An antibody is a protein produced by the immune system to identify and neutralize foreign objects like bacteria and viruses. Antibodies recognize specific antigens unique to their target. Biological therapies for treating diseases employ substances like monoclonal antibodies, interferons, and interleukins. Monoclonal antibodies in particular are increasingly prominent in medicine. They are named using a standardized nomenclature indicating the target, source species, and whether it is a monoclonal, chimeric, or humanized antibody. Common examples of monoclonal antibodies used for treatment include rituximab, infliximab, and adalimumab.

2.  An antibody is a protein used by the immune
system to identify and neutralize foreign objects
like bacteria and viruses. Each antibody
recognizes a specific antigen unique to its target.
 It stimulate or restore the ability of the immune
(defense) system to fight infection and disease.
 Also called immunotherapy or biotherapy/ often
employs substances called biological response
modifiers (BRMs)
 Forms of biological therapy include monoclonal
antibodies, interferon, interleukin-2 (IL-2), and
several types of colony- stimulating factors

3.  Because of the growing prominence of monoclonal
antibodies in medicine,
The United States Adopted Name (USAN) Council has
provided guidelines for nomenclature In 2011.The
USAN council updated the original guidelines.
 The name for a monoclonal antibody is formatted as
PREFIX – TARGET - SOURCE SPECIES – SUFFIX
 Prefix: a unique prefix used to identify the product
 Target: usually a three-letter identifier for the disease
or target
 Source species: 1 or 2 letter identifier of animal
source
 Suffix: for monoclonal antibodies is mab

4.  Eg- the product rituximab (Rituxan) was the
first chimeric monoclonal antibody approved
in the United States for treatment of
malignancy.
 The name can be translated as:
ri = unique prefix
tu = tumor
xi = chimeric
mab = monoclonal antibody

5.  NOMENCLATURE FOR NAMING MONOCLONAL ANTIBODY
PRODUCTS
 Target Source Species
 t = tumors a = rat
 li/l = immunomodulators axo = rat-mouse chimer
 ba/b = bacterial e = hamster
 ci/c = cardiovascular i = primate
 fu/f = antifungal zu = humanized
 ki/k = interleukins o = mouse
 ne/n = Neurons as targets xi = chimeric
 so/s = bone xizu = chimeric-humanized
vi/v = viruses,antiviral targets u = fully humanized/human

6.  POLYCLONAL AND MONOCLONAL ANTIBODIES
 POLYCLONAL -a normal humoral immune response produces
many plasma cells from the selection of many compatible and
useful B-cell lineages producing a pooled polyclonal response
(are antibodies that are derived from different cell lines).
 MONOCLONAL antibodies (mAb) are antibodies that are
identical because they were produced by one type of immune
cell, all clones of a single parent cell. This has become an
important tool in biochemistry, molecular biology and
medicine.
 Murine Monoclonal Antibodies
In 1975, Köhler and Milstein discovered that murine (mouse)
antibody-secreting plasma cells and immortal murine myeloma
cells could be fused with the benefits of each retained.
 Chimeric Monoclonal Antibodies
With the emergence of recombinant DNA technology,
monoclonal antibodies with greater amounts of human
sequences are now being developed and used.

7.  Humanized Monoclonal Antibodies
Designed to reduce murine sequence content was the creation
of humanized antibodies. Humanized monoclonal antibodies
typically retain only the hypervariable regions, or
complementary determining regions (cdrs), of a murine
antibody while the remainder of the antibody is human. Thus,
humanized antibodies typically contain only 5% to 10%
murine composition
 Eg-HUMANIZED MONOCLONAL ANTIBODIES
Palivizumab- Prevention of respiratory syncytial virus (RSV)
infections in infants
Trastuzumab-Treatment of HER2-positive metastatic breast
cancer
Alemtuzumab -Treatment of chronic lymphocytic
leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell
lymphoma

8. 

9.  Tocilizumab - against the IL6-Receptor
 Siltuximab
 Clazakizumab
 sarilumab,
 Olokizumab (CDP6038)
 Elsilimomab
 Bms-945429 (ald518)
 Sirukumab (CNTO 136)
 CPSI-2364 macrophage-specific inhibitor of the
p38 mitogen-activated protein kinase pathway.
 Alx-0061.

