Immunostimulant

&
Immunosuppressant
 IMMUNOSTIMULANTS
Immunostimulants are substances that stimulate the
immune system.

Specific immunostimulants such as vaccines stimulate an

immune response to specific antigenic types.

Non-specific immunostimulants do not have antigenic

specificity and are widely used in chronic infections,
immunodeficiency, autoimmunity and neoplastic diseases.
 IMMUNOSTIMULANTS

INTERLEUKINS COLONY-
INTERFERONS
STIMULATING
FACTORS
Naturally released Chemicals produced
from human cells in by T cells to Used to stimulate
response to viral communicate the bone marrow to
invasion between leukocytes produce more white
blood cells
INTERFERONS
 Therapeutic Action
Interferons act to prevent virus particles from replicating inside cells. They also
stimulate interferon receptor sites on noninvaded cells to produce antiviral proteins,
which prevent viruses from entering the cell. In addition, interferons have been
found to inhibit tumor growth and replication, to stimulate cytotoxic T cell activity
and to enhance the inflammatory response.

Interferons work in a few different ways. They:

• Alert the immune system so it can go after the virus or cancer
• Help the immune system recognize the virus or cancer
• Tell immune cells to attack
• Stop virus and cancer cells from growing and dividing
• Help healthy cells fight infection
Therapeutic Action
 Pharmacokinetics

Route: Subcutaneous or Intramascular injection

Onset of action and peak: within 3 to 8 hours
Half-life: ranges from 3 to 8 hours

Interferon beta-1a
(Onset of action: 12 hours, peak level: 48 hours, half-life: 10 hours)

They are broken down in the liver and kidneys and seem to be excreted primarily
through the kidneys.
 Contraindication and Caution

The use of interferons is contraindicated in:

• Presence of known allergy to any interferon or product components to prevent
hypersensitivity reactions.
• Pregnancy - many of the interferons are teratogenic in animals
• Lactation – it may have potential adverse effects on the baby since it is not known
whether these drugs cross into breast milk.
• Cardiac Disease – these drugs can cause hypertension and arrhythmias
• Myelosuppression - these drugs may further suppress the bone marrow
• Central nervous system (CNS) dysfunction of any kind - potential for CNS
depression and personality changes that have been reported.
 Adverse Effects

The adverse effects associated with the use of interferons are related to
the immune or inflammatory reaction that is being stimulated (stimulating
the immune and inflammatory response causes a flu-like syndrome with
lethargy, myalgia, arthralgia, anorexia, nausea). Other commonly seen
adverse effects include headache, dizziness, bone marrow depression,
depression and suicidal ideation, photosensitivity, and liver impairment.
INTERLEUKINS
Interleukins are synthetic compounds much like the interferons; they
communicate between lymphocytes, which stimulate cellular immunity and
inhibit tumor growth.  Interleukin-1 is responsible for the production of
inflammation, as well as the promotion of fever and sepsis. Interleukin-2
stimulates cellular immunity by increasing the activity of natural killer cells,
platelets, and cytokines.

Two interleukin preparations are available for use:

1. Aldesleukin (Proleukin) - is a human interleukin produced by recombinant
DNA technology using Escherichia coli bacteria
2. Oprelvekin (Neumega) - is a newer agent that is also produced by DNA
technology
INTERLEUKINS
Therapeutic Action

Natural interleukin-2 is produced by various lymphocytes to activate cellular

immunity and inhibit tumor growth by increasing lymphocyte numbers and their
activity. When interleukins are administered, there are increases in the numbers
of natural killer cells and lymphocytes, in cytokine activity, and in the number of
circulating platelets.
Pharmacokinetics

ALDESLEUKIN OPRELVEKIN

Route: intravenous Route: subcutaneous

Peak levels: 13 minutes Peak levels: 3 to 5 hours
Half-life: 85 minutes or 1 Half-life: 7 to 8 hours
hour and 25 minutes

They are primarily cleared from the body by the kidneys.

