Chapter 16: Biologics

2D-PH
AY 2014-2015
33 Rapinan, Erika Faye
34 Rariza, Mary Chelsea
35 Rifareal, Katrina Isabel
36 Rodriguez, Alecs Dale

DEFINITION OF IMMUNITY
The condition of being immune, the protection against
infectious disease conferred either by the immune response
generated
byword
immunization
previous
infection
or by
Origin: Latin
Immunitas, or
from
Immunis
in the sense,
another
non-immunologic exemption
factors. from a liability.
The quality of being unaffected by something.
The state of not being susceptible.
The condition in which an organism can resist disease.
(www.biology-online.org)
The ability of an organism to resist a particular infection or
toxin by the action of specific antibodies or sensitized white
blood cells.
(www.oxforddictionaries.com)

2 Main Categories:
1) NATURAL
2) ACQUIRED

NATURAL IMMUNITY
Natural, innateNatural
or native
immunity immunity:
-Immunity that is
Depends onnaturally
inborn
factors
existing.
-does not require prior
Classified as:
sensitization to an
antigen.
1) SPECIES
IMMUNITY
(www.medicineNet.com)
2)RACIAL IMMUNITY
3)INDIVIDUAL IMMUNITY

1) SPECIES IMMUNITY
Cold-blooded animals
are not
susceptible to diseases
Species
immunity
common to warm-blooded
animals.
-a form of
natural immunity
Humans are not all susceptible
certain disease
of
shared by allto
members
of a
lower animals (chicken
cholera).
species.
(www.medical Humans are susceptible
to a number of infections that
dictionary.thefreedictionary.com)
occur primarily in animals
(anthrax: cattle, sheep,
horses)(plague: rodents)( rabies: cats, dogs, bats and
others).
Animals are not susceptible to a number of human
diseases (gonorrhea, typhoid fever, influenza,
measles, mumps, poliomyelitis).

SUMMARY:
Certain animals are naturally resistant or not susceptible to
certain pathogens.
Certain pathogens infect only humans, not lower animals.
On the other hand, certain pathogens do not infect humans.
It could be due to:
1) Absence of specific tissue or cellular receptors for
attachment (colonization) by the pathogen.
2) Temperature of the host and ability of pathogen to grow.
3) Lack of the exact nutritional requirements to support the
growth of the pathogen.
4) Lack of a target site for a microbial toxin.

2) RACIAL IMMUNITY
Human races differ in susceptibility to common
immunity
infections (yellowRacial
fever,
pneumonia,
tuberculosis). -a form of natural immunity
shared by most of the members
Factors that det. of
Racial
immunitya genetically
related ELUSIVE and
NOT WELL KNOWN.
population.
(www.medicalShould not be used
synonymously/confused with
dictionary.thefreedictionary.com)
Environmental immunity:
-result of resistance to infection among
individuals in a community resulting from the
degree of acquired immunity & other factors
(nutrition, genetic constitution, fatigue).

3) INDIVIDUAL
IMMUNITY
Individual immunity
-a to
form
ofcommon
naturalmicrobiologic
immunity diseases.
Individuals vary in the ability
resist
Some individuals have littlenot
capacity
to resist
skin disorders,
shared
by most
other the
common cold and other familiar
diseases.
members
of the race and
The natural resistance of the
same individual may vary from time to
species.
time.
-It is rare and probably occurs
as the result of an infection
Reasons why individuals of the same animal species may exhibit greater
that was not recognized
or lesser susceptibility to the same ineffective agent could be due to:
when it occurred.
1) Age
2)
3)
4)
5)
6)

(www.medicalSex
Stress
dictionary.thefreedictionary.com)
Diet, malnutrition
Intercurrent disease or trauma
Therapy against other diseases

 General good health provides adequate barriers to bacterial

infiltration, demonstrated by:
Healthy body tissues, skin & mucous membranes
Plentiful supply of leukocytes
Active & positive lifestyle (little/no smoking, alcohol, social
drug use)
Resident bacteria in GI tract & upper respiratory tract:
provide resistance to infection.
plays vital role in resisting invasion by other species of
microorganisms capable of producing infection.
Stomach acid is to a degree capable of destroying ingested
bacteria.
Intestinal enzymes also know to provide secondary defense
mechanisms.