10.  ETANERCEPT
 INFLIXIMAB
 CERTOLIZUMAB
 ADALIMUMAB
 GOLIMUMAB
 ADALIMUMAB
 ETANERCEPT
 INFLIXIMAB
 OZORALIZUMAB

11.  OFATUMUMAB
 RITUXIMAB
 TOSITUMOMAB
 OBINUTUZUMAB
 IBRITUMOMAB
 AFUTUZUMAB
 OCARATUZUMAB –IN CANCER
 OCRELIZUMAB
 FBTA05 – Chronic lyphocytic leukemia
 BOLENTUMOMAB- veternary use

12.  Basiliximab and daclizumab inhibit IL-2 on
activated T cells and thereby help preventing
acute rejection of kidney transplants.
 It is anti-CD25 monoclonal antibody

13.  Alemtuzumab,
 Use langerhans cell histiocytosis.
 Treat graft versus host disease
 Chronic lymphocytic leukemia(cll)
 Multiple sclerosis (ms) -for early relapsing
and remitting ms

14.  ABAGOVOMAB – Used in ovarian cancer

15.  INTERFERON-alpha
 TUVIRUMAB – Chronic hepatitis B

16.  Natalizumab
 Alemtuzumab
 Daclizumab
 Rituximab
 Ocrelizumab
 Ofatumumab

17.  New Biologic Agents in
Treatment of Severe Lupus Nephritis
 Rituximab
(chimeric anti-CD20 MoAb- B cells
and ? Th-17 cells)
 Belimumab
(anti-Blys/BAFF MoAb- B-cells)
 Eculizimab
(anti-C5A MoAb)
 Abatacept
(CTLA-4/Ig fusion protein-inhibits
CD80 and T-cell co-stimulation)
 Atacicept (Fusion protein that
inhibits Blys + APRIL- B-Cells)
 Epratuzimab
(anti-CD20 MoAb- B-cells)
 Ocreluzimab
(fully humanized anti-CD20 MoAb-
B-cells)
 Anifrolumab (interferon
alpha/interferon beta) monoclonal
antobody
 Mavrilimumab

18.  Belimumab is a B-lymphocyte stimulator
(BLyS)-specific inhibitor.
 DOSE :- 10 mg/kg IV at 2-week intervals for
the first 3 doses and at 4-week intervals
thereafter. Dilusion in 0.9 % NS
 ADR- reactivation of latent infection/prone
for infection due to immunosupresion

19.  Atacicept is a fusion protein containing the extracellular,
ligand-binding portion of the TACI (transmembrane
activator and calcium-modulator and cyclophilin-ligand
[CAML]-interactor) receptor, and a modified Fc portion of
human IgG that blocks BLyS (similar to belimumab).
 It also contains a B-cell activating factor (a proliferation-
inducing ligand [APRIL]). Levels of both APRIL and BlyS are
increased in SLE patients, suggesting that blocking both
would be more beneficial than blocking either one alone.
The agent would also block both plasma and B cells.
 Mavrilimumab, currently in Phase 2b, is a human
monoclonal antibody targeting the alpha subunit of the
granulocyte macrophage colony-stimulating factor
receptor, which inhibits the mononuclear phagocyte
pathway

20.  75 mg – 150 mg s/c
twice weekly for 4
weeks then once a
week foe 48 weeks
 Other use- RA,
 MS, and
 hematological
malignancies
relapsed/refractory
multiple myeloma
 active Waldenström's
macroglobulinemia
 ADR-
immunosupresion/
infection

21.  Humanized monoclonal antibody. Potential
uses may be found in oncology and in
treatment of inflammatory autoimmune
disorders, such as systemic lupus
erythematosus (SLE).
 Use only in LN & NEUROPSYCHIATRIC
involment.
 Other use- adult acute lymphoblastic
leukemia (ALL) / follicular lymphoma.[3]
 Early results from a phase II trial for Diffuse
large B-cell lymphoma (DLBCL)

22.  Epratuzumab binds to the glycoprotein CD22 of
mature and malignant B-cells.
 Elevated CD22 and other B-cell receptor (BCR)
proteins are associated with SLE. "Epratuzumab's
mechanism of action transfers these BCR proteins
to helper cells called effector cells which reduces B-
cell destruction and epratuzumab's impact on the
body's immune system" via a process
called trogocytosis (is a process
whereby lymphocytes (B, T and NK cells) conjugated
to antigen-presenting cells extract surface
molecules from these cells and express them on their
own surface.)
 (Other SLE therapies destroy B-cells which
compromises the immune system.)