Contraindication and Caution
Interleukins are contraindicated in:
• The presence of any allergy to an interleukin or Escherichia coli–produced
product to prevent hypersensitivity reactions.
• Pregnancy - they were shown to be embryocidal and teratogenic in animal
studies
• Lactation – It is not clear whether the drugs cross into breast milk, but it is
recommended that they not be used during lactation; if they must
be used, another method of feeding the baby must be chosen because
of the potential for adverse effects in the baby.
Caution should be used with renal, liver, or cardiovascular impairment because
of the adverse effects of the drugs.
Adverse Effects
The adverse effects associated with the interleukins can be attributed to their
effect on the body during inflammation (flu-like effects: lethargy, myalgia,
arthralgia, fatigue, fever). Respiratory difficulties, CNS changes, and cardiac
arrhythmias also have been reported, and the patient should be monitored for
these effects and the drug stopped if they do occur.

Oprelvekin has been associated with severe hypersensitivity reactions, and

patients should be closely watched when beginning therapy and encouraged to
report any difficulty breathing or swallowing, chest tightness, or swelling.
 Colony-stimulating Factors
The colony-stimulating factors are hormone-like proteins that stimulate the
production of infection-fighting immune cells. These are produced by recombinant
DNA technology.
• Filgrastim (Neupogen), pegfilgrastim (Neulasta), and tbo-filgrastim
- increase the production of neutrophils in the bone marrow with little effect on
other hematopoietic cells.
• Sargramostim (Leukine) - increases the proliferation and differentiation of
hematopoietic progenitor cells and can activate mature granulocytes and
monocytes

The colony-stimulating factor of choice will depend on the condition being treated.
COLONY-STIMULATING FACTORS
 Therapeutic Action
By increasing the production of white bloood cells, the colony-stimulating
factors can be used to reduce the incidence of infection in patients with bone
marrow suppression, to decrease the neutropenia associated with bone
marrow transplants and chemotherapy, and to help in the treatment of various
blood-related cancers.
 Pharmacokinetics

FILGRASTIM PEGFILGRASTIM Tbo -FILGRASTIM SARGRAMOSTIM

Route: Route: Route: Route:
intravenous or subcutaneous subcutaneous intravenous or
subcutaneous Peak levels: 8 hrs Peak levels: subcutaneous
Peak levels: Half-life: 15 to 80 hrs 4 to 6 hrs Peak levels:
2 hrs IV 8 hrs SQ Half-life: 3.5 hrs 4 to 6 hrs
Half-life: Half-life: 1 to 3 hrs
220 mins or 3 hrs Duration (IV): 6 hrs
and 40 mins
Duration: 4 days
 Contraindication and Caution
Colony-stimulating Factors are contraindicated in:
• The presence of any allergy to any component of the drug or to Escherichia
coli–produced products to prevent hypersensitivity reactions.
• Sargramostim is contraindicated in neonates because of benzyl alcohol in the
solution and with excessive leukemic myeloid blasts in the bone marrow or
peripheral blood, which could be worsened by the drug.
• Caution in pregnancy and lactation should be given because the potential
effects on the fetus or neonate are not known.
• Sargramostim should also be used with caution in hepatic or renal failure which
could alter the pharmacokinetics of the drug, during or immediately after
radiation or chemotherapy because of a potential loss of effectiveness.
 Adverse Effects
The adverse effects associated with colony-stimulating factors are
gastrointestinal (GI) effects (nausea, vomiting, diarrhea, constipation, anorexia),
headache, fatigue, generalized weakness, alopecia and dermatitis, and
generalized pain and bone pain. The effects are thought to be associated with
the drug effects on the bone marrow cells and their increased activity.
 Clinically Important Drug-Drug
Interaction
The only reported drug–drug interactions associated with these drugs is an
increase in the myeloproliferative effects of sargramostim when combined
with lithium or corticosteroids; these combinations should be used with
caution.
 IMMUNOSUPPRESSANT
Immunosuppressant drugs, also called as anti-rejection drugs,
are a class of drugs that suppress, or reduce, the strength of
the body’s immune system.

