Vaccination Guide for
Immunosuppressed Patients with IBD

Treatment Options Overview

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SHOULD TITRES BE CHECKED?

Considered immune if 2 documented doses of vaccine or positive serology­

BEFORE INITIATION OF IMMUNE SUPPRESSION

Contraindicated if plan to start therapy in < 4 weeks. Contraindicated in pregnancy.
When rapid protection is required, a minimum interval of 4 weeks between the 2 doses is acceptable.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.

           
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VACCINE

SHOULD TITRES BE CHECKED?

Considered immune if the following:

  • History of varicella of herpes zoster diagnosed by health care provider
  • Received 2 doses of varicella-containing vaccine
  • Born before 1970

Serology testing can be considered if patients do not meet above criteria.

BEFORE INITIATION OF IMMUNE SUPPRESSION

Contraindicated if plan to start therapy in < 4 weeks. Contraindicated in pregnancy.
When rapid protection is required, a minimum interval of 4 weeks between the 2 doses is acceptable.

WHAT TO DO IF ALREADY IMMUNOSUPPRESSED
(ON ANTI-TNF OR IMMUNOMODULATOR)

Contraindicated.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (ORIGINAL MARKET DATE)

Stelara®/Janssen/BioAdvance® (2009)

CLASS

Monoclonal antibody interleukin (IL)-12/23 inhibitor

ACTION

Targets an overactive immune system by blocking two receptors called IL-12 and IL-23. By blocking these receptors, cells are slowed down, which reduces inflammation.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (ORIGINAL MARKET DATE)

Entyvio®/Takeda/OnePath® (2015)

CLASS

Monoclonal antibody integrin receptor blocker

ACTION

Blocks integrin α4β7 protein that is found on the surface of white blood cells, thereby reducing intestinal inflammation. Inflammation elsewhere in the body is unaffected.
           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (ORIGINAL MARKET DATE)

Skyrizi®/AbbVie/AbbVie Care (2019)

 

CLASS

Monoclonal antibody interleukin (IL)-23 inhibitor

ACTION

Targets IL-23 protein receptor, which is one of the proteins responsible for inflammation. Blocking this receptor contributes to reducing inflammation.

           
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BRAND NAME / COMPANY / REIMBURSEMENT AND LOGISTICS PROGRAM (ORIGINAL MARKET DATE)

Rinvoq/Abbvie/Abbvie Care (2023)

 

CLASS

JAK Inhibitor

ACTION

JAKs are intracellular enzymes that activate the body’s immune response causing inflammation. JAK inhibitors block this pathway. Works by attaching to the JAK enzyme to lower its activity and to decrease inflammation in the body.

           

Testing, Logistics, and Monitoring

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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

Chest X-ray.
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)

Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.10

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

IV Infusion

LOCATION

Infusion centre

DOSING

Weight-based dosing. Standard dose is 5 mg/kg.
Induction:  wk 0, wk 2, wk 6,  then maintenance every 8 wks*

Pediatric Dosing:

(≥ 9 years of age) with moderately to severely active Crohn’s disease:

5 mg/kg given as an induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks.

The safety and efficacy of Remicade® has not been established in pediatric patients with Crohn’s disease <9 years of age.

TIME REQUIRED

3-4 hrs

Those who do not experience a reaction can be infused <2 hrs

ROUTINE MONITORING

Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)

Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.10

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

SC injection

LOCATION

Home
Infusion centre is also available

DOSING

Induction:
160 mg, 80 mg,
40 mg, wk 0, wk 2, wk 4,

then maintenance
40 mg every 2 wks*

Pediatric Dosing:
13 to 17 years of age

≥ 40 kg: 160 mg at Week 0, 80 mg at Week 2. Maintenance dose regimen is 20 mg every other week beginning at Week 4.

For pediatric patients who experience a disease flare or non-response, dose escalation to 40 mg every other week may be considered

TIME REQUIRED

<15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis

           
Edit Content

PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

Chest X-ray
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)

Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations: HAV, HBV, HPV, and Tdap
Refer to CANIBD Vaccination Guidelines for further information.10

Use with caution in patients with chronic or recurrent infection.

METHOD OF ADMINISTRATION

IV infusion x 1 then SC injection

LOCATION

Infusion centre
Home

DOSING

Induction:
300 mg IV x 1 infusion,

then maintenance 90 mg SC every 8 wks*

TIME REQUIRED

1–2 hrs for initial IV infusion
SC injection <15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
May consider therapeutic drug monitoring (TDM) if available
Screening for osteoporosis with bone mineral density testing periodically after diagnosis

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

TB screening should be considered.