ACQUIRED IMMUNITY
T lymphocytes

Acquired immunity
Regulate cell-mediated immunity
acquired
by infections
Responsible for controlling-Immunity
certain bacterial
& viral
infection
or vaccination
or by rejection
Responsible mediating graft
versus host
disease, allograft
thereactions.
transfer of antibody or
and delayed hypersensitivity
Augment the activity of B lymphocytes
lymphocytes from an
immune donor.
B lymphocytes
(www.medicineNet.com)
Primarily involved w/ humoral immunity & antibody production.
Differentiates into plasma cells that produce antibodies specific to the
invading antigen once an antigen is introduced into the body.
Antibodies/Immunoglobulin
Attaches to the invading antigen & cause its destruction by phagocytes
Structure ofsystem.
an antigen binding fragment of an antibody
and the complement

T & B lymphocytes
Once exposed to an antigen demonstrate memory that allows
them to recognize & respond to a specific antigen when exposed
again.
The memory of an antigen by the immune system- allows sensitized
individuals to resist infections on subsequent exposure.
The second response is far greater in magnitude to the first
immunologic response.

Acquired immunity is a specific immunity that may

be:

1) ACTIVE
2) PASSIVE

1) ACTIVE IMMUNITY
Develops in response to antigenic substances in the body.
It is long-lasting, and sometimes life-long.
results when exposure to a disease organism triggers the
immune system to produce antibodies to that disease.
Exposure to the disease organism can occur through
infection with the actual disease (resulting in natural
immunity)
introduction of a killed or weakened form of the disease
organism through vaccination (vaccine-induced immunity).
Either way, if an immune person comes into contact with that
disease in the future, their immune system will recognize it and
immediately produce the antibodies needed to fight it.

2 Classification:
a) Naturally acquired active immunity

-occurred by natural means

b) Artificially acquired active immunity

-developed in response to
administration of a specific
vaccine/ toxoid.

VACCINES

Diphtheria toxoid Tetanus toxoid - acellular Pertussis-Containing

Vaccines

Administered for prophylactic action to develop acquired

active immunity.
May contain living attenuated (weakened)/ killed
microorganisms or fraction of these microorganisms.

TOXOIDS
Bacterial toxins modified & detoxified w/ moderate heat
& chemical treatment so that antigenic properties
remain while the substance is rendered nontoxic.
Do not cause disease.
Exposure of immuno-competent persons may result in
antibody production that will protect the person against
Measles Mumps Rubella Vaccine
disease cause by the natural toxin.

Disadvantages of Toxoids:
they produce inadequate immunologic
responses when administered alone.
Remedy: they are often combined w/
adjuvants that enhance their antigenicity.

Adjuvants (Alum, Aluminum

phosphate, Aluminum hydroxide)
insoluble in nature.
acts to keep the immunogens in tissue for
longer periods thus prolongs immune
response.

Inactivated Vaccine

Attenuated Vaccine

Vaccine composed of killed whole Vaccines that contain live but

bacteria/viruses/substructures of significantly weakened
these.
microorganisms.
Must be administered again over Typically have more
time to maintain adequate
antigenicity so are more likely
antibody titers.
to confer permanent
immunity.

BOTH TYPES- capable of producing

immunity.

Live Vaccine: caution must be exercised w/

IMMUNOCOMPROMISED PATIENTS.
-patient w/

HIV infection
Thymic abnormalities
Lymphoma
Leukemia
Generalized malignancy
Advanced debilitating diseases
Receives corticosteroids, alkylating agents, antimetabolites,
radiation chemotherapy

-patients unable to mount immune responses against even

weakened microorganisms in w/c the result could be a
disseminated bacterial/viral infection thus Inactivated
vaccines should be employed.

