Chapter 4: Immuneglobulin Products Flashcards

1
Q

IVIG

List 3 types of immune globulin products provided by CBS.

A

IVIg
SCIg
RhIg

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2
Q

IVIG

How do immuneglobulin products affect vaccine efficacy?

A

IVIig leads to decreased response to parenteral live virus vaccines
BUT NOT inactivated virus vaccines Live oral/intranasal vaccines, or BCG

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3
Q

IVIG

What formats do immuneglobulin products come in?

A

sterile solutions
lyophilized concentrates

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4
Q

IVIG

What class of human immunoglobulin are immuneglobulin products made from?

A

IgG

May have traces of others

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5
Q

How can Immunoglobulin administration affect serological testing results?

A

passively transferred antibodies in the patient’s blood may cause positive serological testing results, which can be misinterpreted

E.g.:

Passive transmission of antibodies to red cell antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs) test.

serological testing results for other antibody-mediated tests (e.g., hepatitis B core antibody [anti-HBc], hepatitis A, varicella) may also be misleading

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6
Q

Tests needs to be performed befor IVIG

Why should we do hepatitis B testing with hepatitis B surface antigen (HBsAg) in patients before Ig therapy is initiated?

A

After Ig administration, serological testing results for hepatitis B core antibody [anti-HBc], hepatitis A, may be misleading.

We should test before giving Ig to inform the risk of hepatitis B reactivation

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7
Q

What resource can you consult of you want to know what Ig products are offered by CBS?

A

E-formulary for plasma protein and related products

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8
Q

IVIG mechanism

What is the method of action by which IVIg offers protection against infection and supplementation for congenital/primary and acquired/secondary immune deficiency

A

By supplementing array of IgG antibodies to facilitate destruction and neutralization of pathogens

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9
Q

IVIG mechanism

What is the proposed mechanism by which IVIg helps with immune modulation in autoimmune or modulatory conditions

A

anti-inflammatory activity by dendritic cells and/or blockade of Fc receptors in the reticuloendothelial system

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10
Q

IVIG mechanism

What is the proposed mechanism by which IVIg helps with immune modulation in autoimmune or modulatory conditions

A

anti-inflammatory activity by dendritic cells and/or blockade of Fc receptors in the reticuloendothelial system

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11
Q

IVIG mechanism

What is the proposed mechanism by which RhIg prevents alloimmunization against RhD?

A

Accelerated clearance of RhIg coated cells

Suppression of B-cell mediated response to Rh exposure and mitigation of Rh alloimmunization

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12
Q

IVIG indication

List 6 indications for IVIg

A

Primary immune deficiency (PID)
Secondary immune deficiency (SID)
ITP
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Guillain-Barré syndrome (GBS)
Multifocal motor neuropathy (MMN)

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13
Q

IVIG

Why are there authorization forms for IVIg ordering and who provides regional guidance on the use of IVIg in Canada?

A

BC blood coordinating office
ORBCoN
Atlantic blood utilization strategy working group

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14
Q

IVIG criteria for the clinical use

What group developedcriteria for the clinical use of Igas part of an evidence-based framework to aid transfusion services and clinicians?

A

Prairie Collaborative Immune Globulin Utilization Management Framework Project

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15
Q

IVIG guidance on utilization

Who provides guidance on utilization of there are Ig shortages in Canada?

A

National Advisory Committee on Blood and Blood Products (NAC)

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16
Q

IVIG-Contraindication

IVIg is contraindicated for what groups of individuals?

A

People with:
IgA deficiency and anti-IgA antibodies
Prior anaphylaxis or multiple severe allergic reactions

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17
Q

IVIG-IgA

What Ig products can you use for individuals with IgA deficiency who have anti-IgA antibodies instead of IVIg?

A

SCIg

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18
Q

IVIG-IgA

Do we routinely test for IgA deficiency before IVIg?

A

No

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19
Q

IVIG dose

IVIG dosing?

A

Depends on clinical indication

Immune replacement 0.4–0.6 g/kg a month + extra dose in the first month of therapy if serum IgG low

Immunosuppressive dose: 1–2 g/kg over 1–5 days, +/- monthly maintenance

Reduce the dose or extend the treatment interval as tolerated

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20
Q

IVIG side effects

General side effects of IVIG
What does it related to?