23. fully humanized anti-CD20 MoAb-B-cells.
Immunosupresive action
Dose -200mg to 600mg iv every 6 months
Other uses
Rheumatoid arthritis
Multiple sclerosis (MS)
Hematological cancer
ADR- increase risk of infection

24.  anti-C5A MoAb
Humanized monoclonal antibody that is a terminal complement
inhibitor.
Other uses- Paroxysmal Nocturnal Hemoglobinuria and Hemolytic Uremic
Syndrome
ADR-
 Immunologic
Common- Meningococcal sepsis, aspergillus infection, arthritis bacterial,
oral herpes, viral infection
 Hematologic
Thrombocytopenia, leukopenia, hemolysis
 Respiratory:
Upper respiratory tract infection, nasopharyngitis, bronchitis, dyspnea,
cough, nasal congestion, pharyngolaryngeal pain, rhinorrhea

25.  FOR SLE & Paroxysmal Nocturnal
Hemoglobinuria
600 mg IV every 7 days for 4 weeks, followed
by 900 mg IV for the fifth dose 7 days later,
then 900 mg IV every 14 days thereafter
 Hemolytic Uremic Syndrome
900 mg IV every 7 days for the first 4 weeks,
followed by 1200 mg IV for the fifth dose 7
days later, then 1200 mg IV every 14 days
thereafter

26.  Omalizumab (anti-IgE ab) • It is a
recombinant humanized monoclonal antibody
(rhuMAb-E25) developed by immunizing mice
with human IgE.
 It has been found to be effective and
approved by both the FDA and European
Medicines Agency (EMEA) for the treatment of
difficult allergic asthma.
 Anrukinzumab (IMA-638) is a humanized
monoclonal antibody againce IL 13 designed
for the treatment of asthma & UC.

27. OMALIZUMAB
Reduces serum levels of
free IgE •
Down -regulates
expression of IgE
receptors (FceRI) on mast
cells and basophils. •
In the airways of patients
with allergic asthma, it
reduces Fc εRI+ and IgE+
cells and causes a
profound reduction in
tissue eosinophilia,
together with reductions
in submucosal T -cell and
B -cell numbers

28.  s/c
 150-375 mg s/c every 2-4 weeks
 Not more than 150 mg/inj/ site 7 watch for
anaphylaxis foe first 3 dose.

29.  Chronic Idiopathic Urticaria (CIU)
 indicated for the treatment of adults and
adolescents 12 years of age and older with
chronic idiopathic urticaria who remain
symptomatic despite H1 antihistamine
treatment.

30.  Humanised monoclonal antibodies targeting
amyloid plaques in alzheimer's disease
include
 Bapineuzumab
 Solanezumab
 aducanumab

31.  TOCILIZUMAB
 CERTOLIZUMAB
 ETANERCEPT
 ADALIMUMAB
 ANAKINRA
 ABATACEPT
 INFLIXIMAB
 RITUZUMAB
 GOLIMUMAB
 TOFACITINIB

32.  Tocilizumab is a recombinant monoclonal antibody
that has been humanized by complementarity
determining region (CDR) grafting of a murine anti-
human IL-6R antibody onto human IgG1
 IL-6 is a pleiotropic cytokine with diverse physiological
actions, regulating the immune response, inflammation,
bone metabolism, and hematopoiesis, produce by
activated mononuclear cells .
 patients with RA, IL-6 is produced in large quantities
from synovial cells and macrophages, eliciting
polyclonal hypergammaglobulinemia and the
emergence of autoanti-bodies as a result of B cell
differentiation.

33. Signal transduction of interleukin (IL)-6 /IL-6
receptor (R) complex via gp130 and the
mechanism of signal transduction blockage
by tocilizumab. IL-6 signal is mediated via IL-
6R on the cell surface or soluble form of IL-
6R, followed by dimerization of the signal
transducer gp-130, which is bound to the IL-
6/IL-6R complex. Tocilizumab inhibits the
binding of IL-6 to IL-6R or sIL-6R.