Immunization during Pregnancy

Live Attenuated Vaccines: should be avoided
for pregnant patients because of the danger
of transmission of the microorganisms to
the fetus.
ex.
-Measles, mumps & rubella (MMR) vaccine: should
not be administered during pregnancy.
-Pregnancy should be avoided for 1 month ff.
vaccination w/monovalent measles vaccine & 4
weeks ff. MMR/other rubella-containing vaccines.

2) PASSIVE IMMUNITY
Occurs by introducing immunoglobulin produced in another
individual (human/animal) into the host who is not involved in their
production.
provided when a person is given antibodies to a disease rather than
producing them through his or her own immune system.
A newborn baby acquires passive immunity from its mother through the placenta.
A person can also get passive immunity through antibody-containing blood products
such as immune globulin, which may be given when immediate protection from a
specific disease is needed.
Major advantage to passive immunity- protection is immediate, whereas active
immunity takes time (usually several weeks) to develop.
However, passive immunity lasts only for a few weeks or months. Only active immunity
is long-lasting.

2 Classification:
a) Naturally acquired passive immunity
- occurs by placental transmission of immunoglobulin gamma
G (IgG)
(IgG) from the mother toImmunoglobulin
the fetus.
-the most
abundant
type of
Thus resulting of infant having passive
immunity
to diphtheria,
tetanus, measles,
mumps & other infections
for the first 4-6 months of life.
antibody.
- transient and relatively short-lived.
-found in all body fluids.
-protects against bacterial
and viralpassive
infections. immunity
Artificially acquired
(www.kidshealth.org)
- occurs when an individual
receives antibodies (injections of

b)

gamma globulin) or immune cells (leukocyte transfusions or bone

marrow transplants) from another individual (who had exposure
to a specific antigen)
- transient and relatively short-lived (gamma globulin injections or
leukocyte transfusions) or permanent (bone marrow transplants).

 Immunoglobulin contained in biologic products:

limited to provision of temporary prophylaxis to
susceptible individuals .
provides passive immunity.
Acquired passive immunity provided by immunoglobulin:
Not long lasting usually 1-2 weeks
-because function is to bind to the pathogen as needed.
Important feature: they offer the susceptible patient
protection during a critical period of exposure.
Immunoglobulin- metabolized by the body if not needed
for immunologic purposes.

Notable in this category:

Anti-venin for treatment of snakebite

(ex. North American coral snake

antivenin)
Anti-venin for treatment of spiders
(ex. Black Widow spider antivenin)

Natural Immunity

Acquired Immunity

Any immune response which develops as a result of an

Any immune response which develops as a result of an
individual's exposure to a specific antigen encountered in the individual's exposure to a specific antigen encountered due to
external environment without the intervention of medical
the intervention of medical therapy or practice.
therapy or practice.

Species
Immunity

Racial
Individual
Immunity Immunity

Active
Immunity

Passive
Immunity

A form of natural A form of natural A form of natural Any immune response which Any immune response

immunity shared immunity shared immunity not

by all members of by most of the
shared by most
a species.
members of a
other members
genetically related of the race and
population.
species.
It is rare and
probably occurs
as the result of
an infection that
was not
recognized when
it occurred.

develops as a result of an
individual's exposure to a
specific antigen in which the
response is the product of
the individual's own immune
system becoming activated,
generally through the
generation of clones of
antigen-specific B and T
lymphocytes.

which develops as a result

of an individual receiving
immune molecules
(injections of gamma
globulin) or immune cells
(leukocyte transfusions or
bone marrow transplants)
transferred from another
individual (who had had
exposure to a specific
antigen) and, therefore, the
response is not the product
of the individual's own
immune system becoming
activated.

NATURAL

ACTIVE

PASSIVE

Natural active immunity occurs when a

person develops immunity as a result of
exposure to disease organisms or foreign
toxins, venoms, allergens or drugs; generally,
on initial exposure, the person develops the
disease or has an initial negative response to
the toxin or venom.

