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864 > IBD II > Flashcards

IBD II Flashcards

1
Q

TDM of Biologics

potential for determining concentrations of ___ and ___
- most data with infliximab and adalimumab
- consider if ___ of treatment response (reactive TDM) - role of proactive TDM unclear
- check ___ concurrently
- assay methodology may be important
- economic value unclear
* may help justify dose increases to insurer

A
  • drugs, ADAs
  • lose
  • ADA
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2
Q

TDM of Biologics

optimal trough concentrations not clear – ___ ___

A

moving target

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3
Q

know how to use this chart:
- sub- thera drug levels + ADAs = ____
- sub-thera drug levels, no ADAs = ___
- thera drug levels +ADAs = ___
- thera drug levels, no ADAs = ___

A
  • change to alternate drug wthin the same calss
  • dose escalate
  • repeat TDM, switch to out of class biologic agent
  • switch to out of class biologic agent
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4
Q

Clinical Controversy: “Biosimilars”

  • biological product that is
    approved based on a showing
    that it is highly ___ to an
    already-approved biological
    product
  • must show it has no clinically
    meaningful differences in terms
    of ___ and ___
  • do not switch to corresponding
    biosimilar if loss of ___ to
    the brand
A
  • similar
  • safety, effectiveness
  • response
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5
Q

Tofacitinib (Xeljanz)

oral ___ inhibitor
- family of enzymes involved in immune signaling
- approved for ___ only for pts who have had an inadequate response or who are intolerant to ___ blockers

  • 10 mg bid or 22 mg XR daily for 8 weeks (up to 16)
  • then 5 or 10 mg bid or 11 or 23 mg XR daily
  • D/C after ___ weeks of 10 mg bid or 22 mg XR daily if response not adequate
  • use lowest effective dose to maintain response
A
  • JAK
  • UC
  • TNF
  • 16
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6
Q

Tofacitinib (Xeljanz)

  • relatively ___ onset
  • option for patients who fail ___
  • should NOT be used with ___
    (e.g., AZA, CYA, etc.) or ___
  • relatively ___ half live (3 h)
  • eliminated via ___ metabolism (~70%) (CYP3A and CYP2C19) and renal excretion (~30%)

moderate/severe renal impairment or moderate hepatic impairment:
- decrease daily dosage by 50%
- avoid in severe hepatic impairment

A
  • rapid
  • biologics
  • immunosuppressants, biologics
  • short
  • hepatic
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7
Q

Tofacitinib (Xeljanz) - Drug Interactions

strong CYP3A ___ (e.g., ketoconazole) or moderate CYP3A inhibitor with a strong ___ inhibitor (e.g., fluconazole )
* decrease daily dosage by 50%

strong CYP3A ___ (e.g., rifampin)
* avoid use

A
  • inhibitor
  • CYP2C19
  • inducer
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8
Q

Tofacitinib (Xeljanz) - ADRs

common:
- diarrhea, elevated ___ , headache, ___ , increased creatine phosphokinase,
nasopharyngitis, rash, URI

rare
* malignancy ( ___ and other)
* serious infection (including activation of latent ___ )
* neutropenia (see PI for recommendations)
* hypersensitivity
– angioedema and urticaria

A
  • cholesterol
  • shingles
  • lymphoma
  • TB
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9
Q

Tofacitinib (Xeljanz) - ADRs

black-box warning:
- increase ___ in RA patients 50 years and older with at least one CV risk factor
- ___ (PE, DVT, arterial) = increased risk in RA patients 50 years and older with at least one CV risk factor

FDA Drug Safety Communication (DSC) (02/2021)
- review of surveillance trial including 4,362 RA patients with at least 1 CV risk factor receiving either tofacitinib 5 mg
bid, 10 mg bid, or a TNF blocker
- increased risk of death, serious CV events, blood clots, and malignancies (lymphomas, lung cancer [esp. in
current/past smokers) with both doses of tofacitinib

A
  • mortality
  • thrombosis
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10
Q

Tofacitinib (Xeljanz) - ADRs

increased risk of serious infections (bacterial, viral, fungal)
- avoid if active infection
- tuberculin test ( ___ ), ___ , Hepatitis B/C prior to therapy
- ensure vaccinations up to date
- live vaccines contraindicated during tx and for __ mo after

A
  • PPD, CXR
  • 3
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11
Q

Tofacitinib (Xeljanz) - monitoring

  • CXR, ___
  • Hep B, C
  • ___ - q 3 months
  • ___ - q 1-2 months then q 3 months
  • ___ - 1-2 months after start, then periodically
  • ___ - 1-2 months after start, then periodically
  • infection - monitor for s/s
  • ___ exam - periodically
A
  • PPD
  • ANC
  • CBC
  • lipids
  • LFTs
  • skin
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12
Q

