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Book Cover
E-book
Author Tridente, G., author

Title Adverse events of biomedicines : prevention through understanding / Giuseppe Tridente
Published Verona : Springer, [2014]
©2014
Table of Contents
pt. I General Aspects 
1.Introduction3
1.1.Definitions4
1.1.1.Drugs as Biological Derivative: Biomedicines5
1.2.Adverse Events6
1.2.1.Typology of Adverse Events7
1.2.2.Classification of Adverse Events9
1.2.3.Adverse Drug Events10
1.2.4.Off-Label Observations11
1.2.5.Postmarketing Surveillance11
1.2.6.Adverse Events Analysis12
 References14
2.Adverse Drug Events to Biomedicines15
 References24
3.Systemic Syndromes with Biomedicines25
3.1.Capillary/Vascular Leak Syndrome (CLS/VLS)25
3.2.Cytokine Release Syndrome (CRS)31
3.3.Infusion Reaction Syndrome (IRS)34
3.4.Tumor Lysis Syndrome (TLS)34
3.5.Systemic Inflammatory Response Syndrome (SIRS)36
3.6.Macrophage Activating Syndrome (MAS)37
3.7.Immune Reconstitution Inflammatory Syndrome (IRIS)38
 References45
pt. II Monoclonal Antibodies 
4.Monoclonal Antibodies51
4.1.Structure and Typology52
4.2.Chimeric and Humanized mAb54
4.3.Fully Humanized mAb54
4.4.Nomenclature56
4.5.Basic Structure, Targets and Mechanism of Action56
4.6.Therapeutic Indications60
 References63
5.Abciximab65
5.1.Mechanism of Action65
5.2.Adverse Events66
5.3.Immunogenicity and Immune Thrombocytopenia67
5.4.Off-Label Experience69
5.5.Postmarketing Surveillance69
5.6.Remarks70
 References70
6.Adalimumab71
6.1.Mechanism of Action72
6.2.Immunogenicity74
6.3.Adverse Events74
6.4.Off-Label Experience78
6.5.Postmarketing Surveillance79
6.6.Remarks79
 References80
7.Alemtuzumab81
7.1.Mechanism of Action82
7.2.Immunogenicity83
7.3.Adverse Events83
7.4.Off-Label Experience86
7.4.1.Neoplastic Off-Label Experience86
7.4.2.Non-Neoplastic Off-Label Experience88
7.5.Postmarketing Surveillance92
7.6.Remarks92
 References93
8.Basiliximab97
8.1.Mechanism of Action97
8.2.Immunogenicity98
8.3.Adverse Events99
8.4.Off-Label Experience100
8.5.Postmarketing Surveillance102
8.6.Remarks102
 References103
9.Belimumab105
9.1.Mechanism of Action106
9.2.Immunogenicity107
9.3.Adverse Events107
9.4.Off-Label Experience108
9.5.Postmarketing Surveillance110
9.6.Remarks110
 References111
10.Bevacizumab113
10.1.Mechanism of Action114
10.2.Immunogenicity116
10.3.Adverse Events116
10.4.Off-Label Experience120
10.5.AEs and Tumor Typology121
10.6.The AMD Experience121
10.7.Postmarketing Surveillance122
10.8.Remarks123
 References124
11.Brentuximab127
11.1.Mechanism of Action128
11.2.Immunogenicity129
11.3.Adverse Events129
11.4.Off-Label Experience130
11.5.Postmarketing Surveillance131
11.6.Remarks131
 References132
12.Canakinumab135
12.1.Mechanism of Action136
12.2.Immunogenicity137
12.3.Adverse Events137
12.4.Off-Label Experience138
12.5.Postmarketing Surveillance140
12.6.Remarks140
 References141
13.Catumaxomab143
13.1.Mechanism of Action144
13.2.Immunogenicity145
13.3.Adverse Events145
13.4.Postmarketing Surveillance146
13.5.Remarks146
 References147
14.Certolizumab149
14.1.Mechanism of Action150
14.2.Immunogenicity and Immunity151
14.3.Adverse Events152
14.4.Off-Label Experience154
14.5.Postmarketing Surveillance155
14.6.Remarks156
 References157
15.Cetuximab159
15.1.Mechanism of Action161
15.2.Immunogenicity163
15.3.Adverse Events164
15.3.1.AEs in SCCHN165
15.3.2.AEs in mCRC166
15.4.Off-Label Experience168
15.5.Postmarketing Surveillance169
15.6.Remarks170
 References171
16.Daclizumab173
16.1.Mechanism of Action174
16.2.Immunogenicity174
16.3.Adverse Events175
16.4.Off-Label Experience176
16.5.Postmarketing Surveillance180
16.6.Remarks180
 References181
17.Denosumab183
17.1.Mechanism of Action184
17.2.Immunogenicity185
17.3.Adverse Events186
17.4.Off-Label Experience189
17.5.Postmarketing Surveillance189
17.6.Remarks190
 References192
18.Eculizumab193
18.1.Mechanism of Action194