METHOD OF ADMINISTRATION

IV infusion and SC injection

LOCATION

Infusion centre

DOSING

Induction: 300 mg IV wk 0, wk 2, wk 6, then maintenance 300 mg every 8 wks OR following at least 2 IV infusions, 108 mg SC every 2 wks

TIME REQUIRED

1–2 hrs 

ROUTINE MONITORING

Patients should be monitored for any new onset or worsening of neurological signs and symptoms

Liver enzymes – transaminases and bilirubin.

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide
TB skin test
Blood work (baseline CBC, renal and liver function, HBV)

Ensure all immunizations are current.
Wait at least four weeks to start following administration of live vaccination.
Pneumococcal vaccination recommended for adult patients.
Recommend vaccinations HAV, HBV, HPV, and Tdap.
Refer to CANIBD Vaccination Guidelines for further information.10

Use with caution in patients with chronic or recurrent infection.

Liver tests as per routine patient management prior to initiating therapy.

METHOD OF ADMINISTRATION

IV infusion x 1 then on-body (SC) injector (OBI) with pre-filled cartridge

LOCATION

Infusion centre
Home

DOSING

Induction:
600 mg IV at wk 0, wk 4 and wk 8,

then 360 mg subcutaneous (OBI) at wk 12 and every 8 wks thereafter

TIME REQUIRED

Minimum 1 hr infusion

OBI injection <15 min

ROUTINE MONITORING

Annual cervical cancer screening – pap test
Annual skin exam – skin malignancies
Influenza vaccine recommended
Screening for osteoporosis with bone mineral density testing periodically after diagnosis
Liver enzymes as part of your routine blood work.

           
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PRE-TESTING AND VACCINATION

For more detailed information on vaccinations, please see the CANIBD Vaccination Guide

TB skin test
Blood work (baseline CBC, liver enzymes, lipids, CK, renal function, Hepatitis B serology)
Shingrix zoster 
Recommend receiving live vaccines prior to starting therapy

METHOD OF ADMINISTRATION

Oral

LOCATION

Home

DOSING

Induction:
45mg once daily for 12 weeks

then maintenance 15mg or 30mg once daily

TIME REQUIRED

5 minutes 

ROUTINE MONITORING

Baseline blood work – CBC

Liver enzymes, lipids, CK, renal function and Hepatitis B serology

Blood work q 3 months

Including CBC, liver enzymes, lipids, CK, and renal function

           

*Dose and frequency adjustments can be made at the discretion of the practitioner.

†Frequency of infusions can be adjusted at the discretion of the practitioner.

TB: Tuberculosis, CBC: complete blood count, ­HBV: hepatitis B virus, HAV: hepatitis A virus, HPV: Human papillomavirus, Tdap: tetanus, diphtheria, and pertussis, IV: intravenous, SC: subcutaneous, wk: week, hrs: hours, min: minutes.

Side Effects

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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Infusion-related reactions – sometimes can be managed with pre-medications, IV fluids, or lengthening infusion duration.
  • Increased risk of serious infection (sepsis and pneumonia), invasive fungal infections and viral infections; approximately 10% increased risk at wk 54. Reactivation of latent TB.
  • Can worsen pre-existing CHF.
  • Lupus-like reaction (rare).
  • Anti-TNF–induced psoriasis
  • Hepatocellular damage, hepatitis, jaundice, autoimmune hepatitis; reactivation of HBV.
  • Potential increased risk of malignancy (lymphoma, hepatosplenic T-cell lymphoma, melanoma, and NMSC); increased frequency when used in combination with a thiopurine.
  • Numbness and tingling in legs, arms, etc.
  • Change in vision, weakness in leg, dizziness.
           
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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Infusion-related reactions – sometimes can be managed with pre-medications, IV fluids, or lengthening infusion duration.
  • Increased risk of serious infection (sepsis and pneumonia), invasive fungal infections and viral infections; approximately 10% increased risk at wk 54. Reactivation of latent TB.
  • Can worsen pre-existing CHF.
  • Lupus-like reaction (rare).
  • Anti-TNF–induced psoriasis
  • Hepatocellular damage, hepatitis, jaundice, autoimmune hepatitis; reactivation of HBV.
  • Potential increased risk of malignancy (lymphoma, hepatosplenic T-cell lymphoma, melanoma, and NMSC); increased frequency when used in combination with a thiopurine.
  • Numbness and tingling in legs, arms, etc.
  • Change in vision, weakness in leg, dizziness.
           