Upadacitinib (Rinvoq)

oral selective ___ inhibitor
- family of enzymes involved in immune signaling
- approved for ___ and ___
- who have had an inadequate response to or who are intolerant to ___ blockers

A
  • JAK
  • UC, CD
  • TNF
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13
Q

Upadacitinib (Rinvoq)

UC
- 45 mg daily for __ weeks then 15 mg daily
- can use 30 mg daily for refractory, severe, extensive disease
- D/C if response not adequate with ___ mg daily
- use lowest effective dose to maintain response

CD
- 45 mg daily for __ weeks then 15 mg daily
- can use 30 mg daily for refractory, severe, extensive disease
- D/C if response not adequate with ___ mg daily
- use lowest effective dose to maintain response

A
  • 8, 30
  • 16, 30
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14
Q

Upadacitinib (Rinvoq)

  • relatively ___ onset
  • option for patients who fail ___
  • should NOT be used with ___
    (e.g., AZA, CYA, etc.) or ___
  • relatively ___ half live (4 h)
  • eliminated via ___ metabolism (~35% esp.CYP3A), renal excretion (~25%), unchanged in feces (~38%)
  • dose adjustments required in renal impairment and mild-moderate hepatic impairment
  • not recommended in end stage renal disease or severe hepatic impairment
A
  • rapid
  • biologics
  • immunosuppressants, biologics
  • short
  • hepatic
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15
Q

Upadacitinib (Rinvoq) - Drug interactions

strong CYP3A ___
- 30 mg daily for ___, 15 mg daily for ___

strong CYP3A ___
- avoid use

A
  • inhibitor
  • induction, maintenance
  • inducer
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16
Q

Upadacitinib (Rinvoq) - ADRs

black-box warnings similar to ___
- unclear if same safety concerns extend to upadacitinib

risk of serious ___ (bacterial, viral, fungal)
- avoid if active infection
- tuberculin test ( ___ ), CXR, Hepatitis B/C prior to therapy
- ensure vaccinations up to date
- live vaccines contraindicated immediately ___ to and during therapy

A
  • tofacitinib
  • infections
  • PPD
  • prior
17
Q

Upadacitinib (Rinvoq) - ADRs

common:
- upper respiratory tract infection, ___ , increased creatine phosphokinase, elevated ___ , headache, ___

A
  • acne
  • lipids
  • shingles
18
Q

Upadacitinib (Rinvoq) - ADRs

rare:
- malignancy ( ___ and other)
- serious infection (including activation of latent ___ )
- increases in ___
- anemia
- neutropenia (see PI)
- lymphopenia (see PI)

A
  • lymphoma
  • TB
  • LFTs
19
Q

Upadacitinib (Rinvoq) - ADRs

rare
- hypersensitivity - angioedema and urticaria

potentially ___ , excreted in breast milk
- avoid in ___ and ___

A
  • teratogenic
  • pregnancy, lactation
20
Q

Upadacitinib (Rinvoq) - monitoring

  • ___ , ___
  • Hep B, C
  • ___ / ___ - q 3 months
  • ___ - q 1-2 months then q 3 months
  • ___ - 12 weeks after start, then periodically
  • ___ - 1-2 months after start, then periodically
  • ___ - monitor for s/s
  • ___ - exam periodically
A
  • CXR, PPD
  • ANC/ALC
  • CBC
  • lipids
  • LFTs
  • infection
  • skin
21
Q

Ozanimod (Zeposia)

oral selective ___ receptor modulator
- prevents ___ mobilization to inflammatory sites

approved for ___ only
- moderate – severe active UC
- 7 day dose titration: 0.23 mg daily days 1-4, 0.46 mg daily days 5-7, 0.92 mg daily day 8 and after
- if a dose is missed in the first __ weeks of treatment, ___ titration regimen

should not be used with non-corticosteroid ___ or immune-modulating drugs

A
  • S1P
  • lymphocyte
  • UC
  • 2, reinitiate
  • immunosuppressive
22
Q

Ozanimod (Zeposia)

contraindicated in patients who in last 6 months experienced:
- ___ , unstable angina, ___, TIA, decompensated heart failure
requiring hospitalization, Class III or IV heart failure
- with Mobitz type II 2 nd or 3rd degree AV block, sick sinus syndrome, or SA block unless patient has functioning
pacemaker
- with severe untreated ___ ___
- taking a ___ inhibito r- active metabolite of ozanimod is an ___ inhibitor
- half life ~ __ hours

metabolized by ALDH/ADH and CYP3A4
- active metabolites metabolized by CYP2C8
- not recommended for use in ___ impairment

A
  • MI, stroke
  • sleep apnea
  • MAO, MAO-B
  • 21
23
Q

Ozanimod (Zeposia) - ADRs

potential increased risk of infections
* potential risk of ___ (reported in patients treated with
S1P receptor modulators)
* recommended to vaccinate against ___ prior to
treatment if unvaccinated/not previously infected
* live-attenuated vaccines contraindicated (within __
month of start, during, or __ months after stopping)

