Ulcerative Colitis Treatments- MPR

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	—	800mg	del-rel tabs	Adults: 1600mg 3 times daily for 6wks. Children: Not established.
	Apriso	0.375g	ext-rel caps	Adults: Maintenance: 1.5g once daily in the AM. 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.
sulfasalazine	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.
budesonide	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: IV regimen: infuse over 30mins. 300mg IV at Weeks 0, 2, and 6, then every 8wks thereafter. SC regimen: give SC inj into thighs, abdomen, or upper arms. After the first 2 IV doses given (Week 0 and Week 2), may be switched to 108mg SC every 2wks at Week 6 and thereafter. For those with clinical response or remission beyond Week 6, may be switched from IV infusion to SC inj. For both regimens: discontinue if no therapeutic benefit by Week 14. <18yrs: Not established.
vedolizumab⁴	Entyvio	108mg/0.68mL	soln for SC inj
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.
ustekinumab	Stelara	45mg/0.5mL, 90mg/mL	soln for SC inj
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.
tofacitinib⁵	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.
upadacitinib	Rinvoq⁵	15mg, 30mg, 45mg	ext-rel tabs	Adults: Induction: 45mg once daily for 8wks. Maintenance: 15mg once daily; may consider 30mg once daily for refractory, severe or extensive disease (discontinue if inadequate response with 30mg dose). Severe renal impairment (CrCl 15–<30mL/min), mild to moderate hepatic impairment, concomitant strong CYP3A4 inhibitors: 30mg once daily for 8wks (induction); 15mg once daily (maintenance). Children: Not established.
Sphingosine 1-Phosphate Receptor Modulator
ozanimod	Zeposia	0.23mg, 0.46mg, 0.92mg	caps	Adults: Initiate dose titration regimen (Days 1–4): 0.23mg once daily; (Days 5–7): 0.46mg once daily. Maintenance (starting Day 8): 0.92mg once daily. Re-initiation after dose interruption (during 1st 2wks): start with Day 1 of titration regimen; (after the 1st 2wks): continue treatment as planned. Mild or moderate hepatic impairment: 0.92mg once every other day starting on Day 8 after initial titration. 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.
	Abrilada	10mg/0.2mL, 20mg/0.4mL, 40mg/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: Not established.
	Amjevita	10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL
	Cyltezo	10mg/0.2mL, 20mg/0.4mL, 40mg/0.8mL
	Hadlima	40mg/0.4mL (citrate-free), 40mg/0.8mL
	Hulio	20mg/0.4mL, 40mg/0.8mL
	Hyrimoz	10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL
	Idacio	40mg/0.8mL (citrate-free)
	Yuflyma	20mg/0.2mL, 40mg/0.4mL, 80mg/0.8mL (all citrate-free)
	Yusimry	40mg/0.8mL
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.
	Renflexis
	Avsola
	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. 12/2023)

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