34.  IV: Initial - 4 mg/kg once every 4 weeks; may be
increased to 8 mg/kg once every 4 weeks based
on clinical response (maximum dose: 800 mg).
 IV SubQ:<100 kg: 162 mg once every other
week;
increase to 162 mg once every week based on
clinical response And ≥100 kg: 162 mg once
every week
 Note Do not initiate if ANC is <2,000/mm3,
platelets are <100,000/mm3 or if ALT or AST are
>1.5 times ULN

35.  Polyarticular juvenile idiopathic arthritis: >2
years and older.
 Systemic juvenile idiopathic arthritis: >2
years and older.
 Systemic slerosis

36.  IN
GENERAL
 Abdominal
or stomach
pain
 black, tarry
stools
 bloody or
cloudy urine
 blurred
vision
 body aches
 chest pain
 cough
fever or chills
 diarrhea
 difficulty
swallowing
 frequent
urge to
urinate
 headache
 Hives
 sore throat
 stuffy or
runny nose
 sudden
sweating
 weakness

37.  Respiratory -common Upper respiratory tract
infection
Common -Cough, dyspnea, nasopharyngitis,
bronchitis
 Nervous system- Common -Headache,
dizziness
 Dermatologic Common Rash, pruritus,
urticaria
Angioedema (rare),Stevens-Johnson
Syndrome
 Endocrine Uncommon : Hypothyroidism

38.  FRAGMENT OF A MONOCLONAL ANTIBODY
SPECIFIC TO TUMOR NECROSIS FACTOR
ALPHA (TNF-Α)
 DISEASE-MODIFYING ANTIRHEUMATIC DRUG .
 MAO
IS A TNF BLOCKER BY BLOCKING A
PROTEIN (TNF-ALPHA) FOUND IN THE BODY'S
IMMUNE SYSTEM THAT CAUSES
INFLAMMATION.

39.  Initial dose: 400 mg subcutaneously (given as
two subcutaneous injections of 200 mg) at
weeks 0, 2, and 4, followed by 200 mg
subcutaneously every other week
Maintenance dose: 400 mg subcutaneously
every 4 weeks in patients who obtain a
clinical response
 No renal and hepatic dose adjustment
required

40.  Rheumatoid Arthritis
 Psoriatic Arthritis
 Ankylosing Spondylitis / Axial
spondyloarthritis
 Crohn's Disease - for Maintenance

41.  IN GENERAL
 INJECTION SITE PAIN
 FEVER
 FLUE LIKE SYMPTOMS
 DIFFICULT, BURNING,
OR PAINFUL
URINATION
 FREQUENT URGE TO
URINATE
 LOWER BACK OR SIDE
PAIN
 SORE THROAT
 UNUSUAL TIREDNESS
OR WEAKNESS
 NOTE -Patients who
use certolizumab have
an increased risk of
developing serious and
sometimes fatal
infections (eg,
bacterial, viral, or
fungal infections;
tuberculosis [TB]).

42.  Cardiovascular-
Common Hypertension
Uncommon :Cardiomyopathies (including heart failure),
ischemic coronary artery disorders, arrhythmias (including
atrial fibrillation), hypercoagulation.
 Respiratory-
Common :Upper respiratory tract infection, nasopharyngitis,
pharyngitis, acute bronchitis, pneumonia, inflammation
Uncommon :Asthma, pleural effusion, respiratory tract
congestion, lower respiratory tract infection, oropharyngeal
dryness, cough
 Immunologic –Rarely vasculitis ,lupus erythromatus
 Dermatologic - Rash
 Hepatic
Common :Hepatitis (including hepatic enzyme increased)
Uncommon : Hepatopathy (including cirrhosis), cholestasis

43.  Hypersensitivity -Drug hypersensitivity
 Ocular - Conjunctivitis
 Oncological -Uncommon Blood and lymphatic
system malignancies (including lymphoma and
leukemia), solid organ tumors
 Gastrointestinal Common Abdominal pain (including
upper abdominal pain), diarrhea, dyspepsia, gastritis,
nausea
Uncommon Ascites, gastrointestinal infections
 Endocrine Rare Thyroid disorders
 Musculoskeletal Common : Back pain, arthralgia,
muscle spasms, pain in extremity
Uncommon : Muscle disorders, blood creatine
phosphokinase increased

