Immunoglobulin

therapy

Immunoglobulin therapy is t he use of a mixt ure of ant ibodies (normal human immunoglobulin
or NHIG) t o t reat a number of healt h condit ions.[4][5] These condit ions include primary
immunodeficiency, immune t hrombocyt openic purpura, chronic inflammat ory demyelinat ing
polyneuropat hy, Kawasaki disease, cert ain cases of HIV/AIDS and measles, Guillain-Barré
syndrome, and cert ain ot her infect ions when a more specific immunoglobulin is not available.[4]
Depending on t he formulat ion it can be given by inject ion int o muscle, a vein, or under t he skin.[4]
The effect s last a few weeks.[5]
 Immunoglobulin therapy

Clinical data

Trade names Flebogamma, Gammagard, Hizentra, others

Other names normal human immunoglobulin (HNIG), human

normal immunoglobulin (HNIG)

AHFS/Drugs.com Monograph (https://www.drugs.com/monograp

h/immune-globulin.html)

License data US DailyMed: Immune_ globulin (https://dailymed.

nlm.nih.gov/dailymed/search.cfm?labeltype=all&
query=Immune_ globulin)

Pregnancy
AU: Exempt [1]
category

Routes of Intravenous, intramuscular, subcutaneous

administration

ATC code J06BA (WHO (https://www.whocc.no/atc_ ddd_ in

dex/?code=J06BA) )

Legal status

Legal status AU: S4 (Prescription only) [1]

CA: ℞-only [2][3]

US: ℞-only

EU: Rx-only

In general: ℞ (Prescription only)

Identifiers

CAS Number 9007-83-4 (https://commonchemistry.cas.org/d

etail?cas_ rn=9007-83-4)  

ChemSpider none

UNII 66Y330CJHS (https://precision.fda.gov/uniisearc

h/srs/unii/66Y330CJHS)
Common side effect s include pain at t he sit e of inject ion, muscle pain, and allergic react ions.[4]
Ot her severe side effect s include kidney problems, anaphylaxis, blood clot s, and red blood cell
breakdown.[4] Use is not recommended in people wit h some t ypes of IgA deficiency.[4] Use
appears t o be relat ively safe during pregnancy.[4] Human immunoglobulin is made from human
blood plasma.[4] It cont ains ant ibodies against many viruses.[5]

Human immunoglobulin t herapy first occurred in t he 1930s and a formulat ion for inject ion int o a
vein was approved for medical use in t he Unit ed St at es in 1981.[6] It is on t he World Healt h
Organizat ion's List of Essent ial Medicines.[7][8] Each formulat ion of product is somewhat
different .[5] A number of specific immunoglobulin formulat ions are also available including for
hepat it is B, rabies, t et anus, varicella infect ion, and Rh posit ive blood exposure.[5]

Medical uses

Immunoglobulin t herapy is used in a variet y of condit ions, many of which involve decreased or
abolished ant ibody product ion capabilit ies, which range from a complet e absence of mult iple
t ypes of ant ibodies, t o IgG subclass deficiencies (usually involving IgG2 or IgG3), t o ot her
disorders in which ant ibodies are wit hin a normal quant it at ive range, but lacking in qualit y – unable
t o respond t o ant igens as t hey normally should – result ing in an increased rat e or increased
severit y of infect ions. In t hese sit uat ions, immunoglobulin infusions confer passive resist ance t o
infect ion on t heir recipient s by increasing t he quant it y/qualit y of IgG t hey possess.
Immunoglobulin t herapy is also used for a number of ot her condit ions, including in many
aut oimmune disorders such as dermat omyosit is in an at t empt t o decrease t he severit y of
sympt oms. Immunoglobulin t herapy is also used in some t reat ment prot ocols for secondary
immunodeficiencies such as human immunodeficiency virus (HIV), some aut oimmune disorders
(such as immune t hrombocyt openia and Kawasaki disease), some neurological diseases
(mult ifocal mot or neuropat hy, st iff person syndrome, mult iple sclerosis and myast henia gravis)
some acut e infect ions and some complicat ions of organ t ransplant at ion.[9]

