Interleukins
50 Denileukin-diftitox
51 Anakinra
52 Interferons
53 Hemopoietic stimulatory factors
54 Myelopoietic stimulatory factors
55 Thrombopoietic stimulatory factor
56 Pluripotent growth factors
57 Epidermal growth factors
Part V Overview: 58 Biomedicines as adverse event inducers
59 Conclusions and perspectives.