ARTIFICIAL
Artificial active immunity occurs when a
person develops immunity as a result of
exposure to a vaccine designed to protect
against disease organisms or foreign
toxins, venoms, or allergens; generally, on
initial exposure, the person does not
develop symptoms of the disease or has
only minimal response to the toxin or
venom.

Passive active immunity occurs when a

Passive artificial immunity occurs when
mother transmits her own antibodies to her an individual receives antibodies
fetus across the placenta or to her infant in her (injections of gamma globulin) or immune
milk; such immunity is transient and relatively cells (leukocyte transfusions or bone
short-lived.
marrow transplants) from another
individual (who had had exposure to a
specific antigen); such immunity may be
transient and relatively short-lived
(gamma globulin injections or leukocyte
transfusions) or it may be permanent
(bone marrow transplants).

Production of
Biologics,

Storage, handling and

shipping

Production of Biologics
Produced by manufacturers
licensed to do so in accordance
with the terms of the federal
Public Health Service Act (58
Stat. 682) approved July 1, 1944
Each
product
must
meet
specified
standards
as
administered by the Center for
Biologics
Evaluation
and
Research of the FDA

 Each lot of a licensed biologic

is approved for distribution
when it has determined that
the lot meets the control
requirements of the product.
Licensing includes approval
of a specific series of
production steps and inprocess control tests as well
as end product specifications
that must be met lot by lot.

Provisions applicable to biologic

products include:

Test for potency

General safety
Sterility
Purity
Water (residual moisture)
Identity and constituent materials
Additional safety test on live
vaccines and certain other items

Constituent materials include:

Preservatives
Diluents
Adjuvants
Extraneous protein in cell-cultured
vaccines
Antibiotics other than penicillin
added to the production substrate of
viral vaccines

Production of Biologics
Packaged and labeled in the same
manner as other injections
Label of the product must include
those mentioned in the next slide.

Label of he product must

include:

Title or proper name

Name
Address
License number of the manufacturer
Lot number
Expiration date
Recommended individual dose for
multiple containers

Package label must also

include:

The preservative and its amount

Number of containers
Amount of product in the container
The recommended storage temperature
A statement (if necessary), that freezing
is to be avoided
Other information as FDA regulations
may require

Storage
Most biologics are stored in a refrigerator
(2C to 8C or 35F to 46F)
Freezing is avoided
Diluents packaged with biologics should
not be frozen
Some products are to be held at specified
temperatures during shipment

Expiration date
Varies with the product and the
storage temperature
Most have an expiration of a year or
longer after the date of manufacture
or issue
Stated date on each lot determines
dating period

Dating Period
Begins on the date of manufacture and
beyond which the product cannot be
expected to retain the required safety,
purity, and potency
May be compromised of an in-house
storage period
Individual monographs for biologics
indicate both, the after-issue time frame
for use and the permissible in-house
storage period

Storage, Handling, and

Shipping of Biologics
Biologics are sensitive to
extreme temperatures
Exposure to heat or freezing
can decrease potency and
reduce effectiveness

Dangers of administration of
damaged products

Person may get little or none of the

intended benefit
Person may not be able to build up
immunity
May result in an infection or
inadequate protection from disease

The overriding theme for a

pharmacist in storage,
handling, and shipping is to
maintain the cold chain.

Key ingredient is good

storage equipment.

Tips

Separate commercial
refrigerators
Freezers are used for biologics
Frost-free freezers should be
used
Defrosting requires that product
must be temporarily removed in
storage.

Guidelines
Cool air must have room to circulate
WHO recommends that the door may not
be opened frequently than 4 times per
day.
Doors should be closed quickly as
possible.
Pharmacists should avoid storing at the
refrigerator door
Vaccines should be stored in the top or in
the bottom shelves of the refrigerator

 If vaccines must be kept

outside of the refrigerator for
a few minutes, it is advisable
to put the product in an
insulated container with
coolant packs from the freezer
Freezer packs provide extra
insulation and cooling power
in the freezer.

Coolant Packs
Have cooling capacity of ethylene
glycol
Product must not come in direct
contact with these because the vial
contents may freeze and be
damaged.

