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Pharm II Exam 4 > GI Agents: IBS, IBD > Flashcards

GI Agents: IBS, IBD Flashcards

1
Q

IBD stands for what?

A

Inflammatory bowel disease

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2
Q

IBS stands for what?

A

Irritable bowel syndrome

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3
Q

Two conditions of IBD?

A

CD: Crohn’s, UC: Ulcerative colitis

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4
Q

IBS-C stands for what?

A

IBS w/ consipation

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5
Q

IBS-D stands for what?

A

IBS w/ diarrhea

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6
Q

Crohn’s disease affects which part of the GI tract?

A

Any part of the GI tract (mouth to anus)
*Most often: portion of SI before LI/colon

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7
Q

Ulcerative colitis affects which part of the GI tract?

A

LI (colon) and rectum

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8
Q

Non-pharm tx for IBD?

A

Nutrition, Surgery

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9
Q

Nutrition recommendations for IBD?

A

-Eliminate foods that exacerbate disease sx (pt. specific, do not restrict wide range w/o evidence)
-Enteral nutrition if possible
-Parenteral nutrition only when bowel rest needed
-Probiotics studied

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10
Q

What can enteral nutrition help facilitate?

A

Remission induction

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11
Q

Conditions that can require parenteral nutrition?

A

failed enteral, perf, vomiting, short bowel synd., severe stenosis

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12
Q

Probiotics contain what bacteria?

A

Non-patho E. coli, bifidobacteria, lactobacilli, S. thermophilus

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13
Q

Colectomy rate for UC?

A

0.55-20% (wide range)
*can be curative

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14
Q

10 year cumulative risk of surgery for CD?

A

40-50%

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15
Q

Indications for surgery for IBD?

A

Complications (fistulas), Uncontrolled disease even w/ max therapy, Long standing disease (8-10 yrs), Prophylactic measure against colon cancer

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16
Q

Surgery in CD cases results in what?

A

High rates of recurrence

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17
Q

First line tx for mild-severe UC?

A

Mesalamine (aminosalicylates)
aka 5-ASA’s

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18
Q

Are 5-ASA’s effective for CD tx?

A

Less effective, can be trialed for mild-mod disease

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19
Q

Absorption of 5-ASA’s?

A

Rapidly/completely in SI, poorly in colon

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20
Q

Drug formulations of Mesalamine are designed for what?

A

Delivery to the affected areas of the GI tract/prevent premature absorption

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21
Q

Mesalamine products differ by what?

A

Areas of bowel where drug is released & Frequency of dosing

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22
Q

Mesalamines and pregnancy?

A

Fetal malformations not observed

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23
Q

Common ADR’s of Mesalamines?

A

N/V, headache

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24
Q

Formulation and site of action of Sulfasalazine?

A

IR & enteric coated tabs
Act @ colon

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25
Q

Formulation and site of action of Rowasa (Mesalamine)?

A

Enema
Acts @ Rectum-distal colon

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26
Q

Formulation and site of action of Canasa (Mesalamine)?

A

Suppository
Acts @ Rectum

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27
Q

Formulation and site of action of Asacol (Mesalamine)?

A

Coated in pH resin (dissolves at pH 6-7 in distal ileum/colon)
Acts @ Rectum-Ileum

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28
Q

Formulation and site of action of Pentasa (Mesalamine)?

A

Timed-release microgranules in SI
Acts @ Rectum-Jejunum

**widest distribution of action

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29
Q

Formulation and site of action of Lialda (Mesalamine)?

A

Coated in pH resin (dissolves in colon)
Acts @ Colon

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30
Q

Formulation and site of action of Apriso (Mesalamine)?

A

Coated in pH resin (dissolves at pH 6-7 in distal ileum/colon)
Acts @ Colon

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31
Q

Formulation and site of action of Balsalazide?

A

Azo compound
Acts @ Colon

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32
Q

Formulation and site of action of Olsalazine?

A

Azo compound
Acts @ Colon

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33
Q

Avoid what med w/ sulfa allergy?

A

Sulfasalazine

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34
Q

Composition of Sulfasalazine?