18.2.Immunogenicity195
18.3.Adverse Events195
18.4.Off-Label Experience196
18.5.Postmarketing Surveillance198
18.6.Remarks198
 References199
19.Edrecolomab201
 References202
20.Efalizumab203
20.1.Mechanism of Action204
20.2.Immunogenicity205
20.3.Adverse Events206
20.4.The PML Case and Postmarketing Surveillance208
20.5.Remarks209
 References210
21.Gemtuzumab211
21.1.Mechanism of Action212
21.2.Immunogenicity213
21.3.Adverse Events213
21.4.Postmarketing Surveillance215
21.5.Remarks216
 References216
22.Golimumab219
22.1.Mechanism of Action220
22.2.Immunogenicity221
22.3.Adverse Events221
22.4.Off-Label Experience224
22.5.Postmarketing Surveillance225
22.6.Remarks226
 References227
23.Ibritumomab229
23.1.Mechanism of Action230
23.2.Immunogenicity231
23.3.Adverse Events231
23.4.Off-Label Experience233
23.5.Postmarketing Surveillance234
23.6.Remarks235
 References235
24.Infliximab237
24.1.Mechanism of Action238
24.2.Immunogenicity and Related Events240
24.3.Adverse Events241
24.3.1.AEs Peculiarities243
24.4.Off-Label Experience244
24.5.Postmarketing Surveillance246
24.6.Remarks246
 References248
25.Ipilimumab251
25.1.Mechanism of Action252
25.2.Immunogenicity253
25.3.Adverse Events254
25.4.Off-Label Experience257
25.5.Postmarketing Surveillance259
25.6.Remarks259
 References260
26.Muromonab263
 References265
27.Natalizumab267
27.1.Mechanism of Action268
27.2.Immunogenicity269
27.3.Adverse Events269
27.4.Postmarketing Surveillance273
27.5.Remarks273
 References274
28.Nimotuzumab277
28.1.Mechanism of Action278
28.2.Adverse Events278
28.3.Remarks279
 References280
29.Ofatumumab281
29.1.Mechanism of Action281
29.2.Immunogenicity282
29.3.Adverse Events283
29.4.Off-Label Experience285
29.5.Postmarketing Surveillance286
29.6.Remarks287
 References288
30.Omalizumab291
30.1.Mechanism of Action292
30.2.Immunogenicity293
30.3.Adverse Events294
30.4.Off-Label Experience295
30.5.Unexpected Adverse Events297
30.6.Postmarketing Surveillance297
30.7.Remarks298
 References299
31.Palivizumab301
31.1.Mechanism of Action302
31.2.Immunogenicity303
31.3.Adverse Events304
31.4.Off-Label Experience306
31.5.Postmarketing Surveillance307
31.6.The Motavizumab Experience308
31.7.Remarks310
 References311
32.Panitumumab313
32.1.Mechanism of Action314
32.2.Immunogenicity315
32.3.Adverse Events316
32.4.Off-Label Experience320
32.5.Postmarketing Surveillance322
32.6.Remarks322
 References324
33.Pertuzumab327
33.1.Mechanism of Action327
33.2.Immunogenicity329
33.3.Adverse Events329
33.4.Off-Label Experience331
33.5.Postmarketing Surveillance332
33.6.Remarks333
 References333
34.Ranibizumab335
34.1.Mechanism of Action336
34.2.Immunogenicity338
34.3.Adverse Events339
34.3.1.Ocular Adverse Events339
34.3.2.Systemic Adverse Events340
34.4.Off-Label Experience345
34.5.Postmarketing Surveillance346
34.6.Remarks346
 References348
35.Rituximab351
35.1.Mechanism of Action353
35.2.Immunogenicity355
35.3.Adverse Events355
35.4.Off-Label Experience360
35.5.Postmarketing Surveillance365
35.6.Remarks365
 References367
36.Tocilizumab369
36.1.Mechanism of Action370
36.2.Immunogenicity372
36.3.Adverse Events373
36.4.Off-Label Experience377
36.5.Postmarketing Surveillance378
36.6.Remarks379
 References380
37.Tositumomab383
37.1.Mechanism of Action384
37.2.Immunogenicity386
37.3.Adverse Events386
37.4.Off-Label Experience389
37.5.Postmarketing Surveillance389
37.6.Remarks390
 References390
38.Trastuzumab393
38.1.Mechanism of Action394
38.2.Immunogenicity397
38.3.Adverse Events397
38.4.Off-Label Experience402
38.5.Postmarketing Surveillance403
38.6.Remarks404
 References405
39.Ustekinumab409
39.1.Mechanism of Action410
39.2.Immunogenicity411
39.3.Adverse Events411
39.4.Off-Label Experience417
39.5.Postmarketing Surveillance418
39.6.Remarks419
 References420
pt. III Fusion Proteins 
40.Fusion Proteins425
 References428
41.Abatacept429
41.1.Mechanism of Action431
41.2.Immunogenicity432