A
  • Lower doses associated with less side effects
  • Minor side effects with infusion - headache, chills, fever, malaise, anxiety, chest pain, nausea, pruritus, rash, nausea/vomiting, tachycardia, hypo or hypertension
    o Common (21%)
    o Related to infusion rate and will resolve by slowing or stopping IVIG infusion
    o Premedication
    o Trial different brand or switch to SCIG if appropriate
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21
Q

IVIG side effects

List 4 IVIG adverse reaction:

A

1-IVIG associated Hemolysis
2- Aseptic meningitis: within 6 to 48 hours of infusion
3-Anaphylaxis
4-Thromboembolic events: o Can occur during infusion up to 8 days after
5-Transfusion-related acute lung injury
6-Viral transmission
7- Neutropenia

22
Q

IVIG side effects

IVIG associated Hemolysis Risk factors:

A
  • 32% can have clinically significant hemolytic events
  • More common in patients receiving high doses (2g/kg)
  • More common in patients with non-O blood groups
  • Some products are isohemagglutinin depleted to minimize this risk
23
Q

IVIG side effects

IVIg hemolysis Lab tests?

A
  • Increased reticulocyte count
  • Increased lactate dehydrogenase level
  • Low haptoglobin level
  • Increased unconjugated bilirubin level
  • Hemoglobinemia - grossly hemolyzed
  • Hemoglobinuria
  • OR presence of significant spherocytes with no alternate etiology
24
Q

IVIG side effects

Aseptic meningities approach?

A

o Meningeal signs and symptoms present
**1- Stop infusion and administer analgesics
- Most patient recover within 5 days (usually resolves spontaneously in 24-48 hours) and are OK to get subsequent infusions
- May have recurrence with future infusions
- Premedicate and/or change to another product or to SCIG if appropriate

The majority of patients recover within five days of symptom onset and tolerate subsequent infusions, but some patients report the recurrence of symptoms with subsequent infusions.

25
Q

IVIG side effects

Aseptic meningities CSF findings ?

A
  • Elevated protein
  • Normal to low glucose
  • leukocyte pleocytosis
  • Negative cultures
26
Q

IVIG side effects

Anaphylaxis approach?

A

1- Stop infusion, may require epinephrine
2- Consider using SCIG in these patients or use IgA-depleted products

Sometimes in patients with IgA deficiency with anti-IgA antibodies

27
Q

IVIG side effects

Thromboembolic events risk factor?
2- approach?

A

1-Higher risk in patients already at risk of thromboembolic events, Cardiovascular risk factors, advanced age, prolonged immobilization, history of thromboembolic events.
2- Adequate hydration prior to infusion and opt for lowest effective dose

28
Q

SCIG

Predominant use of subcutaneous immunoglobulin in Canada (SCIg) ?

A

used as replacement therapy for
* primary and secondary immunodeficiency patients.
* immunomodulation in patients with the neurologic condition chronic inflammatory demyelination polyneuropathy (CIDP)

Since these patients require lifelong therapy with Ig replacement, many may have better quality of life parameters with SCIg use instead of IVIg

29
Q

SCIG

SCIG contraindication?

A

**The main contraindication for SCIg **is a history of anaphylactic or severe allergic reactions to Ig preparations.
However, this is often a reason for switching a patient from intravenous to subcutaneous products.
Some, but not all, products advise against use in those with a history anti-IgA antibodies. One product, Hizentra, recommends against use in patients with hyperprolinemia.

30
Q

SCIG

SCIG dose in replacement therapy?

A

For initiation of replacement therapy in patients with primary immunodeficiency, SCIg starting dose depends on the specific brand being used.
Generally, the doses vary between 100–200 mg/kg per week depending on the product used.
The recommended rate of infusion varies by brand.

  • One additional dose of 0.4 g/kg may be given in the first month of therapy if the serum IgG level is markedly reduced.

Syorage: Storage temperatures range from 2–25°C but product shelf life may differ

31
Q

SCIG

Which SCIG product can be infused with longer interval?

A

HyQvia, approved for primary and secondary immunodeficiency, may be administered once monthly. It is administered along with hyaluronidase, which allows a larger volume of Ig to be injected. The usual dose is 100-125 mg/kg per week, which may begin as weekly doses then be given cumulatively every 3 to 4 weeks
CIDP: dosing between 200 to 400 mg/kg per week

32
Q

SCIG side effects

SCIG Adverse events

A

The minor adverse event profile with SCIg is similar to that of IVIg, with the additional side effect of discomfort from subcutaneous injection.

33
Q

hyperimmune globulins

What are hyperimmune globulins?

A

Fractionation products created from pools of human plasma specifically chosen for high titers of antibodies with selected specificities.

34
Q

hyperimmune globulins

What are the four types of hyperimmune immunoglobulins mentioned?