Immunoglobulin t herapy is especially useful in some acut e infect ion cases such as pediat ric HIV
infect ion and is also considered t he st andard of t reat ment for some aut oimmune disorders such
as Guillain–Barré syndrome.[10][11] The high demand which coupled wit h t he difficult y of producing
immunoglobulin in large quant it ies has result ed in increasing global short ages, usage limit at ions
and rat ioning of immunoglobulin.[12]

United Kingdom
The Unit ed Kingdom's Nat ional Healt h Service recommends t he rout ine use of immunoglobulin
for a variet y of condit ions including primary immunodeficiencies and a number of ot her condit ions,
but recommends against t he use of immunoglobulin in sepsis (unless a specific t oxin has been
ident ified), mult iple sclerosis, neonat al sepsis, and pediat ric HIV/AIDS.[13]

United States

The American Academy of Allergy, Ast hma, and Immunology support s t he use of immunoglobulin
for primary immunodeficiencies, while not ing t hat such usage act ually account s for a minorit y of
usage and acknowledging t hat immunoglobulin supplement at ion can be appropriat ely used for a
number of ot her condit ions,[14] including neonat al sepsis (cit ing a sixfold decrease in mort alit y),
considered in cases of HIV (including pediat ric HIV), considered as a second line t reat ment in
relapsing-remit t ing mult iple sclerosis, but recommending against it s use in such condit ions as
chronic fat igue syndrome, PANDAS (pediat ric aut oimmune neuropsychiat ric disorders associat ed
wit h st rept ococcal infect ion) unt il furt her evidence t o support it s use is found (t hough not ing
t hat it may be useful in PANDAS pat ient s wit h an aut oimmune component ), cyst ic fibrosis, and a
number of ot her condit ions.[9]

Brands include

Asceniv (immune globulin int ravenous, human – slra)[15]

Bivigam (immune globulin int ravenous – human 10% liquid)[16]

Gamunex-C, (immune globulin inject ion human)[17]

Hizent ra (immune globulin subcut aneous human)[18]

Hyqvia (immune globulin 10 percent – human wit h recombinant human hyaluronidase)[19]

Oct agam (immune globulin int ravenous, human)[20][21]

Panzyga (immune globulin int ravenous, human – ifas)[22]

Xembify (immune globulin subcut aneous, human – klhw)[23]

Canada

The Nat ional Advisory Commit t ee on Blood and Blood Product s of Canada (NAC) and Canadian
Blood Services have also developed t heir own separat e set of guidelines for t he appropriat e use
of immunoglobulin t herapy, which st rongly support t he use of immunoglobulin t herapy in primary
immunodeficiencies and some complicat ions of HIV, while remaining silent on t he issues of
sepsis, mult iple sclerosis, and chronic fat igue syndrome.[24]

Australia

The Aust ralian Red Cross Blood Service developed t heir own guidelines for t he appropriat e use
of immunoglobulin t herapy in 1997.[25] Immunoglobulin is funded under t he Nat ional Blood Supply
and indicat ions are classified as eit her an est ablished or emerging t herapeut ic role or condit ions
for which immunoglobulin use is in except ional circumst ances only.[26]

Subcut aneous immunoglobulin access programs have been developed t o facilit at e hospit al
based programs.[27]

Human normal immunoglobulin (human immunoglobulin G) (Cut aquig) was approved for medical
use in Aust ralia in May 2021.[28]

European Union

Brands include HyQvia (human normal immunoglobulin), Privigen (human normal immunoglobulin
(IVIg)), Hizent ra (human normal immunoglobulin (SCIg)), Kiovig (human normal immunoglobulin), and
Flebogamma DIF (human normal immunoglobulin).[29][30][31][32]

