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. |
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. |
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. |
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. |
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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. 10/2022) |
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