They are especially beneficial in cases of organ transplantation

and in the treatment of autoimmune diseases.
 IMMUNOSUPPRESSANTS

I M MU NE T & B INTERLEUKIN MONOCLONAL

MO DU L ATO R S SUPPRESSORS RECEPTOR ANTIBODIES
ANTAGONIST
Block the release of Block antibody Antagonist works to Antibodies that attach
various cytokines production by B cells, block the activity of the to specific receptor
involved in the inhibit suppressor and interleukins that are sites are being
inflammatory response helper T cells released in an developed to respond
and activation of inflammatory or immune to very specific
lymphocytes response situations
 IMMUNE MODULATORS
The immune modulators block the release of various cytokines involved in
the inflammatory response and activation of lymphocytes, decreasing immune
activity. The result of blocking these chemicals is immune suppression.

The immune modulators are a relatively new class of drugs and include
fingolimod (Gilenya), lenalidomide (Revlimid), and thalidomide (Thalomid), an
old drug with new uses, apremilast (Otezla), dimethyl fumarate (Tecfidera),
pomalidomide (Pomalyst), and teriflunomide (Aubagio).
IMMUNE MODULATORS
 Therapeutic Action
Lenalidomide and Thalidomide Fingolimod
- inhibit the secretion of - inhibits the release of
proinflammatory cytokines and lymphocytes from lymph nodes
increase the secretion of anti- into the peripheral blood so they
inflammatory cytokines from cannot migrate to activate
monocytes and have varying effects immune and inflammatory
on cell proliferation. reactions. It is the first oral agent
Lenalidomide is used in treating for the treatment of relapsing
multiple myeloma and forms of multiple sclerosis.
myelodysplastic syndromes.
Thalidomide is also used for treating
multiple myeloma and erythema
nodosum leprosum.
 Therapeutic Action

Premilast Pomalidomide
– a newer agent, it is used for - is a thalidomide analog that
adults with psoriatic arthritis. is used in treating multiple
myeloma.

Dimethyl fumarate and

Teriflunomide
- are used to treat multiple
sclerosis
 Pharmacokinetics
FINGOLIMOD
Route: PO
Peak level: 12 – 16 hrs
Half-life: 6-9 days
Metabolized in the liver &
excreted thru kidneys
THALIDOMIDE
Route: PO
Peak level: 3 – 6 hrs
Half-life: 12 – 24 hrs
Metabolism is not known &
excreted thru kidneys

LENALIDOMIDE
Route: PO
Peak level: 30 – 90 mins
Half-life: 3 hrs
Metabolized in the liver &
excreted thru kidneys
POMALIDOMIDE
Route: PO
Peak level: 2 – 3 hrs
Half-life: 7.5 – 9.5 hrs
Metabolized in the liver &
excreted thru kidneys
 Pharmacokinetics
APREMILAST DIMETHYL FUMARATE
Route: PO AND TERIFLUNOMIDE
Peak level: 2.5 hrs Route: PO
Half-life: 6-9 hrs Peak level: 2 - 2.5 hrs
Metabolized in the liver & Half-life: about an hour
excreted thru kidneys & feces Metabolized by esterases,
excreted as CO2
TERIFLUNOMIDE
Route: PO
Peak level: 1 – 4 hrs
Half-life: Most of the drug is eliminated
Excreted unchanged in the from the body within 21 days.
bile
 Contraindication and Caution
All of these drugs are contraindicated during pregnancy because their effects
on cells can cause serious fetal harm; women of childbearing age should be
advised to use barrier contraceptives when using this drug, and proof that the
patient is not pregnant needs to be documented in the chart before beginning
therapy and periodically during therapy.