Storage Monitoring
Advisable to the pharmacist to check the
temperature twice a day as recommended by
The National Immunization Program (NIP)
Temperature logs should be kept for 3 years
Refrigerator temperature: 2C - 8C
Freezer temperature: Below 0C

Pharmacists should
Educate and train very perosn who will
handle bioloics in good storage and
handling procedures.
Store containers of the same vaccine
together

Centers for
Disease and
Control

BIOLOGICS FOR ACTIVE IMMUNITY

Vaccine
a suspension of attenuated (live) or
inactivated (killed) microorganisms that
are administered to induce immunity and
prevent diseases.

A. Bacterial Vaccines
The organism is grown in a suitable
medium in a controlled environment of
temperature, pH and oxygen tension.
To reduce hypersensitivity reactions of
products, it should consist chemically
defined ingredients.

 The culture is processed in 2 steps:

1. The organisms are treated with phenol
or formaldehyde if the vaccine is to be
inactivated microorganisms.

Heat and Phenol or heat and acetone

employed for typhoid vaccine

2. The organisms are separated from the

medium through centrifugation and
suspended in sterile H2O or 0.9% NaCl for
injection.

Live attenuated vaccines:

- produced by genetic alteration of
pathogenic organisms
- this allows organisms to multiply but not
produce the disease
- several base pairs of DNA are altered
- organisms are incapable of reverting to its
more pathogenic form

 Another way of creating a vaccine is to

employ purified antigen subunits produced
by using recombinant DNA.

Subunit vaccines:
- no potential to harm the patient
- has a lower incident of side effects
Example: Hepatitis B vaccine made by
recombinant DNA and hepatitis B surface
antigen (HBsAg)

Subunit vaccines:
- have no sufficient immune response
Strategies to enhance immune response of
subunit vaccines:
1. May contain single or multiple immunogens
to promote immunity against the same
disease state
Example: MMR (with 3 immunogens)

2. Mixed biologic may contain vaccine and

toxoid at the same product
Example: Pediarix (diptheria, tetanus
toxoids, acellular pertussis, hepatitis B and
poliovirus vaccine)

The strength of vaccines may be expressed in:

- Total number of organisms
- Total protective units per milliliter or dose
- Micrograms of immunogen in each milliliter or
dose

B. Viral Vaccines
Viruses cannot be grown on inanimate
media to grow bacteria
Examples of animate media:
- embryonic egg, cell cultures of chick
embryo, human diploid cell culture,
monkey cell culture skin of calves and
intact mice

Techniques to separate the virus from host cell:

1. Purification steps to reduce hypersensitivty reactions
2. May contain single or mutiple immunogens to elicit
immunity against same disease
3. May remain a a whole virion or further chemicall
processed to split into subvirion
Example: Influenza Virus Vaccine (influenza A H1N1,
influenza A H3N2 and influenza B)

 Communities may experience outbreaks with

more than on strain of influenza in a year.
Strains are selected during February because of
scheduling requirements for production, quality
control , packaging, distribution and administration
before the onset of next influenza season.

 To prolong stimulation of antibodies, the virion may be

absorbed onto aluminum phosphate
Example: Rabies Vaccine

Viral vaccines are available as:

1. Lyophilized products that require reconstitution
2. Inactivated Vaccines in suspensions for injection

 The strength of Viral vaccines can be provided in:

1. Tissue culture infectious doses
2. The quantity of virus estimated to infect 50% of inoculated
cultures
Employed in viral vaccines are:
1. Micrograms of immunogen
2. D-antigen units
3. International units
4. Plaque-unit forming for yellow fever vaccine

C. Cancer Vaccines
Cancer vaccines in development are
intended to increase recognition of cancer
cells by immune system.
These vaccines also play a role in
preventing cancer patients at high risk
because of familial diseases.
For the immune system to recognize and kill a
tumor cell, it must recognize antigents on the
tumor cells.