44.  human monoclonal antibody which is used as
an immunosuppressive drug
 MOA -Golimumab targets tumor necrosis
factor alpha with affinity for both soluble and
transmembrane TNF

45.  0.1 to 10 mg/kg following a single
intaravenous (IV) dose
 Followed by 50-mg administered
subcutaneous every 4 weeks

46.  Active tuberculosis,
including reactivation of
latent tuberculosis.
Patients with tuberculosis
have frequently
presented with
disseminated or
extrapulmonary disease.
.
 Invasive fungal infections
including histoplasmosis,
coccidioidomycosis,
candidiasis, aspergillosis,
blastomycosis, and
pneumocystosis. Patients
with histoplasmosis or
other invasive fungal
infections may present
with disseminated, rather
than localized, disease. .
 Bacterial, viral, and other
infections due to
opportunistic pathogens,
including Legionella and
Listeria.

47.  Ankylosing spondylitis
 Psoriatic arthritis
 Ulcerative colitis

48.  Acting as a TNF inhibitor(TNF ALPHA ). Fusion
protein produced by recombinant DNA
,Directed againce Fc end of immunoglobulin
G1 (IgG1) , it is dimeric molecule
 U.S. F.D.A. approval to treat rheumatoid
arthritis, juvenile rheumatoid arthritis and
psoriatic arthritis, plaque psoriasis and
ankylosing spondylitis.
 Can be used alone or with METHOTREXATE.

49.  Tumor necrosis factor-alpha (TNFα) is a
cytokine produced by lymphocytes and
macrophages
+ (-) etanarcept
attract other infamatory cell

50.  Given Subcutaneously
 The recommended dose for adult rheumatoid
arthritis, ankylosing spondylitis, and psoriatic
arthritis patients is 50 mg once a week.
 For adult patients with plaque psoriasis, a starting
dose of 50 mg twice a week for 3 months is followed
with 50 mg once a week for maintenance.
 Juvenile idiopathic arthritis and plaque psoriasis in
children:
For children weighing 60 kg or more, the
recommended dose is 50 mg weekly.
less than 60 kg the recommended dose is 0.8 mg/kg
once a week.

51. USA the FDA has licensed Enbrel for :
 Polyarticular Juvenile Rheumatoid Arthritis .
 Psoriatic Arthritis
 Ankylosing Spondylitis (AS)
 Plaque Psoriasis

52.  IN GENERAL
 Common side effects. Injection site
reactions such as redness, swelling, itching or
pain. These symptoms usually go away within
3 to 5 days.
 Upper respiratory infections (sinus
infections).
 Headache.

53.  Infections. . Some people have serious infections while
taking These infections include tuberculosis (TB), and
infections caused by viruses, fungi or bacteria that spread
throughout their body. .
 Hepatitis B infection in people who carry the virus in their
blood. If you are a carrier of the hepatitis B virus (a virus
that affects the liver), the virus can become active.
 Nervous system problems. Rarely, people who use TNF-
blocker medicines have developed nervous system
problems such as multiple sclerosis, seizures, or
inflammation of the nerves of the eyes.
 Blood problems. Low blood counts have been seen with
other TNF-blocker medicines
 Heart failure including new heart failure or worsening of
heart failure .

54.  Psoriasis. new psoriasis or worsening of psoriasis they already
had . Allergic reactions. Allergic reactions can happen to people
who use TNF-blocker medicines.
 Autoimmune reactions, including: Lupus-like
syndrome. Symptoms include a rash on face and arms that gets
worse in the sun. .
 Autoimmune hepatitis. Liver problems can happen in people who
use TNF-blocker These problems can lead to liver failure and
death
 Unusual cancers in children and teenage patients who started
using TNF-blocking agents at less than 18 years of age. For
children, teenagers and adults taking TNF-blocker medicines
chances of getting lymphoma(Hodgkin’s and non-Hodgkin’s
lymphoma) or other cancers may increase.
 People with rheumatoid arthritis or psoriasis, especially those
with very active disease, may be more likely to get lymphoma.