In t he EU human normal immunoglobulin (SCIg) (Hizent ra) is used in people whose blood does not
cont ain enough ant ibodies (prot eins t hat help t he body t o fight infect ions and ot her diseases),
also known as immunoglobulins.[30] It is used t o t reat t he following condit ions:

primary immunodeficiency syndromes (PID, when people are born wit h an inabilit y t o produce
enough ant ibodies);[30]

low levels of ant ibodies in t he blood in people wit h chronic lymphocyt ic leukaemia (a cancer of
a t ype of whit e blood cell) or myeloma (a cancer of anot her t ype of whit e blood cell) and who
have frequent infect ions;[30]

low levels of ant ibodies in t he blood in people before or aft er allogeneic haemat opoiet ic st em
cell t ransplant at ion (a procedure where t he pat ient 's bone marrow is cleared of cells and
replaced by st em cells from a donor);[30]

chronic inflammat ory demyelinat ing polyneuropat hy (CIDP). In t his rare disease, t he immune
syst em (t he body's defence syst em) works abnormally and dest roys t he prot ect ive covering
over t he nerves.[30]
It is indicat ed for replacement t herapy in adult s and children in primary immunodeficiency
syndromes such as:

congenit al agammaglobulinaemia and hypogammaglobulinaemia (low levels of ant ibodies);[30]

common variable immunodeficiency;[30]

severe combined immunodeficiency;[30]

immunoglobulin-G-subclass deficiencies wit h recurrent infect ions;[30]

replacement t herapy in myeloma or chronic lymphocyt ic leukaemia wit h severe secondary

hypogammaglobulinaemia and recurrent infect ions.[30]

Flebogamma DIF is indicat ed for t he replacement t herapy in adult s, children and adolescent s (0–
18 years) in:

primary immunodeficiency syndromes wit h impaired ant ibody product ion;[33]

hypogammaglobulinaemia (low levels of ant ibodies) and recurrent bact erial infect ions in
pat ient s wit h chronic lymphocyt ic leukaemia (a cancer of a t ype of whit e blood cell), in whom
prophylact ic ant ibiot ics have failed;[33]

hypogammaglobulinaemia (low levels of ant ibodies) and recurrent bact erial infect ions in
plat eau-phase-mult iple-myeloma (anot her cancer of a t ype of whit e blood cell) pat ient s who
failed t o respond t o pneumococcal immunisat ion;[33]

hypogammaglobulinaemia (low levels of ant ibodies) in pat ient s aft er allogenic haemat opoiet ic-
st em-cell t ransplant at ion (HSCT) (when t he pat ient receives st em cells from a mat ched
donor t o help rest ore t he bone marrow);[33]

congenit al acquired immune deficiency syndrome (AIDS) wit h recurrent bact erial infect ions.[33]

and for t he immunomodulat ion in adult s, children and adolescent s (0–18 years) in:

primary immune t hrombocyt openia (ITP), in pat ient s at high risk of bleeding or prior t o surgery
t o correct t he plat elet count ;[33]

Guillain–Barré syndrome, which causes mult iple inflammat ions of t he nerves in t he body;[33]

Kawasaki disease, which causes mult iple inflammat ion of several organs in t he body.[33]

Side effects
Alt hough immunoglobulin is frequent ly used for long periods of t ime and is generally considered
safe, immunoglobulin t herapy can have severe adverse effect s, bot h localized and syst emic.
Subcut aneous administ rat ion of immunoglobulin is associat ed wit h a lower risk of bot h syst emic
and localized risk when compared t o int ravenous administ rat ion (hyaluronidase-assist ed
subcut aneous administ rat ion is associat ed wit h a great er frequency of adverse effect s t han
t radit ional subcut aneous administ rat ion but st ill a lower frequency of adverse effect s when
compared t o int ravenous administ rat ion). Pat ient s who are receiving immunoglobulin and
experience adverse event s are somet imes recommended t o t ake acet aminophen and
diphenhydramine before t heir infusions t o reduce t he rat e of adverse effect s. Addit ional
premedicat ion may be required in some inst ances (especially when first get t ing accust omed t o a
new dosage), prednisone or anot her oral st eroid.