41.3.Adverse Events433
41.4.Off-Label Experience438
41.5.Postmarketing Surveillance440
41.6.Remarks440
 References442
42.Aflibercept445
42.1.Mechanism of Action447
42.2.Immunogenicity449
42.3.Adverse Events449
42.3.1.Aflibercept (Eylea)450
42.3.2.Aflibercept (Zaltrap; Ziv-Aflibercept)452
42.4.Off-Label Experience453
42.4.1.Aflibercept (Eylea)454
42.4.2.Aflibercept (Zaltrap; Ziv-Aflibercept)455
42.5.Postmarketing Surveillance458
42.6.Remarks458
 References459
43.Alefacept463
 References464
44.Belatacept465
44.1.Mechanism of Action466
44.2.Immunogenicity467
44.3.Adverse Events468
44.4.Off-Label Experience and Postmarketing Surveillance470
44.5.Remarks471
 References472
45.Etanercept473
45.1.Mechanism of Action475
45.2.Immunogenicity478
45.3.Adverse Events478
45.3.1.Additional Adult Safety Profiles (Ps, PsA, AS)481
45.3.2.Pediatric Additional Profiles (JIA, Ps, PsA)482
45.3.3.Safety Profiles in Other Studies484
45.4.Off-Label Experience487
45.5.Postmarketing Surveillance489
45.6.Remarks489
 References491
46.Rilonacept495
46.1.Mechanism of Action496
46.2.Immunogenicity498
46.3.Adverse Events498
46.4.Experience in Gout Studies499
46.5.Off-Label Experience500
46.6.Postmarketing Surveillance501
46.7.Remarks501
 References501
47.Romiplostim503
47.1.Mechanism of Action504
47.2.Immunogenicity504
47.3.Adverse Events505
47.4.Off-Label Experience507
47.5.Postmarketing Surveillance509
47.6.Remarks510
 References511
pt. IV Cytokines 
48.Cytokines515
 References521
49.Interleukins523
49.1.Interleukin-1 (IL-1)524
49.2.Interleukin-2 (IL-2)526
 References529
50.Denileukin-Diftitox531
50.1.Mechanism of Action531
50.2.Immunogenicity532
50.3.Adverse Events533
50.4.Off-Label Experience534
50.5.Postmarketing Surveillance536
50.6.Remarks536
 References537
51.Anakinra539
51.1.Mechanism of Action540
51.2.Immunogenicity542
51.3.Adverse Events542
51.4.Off-Label Experience544
51.5.Postmarketing Surveillance547
51.6.Remarks547
 References549
52.Interferons551
52.1.Alpha Interferons552
52.2.Beta Interferons555
52.3.Gamma Interferon559
52.4.Remarks560
 References562
53.Hemopoietic Stimulatory Factors563
53.1.Erythropoietins and Epoetins563
53.2.Remarks569
 References570
54.Myelopoietic Stimulatory Factors573
54.1.Filgrastim, Pegfilgrastim, Sargramostim574
54.2.Remarks578
 References578
55.Thrombopoietic Stimulatory Factor579
55.1.Interleukin-11579
55.2.Remarks581
 References581
56.Pluripotent Growth Factors583
56.1.Ancestim584
 References585
57.Epidermal Growth Factors587
57.1.Palifermin and Becaplermin588
 References590
pt. V Overview 
58.Biomedicines as Adverse Event Inducers593
58.1.General Safety Profile603
58.1.1.Infusion Reactions and Injection Site Reactions603
58.1.2.Infections604
58.1.3.Hematological Events606
58.1.4.Anti-Drug Antibody Response606
58.1.5.Autoimmune Events607
58.1.6.Cutaneous Reactions608
58.1.7.Cardiotoxicity610
58.1.8.Systemic Syndromes610
58.1.9.Malignancies611
58.1.10.Other AEs Typologies612
58.2.Drug Class Analysis613
58.2.1.TNF Inhibitors613
58.2.2.T Lymphocyte Inhibitors614
58.2.3.B Lymphocyte Inhibitors616
58.2.4.VEGF Inhibitors617
58.2.5.Cytokines617
58.2.6.Interferons619
58.2.7.Hemopoietic Stimulatory Factors619
58.2.8.Epidermal Growth Factors620
 References622
59.Conclusion and Perspectives625
 References632
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Description 1 online resource (xxx, 633 pages)
Contents General Aspects -- Monoclonal antibodies -- Fusion proteins -- Overview
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
Bibliography Includes bibliographical references
Notes Print version record
Subject Drugs -- Side effects.
Drug-Related Side Effects and Adverse Reactions -- prevention & control.
Antibodies, Monoclonal -- adverse effects.
Cytokines -- adverse effects.
Recombinant Fusion Proteins -- adverse effects.
Form Electronic book
ISBN 9788847053137 (electronic bk.)
8847053137 (electronic bk.)