Ulcerative Colitis Treatments

ULCERATIVE COLITIS TREATMENTS
Generic Brand Strength Form Dose
MILDLY TO MODERATELY ACTIVE DISEASE
Aminosalicylate
balsalazide disodium Colazal 750mg caps Adults: 2.25g 3 times daily for 8wks; max 12wks.
Children: <5yrs: not recommended. ≥5yrs: 2.25g 3 times daily or 750mg 3 times daily; max 8wks.
mesalamine Apriso 0.375g ext-rel caps Adults: Maintenance: 1.5g once daily in the AM.
Children: Not established.
Asacol HD 800mg del-rel tabs Adults: 1600mg 3 times daily for 6wks.
Children: Not established.
Canasa 1g supp Adults: 1g once daily at bedtime for 3−6wks. Retain supp in rectum for at least 1−3hrs.
Children: Not established.
Delzicol 400mg del-rel caps Adults: 800mg 3 times daily for 6wks. Maintenance: 1.6g daily in 2−4 divided doses.
Children: <5yrs: not established. Give twice daily for 6wks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in AM + 1200mg in the afternoon).
Lialda 1.2g del-rel tabs Adults: Induction: 2.4–4.8g once daily. Maintenance: 2.4g once daily.
Children: <24kg: not established. Take once daily. 24–35kg (Weeks 0 to 8): 2.4g; (after Week 8): 1.2g. >35–50kg (Weeks 0 to 8): 3.6g; (after Week 8): 2.4g. >50kg (Weeks 0 to 8): 4.8g; (after Week 8): 2.4g.
Pentasa 250mg, 500mg controlled-rel caps Adults: 1g four times daily for up to 8wks.
Children: Not established.
Rowasa 4g/
60mL
enema Adults: 4g (60mL) daily at bedtime for 3−6wks. Retain enema for 8hrs.
Children: Not established.
olsalazine sodium Dipentum 250mg caps Adults: Maintenance: 500mg twice daily with meals.
Children: Not established.
sulfasalazine Azulfidine 500mg scored tabs Adults: Initially 1−2g daily, increase gradually to 3−4g daily in equally divided doses after meals until symptoms controlled. Maintenance: 2g daily; max 4g/day.
Children: <6yrs: not established. ≥6yrs: initially 40−60mg/kg/day in 3−6 doses. Maintenance: 30mg/kg/day in 4 doses.
Azulfidine EN-tabs 500mg e-c tabs
Corticosteroid1
budesonide Uceris2 9mg ext-rel tabs Adults: Remission induction: 9mg once daily in the AM for up to 8wks.
Children: Not established.
Uceris Rectal Foam3 2mg emulsion Adults: Remission induction: apply 1 metered dose per rectum twice daily (AM & PM) for 2wks, then 1 metered dose once daily (PM) for 4wks.
Children: Not established.
MODERATELY TO SEVERELY ACTIVE DISEASE
Integrin Receptor Antagonist
vedolizumab4 Entyvio 300mg/
vial
pwd for IV infusion after reconsti
tution
≥18yrs: Infuse over 30mins. 300mg at Weeks 0, 2, and 6, then every 8wks thereafter. Discontinue if no therapeutic benefit by Week 14.
<18yrs: Not established.
Interleukin-12 and Interleukin-23 Antagonist
ustekinumab Stelara 130mg/
26mL
soln for IV infusion after dilution Adults: Induction: give as a single IV infusion over 1hr. ≥18yrs (≤55kg): 260mg; (>55–85kg): 390mg; (>85kg): 520mg. Maintenance: 90mg SC given 8wks after initial IV dose, then every 8wks thereafter.
Children: Not established.
Janus Kinase Inhibitor
tofacitinib5 Xeljanz 5mg, 10mg tabs Adults: 10mg twice daily for ≥8wks, then 5mg twice daily. May continue 10mg twice daily dose for up to max 16wks if needed; limit to those with loss of response. Discontinue after 16wks if inadequate response with 10mg twice daily.
Children: Not established.
Xeljanz XR 11mg, 22mg ext-rel tabs Adults: 22mg once daily for ≥8wks, then 11mg once daily. May continue 22mg once daily dose for up to max 16wks if needed; limit to those with loss of response. Discontinue after 16wks if inadequate response with 22mg once daily.
Children: Not established.
TNF-Alpha Blocker
adalimumab Humira 10mg/
0.1mL, 10mg/
0.2mL, 20mg/
0.2mL, 20mg/
0.4mL, 40mg/
0.4mL, 40mg/
0.8mL, 80mg/
0.8mL
soln for SC inj Adults: Initially 160mg SC on Day 1 (in 1 day or divided over 2 days), then 80mg on Day 15. Maintenance: on Day 29, start 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. Discontinue in those without evidence of clinical remission by 8wks of therapy.
Children: <5yrs: not recommended. ≥5yrs (20–<40kg): initially 80mg SC on Day 1, then 40mg on Day 8 and Day 15. Maintenance: on Day 29, start 40mg every other week or 20mg every week. ≥40kg: initially 160mg on Day 1 (given in 1 day or divided over 2 days), then 80mg on Day 8 and Day 15. Maintenance: on Day 29, start 80mg every other week or 40mg every week. Continue recommended pediatric dose in those who turn 18yrs of age and are well-controlled.
golimumab6 Simponi 50mg/
0.5mL, 100mg/
mL
soln for SC inj Adults: Initially 200mg SC at Week 0, followed by 100mg at Week 2, then 100mg every 4wks.
<18yrs: Not established.
infliximab Remicade 100mg/
vial
pwd for IV infusion after reconsti
tution and dilution
Adults: Infuse over ≥2hrs. 5mg/kg at Weeks 0, 2, 6, then once every 8wks. Heart failure: max 5mg/kg.
Children: <6yrs: Not established. ≥6yrs: Same as adult dose.
infliximab-abda Renflexis
infliximab-

axxq
Avsola
infliximab-

dyyb
Inflectra
NOTES

1 Systemic corticosteroids are not recommended for maintenance of remission.

2 The ACG Clinical Guideline for UC recommends initiating oral budesonide multi-matrix (MMX) 9mg/day for patients with mildly active disease who are intolerant or nonresponsive to oral/rectal 5-ASA. For mildly to moderately active UC nonresponsive to oral 5-ASA, add budesonide MMX 9mg/day. For moderately to severely active disease, budesonide MMX has not been studied for maintenance of remission.

3 For adults with active, mild to moderate distal ulcerative colitis extending up to 40cm from the anal verge.

4 For adults who have had inadequate response with 1 or more standard therapies (eg, immunomodulators, TNF blockers).

5 For adults who have had inadequate response or intolerance to 1 or more TNF blockers.

6 For adults who have demonstrated corticosteroid dependence or have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine or 6-MP.

 

Not an inclusive list of medications, indications, or dosing details. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling.

REFERENCES

Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J of Gastroenterology. 2019;114(3):384-413. doi: 10.14309/ajg.0000000000000152. Accessed April 19, 2022.

(Rev. 4/2022)