A

Sulfonamide moiety (sulfapyridine) and Mesalamine (5-ASA) joined by diazo bond (reduced absorption w/ PO) in same molecule

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35
Q

First line tx for UC and CD?

A

Sulfasalazine

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36
Q

Pregnancy w/ Sulfasalazine?

A

Folate supplement recommended w/ use d/t sulfa component

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37
Q

Common ADR’s of Sulfasalazine?

A

N/V, headaches, rash, anemias

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38
Q

Severe ADR’s of Sulfasalazine?

A

Hepatotoxicity, thrombocytopenia, nephrolithiasis

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39
Q

Use of corticosteroids in acute to mod-severe UC and CD?

A

Induce remission

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40
Q

ROAs for corticosteroids in IBD?

A

PO, PR, IV

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41
Q

Common ADRs of corticosteroids for IBD?

A

Hyperglycemia, infections, electrolyte disturbances

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42
Q

Long-term ADRs of corticosteroids for IBD?

A

Osteoporosis, HTN, myopathy, dyslipidemia, adrenal (HPA axis) suppression

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43
Q

Use of corticosteroids w/ pregnancy?

A

Ok for acute flares, avoid maintenance therapy
**Prednisone preferred
**Avoid Dexamethasone

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44
Q

Budesonide (corticosteroid) use for IBD?

A

PO controlled release for terminal ileum or colon depending on product

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45
Q

Extensive first-pass metabolism of Budesonide minimizes what?

A

Systemic exposure (designed for longer term use/less side effects)

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46
Q

Immunomodulator meds for IBD?

A

Azathioprine, Mercaptopurine, Methotrexate, Cyclosporine

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47
Q

Indication for Immunomodulator meds for IBD?

A

Patients who:
-fail 5-ASA tx
-refractory or dependent on corticosteroids

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48
Q

Immunmodulators can be used as preferred therapy along w/ which meds for mild-mod CD in the terminal ileum/ascending colon?

A

Prednisone or Budesonide

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49
Q

Immunmodulators can be used in conjunction w/ what meds for IBD?

A

Mesalamine derivatives, Corticosteroids, TNF-a agonsists

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50
Q

How long should immunmodulators be used in IBD before benefits are observed?

A

Extended periods of time (a few weeks - 12 months)

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51
Q

Long-term use of immunmodulators for IBD may be associated w/ risk of developing what?

A

Significant adverse effects such as infection and lymphoma

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52
Q

Azathioprine (AZA)/Mercaptopurine (6-MP) is what kind of drug?

A

Immunosuppressant

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53
Q

AZA is a prodrug of what?

A

6-MP

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54
Q

In patients with TPMT polymorphisms, tx with AZA/6-CMP may require what?

A

30-70% dose reduction
*genotype or phenotype testing recommended prior to tx

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55
Q

AZA/CMP with pregnancy?

A

Used commonly in IBD without detriment
**continue if current therapy is stable, don’t start as new drug if patient is already pregnant

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56
Q

Common ADRs of AZA/6-CMP?

A

Rash, arthralgia, malaise, nausea, infection

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57
Q

Severe ADRs of AZA/6-CMP?

A

Bone marrow suppression, pancreatitis, liver dysfunction
*Monitor LFTs,CBC

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58
Q

Methotrexate indications?

A

Reserved for refractory moderate-severe CD (not used as 1st line for induction)

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59
Q

Mechanism of methotrexate?

A

Antifolate/immunosuppressive agent

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60
Q

Methotrexate use w/ pregnancy?

A

KNOWN ABORTIFACIENT (former category X)
**STOP 3 MONTHS PRIOR TO PREGNANCY

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61
Q

Common ADRs of Methotrexate?

A

N/V, photosensitivity, rash

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62
Q

Severe/long-term ADRs of Methotrexate?

A

Bone marrow suppression, pancreatitis, hepatitis, pulmonary fibrosis

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63
Q

Short term benefit of Cyclosporine (Neoral)?

A

Treatment of acute, severe/fulminant UC to avoid colectomy in pts who fail corticosteroids

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64
Q

MOA of Cyclosporine (Neoral)?

A

Calcineurin inhibitor/immunosuppressant

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65
Q

Cyclosporine (Neoral) use with pregnancy?