Teriflunomide is also contraindicated with severe hepatic impairment which

could become more severe due to the drug effects.
T & B CELL SUPPRESSORS
Several T and B cell immune suppressors are available for use. Of the
numerous agents available, cyclosporine is the most commonly used
immune suppressant. Additional agents include abatacept (Orencia),
alefacept (Amevive), azathioprine (Imuran), cyclosporine (Sandimmune,
Neoral), glatiramer (Copaxone), mycophenolate (CellCept), pimecrolimus
(Elidel), sirolimus (Rapamune), and tacrolimus (Prograf).
T AND B CELL SUPPRESSORS
T AND B CELL SUPPRESSORS
Therapeutic Action

The exact mechanism of action of the T and B cell suppressors is not clearly
understood. It has been shown that they block antibody production by B
cells, inhibit suppressor and helper T cells, and modify the release of
interleukins and of T cell growth factor

The T and B cell suppressors are indicated for the prevention and treatment
of specific transplant rejections.
 Pharmacokinetics
CYCLOSPORINE ABATACEPT TACROLIMUS
Route: PO Route: IV
Peak level: 1 – 2 hrs Must be given as 30 mins Route: PO
Metabolized in the liver by infusuion every 2-4 weeks Peak level: 1.5 – 3.5 hrs
the cytochrome P450 Peak level:
system & primarily excreted reached at the end of Metabolized in the liver
in the bile. infusion by the CP450 system.
Half-life: 12 – 23 days, Excreted thru the
Sandimmune usually reaches a steady kidneys
Half-life: 19 hrs state by 60 days of
treatment
Neoral
Half-life: 8.4 hrs Excreted thru the kidneys
 Pharmacokinetics
ALEFACEPT
Route: IM or IV
Peak level: 4 – 6 hrs
Half-life:
270 hours / 11 days, 6 hrs
AZATHIOPRINE
Route: PO
Peak level: 1 – 2 hrs
Half-life: 3 hrs
Metabolized in the liver &
excreted thru kidneys
MYCOPHENOLATE
- It is readily absorbed 7
immediately metabolized
to its active metabolite.
- Excreted thru kidneys
SIROLIMUS
Route: PO
Peak level: 1 hr
Half-life: 7.5 – 9.5 hrs
Metabolized in the liver,
partly by CP450. Excreted
thru feces
Contraindication and Caution
The use of T and B cell suppressors is contraindicated in the presence of
any known allergy to the drug or its components to prevent
hypersensitivity reactions and during pregnancy and lactation because of
the potential serious adverse effects on the fetus or neonate.

Caution should be used with renal or hepatic impairment, which could

interfere with the metabolism or excretion of the drug, and in the presence
of known neoplasms, which potentially could spread with immune system
suppression.
Adverse Effects
Patients receiving these drugs are at increased risk for infection and for the
development of neoplasms due to their blocking effect on the immune
system. Other potentially dangerous adverse effects include hepatotoxicity,
renal toxicity, renal dysfunction, and pulmonary edema. Patients may
experience headache, tremors, secondary infections such as acne, GI
upset, diarrhea, and hypertension.

Clinically Important Drug-Drug Interactions

There is an increased risk of toxicity if these drugs are combined with other
drugs that are hepatotoxic or nephrotoxic. Extreme care should be used if
such combinations are necessary. Other reported drug–drug interactions are
drug specific; consult a drug guide or drug handbook.
INTERLEUKIN RECEPTOR ANTAGONIST
 INTERLEUKIN RECEPTOR
ANTAGONIST
An interleukin receptor antagonist works to block the activity of the interleukins
that are released in an inflammatory or immune response. The only available
interleukin receptor antagonist is anakinra (Kineret).
 Therapeutic Action
Anakinra specifically antagonizes human interleukin-1 receptors, blocking the
activity of interleukin-1. Interleukin-1 levels are elevated in response to
inflammation or immune reactions and are thought to be responsible for the
degradation of cartilage that occurs in rheumatoid arthritis. It is used to reduce
the signs and symptoms of moderately to severely active rheumatoid arthritis in
patients 18 years of age and older who have not responded to the traditional
antirheumatic drugs.
Pharmacokinetics