Local side effect s of immunoglobulin infusions most frequent ly include an inject ion sit e react ion
(reddening of t he skin around t he inject ion sit e), it ching, rash, and hives.[34] Less serious syst emic
side effect s t o immunoglobulin infusions include an increased heart rat e, hyper or hypot ension, an
increased body t emperat ure, diarrhea, nausea, abdominal pain, vomit ing, art hralgia or myalgia,
dizziness, headache, fat igue, fever, and pain.[34]

Serious side effect s of immunoglobulin infusions include chest discomfort or pain, myocardial
infarct ion, t achycardia, hyponat remia, hemolysis, hemolyt ic anemia, t hrombosis, hepat it is,
anaphylaxis, backache, asept ic meningit is, acut e kidney injury, hypokalemic nephropat hy,
pulmonary embolism, and t ransfusion relat ed acut e lung injury.[34] There is also a small chance
t hat even given t he precaut ions t aken in preparing immunoglobulin preparat ions, an
immunoglobulin infusion may pass a virus t o it s recipient .[34] Some immunoglobulin solut ions also
cont ain isohemagglut inins, which in rare circumst ances can cause hemolysis by t he
isohemagglut inins t riggering phagocyt osis.[35]

In t he case of less serious side effect s, a pat ient 's infusion rat e can be adjust ed downwards unt il
t he side effect s become t olerable, while in t he case of more serious side effect s, emergency
medical at t ent ion should be sought .[36]

Immunoglobulin t herapy also int erferes wit h t he abilit y of t he body t o produce a normal immune
response t o an at t enuat ed live virus vaccine for up t o a year,[34] can result in falsely elevat ed
blood glucose levels,[34] and can int erfere wit h many of t he IgG-based assays oft en used t o
diagnose a pat ient wit h a part icular infect ion.[37]

Routes of administration
1950s – intramuscular

Aft er immunoglobulin t herapy's discovery and descript ion in Pediatrics in 1952, weekly
int ramuscular inject ions of immunoglobulin (IMIg) were t he norm unt il int ravenous formulat ions
(IVIg) began t o be int roduced in t he 1980s.[38] During t he mid and lat e 1950s, one-t ime IMIg
inject ions were a common public healt h response t o out breaks of polio before t he widespread
availabilit y of vaccines. Int ramuscular inject ions were ext remely poorly t olerat ed due t o t heir
ext reme pain and poor efficacy – rarely could int ramuscular inject ions alone raise plasma
immunoglobulin levels enough t o make a clinically meaningful difference.[38]

1980s – intravenous

Int ravenous formulat ions began t o be approved in t he 1980s, which represent ed a significant
improvement over int ramuscular inject ions, as t hey allowed for a sufficient amount of
immunoglobulin t o be inject ed t o reach clinical efficacy, alt hough t hey st ill had a fairly high rat e
of adverse effect s (t hough t he addit ion of st abilizing agent s reduced t his furt her).[38]

1990s – subcutaneous

The first descript ion of a subcut aneous rout e of administ rat ion for immunoglobulin t herapy dat es
back t o 1980,[39] but for many years subcut aneous administ rat ion was considered t o be a
secondary choice, only t o be considered when peripheral venous access was no longer possible
or t olerable.[38]

During t he lat e 1980s and early 1990s, it became obvious t hat for at least a subset of pat ient s
t he syst emic adverse event s associat ed wit h int ravenous t herapy were st ill not easily t olerable,
and more doct ors began t o experiment wit h subcut aneous immunoglobulin administ rat ion,
culminat ing in an ad hoc clinical t rial in Sweden of 3000 subcut aneous inject ions administ ered t o
25 adult s (most of whom had previously experienced syst emic adverse effect s wit h IMIg or
IVIg), where no infusion in t he ad hoc t rial result ed in a severe syst emic adverse react ion, and
most subcut aneous inject ions were able t o be administ ered in non-hospit al set t ings, allowing for
considerably more freedom for t he people involved.[38]