A

Has been used in pregnant pts w/ success, an option for pts w/ severe disease

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66
Q

Are biologics safe in pregnancy?

A

Generally OK to use

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67
Q

Anti-TNF alpha biologics for IBD?

A

Adalimumab, Certolizumab, Infliximab, Golimumab

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68
Q

Anti-TNF alpha biologics MOA?

A

Monoclonal antibodies that bind to endogenous TNF alpha blocks activity

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69
Q

Recommended screening for Anti-TNF alpha biologics for IBD prior to therapy?

A

HBV, HCV, Varicella, HIV, TB
*avoid reactivation of dormant virus w/ suppression of immune system

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70
Q

Use Anti-TNF alpha biologics for IBD with caution in patients with what?

A

Heart failure

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71
Q

Janus kinase (JAK) inhibitor biologics for IBD?

A

Tofacitinib, Upadacitinib

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72
Q

MOA of Janus kinase (JAK) inhibitor biologics?

A

Inhibit signalling pathway for enzymes that stimulate hematopoiesis & immune cell function (dec. inflammatory markers)

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73
Q

IL-21 and IL-23 inhibitor biologic therapy med for IBD?

A

Ustekinumab

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74
Q

IL-21 and IL-23 are thought to play a role in what for IBD?

A

Inflammatory process

75
Q

Intergrin receptor antagonists biologic therapy med for IBD?

A

Natalizumab, Vedolizumab

76
Q

MOA for Intergrin receptor antagonists biologic therapy meds for IBD?

A

Monoclonal antibodies directed against cell adhesion molecules (inhibit migration of memory T-cells across endothelium into inflamed GI tissue)

77
Q

Are biosimilars interchangeable with biologics?

A

No, need specific Rx for biosimilars (same clinical effect but slight structural differences –> manufactured separately)

78
Q

What is Infliximab (Remicade) for IBD?

A

Prototype biologic associated w/ most robust clinical data to support its use

79
Q

Use of Infliximab (Remicade) with pregnancy?

A

Safe during 1st/2nd trimester, concerns for fetal transfer

80
Q

Common ADRs of Infliximab (Remicade) for IBD?

A

Infusion related rxn, infections, rash

81
Q

50% of patients may lose efficacy for Infliximab (Remicade) after 1 yr of tx for IBD due to what?

A

Development of antidrug antibodies (immunogenic)

82
Q

Reason for PPD test before Infliximab (Remicade) for IBD?

A

The drug causing TB reactivation (C/I in TB)

83
Q

Dosing of Adalimumab (Humira) for IBD?

A

Initial high dose to induce remission, then switch to lower dose

84
Q

Administration of Adalimumab (Humira) for IBD?

A

(SC) Inject info thigh/lower abdomen (comes in pen - can be injected by pt at home), rotate injection site

85
Q

Syringes for Adalimumab (Humira), Golimumab (Simponi), and Certolizumab (Cimzia) may contain what?

86
Q

ADRs of Adalimumab (Humira) for IBD?

A

Rash, ADA, injection site rxn, headache, infection

87
Q

Administration of Certolizumab (Cimzia) for IBD?

A

(SC) Prefilled syringes and vials (vials must be reconstituted), thigh or abdomen, rotate injection sites

88
Q

ADRs of Certolizumab (Cimzia)?

A

Rash, ADA, injection site rx, headache, infection

89
Q

Warnings for Certolizumab (Cimzia)?

A

Rare demyelinating CNS disease (optic neuritis, seziures, MS, Guillian Barre)

90
Q

Golimumab (Simponi) administration for IBD?

A

(SC) self-administer w/ auto-injector

91
Q

Monitoring for Golimumab (Simponi) tx for IBD?

A

CBC w/ diff, Infections, HF

92
Q

Administration of Tofacitinib (Xeljanz) for IBD?

A

PO - approved for UC

93
Q

BBW for Tofacitinib (Xeljanz)?

A

-Inc. risk of serious infection, cancers, lymphoma
-Inc. mortality & thrombosis risk w/ 10mg dose compared to 5mg of TNF inhibitors (if sx of thrombosis: D/C med and evaluate)

94
Q

How is Tofacitinib (Xeljanz) available?

