Ulcerative Colitis Primary Care Support & Referral

Maintenance: 1.6-2.4 g daily once daily or in divided doses; Acute flare: 2.4-4.8 g once daily - long-term

30-50 mg/kg/day [child max 2400 mg]

(30-50 mg/kg daily in divided doses (max 2.4 g daily) under pediatric gastroenterology care)

Mesalazine is the first choice here; sulfasalazine is an alternative.

ACG Clinical Guideline: Ulcerative Colitis in Adults 2019

First-line 5-ASA maintenance agent for mild-to-moderate ulcerative colitis available in Egypt

Ulcerative Colitis - disease-level clinical article (ulcerative-colitis-referral-clinical.txt)

Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.

Initial or attacks: Oral: 1-2 gm daily up to 1-2 gm four times daily in evenly divided doses with dose intervals not exceeding 8 hours. Maintenance: Oral: 2 gm daily continued indefinitely to avoid relapse. - long-term

40-60 mg/kg/day [child max 2400 mg]

(Children over 2 years: Initial or attacks: 40 to 60 mg/kg daily divided into 3 to 6 doses; Maintenance: 20-30 mg/kg daily divided into 4 doses)

Egyptian National Drug Formulary - Gastrointestinal

First-line 5-ASA agent for mild-to-moderate ulcerative colitis; the source lists sulfasalazine as an equivalent first-line option to mesalazine.

40 mg once daily in the morning for 1-2 weeks, then taper by 5 mg weekly x 8 weeks tapering course

1-1.5 mg/kg/day [child max 40 mg]

(1-1.5 mg/kg once daily in the morning (max 40 mg) tapering over 6-8 weeks under specialist care)

ACG Clinical Guideline: Ulcerative Colitis in Adults 2019 for the regimen, with the dose from Egyptian National Drug Formulary - Endocrine System Drugs 2024, Prednisolone monograph (printed pages 169-170), which carries "GI diseases: During acute episodes of Crohn's disease or ulcerative colitis" among its indications and states "Oral: Usual Initial doses: 5 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses." and, for children, "Infants, Children, and Adolescents: Oral: initial: 0.1 to 2 mg/kg/day (4 to 60 mg/m2 BSA/day), in divided doses 1 to 4 times daily." The 40 mg start and the weekly taper are from the ACG guideline, which is not held in this corpus.

Oral corticosteroid for acute moderate-to-severe flare induction of remission under specialist guidance

1 to 3 mg/kg body weight daily by mouth, titrated inside that band on response and blood counts. SmPC verbatim, for indications other than transplantation: "In general, the starting dosage is from 1 to 3mg/kg bodyweight/day, and should be adjusted, within these limits, depending on the clinical response (which may not be evident for weeks or months) and haematological tolerance." Maintenance verbatim: "The maintenance dosage required may range from less than 1mg/kg bodyweight/day to 3mg/kg bodyweight/day". Check thiopurine methyltransferase before the first tablet - "Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe azathioprine toxicity from conventional doses of azathioprine and generally require substantial dose reduction." - A year before judging it. SmPC verbatim: "for patients with IBD, a treatment duration of at least twelve months should be considered and a response to treatment may not be clinically apparent until after three to four months of treatment."

1-3 mg/kg/day

(Same milligram-per-kilogram band as adults. SmPC verbatim: "Other indications: The posology in children is the same as in adults", with the caveat "Children considered to be overweight may require doses at the higher end of the dose range and therefore close monitoring of response to treatment is recommended".)

Azathioprine 50mg Film-Coated Tablets SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143)

Both claims come from documents that were opened. The disease article names the step and the drug, verbatim: "If patients are refractory to glucocorticoids, thiopurines or biological drugs can be added to therapy." and "Thiopurines are immunosuppressants such as azathioprine or 6-mercaptopurine." The SmPC's own indication list names the disease, verbatim: "Azathioprine is indicated for the treatment of moderate to severe inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis) in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy." Gastroenterology starts it; the regimen and its blood-count schedule are printed so a prescription can be continued and a falling count acted on. Egypt registers twelve azathioprine products, from AZARIN 50 mg at 24 EGP to IMURAN.

Subcutaneous. SmPC verbatim: "The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40 mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection." Where response fades: "Some patients who experience decrease in their response to 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week." - Reviewed at 8 weeks. SmPC verbatim: "Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. Humira therapy should not be continued in patients failing to respond within this time period."

(Licensed from 6 years, by weight. SmPC verbatim: "The recommended dose of Humira for patients from 6 to 17 years of age with ulcerative colitis is based on body weight" - under 40 kg, 80 mg at Week 0 and 40 mg at Week 2, then 40 mg every other week; 40 kg and over, 160 mg at Week 0 and 80 mg at Week 2, then 80 mg every other week. "There is no relevant use of Humira in children aged less than 6 years in this indication.")