Tumor-killing cells recognize TumorAssociated Antigens (TAAs)

TAAs fall into 3 categories:
1. Patient specific - antigens unique to a
specific patient
Example: antigen on B-cell malignancy
2. Tumor specific unique to a particular tumor
Example: prostate-specific antigen
3. Shared created by tumor cells with
common histology
Example: carcinoembryonic antigen

Four Types of Cancer Vaccines

1. Autologous tumor vaccines
- Developed from antigenic material
procured from the tumor of the patient
- Tumor cells are isolated during biopsy
- These cells are killed or infused into the
patients
- To enhance immunogenicity, they are
combined with bacille Calmette-Guerin or
C paravuum

2. Allogeneic tumor vaccines

- produced from cell lines that express tumorspecific or shared TAAs
- to induce an immune response, either the
fragment or whole tumor cell is injected
3. Anti-idiotypic vaccines
- are 3 dimensional immunogenic regions on the
antibody that binds antigen
- the anti-idiotypic antibody closely resembles the
antigen which can be used to induce immune
responses to a given antigen

4. Gene therapy
- allows a DNA template to be placed within a cell,
transcribed into mRNA and expressed as a
costimulatory protein
Example: Quadrivalent Human Papillomavirus
Recombinant Vaccine (used to prevent vaginal
cancers)

D. Toxoids
Process of Toxoids:
Bacteria are propagated
Culture is filtered
through a sterilizing membrane
filter
filtrate is added with salt solution to
precipitate toxin
purify toxin
toxin is
detoxified with formaldehyde

Detoxified Toxin may be:

1. Plain or with adjuvants
2. May contain single, multiple or mixed
immunogens
Strength of a toxoid:
- In flocculating units (Lf)
Flocculating unit smallest amount of toxin that
flocculates most rapidly one unit of standard
antitoxin in a series of mixtures containing fixed
amounts of antitoxin

BIOLOGICS FOR PASSIVE

IMMUNITY

(HOMOLOGOUS SERA)

HUMAN IMMUNE
GLOBULINS

SERA

AND

HUMAN
IMMUNE
SERA
AND
GLOBULINS (HOMOLOGOUS SERA)
Include immunoglobulin and hyperimmune sera
for specific diseases
Contain antibodies obtained from human blood, and
produced as a result of having had the specific disease
or having been immunized against it with a specific
biologic product

Source: pooled plasma from adult donors (thus

confer passive immunity)
From the general population: for immunoglobulin
From hyperimmunized donors: for immunoglobulins
for specific diseases

HUMAN
IMMUNE
SERA
AND
GLOBULINS (HOMOLOGOUS SERA)
Pooled plasma from adult donors:
Must be free of hepatitis B antigen and antibodies to
HIV
Processing steps:

Fractional Precipitation (e.g. with cold ethanol)

Maintaining rigorous control of pH
Ionic strength
Further purification of finished product

For intramuscular injection: biologic product

must contain N.L.T. 15% and N.M.T. 18% protein
For intravenous injection: immunoglobulin
intravenous (3% to 6% protein) and
cytomegalovirus immunoglobulin

HUMAN
IMMUNE
SERA
AND
GLOBULINS (HOMOLOGOUS SERA)
Sera
Greatest value for the treatment of acute disease
Useful in some instances to prevent illness when
immediate protection is needed

Immune serum
Gives brief immunity because the foreign serum
and the antibodies it produces are eliminated
from the body within a few weeks

(HETEROLOGOUS SERA)

ANIMAL IMMUNE SERA

ANIMAL
IMMUNE
(HETEROLOGOUS SERA)

SERA

Most commonly employed immune sera:

prepared by immunization of horses against
the specific immunogen
After the plasma is harvested, it is separated
by fractional precipitation into:
Immunologically
(immunoglobulins)

active

components

Treated with pepsin to remove the complementactivating component of the molecules and render it
less immunogenic. The active component is recovered
through dialysis and fractional precipitation or
centrifugation

ANIMAL
IMMUNE
(HETEROLOGOUS SERA)