A

Through specialty/network pharmacies

95
Q

Dosage of Tofacitinib (Xeljanz) for IBD?

A

Start high & transition to lower
(can go back up higher if response lost)

96
Q

Baseline labs for Tofacitinib (Xeljanz)?

A

Lymphocyte, Neutrophil/platelet, Hemoglobin, Lipids, HR & BP

97
Q

Lab monitoring at 4-8 weeks after starting Tofacitinib (Xeljanz)?

A

Neutrophil/platelet, Hemoglobin, Lipids

98
Q

Lab monitoring Q3 months after starting Tofacitinib (Xeljanz)?

A

Lymphocyte, Neutrophil/platelet, Hemoglobin

99
Q

Periodic lab monitoring for Tofacitinib (Xeljanz)?

A

Lipids, HR & BP

100
Q

Administration of Upadacitinib (Rinvoq) for IBD?

A

PO
*just approved for CD

101
Q

BBW of Upadacitinib (Rinvoq) for IBD?

A

Inc. risk of infections, cancers, thrombosis
Inc. mortality (similar to Xeljanz)

102
Q

Administration of Ustekinumab (Stelara) for IBD?

A

Weight-based dose initially IV, then SubQ use every 8 wks

103
Q

Rare instance of what occurring with Ustekinumab (Stelara) for IBD?

A

Reversible posterior leukoencephalopathy syndrome (RPLS)

Heterogenous: headache, altered MS, seizures

104
Q

Administration of Natalizumab (Tysabri) for IBD?

A

IV every 4 wks

105
Q

Taper what meds if patient is taking them once response is observed with Natalizumab (Tysabri) for IBD?

106
Q

D/C Natalizumab (Tysabri) for IBD when?

A

No benefit by wk 12, unable to taper steroids w/in 6mos, steroid use for >3mos of the year

107
Q

What is required with use of Natalizumab (Tysabri) for IBD?

A

Patient enrollment in CD TOUCH program d/t adverse effects: all parties must be informed of risks
(restricts use to prescribers, infusion centers, pharmacies involved)

108
Q

Main risk with use of Natalizumab (Tysabri) for IBD?

A

Progressive multifocal leukoencephalopathy (PML)

109
Q

What is Progressive multifocal leukoencephalopathy (PML)?

A

Assoc w/ exposure to JC virus, occurs in immunocompromised pts, risk increases w/ duration of tx >2yrs/prev use of immunosuppressants/pre-existing anti-JC virus antibodies

110
Q

Adverse effects of Natalizumab (Tysabri) for IBD?

A

Headache, fatigue, nausea, hypersensitivity rxn, infections

111
Q

Administration of Vedolizumab (Entyvio) for IBD?

A

Induction & maintenance infusion
Infuse over 30 min, observe for infusion rxns

112
Q

Monitoring with Vedolizumab (Entyvio) for IBD?

A

LFTs, infection

113
Q

Adverse effects of Vedolizumab (Entyvio) for IBD?

A

Headache, arthralgia, antibody development

114
Q

Patients should be up to date on what when taking Vedolizumab (Entyvio) for IBD?

A

Immunizations

115
Q

Do not give live vaccines if patients are taking what meds for IBD?

116
Q

Use of Ozanimod (Zeposia) for IBD?

A

Option for high risk or mod-severe active UC in outpatients & those w/ UC who are corticosteroid dependent

117
Q

Mechanism of Ozanimod (Zeposia) for IBD?

A

Sphingosine 1-Phosphatase (S1P) receptor modulator: inhibits lymphocytes from leaving lymph nodes/migrating to GI tract

118
Q

Administration of Ozanimod (Zeposia) for IBD?

A

PO (initial days 5-7 and maintenance day 8)

119
Q

Adverse effects of Ozanimod (Zeposia) for IBD?

A

Infection, bradycardia, BP changes (early on: hypotension, later: risk for HTN), macular edema, headache, increased LFTs

120
Q

C/I of Ozanimod (Zeposia) for IBD?

A

MI, unstable angina, stroke, TIA, decompensated HF, Mobitz type II second/third degree AV block, sick sinus synd in last 6 mos, sleep apnea, use of MAOI

121
Q

Considerations with use of Ozanimod (Zeposia) for IBD with pregnancy?