55.  is a TNF-inhibiter anti-inflammatory, biologic
medication. It binds to tumor necrosis factor-
alpha (TNFα), which normally binds to TNFα
receptors, leading to the inflammatory
response of autoimmune diseases.
 Increased risk of developing serious and
sometimes fatal infections

56.  40 mg subcutaneously every other week
 ForCrohn's Disease - Maintenance
 -Initial dose: 160 mg subcutaneously on Day 1 (given as
four 40 mg injections in one day or as two 40 mg
injections per day for two consecutive days), followed by
80 mg two weeks later (Day 15)
-Maintenance dose: Two weeks later (Day 29): Begin a
maintenance dose of 40 mg every other week
 Methotrexate, glucocorticoids, salicylates, nonsteroidal
anti-inflammatory drugs, analgesics, or other disease
modifying agents may be given concomitantly.
 for Plaque Psoriasis
-Initial dose: 80 mg subcutaneously once
-Maintenance dose: 40 mg subcutaneously every other
week, starting one week after the initial dose

57.  FOR Crohn's Disease IN CHIDREN
17 kg (37 pounds) to less than 40 kg (88 pounds):
-Initial dose: 80 mg subcutaneously on Day 1 (administered as
two 40 mg injections in one day); and 40 mg subcutaneously two
weeks later (on Day 15)
-Maintenance dose: 20 mg subcutaneously every other week
Greater than or equal to 40 kg (88 pounds):
-Initial dose: 160 mg subcutaneously on Day 1 (administered as
four injections in one day or as two 40 mg injections per day for
two consecutive days); and 80 mg subcutaneously two weeks
later (on Day 15) (administered as two 40 mg injections in one
day)
-Maintenance dose: 40 mg subcutaneously every other week
NO RENAL AND HEPATIC DOSE ADJUSMENT REQUIRED

58.  Rheumatoid arthritis
 Psoriatic arthritis
 Ankylosing spondylitis
 Crohn's disease and ulcerative colitis,
 Chronic psoriasis
 Hidradenitis suppurativa
 Juvenile idiopathic arthritis.

59.  IN GENERAL
 Abdominal or
stomach
fullness
 body aches
Flue like
symptoms
 gas with
abdominal or
stomach pain
 lightheadedn
ess
 lower back
pain
most
serious
adverse
reactions
have been
serious
infections,
neurologic
events, and
malignancies

60.  Nervous system
Very common Headache (12%)
Uncommon :Confusion, paresthesia, subdural
hematoma, tremor, demyelinating disorders
(e.g., optic neuritis, Guillain-Barre syndrome),
cerebrovascular accident, multiple sclerosis,
Very rare Hypertrophic pachymeningitis
 EndocrineUncommon -Parathyroid disorder

61.  IT IS AN INTERLEUKIN 1 (IL1) RECEPTOR ANTAGONIST
 MAO :- recombinant, non-glycosylated version of
human IL-1RA (RA for receptor antagonist) prepared
from cultures of genetically modified Escherichia coli
using recombinant DNA technology.
 Anakinra differs from native human IL-1Ra in that it
has the addition of a single methionine residue at its
amino terminus .
 Anakinra blocks the biologic activity of naturally
occurring IL-1, including inflammation and cartilage
degradation associated with rheumatoid arthritis, by
competitively inhibiting the binding of IL-1 to the
Interleukin-1 type receptor, which is expressed in
many tissues and organs

62.  100 mg subcutaneously once a day.
 Dose reduction to 100 mg subcutaneously
every other day should be considered in
patients with severe renal impairment.
 Usual duration of therapy was 24 weeks
 Anakinra-treated patients experienced
defined neutropenia (ANC < 1 x 109/L) in
0.4%.

63.  CONTRAINDICATIONS:
 ABSOLUTELY CONTRAINDICATED
 Hypersensitivity to anakinra,
 Preexisting malignant diseases (e.g., solid cancers, leukemia):
(anakinra may worsen already existing malignancies).
 Patients with neutropenia due to any reason .
 Severely impaired renal function (creatinine clearance less than
30 ml/minute).
 Preexisting active tuberculosis (disease may be worsened )
 Precautions:
 Geriatric patients (over 65 yrs of age): risk of infections is
increased.
 Asthma: increased risk of severe infections.
 Mild to moderately impaired renal function: caution.