___ /AV conduction delays
* consult with cardiologist if any underlying ___ ,
CV disease

A
  • infections
  • PML
  • varicella
  • 1, 3
  • bradycardia, arrhythmias
24
Q

Ozanimod (Zeposia) - ADRs

___ injury/elevated transaminases
* ~1-1.6% of patients with elevations of ALT to 5-fold
upper limit of normal, ~2.6-5.5% with elevations up to 3-fold upper limit of normal
* not recommended in patients with LFTs > __ -fold upper
limit of normal

moderate increase in ___ (~5 mm Hg)
* ___ crisis has been reported

  • ___ effects are dose dependent reductions in FEV1
  • ___ edema
  • reversible posterior leukeoencephalopathy syndrome
    ( ___ )/posterior reversible encephalopathy syndrome ( ___ )) (case report)
A
  • liver
  • 5
  • SBP
  • hypertensive
  • respiratory
  • macular
  • RPLS, PRES
25
Q

Ozanimod (Zeposia) - Drug interactions

___ and ___ drugs
* potential ___ crisis (active metabolite inhibits ___ )

combination ___ and ___
* potential additive effects on heart rate (not studied)

foods high in ___
- ___ inhibitors = contraindication (active metabolite inhibits ___ )

strong CYP2C8 inhibitors = ___ exposure of active metabolites, co-administration not recommended

strong CYP2C8 inducers = ___ exposure of active metabolites (possible reduced efficacy), co-administration should be avoided

A
  • adrenergic, serotonergic
  • hypertensive, MAO-B
  • BB, CCB
  • tyramine
  • MAO, MAO-B
  • increases
  • decreases
26
Q

Ozanimod (Zeposia) - monitoring

**“treat it like a ___ ”
- ___ , ___
- Hep B, C
- CBC - periodically
- ___ - periodically
- infection - monitor for s/s (for 3 months after d/c)
- ___ - each visit
- spirometry - if clinically indicated
- ___
- ___ - regular exams

A

biologic
- CXR, PPD
- LFTs
- BP
- ECG
- optho

27
Q

Estrasimod (Velsipity)

oral selective ___ receptor modulator - interacts with S1P receptors on ___
- prevents lymphocyte ___ to inflammatory sites

approved for ___ only
- moderate – severe active UC
- 2 mg daily

should not be used with non-corticosteroid ___ or immune-modulating drugs

A
  • S1P, lymphocytes
  • mobilization
  • UC
  • immunosuppressive
28
Q

Estrasimod (Velsipity)

contraindicated in patients who in last 6 months experienced:
- ___ , unstable angina, ___ , TIA, decompensated ___ requiring hospitalization, Class III or IV heart failure
- various cardiac ___ abnormalities
- half life ~ __ hours

metabolized by CYP2C8, CYP2C9, CYP3A4
- interactions possible (see PI)
- does not have same warnings regarding ___ inhibitors
as oxanimod

A
  • MI, stroke, HF
  • conduction
  • 30
  • MAO
29
Q

Estrasimod (Velsipity) - ADR

potential increased risk of infections
* potential risk of ___ due to __ virus infection
* recommended to vaccinate against ___ prior to treatment if unvaccinated/not previously infected
* live-attenuated vaccines contraindicated (within __
month of start, during, or __ months after stopping)
- ___ / AV conduction delays
* consult with cardiologist if any underlying ___ , CV disease

A
  • PML, JC
  • varicella
  • 1, 3
  • bradycardia
  • arrhythmias
30
Q

Estrasimod (Velsipity) - ADRs

___ injury/elevated transaminases
* not recommended in patients with severe ___ impairment

  • moderate increase in ___
  • ___ edema
  • reversible posterior leukeoencephalopathy syndrome
    ( ___ )/posterior reversible encephalopathy syndrome ( ___ )) (case report)
  • ___ effects (recall oxanimod is c/o with ___ ___)
A
  • liver
  • hepatic
  • SBP
  • macular
  • RPLS, PRES
  • respiratory, sleep apnea
31
Q

Estrasimod (Velsipity)

“treat it like a ___ ”

  • ___ , ___
  • Hep B, C*
  • CBC - periodically*
  • ___ - periodically*
  • ___ - monitor for s/s (for 3 months after d/c)
  • ___ - each visit*
  • spirometry if clinically indicated
  • ___
  • ___ regular exams*
A

biologic
- CXR, PPD
- LFTs
- infection
- BP
- ECG
- optho

32
Q

Antimicrobials

ciprofloxacin, metronidazole, rifamycin antibiotics
- can be used as ___ therapy for treatment of complications
* may be used in ___ associated with fistulas/abscesses, perianal
involvement, post resection

little efficacy in treating luminal disease, generally not recommended

ADRs
* agent specific ADRs
* resistance
* Clostridium difficile

A
  • adjunctive
  • CD

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