A

CONTRADINDICATED, use contraceptives during use and 3 months after d/c

122
Q

Abx use in IBD?

A

Possible adjunctive therapy, perineal CD w/ fistula, infectious abscess or pouchitis

123
Q

Abx for IBD?

A

Metronidazole PO/IV, Ciprofloxacin PO/IV

124
Q

Long term adverse effects of Abx use for IBD?

A

abx resistance, predisposition to C. diff, neurotoxicity secondary to metro use

125
Q

Short term adverse effects of Abx use?

A

Metronidazole: Nausea, metallic taste, peripheral neuropathy
Cipro: GI upset, QT prolongation, tendon rupture, photosensitivity

126
Q

Abx use for IBD considerations w/ pregnancy?

A

Metro: crosses placenta, cleft palate/lip in 1st trimester, may be ok for certain infections
Cipro: no increased major birth defects/miscarriage/adverse maternal outcomes

127
Q

Nonpharmacologic therapy for IBS?

A

Diet (avoid exacerbating food-lactose, etc.), Inc. insoluble fiber intake may help w/ IBS-C, Drink 8+ cups of fluid/day

128
Q

Alternative medicine options for IBS?

A

Acupuncture, Cognitive-behavioral therapy, Hypnotherapy

129
Q

Recommended nonpharmacologic/adjunctive therapy for IBS?

A

Strong recommendations: NO fecal transplant, soluble (NOT non-soluble) fiber
Conditional recommendations: FODMAP diet, NO probiotics, gut-directed psychotherapy, peppermint

130
Q

Fiber supplements for IBS-C?

A

Psyllium, Methylcellulose, Calcium Polycarbophil

131
Q

MOA of Fiber supplements for IBS-C?

A

Absorbs water to inc. peristalsis

132
Q

Side effects of Fiber supplements for IBS-C?

A

Bloating, flatulence (increase dose gradually)

133
Q

Antidiarheals for IBS-D?

A

Loperamide and Diphenocylate/atropine

134
Q

MOA of Loperamide for IBS-D?

A

Acts on opioid R (antidiarrheal)

135
Q

Indications for Loperamide for IBS-D?

A

Diarrhea, urgency, incontinence

136
Q

Side effects of Loperamide for IBS-D?

A

Constipation

137
Q

MOA of Diphenocylate/atropine for IBS-D?

A

Antidiarrheal that inhibits GI motility and propulsion

138
Q

Indication for Diphenocylate/atropine for IBS-D?

139
Q

Side effects of Diphenocylate/atropine for IBS-D?

A

Constipation, tachyarrhythmia

140
Q

Antispasmodics for IBS-D?

A

Hyoscyamine, Dicyclomine

141
Q

MOA of Hyoscyamine, Dicyclomine (antispasmodics) for IBS-D?

A

Anticholinergic agent

142
Q

Indications for Hyoscyamine, Dicyclomine (antispasmodics) for IBS-D?

A

Pain, post-prandial urgency

143
Q

Side effects of Hyoscyamine, Dicyclomine (antispasmodics) for IBS-D?

A

Xerostomia, urinary retention, tachycardia, anticholinergic effects (drying)

144
Q

Meds for IBS-D or abdominal pain?

A

Amitriptyline, Peppermint oil (OTC)

145
Q

MOA of Amitriptyline for IBS-D or abdominal pain?

A

Tri-cyclic antidepressant

146
Q

MOA of Peppermint oil?

A

Thought to cause smooth muscle relaxation in gut (limited studies)

147
Q

Indication for Amitriptyline, Peppermint oil (OTC)?

A

Pain or other discomfort in IBS-D

148
Q

Side effects of Amitriptyline?

A

Anticholinergic effects, sedation, orthostatic hypotension, possible wt. gain (start low, inc gradually)

149
Q

Side effects of peppermint oil (OTC)?

A

Heartburn, N/V, avoid w/ severe GERD, gallbladder dz, pregnancy

150
Q

Pharmacologics for IBS-D?

A

Alosetron, Rifaximin, Eluxadoline

151
Q

MOA of Alosetron for IBS-D?