64. Gastrointestinal tract : nausea (8%), diarrhea (7%), unspecific abdominal
pain (5%).
Gastrointestinal tract : elevated liver transaminases
 Allergy
 Respiratory tract : Frequently, infections of upper respiratory tract (13%),
sinusitis (7%), flu-like syndrome (6%), Infrequently, pneumonia and
tuberculosis.
 Skin : Frequently ecchymoses
 Immune system : Frequently, infections (40%, severe in 2%). Infrequently,
production of antibodies with neutralizing activity.
 Blood and blood forming organs : Frequently, decrease in neutrophil
counts (8% under anakinra, placebo 2%), infrequent significant
neutropenia (0.4% under anakinra), moderate eosinophilia, moderately
low platelet count, and malignant lymphomas
 Pain, inflammation, and erythema at injection sites : Very frequently (70%
of patients), usually during first 4 weeks of therapy, reversible within 1
to 2 weeks.

65.  TNF-blocking agentsserious infections and an
increased risk of neutropenia :
 Methotrexate:
 Methotrexate has been coadministered with
anakinra in quite extended clinical studies.
 Vaccines Live-virus vaccines should not be
given to patients during anakinra treatment.

66.  Is a fusion protein composed of the fc region
of the immunoglobulin igg1 fused to the
extracellular domain of CTLA-4
 MOA
prevents antigen-presenting cells (apcs) from
delivering the co-stimulatory signal. This
prevents the T cells from being fully
activated, and even downregulates them
In order for T cells to be activated and attack
an antigen, that antigen must be presented to
the T cell by an APC.

67. Abatacept
consists of a
fusion protein of
the extracellular
domain of
CTLA-4 and
human IgG1
Binds to the B7
protein on the
APC
prevents it from
delivering the
co-stimulatory
signal to the T
cell.

68.  IV administration:
-If less than 60 kg, give 500 mg
-If 60 to 100 kg, give 750 mg
-If greater than 100 kg, give 1000 mg
 Administer once as a 30-minute IV infusion. The dose is
repeated 2 and 4 weeks after the initial dose, then every 4 weeks
thereafter. (WITH OR WITHOUT DMRD)
 Subcutaneous administration:
-After a single IV infusion as a loading dose
125 mg administered by subcutaneous injection should be given
within a day, followed by 125 mg subcutaneously once a week.
-Patients who are unable to receive an infusion may initiate
weekly injections subcutaneously without an IV loading dose.

69.  Juvenile Idiopathic Arthritis

70.  Back pain
 Bloody or
cloudy urine
 Body aches
 Sore throat
 Tightness of
the chest
 Troubled
breathing

71.  Chimeric monoclonal antibody biologic drug
that works against tumor necrosis factor
alpha (tnf-α) and is used to treat
autoimmune diseases.

72. Infliximab
Neutralizes the
biological activity of
tnf-α by binding with
high affinity to the
soluble (free floating
in the blood) and
transmembrane
(located on the outer
membranes of T cells
and similar immune
cells) forms of tnf-α
Inhibits or prevents
the effective binding
of tnf-α with its
receptors.

73.  Recommended dose for the treatment of
moderately to severely active rheumatoid
arthritis is 3 mg/kg at 0, 2, and 6 weeks
followed by 3 mg/kg every 8 weeks.
Infliximab should be combined with
methotrexate.
 If response is incomplete, up to 10 mg/kg or
treating every 4 weeks may be tried.