ANAKINRA
Route: Subcutaneous
Peak level: 3 - 7 hrs
Half-life: 4 – 6 hrs
Metabolized in the tissues & excreted thru
kidneys
Recommended dosage is 100 mg/d
 Contraindication and Caution
Anakinra is contraindicated with
• Any known allergy to Escherichia coli–produced products or to anakinra
itself to prevent hypersensitivity reactions.
• Pregnancy and lactation - the drug may cross the placenta and enter breast
milk.
• Patients with renal impairment, immunosuppression, or any active infection -
these drug could be exacerbated by the effects of the drug.
There is an increased risk of infection whenever this drug is used, and the
patient needs to be protected from exposure to infections and monitored
closely after any invasive procedures. Immunizations cannot be given while
the patient is on this drug.
 Adverse Effects
Headache, sinusitis, nausea, diarrhea, upper respiratory and
other infections, and injection site reactions are among the most
common adverse effects.

Clinically Important Drug-Drug Interaction

Patients who are also receiving etanercept (Enbrel) must be monitored
very closely because severe and even life-threatening infections have
occurred. Anakinra should not be combined with abatacept because of the
potential for serious infections.
MONOCLONAL ANTIBODIES

Antibodies that attach to specific receptor sites are being developed to

respond to very specific situations. Every year, several new monoclonal
antibodies are marketed, showing the rapid pace with which these agents
are being developed and approved for clinical use.
MONOCLONAL ANTIBODIES
MONOCLONAL ANTIBODIES
MONOCLONAL ANTIBODIES
MONOCLONAL ANTIBODIES
MONOCLONAL ANTIBODIES
Therapeutic Action
Muromonab-CD3, the first monoclonal antibody approved for use, is a T
cell–specific antibody that was available as an IV agent. It reacted as an
antibody to human T cells, disabling the T cells and acting as an immune
suppressor. Muromonab was withdrawn from the market in 2014 when
other treatments became more readily available.

Adalimumab, certolizumab, golimumab, and

infliximab are antibodies specific for human tumor
necrosis factor. They keep the inflammatory reaction
in check by reacting with and deactivating the free-
floating tumor necrosis factor released by active
leukocytes. They are used for treating various forms
of arthritis, Crohn’s disease and ulcerative colitis.
Therapeutic Action

• Alemtuzumab is an antibody specific for lymphocyte receptor

sites.
• Basiliximab and daclizumab are specific to interleukin-2
receptor sites on activated T lymphocytes; they react with
those sites and block cellular response to allograft
transplants.
• Canakinumab is a specific interleukin-6 blocker and is used
for cryopyrin-associated periodic syndromes and juvenile
arthritis
• Cetuximab is an antibody specific to epidermal growth factor
receptor sites.
Therapeutic Action
• Trastuzumab also reacts with human epidermal growth factor
receptor 2 (HER2), a genetic defect that is seen in certain metastatic
breast cancers. It is used in the treatment of metastatic breast cancer
in tumors that overexpress HER2.
• Blinatumomab, brentuximab, and obintuzumab are specific T cell
antibodies, altering their function.
• Eculizumab binds to complement proteins and prevents the
formation of the complement complex.
• Ranibizumab binds to sites of active forms of vascular endothelial
growth factor, preventing new vascular growth in the area of injection.
Ranibizumab is used for treating macular edema and macular
degeneration.
• Ramucirumab is effective in gastric and lung cancers.

Ramucirumab and ranibizumab also inhibit endothelial growth receptors.