A
  1. Rh Immunoglobulin (RhIG)
  2. Hepatitis B Immunoglobulin (HBIG)
  3. Varicella-Zoster Immunoglobulin (VZIG)
  4. Cytomegalovirus Immunoglobulin (CMVIG)
35
Q

RHIG

What are the contraindications for Rh Immunoglobulin?

A

RhD-positive individuals
RhD-negative women who are already alloimmunized
History of anaphylactic or severe allergic reactions
Caution in IgA-deficient individuals with anti-IgA antibodies

36
Q

hyperimmune globulins

What are the contraindications for hyperimmune globulins?

A

1-History of anaphylactic or severe allergic reactions
2-Individuals with IgA deficiency who have anti-IgA antibodies
3-Any contraindication for intramuscular injections

37
Q

RhIG

What is Rh Immunoglobulin (RhIG)?

A

: A freeze-dried preparation of IgG specific to RhD antigen made from pooled human plasma, used to prevent alloimmunization to RhD antigen.

38
Q

What are the indications for Rh Immunoglobulin

A

Prophylaxis for RhD hemolytic disease of the newborn
Prophylaxis against anti-D formation following transfusion

39
Q

What are the contraindications for Rh Immunoglobulin?

A

RhD-positive individuals
RhD-negative women who are already alloimmunized
History of anaphylactic or severe allergic reactions
Caution in IgA-deficient individuals with anti-IgA antibodies

40
Q

RhIG Prevention of alloimmunization to the RhD antigen

When should RhIG be given for pregnancy?

A

1500IU (300ug) at 28 weeks gestation
600IU (120ug) or 1500IU (300ug) postpartum if the newborn is RhD positive, within 72 hours

41
Q

RhIG Prevention of alloimmunization to the RhD antigen

What is the dose of RhIG for transfusion-related prophylaxis?

A

1500IU (300ug) per 15mL of RhD positive red cells or 30mL of whole blood
For larger exposures, 3000IU (600ug) every 8 hours until the total dose is administered

42
Q

RhIG in ITP

How is RhIG administered for ITP treatment?

A

IV is the most common route for ITP treatment, as IM is not recommended due to bleeding risks.

43
Q

RhIG in ITP

What is the indication for RhIG in Immune Thrombocytopenic Purpura (ITP)?

What should be considered when administering RhIG for transfusion prophylaxis?

A

Category 1: Prevention of alloimmunization to the RhD antigen Treatment of ITP in RhD-positive patients with an intact and functional spleen.

Category 2: Immune thrombocytopenic purpura

Consider volume of Rh-mismatch blood transfused, availability of Rh-negative red blood cell support, renal function, clinical status, and the risk of hemolysis.

44
Q

RhIG in ITP

What are the contraindications for RhIG in ITP treatment?

why need to be caucious in patients with secondary ITP?

A
  • RhD-negative patients
  • Patients with prior splenectomy
  • Individuals with a history of anaphylactic or severe allergic reactions

Caution in patients with secondary ITP, evidence of autoimmune hemolytic anemia (Evan’s syndrome), systemic lupus erythematosus, antiphospholipid antibody syndrome, and underlying cardiac, renal, or hepatic comorbidities predisposed to complications from acute hemolysis caused by RhIG.

45
Q

RGIG in ITP

What should be monitored after RhIG administration in ITP patients?

A

Hemoglobin levels should be monitored post-administration to detect significant hemolysis

46
Q

HBIG

What is Hepatitis B Immunoglobulin (HBIG) used for?

A
  • To provide passive immunization to hepatitis B, especially in cases of acute exposure or** perinatal exposure of infants born **to HBsAg-positive mothers.
47
Q

VZIG

1- What is Varicella-Zoster Immunoglobulin (VZIG) used for?
2- dose?

A

1- Prevention or reduction of severity of maternal infections in pregnant women with significant varicella exposure, given within 96 hours.
2- 125IU/10kg of body weight, up to a maximum of 625IU.

48
Q

hyperimmune globulins

How should hyperimmune globulins be stored?

A

At 2-8°C and used within 4 hours of reconstitution

49
Q

CMVIG

What is Cytomegalovirus Immunoglobulin (CMVIG) used for?

A

To prevent CMV infection in seronegative solid organ transplant recipients receiving organs from CMV seropositive donors.

50
Q

CMVIG

For which solid organ transplant is Cytomegalovirus Immunoglobulin (CMVIG) approved in Canada?

A

CMVIG is approved for kidney transplants in Canada.