The disease article lists it ahead of golimumab, nine adalimumab presentations are registered in Egypt against one golimumab pen, and biosimilars make it the cheaper of the two.

Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986)

The disease article names the class and the drug, verbatim: "If patients are refractory to glucocorticoids, thiopurines or biological drugs can be added to therapy." and "Biological drugs include anti-TNF-alpha drugs, such as infliximab, adalimumab, and golimumab." The SmPC's indication section names the disease, verbatim: "Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies." This is a hospital prescription; the regimen is printed so a shared-care clinic can recognise it, hold it during infection and check the schedule. Nine Egyptian adalimumab products are registered, HUMIRA and biosimilars among them, at several thousand EGP a pack.

Subcutaneous, dosed by body weight. SmPC verbatim, under 80 kg: "Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter". At 80 kg and over: "Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter". Steroids come down alongside - "During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines." - Reviewed after four doses. SmPC verbatim: "Available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period."

Not a paediatric prescription in ulcerative colitis. The SmPC's ulcerative colitis indication is written for adults only; paediatric use of Simponi is licensed in polyarticular juvenile idiopathic arthritis, a different disease.

Simponi 50 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122)

The disease article names it by name, verbatim: "Biological drugs include anti-TNF-alpha drugs, such as infliximab, adalimumab, and golimumab." The SmPC's indication section names the disease, verbatim: "Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies." Egypt registers one golimumab product, SIMPONI 50 mg prefilled pen, at several thousand EGP a pack.

Intravenous infusion, dosed by body weight. SmPC verbatim: "5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter." Re-timing is not free - "The safety and efficacy of re-administration, other than every 8 weeks, has not been established." - Judged after three doses. SmPC verbatim: "Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i.e. three doses. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period."

Age restriction: minimum 72 months

(Licensed from 6 years, same milligram-per-kilogram dose. SmPC verbatim, for ulcerative colitis in patients 6 to 17 years: "5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Available data do not support further infliximab treatment in paediatric patients not responding within the first 8 weeks of treatment". Below 6 years the SmPC states that "no recommendation on a posology can be made".)

Remsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709)

The disease article names the step and the drug, verbatim: "If patients are refractory to glucocorticoids, thiopurines or biological drugs can be added to therapy." and "Biological drugs include anti-TNF-alpha drugs, such as infliximab, adalimumab, and golimumab." The SmPC's indication section names the disease, verbatim: "Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies." It completes the article's own list of three anti-TNF drugs, the other two of which already sit on the card. Gastroenterology starts it; the regimen is printed so a shared-care clinic can recognise it, hold it during infection and know when the next infusion is due. Egypt registers one infliximab product, REMICADE 100 mg powder for intravenous infusion at roughly 5,900 EGP a vial, and a course is several vials per infusion at adult body weights.

Intravenous infusion at a fixed 300 mg dose, not by weight. US label verbatim: "Week 0: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes. Week 2: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes. Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2. Intravenous Infusion: Administer ENTYVIO 300 mg by intravenous infusion over approximately 30 minutes and then every eight weeks thereafter. Subcutaneous Injection: Administer ENTYVIO 108 mg subcutaneously once every 2 weeks." - Judged at week 14 and stopped there if nothing has changed. US label verbatim: "Discontinue therapy in patients who show no evidence of therapeutic benefit by Week 14."

Not a paediatric prescription on this label. US label verbatim: "Safety and effectiveness of ENTYVIO in pediatric patients have not been established." A child or adolescent with inflammatory bowel disease belongs with paediatric gastroenterology.

ENTYVIO (vedolizumab) for injection US prescribing information, section 1 Indications and Usage, section 2.2 Recommended Dosage in Adults with Ulcerative Colitis and Crohn's Disease, section 4 Contraindications and section 5 Warnings and Precautions (DailyMed SetID 6e94621c-1a95-4af9-98d1-52b9e6f1949c)

The disease article names the drug and how it works: the newest class of biologics are the anti-adhesion molecule inhibitors, vedolizumab among them, which blocks the alpha-4-beta-7 integrin. It places this biologic step at the point where a patient has not responded to glucocorticoids, when a thiopurine or a biological drug is added. The US label's indication section covers adults with moderately to severely active ulcerative colitis. The card already carried all three of the article's anti-TNF drugs; vedolizumab is the next class it names, and the one whose action stays confined to the gut - which is why it is often chosen where systemic immunosuppression is the concern.