Therapeutic Action
• Erlotinib, bevacizumab, pegaptanib, and tositumomab combined
with iodine-131 tositumomab are effective against specific malignant
receptor sites.
• Ibritumomab, ofatumumab, and rituximab are antibodies specific
to sites on activated B lymphocytes.
• Natalizumab is an antibody specific to surface receptors on all
leukocytes except neutrophils.
• Nivolumab and pembrolizumab are antibodies to programmed
death receptor-1 sites and are used for treating specific cancers.
• Omalizumab is an antibody to immunoglobulin E, an important factor
in allergic reactions. It has not had a great deal of success because
of related respiratory adverse effects but is now approved for chronic
urticaria conditions.
Therapeutic Action

• Palivizumab is specific to the antigenic site on respiratory syncytial

virus (RSV); it inactivates that virus. It is used to prevent RSV
disease in high-risk children.
• Tocilizumab, siltuximab, and ustekinumab are antibodies specific
to interleukins.
• Belimumab, which is a specific inhibitor of B lymphocyte stimulator
which inhibits the survival of B lymphocytes and their differentiation
into immunoglobulin-producing cells. It is used for adult patients with
active, autoantibody-positive systemic lupus erythematosus who are
receiving standard therapy.
Therapeutic Action

• Ipilimumab is a human cytotoxic T cell antigen- 4–blocking antibody.

By blocking this site, T cells are activated and proliferate at a faster
rate. It is used to treat patients with unresectable or metastatic
melanoma. It is associated with potentially fatal immunemediated
reactions, and its use must be carefully evaluated.
• Vedolizumab is an integrin blocker that inhibits the movement of T
cells across the gastric mucosa. It is used for treating ulcerative
colitis and Crohn’s disease in patients who do not respond to
traditional therapies.
Pharmacokinetics
With the exception of erlotinib (an oral agent), all of the monoclonal
antibodies have to be injected. They can be given IV, IM, or
subcutaneously. Because antibodies are proteins, they are rapidly broken
down in the GI tract. They are processed by the body like naturally
occurring antibodies.
Contraindication and Caution
Monoclonal antibodies are contraindicated in the presence of any known
allergy to the drug or to murine products to prevent hypersensitivity
reactions and in the presence of fluid overload, which could be
exacerbated. They should be used cautiously with fever (treat the fever
before beginning therapy) and in patients who have had previous
administration of the monoclonal antibody (serious hypersensitivity
reactions can occur with repeat administration). Because of the potential
for adverse effects, they should not be used during pregnancy or lactation
unless the benefit clearly outweighs the potential risk to the fetus or
neonate.
Adverse Effects

The most serious adverse effects associated with the use of monoclonal
antibodies are acute pulmonary edema (dyspnea, chest pain, wheezing),
which is associated with severe fluid retention, and cytokine release
syndrome (flu-like symptoms that can progress to third spacing of fluids
and shock). Other adverse effects that can be anticipated include fever,
chills, malaise, myalgia, nausea, diarrhea, vomiting, and increased
susceptibility to infection and cancer development
Adverse Effects
• Eculizumab can lead to intravascular hemolysis with resultant fatigue, pain,
dark urine, shortness of breath, and blood clots.
• Bevacizumab is associated with GI perforation, hemorrhage, and impaired
healing.
• Erlotinib is reserved for patients whose disease has progressed after other
therapies.
• The manufacturer of natalizumab stopped marketing the drug weeks after
its release because of reports of CNS complications. It was returned to the
market in June 2006 with warnings about the potential for CNS
complications.
• Blinatumomab is associated with potentially life-threatening cytokine
release syndrome and life-threatening neurological toxicities.
• Brentuximab and obinutuzumab are associated with progressive multifocal
leukoencephalopathy.
Adverse Effects
• Ramucirumab is associated with potentially life-threatening hemorrhage.
• Belimumab is associated with CNS effects including an increased risk for
depression and suicidality. There is also a risk of hypersensitivity reactions
during the IV infusion, and patients should be premedicated before each
infusion.
• Ipilimumab has been associated with severe to fatal immune-mediated
reactions due to the activation and proliferation of T cells. It has a black
box warning about the possibility and suggests baseline thyroid and liver
function tests and exams of the skin, neurological function, and GI
function.
Clinically Important Drug-Drug Interactions