A

Selective 5HT3 R antagonist in gut

152
Q

MOA of Rifaximin for IBS-D?

A

Inhibits RNA synthesis

153
Q

Indications for Rifaximin for IBS-D?

A

Pain, urgency, diarrhea in IBS-D

154
Q

Side effects of Alosetron, Rifaximin?

A

Constipation

155
Q

MOA of Eluxadoline for IBS-D?

A

Mixed mu agonist, kappa agonist, delta antagonist on opioid R’s

156
Q

Take Eluxadoline for IBS-D with what?

157
Q

Indications for Eluxadoline for IBS-D?

A

Pain, stool consistency in IBS-D

158
Q

Side effects of Eluxadoline for IBS-D?

A

Constipation, nausea, abdominal pain, increased LFTs

159
Q

Alosteron is only available through what program?

A

LOTRONEX program d/t side effects

159
Q

Indications for Alosteron?

A

ONLY indicated for females w/ sx for >6 months that don’t respond to conventional tx

160
Q

Warnings/precautions of Alosteron?

A

C/I in pts w/ hx of constipation, ischemic colitis, intestinal obstruction, Crohn’s, UC, severe hepatic impairment

D/C in pts who develop constipation (ischemic colitis reported w/ fatalities)

161
Q

Monitoring of pts on Alosteron?

A

Resolution of sx, Severe constipation

162
Q

Dose adjustments for Eluxadoline?

A

Decrease in patients w/o gallbladder

163
Q

Warnings/precautions w/ use of Eluxadoline?

A

D/c use w/ constipation >4 days or sphincter Oddi spasms
C/I with pmhx of pancreatitis, alcohol use disorder, liver disease

164
Q

Monitoring for pts using Eluxadoline?

A

New or worsening abdominal pain (biliary/pancreatic issues) esp in those w/o gallbladder, LFTs

165
Q

Pharmacologic agents for IBS-C?

A

Lubiprostone, Linaclotide, Plecanatide, Tenapanor

166
Q

MOA of Lubiprostone for IBS-C?

A

Chloride channel activator

167
Q

MOA of Linaclotide, Plecanatide for IBS-C?

A

Guanylate Cyclase Agonist

168
Q

Indications of Lubiprostone for IBS-C?

A

Pain, IBS-C in females >18y/o

169
Q

Indications of Linaclotide, Plecanatide for IBS-C?

A

IBS-C in adults

170
Q

Side effects of Lubiprostone for IBS-C?

A

Diarrhea, headache, nausea, edema, dizzy

171
Q

Side effects of Linaclotide, Plecanatide for IBS-C?

A

Diarrhea, flatulence, GI upset

172
Q

MOA of Tenapanor for IBS-C?

A

Sodium/hydrogen exchanger 3 indicator

173
Q

When to take Tenapanor for IBS-C?

A

Before breakfast and dinner

174
Q

Side effects of Tenapanor for IBS-C?

175
Q

Warnings/Precautions of Lubiprostone?

A

Pregnancy category C (fetal loss in animal studies)
C/I in known mechanical bowel obstruction

176
Q

Monitoring for Lubiprostone?

A

Liver function in hepatic impairment, first dose may cause dyspnea (acute, usually goes away w/ use), K+ (risk of hypokalemia)

177
Q

Lubiprostone onset?

A

Can work fast, may have BM within 24 hrs

178
Q

Warnings/precautions of Linaclotide/Plecanatide?

A

C/I if known mechanical bowel obstruction
D/C and alert provider if severe diarrhea
Administration w/ high fat meal may worsen diarrhea

179
Q

Monitoring with Lubiprostone/Plecanatide?

A

Efficacy (change in bowel movements)

180
Q

Reserve Tenapanor for what patients?

A

Pts who have failed other therapy

181
Q

Warnings/precautions with Tenapanor?

A

C/I in pts <6y/o
Avoid use in 6-12y/o
Renal impairment may inc. risk of hyperkalemia and diarrhea

182
Q

Monitoring with Tenapanor?

A

Frequency of dehydration, K+ in pts w/ renal impairment

Pharm II Exam 4 (3 decks)

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