In t he lat er 1990s, large-scale t rials began in Europe t o t est t he feasibilit y of subcut aneous
immunoglobulin administ rat ion, alt hough it was not unt il 2006 t hat t he first subcut aneous-
specific preparat ion of immunoglobulin was approved by a major regulat ory agency (Vivaglobin,
which was volunt arily discont inued in 2011).[38][40] A number of ot her t rade names of
subcut aneous immunoglobulin have since been approved, alt hough some small-scale st udies
have indicat ed t hat a part icular cohort of pat ient s wit h common variable immunodeficiency
(CVID) may develop int olerable side effect s wit h subcut aneous immunoglobulin (SCIg) t hat t hey
do not wit h int ravenous immunoglobulin (IVIg).[38]

Alt hough int ravenous was t he preferred rout e for immunoglobulin t herapy for many years, in 2006,
t he US Food and Drug Administ rat ion (FDA) approved t he first preparat ion of immunoglobulin t hat
was designed exclusively for subcut aneous use.[38]

Mechanism of action

The precise mechanism by which immunoglobulin t herapy suppresses harmful inflammat ion is
likely mult ifact orial.[41] For example, it has been report ed t hat immunoglobulin t herapy can block
Fas-mediat ed cell deat h.[42]

Perhaps a more popular t heory is t hat t he immunosuppressive effect s of immunoglobulin

t herapy are mediat ed t hrough IgG's Fc glycosylat ion. By binding t o recept ors on ant igen
present ing cells, IVIG can increase t he expression of t he inhibit ory Fc recept or, FcgRIIB, and
short en t he half-life of aut o-react ive ant ibodies.[43][44][45] The abilit y of immunoglobulin t herapy
t o suppress pat hogenic immune responses by t his mechanism is dependent on t he presence of a
sialylat ed glycan at posit ion CH2-84.4 of IgG.[43] Specifically, de-sialylat ed preparat ions of
immunoglobulin lose t heir t herapeut ic act ivit y and t he ant i-inflammat ory effect s of IVIG can be
recapit ulat ed by administ rat ion of recombinant sialylat ed IgG1 Fc.[43]

Sialylat ed-Fc-dependent mechanism was not reproduced in ot her experiment al models

suggest ing t hat t his mechanism is funct ional under a part icular disease or experiment al
set t ings.[46][47][48][49] On t he ot her hand, several ot her mechanisms of act ion and t he act ual
primary t arget s of immunoglobulin t herapy have been report ed. In part icular, F(ab')2-dependent
act ion of immunoglobulin t o inhibit act ivat ion of human dendrit ic cells,[50] induct ion of
aut ophagy,[51] induct ion of COX-2-dependent PGE-2 in human dendrit ic cells leading t o expansion
of regulat ory T cells,[52] inhibit ion of pat hogenic Th17 responses,[53] and induct ion of human
basophil act ivat ion and IL-4 induct ion via ant i-IgE aut oant ibodies.[54][55] Some believe t hat
immunoglobulin t herapy may work via a mult i-st ep model where t he inject ed immunoglobulin first
forms a t ype of immune complex in t he pat ient .[56] Once t hese immune complexes are formed,
t hey can int eract wit h Fc recept ors on dendrit ic cells,[57] which t hen mediat e ant i-inflammat ory
effect s helping t o reduce t he severit y of t he aut oimmune disease or inflammat ory st at e.
Ot her proposed mechanisms include t he possibilit y t hat donor ant ibodies may bind direct ly wit h
t he abnormal host ant ibodies, st imulat ing t heir removal; t he possibilit y t hat IgG st imulat es t he
host 's complement syst em, leading t o enhanced removal of all ant ibodies, including t he harmful
ones; and t he abilit y of immunoglobulin t o block t he ant ibody recept ors on immune cells
(macrophages), leading t o decreased damage by t hese cells, or regulat ion of macrophage
phagocyt osis. Indeed, it is becoming more clear t hat immunoglobulin can bind t o a number of
membrane recept ors on T cells, B cells, and monocyt es t hat are pert inent t o aut oreact ivit y and
induct ion of t olerance t o self.[43][58]