Use caution and arrange to reduce the dose if a monoclonal antibody

is combined with any other immunosuppressant drug because severe
immune suppression with increased infections and neoplasms can
occur.
NEW IMMUNOSUPPRESSANT
AGENT
• In 2011 belatacept (Nulojix) was approved for the
prevention of acute transplant rejection in adults with kidney
transplants.
• It is included in new class of drug: T cell costimulation
blocker.
• It is given as an IV infusion over 30 min the day prior to
transplant and on day 5 post transplant, then at the end of
week 2, 4, 8, 16, and then once every 4 wk.
• Px has increased risk for post transplant
lymphoproliferative disorder
• Most frequent in Px who were never exposed to Epstein-
Barr virus
• Limit sun exposure & avoid live vaccines
 Drug Therapy Across the Life Span:
Immune Modulators
CHILDREN
Most of the drugs that affect the immune system
are not recommended for use in children or have
not been tested in children. The exceptions—
interferon alfa-2b, azathioprine, raxibacumab,
cyclosporine, tacrolimus, and palivizumab—should
be used cautiously, monitoring the child frequently
for infection, GI, renal, hematological, or CNS
effects.
The immune suppressants (azathioprine,
cyclosporine, and tacrolimus) are usually needed in
higher doses for children than for adults to achieve
the same therapeutic effect.
Protecting the child from infection and injury is a
very important part of the care of a child taking an
immune modulator. This can be a great challenge
with an active child.
ADULTS
Both the adult patient who is receiving a
parenteral immune modulator and a significant other
should learn the proper technique for injection,
disposal of needles, and special storage precautions
for the drug. It is important to stress ways to avoid
exposure to infection and injury to prevent further
complications. The patient should be encouraged to
seek regular follow-up and medical care.
Immune modulators are contraindicated during
pregnancy and lactation because of the potential for
adverse effects on the fetus or neonate and
complications for the mother. Women of childbearing
age should be advised to use barrier contraceptives
while taking these drugs and, if breastfeeding,
should be counseled to find another method of
feeding the baby. Some of these drugs impair
fertility, and the patient should be advised of this fact
before taking the drug
Drug Therapy Across the Life Span:
Immune Modulators

OLDER ADULTS
Older patients may be more susceptible to the effects of the immune
modulators, partly because the aging immune system is less efficient and less
responsive.
These patients need to be monitored closely for infection, GI, renal, hepatic,
and CNS effects. Baseline renal and liver function tests can help to determine
whether a decreased dosage will be needed before beginning therapy.
Because these patients are more susceptible to infection, they need to
receive extensive teaching about ways to avoid infection and injury sites on
noninvaded cells to produce antiviral proteins, which prevent viruses from
entering the cell. In addition, interferons have been found to inhibit tumor growth
and replication, to stimulate cytotoxic T cell activity, and to enhance the
inflammatory response. Of interest, interferon gamma-1b also acts like an
interleukin, stimulating phagocytes to be more aggressive.
 General Consideration:
IMMUNE MODULATOR & PREGNANCY
Generally, immune modulators are contraindicated for use during pregnancy and
lactation, largely because these drugs have been associated with fetal abnormalities,
increased maternal and fetal infections, and suppressed immune responses in
nursing babies. Female patients should be informed of the risk of using these drugs
during pregnancy and receive counseling in the use of barrier contraceptives. (The
use of barrier contraceptives is advised because the effects of oral contraceptives
may be altered by liver changes or by changes in the body’s immune response,
potentially resulting in unexpected pregnancy.)
If a patient taking immune modulators becomes pregnant or decides that she
wants to become pregnant, she should discuss this with her health care provider and
review the risks associated with use of the drug or drugs being taken. The
monoclonal antibodies should be used with caution during pregnancy and lactation.
Because long-term studies of most of these drugs are not yet available, it may be
prudent to advise patients taking these drugs to avoid pregnancy if possible.
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