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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Injection-site reactions
  • Headaches
  • Diarrhea
  • Skin rash or itching
  • Possible infusion reaction
           
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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Nasopharyngitis
  • Arthralgia
  • Headache
  • Nausea
  • Pyrexia
  • Upper respiratory tract infection
  • Fatigue
  • Malignancy
  • Elevated transaminase has been reported
  • No serious infections
           
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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Fatigue
  • Upper respiratory infections
  • Headache
  • Arthralgia
  • Injection-site reaction
  • Elevated liver enzymes reported during induction
           
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SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

  • Nasopharyngitis
  • Opportunistic infections
  • Upper respiratory tract infections
  • Herpes zoster
  • CPK elevation
  • Liver enzyme increase
  • Neutropenia
           

IV: intravenous, wk: week, TB: tuberculosis, CHF: congestive heart failure, Anti-TNF: Anti-tumour necrosis factor, HBV: hepatitis B virus, NMSC: non-melanoma skin cancer.

Special Populations

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PAEDIATRICS

Approved for use in paediatric patients

ELDERLY

Data supporting the efficacy of anti-TNF therapy in the elderly is limited with some studies showing similar results in elderly and younger onset IBD and others suggesting lower efficacy.

Caution should be used when treating the elderly.

Data on safety of anti-TNF therapy reports increased rates of adverse events in elderly patients.

Anti-TNF therapy is not suitable for patients with history of either CHF and recent malignancy (< 2 years).

PREGNANCY

The authors of the 2023 Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breastfeeding recommend:10
  • Anti-TNF-α agents can be initiated or continued throughout pregnancy.
  • Anti-TNF-α agents can be continued uninterrupted throughout the third trimester, with premature cessation being associated with an increased risk of disease flare.
  • Anti-TNF therapy can be resumed 24 hrs after an uncomplicated vaginal delivery and 48 hrs after an uncomplicated Caesarean delivery if it was ceased or altered during gestation.
  • Live vaccines (including MMR, BCG, and rotavirus) should be avoided for 12 months if the neonate was exposed to a biological agent in utero. Non-live vaccines should be given on schedule.

BREASTFEEDING

The authors of the 2023 Australian inflammatory bowel disease consensus statement for preconception, pregnancy, and breastfeeding recommend:11

  • Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
           
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PAEDIATRICS

Approved for use in paediatric patients

ELDERLY

Data supporting the efficacy of anti-TNF therapy in the elderly is limited with some studies showing similar results in elderly and younger onset IBD and others suggesting lower efficacy.

Caution should be used when treating the elderly.

Data on safety of anti-TNF therapy reports increased rates of adverse events in elderly patients.

Anti-TNF therapy is not suitable for patients with history of either CHF and recent malignancy (< 2 years).

PREGNANCY

The authors of the 2023 Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breastfeeding recommend:10
  • Anti-TNF-α agents can be initiated or continued throughout pregnancy.
  • Anti-TNF-α agents can be continued uninterrupted throughout the third trimester, with premature cessation being associated with an increased risk of disease flare.
  • Anti-TNF therapy can be resumed 24 hrs after an uncomplicated vaginal delivery and 48 hrs after an uncomplicated Caesarean delivery if it was ceased or altered during gestation.
  • Live vaccines (including MMR, BCG, and rotavirus) should be avoided for 12 months if the neonate was exposed to a biological agent in utero. Non-live vaccines should be given on schedule.

BREASTFEEDING

The authors of the 2023 Australian inflammatory bowel disease consensus statement for preconception, pregnancy, and breastfeeding recommend:11

  • Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.
           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

At present, there is not enough data to determine the safety in the elderly.

PREGNANCY

Not associated with an increased rate of adverse maternofetal outcomes, and it is reasonable to continue after discussing the potential risks with the patient.

BREASTFEEDING

Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

Clinical trials of vedolizumab did not include sufficient numbers of subjects aged 65+ to determine whether they respond differently from younger subjects.

PREGNANCY

Does not appear to be associated with an increased rate of adverse maternofetal outcomes, and it may be continued after discussing the potential risks with the patient.

BREASTFEEDING

Mesalazines, thiopurines, corticosteroids (budesonide, prednisolone), anti-TNF-α agents, vedolizumab and ustekinumab can be safely administered during breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

Clinical trial analysis in this limited patient population found no clinically meaningful difference in risankizumab exposure between patients 65 years of age or older and adult population.

PREGNANCY

Insufficient data to make a recommendation regarding safety in pregnancy.

As it is a monoclonal antibody, its safety profile is expected to be similar to that of other biologics, and it can be continued throughout pregnancy.12

BREASTFEEDING

Insufficient data regarding the safety in breastfeeding.

           
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PAEDIATRICS

Not currently approved for paediatric use

ELDERLY

For patients older than 65 years of age, the recommended maintenance dose is 15mg once daily.

PREGNANCY

Contraindicated in use with Pregnancy.

BREASTFEEDING

Contraindicated in use with breastfeeding.

           

CHF: congestive heart failure, TNF: tumour necrosis factor, anti-TNFα: anti-tumour necrosis factor alpha, IBD: inflammatory bowel disease, hrs: hours, MMR: measles, mumps, rubella, BCG: Bacille Calmette-Guérin