A recent report st at ed t hat immunoglobulin applicat ion t o act ivat ed T cells leads t o t heir
decreased abilit y t o engage microglia. As a result of immunoglobulin t reat ment of T cells, t he
findings showed reduced levels of t umor necrosis fact or-alpha and int erleukin-10 in T cell-
microglia co-cult ure. The result s add t o t he underst anding of how immunoglobulin may affect
inflammat ion of t he cent ral nervous syst em in aut oimmune inflammat ory diseases.[59]

Hyperimmune globulin

Hyperimmune globulins are a class of immunoglobulins prepared in a similar way as for normal
human immunoglobulin, except t hat t he donor has high t it ers of ant ibody against a specific
organism or ant igen in t heir plasma. Some agent s against which hyperimmune globulins are
available include hepat it is B, rabies, t et anus t oxin, varicella-zost er, et c. Administ rat ion of
hyperimmune globulin provides "passive" immunit y t o t he pat ient against an agent . This is in
cont rast t o vaccines t hat provide "act ive" immunit y. However, vaccines t ake much longer t o
achieve t hat purpose while hyperimmune globulin provides inst ant "passive" short -lived immunit y.
Hyperimmune globulin may have serious side effect s, t hus usage is t aken very seriously.

Hyperimmune serum is blood plasma cont aining high amount s of an ant ibody. It has been
hypot hesised t hat hyperimmune serum may be an effect ive t herapy for persons infect ed wit h
t he Ebola virus.[60]

Society and culture

Economics

In t he Unit ed Kingdom a dose cost t he NHS bet ween 11.20 and 1,200.00 pounds depending on
t he t ype and amount .[5]
Brand names

As biologicals, various t rade names of immunoglobulin product s are not necessarily

int erchangeable, and care must be exercised when changing bet ween t hem.[61] Trade names of
int ravenous immunoglobulin formulat ions include Flebogamma, Gamunex, Privigen, Oct agam and
Gammagard, while t rade names of subcut aneous formulat ions include Cut aquig, Cuvit ru, HyQvia,
Hizent ra,[30][62][63] Gamunex-C, and Gammaked.[64]

Supply issues

The Unit ed St at es is one of a handful of count ries t hat allow plasma donors t o be paid, meaning
t hat t he US supplies much of t he plasma-derived medicinal product s (including immunoglobulin)
used across t he world, including more t han 50% of t he European Union's supply.[65] The Council of
Europe has officially endorsed t he idea of not paying for plasma donat ions for bot h et hical
reasons and reasons of safet y, but st udies have found t hat relying on ent irely volunt ary plasma
donat ion leads t o short ages of immunoglobulin and forces member count ries t o import
immunoglobulin from count ries t hat do compensat e donors.[65]

In Aust ralia, blood donat ion is volunt ary and t herefore t o cope wit h increasing demand and t o
reduce t he short ages of locally produced immunoglobulin, several programs have been
undert aken including adopt ing plasma for first t ime blood donors, bet t er processes for donat ion,
plasma donor cent res and encouraging current blood donors t o consider plasma only donat ion.[66]

Research

Experiment al result s from a small clinical t rial in humans suggest ed prot ect ion against t he
progression of Alzheimer's disease, but no such benefit was found in a subsequent phase III
clinical t rial.[67][68][69] In May 2020, t he US approved a phase t hree clinical t rial on t he efficacy and
safet y of high-concent rat ion int ravenous immune globulin t herapy in severe COVID-19.[70]

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External links
 "Immune globulin" (ht t ps://druginfo.nlm.nih.gov/drugport al/name/immune%20globulin) . Drug
Information Portal. U.S. Nat ional Library of Medicine.

Portal:  Medicine

Retrieved from
"https://en.wikipedia.org/w/index.php?
title=Immunoglobulin_therapy&oldid=1113174746"

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