SERA

Antitoxins
Produced by inoculating horses with increasing doses
of the toxoids and exotoxins. The animal is bled with
adequate safeguards after several injections over
weeks/months to avoid contamination and the plasma
harvested

Antivenins
Produced by inoculating horses with the venom of
selected species and harvesting the plasma

A sensitivity test with suitable controls should be

taken to detect any dangerous hypersensitivity
before using these products to ensure the safety
of the patient who may be sensitive to horse
protein

TABLE 16.1 (pgs. 502-504)

EXAPLES OF OFFICIAL BIOLOGIC

PRODUCTS

VACCINES
AND
COMBINATIONS

VACCINE

BIOLOGIC PRODUCT

ROUTE

USE

Anthrax adsorbed

SQ

Active immunizing agent

BCG

ID

Active immunizing agent

Hepatitis B

IM

Active immunizing agent

Human Papilloma Virus

IM

Active immunizing agent

IM

Active immunizing agent

IN

Active immunizing agent

Measles virus, live

SQ

Active immunizing agent

Measles, mumps, rubella virus, live

SQ

Active immunizing agent

Measles, mumps, rubella, varicella

virus, live

SQ

Active immunizing agent

Influenza virus

VACCINES
AND
COMBINATIONS

VACCINE

BIOLOGIC PRODUCT

ROUTE

USE

Measles, rubella virus, live

SQ

Active immunizing agent

Mumps virus, live

SQ

Active immunizing agent

Pneumococcal, polyvalent

IM, SQ

Active immunizing agent

Pneumococcal 7-valent conjugate

IM

Active immunizing agent

HDCV, IMD, ID; RDCV, IM

Active immunizing agent

IN

Active immunizing agent

Rubella virus, live

SQ

Active immunizing agent

Rubella and mumps, live

SQ

Active immunizing agent

Smallpox

ID

Active immunizing agent

Rabies

VACCINES
AND
COMBINATIONS

VACCINE

BIOLOGIC PRODUCT

ROUTE

USE

Typhoid

SQ or ID; oral

Active immunizing agent

Varicella virus, live

SQ

Active immunizing agent

Yellow fever

SQ

Active immunizing agent

Zoster virus, live

SQ

Active immunizing agent

TOXOIDS
BIOLOGIC PRODUCT

ROUTE

USE

Diphtheria and tetanus, adsorbed

Deep IM

Active immunizing agent

Tetanus

IM, SQ

Active immunizing agent

Tetanus, adsorbed

Deep IM

Active immunizing agent

Tetanus, diphtheria adsorbed for

adult use

IM

Active immunizing agent

ANTITOXINS

BIOLOGIC PRODUCT

ROUTE

USE

Botulism

IM or IV

Passive immunizing agent

Tetanus

IM or SQ (prophylactic)
(therapeutic)

or

IV

Passive immunizing agent

IMMUNE SERA
BIOLOGIC PRODUCT

ROUTE

USE

Cytomegalovirus

IV

Passive
for
kidney
transplant
recipients seronegative for CMV who
receive kidney from CMV seropositive
donor

Immunoglobulin IM

IM

Passive immunity to hepatitis A and

B, measles, varicella zoster, primary
immunodeficiency diseases

Immunoglobulin IV

IV

Primary immunodeficiency diseases,

HIV, ITP, bone marrow transplant,
beta cell CLL

Rho (D) globulin

IM

Passive immunizing agent

Tetanus immunoglobulin

IM

Passive immunizing agent

MISCELLANEOUS BIOLOGIC PRODUCTS

BIOLOGIC PRODUCT

ROUTE

USE

Antivenin (Crotalidae) Polyvalent

IM or IV

Neutralizes venom of crotalids native

to the Americas

Candida albicans skin test antigen

ID

Detects
reduced
cellular
hypersensitivity,
DTH;
assesses
diminished cellular immunity in HIV

Histoplasmin, USP

ID

Diagnostic aid (histoplasmosis)

Plasma Protein Fraction, USP

IV

Blood-volume expansion

Tuberculin, USP

ID

Diagnostic aid (tuberculosis)