74. FOR
 Ulcerative colitis,
 Psoriatic arthritis,
 Plaque psoriasis
 Ankylosing spondylitis
 Moderate to severe active crohn's disease or
fistulizing crohn's disease in adult or
pediatric patients.
 Dose is 5 mg/kg infusion at 0, 2, and 6
weeks and then 5 mg/kg every 8 weeks

75.  Crohn's disease
 Ulcerative colitis, psoriasis
 Psoriatic arthritis
 Ankylosing spondylitis
 Psoriatic arthritis
 Psoriasis
 Relapsing polychondritis

76.  Serious infections
 Reactivation of hepatitis B
 Reactivation of tuberculosis[17]
 Lethal hepatosplenic t-cell lymphoma
(generally only when combined with 6-
mercaptopurine)
 Drug-induced lupus
 Demyelinating central nervous system
disorders
 Psoriasis and psoriasiform skin lesions
 New-onset vitiligo

77.  Antibody binds to CD20.
 Dose
Premedicate with glucocorticoids 30 minutes
before infusion to reduce infusion rxn
 1000 mg IV infusion, repeat after 2 week (2
infusions separated by 2 week is 1 course)
 Repeat course q24weeks (6 months) or based
on clinical evaluation (but no sooner than 16
weeks)
 For other disease like non-hodgkin lymphoma
chronic lymphocytic leukemia , wegener
granulomatosis , microscopic polyangiitis
dose is->375 mg/m² IV infusion

78. Rituximab tends
to stick to one
side of B cells,
where CD20 is,
forming a cap
and drawing
proteins over to
that side.
The presence of
the cap changed
the effectiveness
of natural killer
(NK) cells in
destroying these
B cells.
When an NK cell
latched onto the
cap, it had an
80% success rate
at killing the cell

79.  Non-hodgkin's lymphoma
 Chronic lymphocytic leukemia
 Wegener's granulomatosus
 Microscopic polyangiitis

80.  Serious adverse events,
which can cause death
and disability, include
 Severe infusion reaction.
 Cardiac arrest
 Cytokine release
syndrome
 Tumor lysis syndrome,
causing acute renal
failure
 Infections
 Hepatitis B reactivation
 Progressive multifocal
leukoencephalopathy
(PML)
 Immune toxicity, with
depletion of B cells in
70% to 80% of
lymphoma patients
 Pulmonary toxicity
 Bowel obstruction and
perforation
 Activation of JC virus, a
common virus in the
brain which is usually
latent. Reactivation of
the JC virus usually
results in death or
severe brain damage

81.  It is janus kinase (JAK) inhibitor

82.  Dose – 5 mg twice a day (immediate release) or 11
mg extended release once a day oral.
 Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate or severe renal impairment: 5 mg orally
once a day.
 Liver Dose Adjustments
Mild hepatic impairment: No adjustment
recommended.
Moderate hepatic impairment: 5 mg orally once a day
Severe hepatic impairment.

83. It is an inhibitor
of the enzyme
janus kinase 1
(JAK1) and janus
kinase 3 (JAK 3),
That it interferes
with the JAK-
STAT signaling
pathway.
Resulting in DNA
transcription and
expression of
genes involved in
immunity,
proliferation,
differentiation,
apoptosis and
oncogenesis

84.  JAK-STAT signaling pathway transmits
information from
 extracellular chemical signals to the nucleus
 resulting in DNA transcription and expression
of genes involved in immunity, proliferation,
differentiation, apoptosis and oncogenesis

85.  Psoriasis
 Inflammatory bowel disease - Ulcerative
colitis
 Alopecia areata .
 Vitiligo
 Atopic dermatitis
 Ankylosing spondylitis
 Immunological diseases, as well as for the
prevention of organ transplant rejection

86.  General
The most common
serious adverse
reactions are serious
infections.
 Dermatologic
Rash, erythema,
pruritus
 Gastrointestinal
Diarrhea
Rare: Abdominal
pain, dyspepsia,
vomiting, gastritis,
nausea.
 Hematologic
Rare: Anemia,
neutropenia,
lymphopenia
 Hepatic
AST elevation, ALT
elevation
 Immunologic
Very common
Overall infections
, cellulitis, herpes
zoster and urinary
tract infection), other
non-TB opportunistic
infection
 Metabolic
: Dehydration,
increased total
cholesterol, increased
LDL cholesterol,
increased HDL
cholesterol, increased
triglycerides
 Musculoskeletal
Musculoskeletal
pain, arthralgia,
tendonitis, joint
swelling
 Nervous system
Headache
Oncologic
Rare : Lung cancer,
breast cancer, gastric
cancer, colorectal
cancer, renal cell
cancer, prostate
cancer, lymphoma,
malignant melanoma,
non-melanoma skin
cancer
 Other
Pyrexia, fatigue,
peripheral edema