# Ulcerative Colitis Primary Care Support & Referral

- Category: chronic
- Review status: reviewed (every claim checked against a document named on this page)
- Sources: 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. · ACG Clinical Guideline: Ulcerative Colitis in Adults 2019 · Azathioprine 50mg Film-Coated Tablets SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143) · Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986) · Simponi 50 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122) · 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) · Ulcerative Colitis - disease-level clinical article (ulcerative-colitis-referral-clinical.txt) · 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)
- Verified date: 2026-08

## Verified against

- 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.
- ACG Clinical Guideline: Ulcerative Colitis in Adults 2019
- Ulcerative Colitis - disease-level clinical article (ulcerative-colitis-referral-clinical.txt)
- Egyptian National Drug Formulary - Gastrointestinal
- Ulcerative Colitis Primary Care Support & Referral - disease-level clinical article (ulcerative-colitis-referral-full.txt)
- Azathioprine 50mg Film-Coated Tablets SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143)
- Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986)
- Simponi 50 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122)
- 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)
- 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)

## Treatment metadata

- Mesalazine — 800 mg — oral.solid
- Referral & safety-netting (no drug therapy)
- Sulfasalazine — 500 mg — oral.solid
- Azathioprine — oral.solid
- Adalimumab — injection
- Golimumab — injection
- Infliximab — injection
- Vedolizumab — 300 mg — injection
- Prednisolone — 5 mg — oral.solid

## Complete treatment card

```text
ULCERATIVE COLITIS PRIMARY CARE SUPPORT & REFERRAL
Sources: 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. · ACG Clinical Guideline:
         Ulcerative Colitis in Adults 2019 · Azathioprine 50mg Film-Coated Tablets SmPC sections
         4.1, 4.2 and 4.4 (eMC product 11143) · Humira 40 mg solution for injection in pre-filled
         pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986) · Simponi 50 mg solution for
         injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122) · 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) · Ulcerative Colitis - disease-level clinical article
         (ulcerative-colitis-referral-clinical.txt) · 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)
Review status: REVIEWED against 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., ACG Clinical Guideline: Ulcerative Colitis in
               Adults 2019, Ulcerative Colitis - disease-level clinical article
               (ulcerative-colitis-referral-clinical.txt), Egyptian National Drug
               Formulary - Gastrointestinal, Ulcerative Colitis Primary Care
               Support & Referral - disease-level clinical article (ulcerative-
               colitis-referral-full.txt), Azathioprine 50mg Film-Coated Tablets
               SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143), Humira 40 mg
               solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and
               4.4 (eMC product 7986), Simponi 50 mg solution for injection in pre-
               filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122),
               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),
               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)  (2026-08)

IS IT THIS? - reference only, to read alongside your own examination
  SYMPTOMS - what the patient reports (3)
    - Bloody diarrhea, with or without mucus, is the main symptom  [bloody diarrhoea · diarrhoea]
    - Onset is usually gradual, with spontaneous remissions followed by later relapses  [relapse]
    - Stopping smoking or using NSAIDs can bring on a flare
  SIGNS - what you find (3)
    - Extraintestinal features occur in 10-30% of patients, including eye inflammation, joint pain,
      and skin lesions such as erythema nodosum or pyoderma gangrenosum, tracking with disease
      activity  [joint pain · redness · skin lesions]
    - Axial joint involvement such as sacroiliitis or ankylosing spondylitis occurs independent of
      how active the bowel disease is
    - Primary sclerosing cholangitis is a liver-related extraintestinal finding tied to a higher
      colorectal cancer risk
  TESTS (8)
    - Diagnosis is clinical, supported by endoscopy and biopsy, plus a negative stool workup for
      infection
    - A stove-pipe appearance on barium enema can be seen in longstanding disease
    - Colonoscopy typically shows loss of the normal vascular pattern, granularity, friability, and
      ulceration starting in the rectum and spreading continuously upward
    - Inflammatory markers such as ESR, CRP, and white cell count typically rise, especially during
      a flare
    - 60-70% of patients test positive for perinuclear ANCA, though it also occurs in some Crohn
      disease patients
    - Anti-Saccharomyces cerevisiae antibodies are more typical of Crohn disease, so testing both
      antibodies together helps distinguish the two
    - A rising carcinoembryonic antigen level can indicate a flare
    - Under 1% of patients with a low fecal calprotectin turn out to have inflammatory bowel disease
  IF NOT THIS - what else fits (8)
    - Colonic infection can look identical to this condition on exam and endoscopy, so infection is
      checked for before diagnosing it
    - Crohn disease is on the differential
    - Parasitic colitis is on the differential
    - Tuberculosis is on the differential
    - Radiation colitis is on the differential
    - Colon cancer is on the differential
    - Toxic megacolon is on the differential
    - Bacterial or viral gastroenteritis is on the differential
  Source  StatPearls "Ulcerative Colitis" - disease-level clinical article
  Status  traced to the source above

Rx: Main treatment  |  Thiopurine steroid-sparing maintenance - specialist-initiated
    (gastroenterology)  |  Anti-TNF biologic for glucocorticoid-refractory disease - hospital-
    initiated  |  Gut-selective anti-integrin biologic when conventional therapy fails - hospital-
    initiated

MAIN TREATMENT - choose one, plus any add-on marked below
1. MESALAZINE                                             [1st line]
   Adult    Maintenance: 1.6-2.4 g daily once daily or in divided doses; Acute flare: 2.4-4.8 g once
            daily - long-term
   Peds     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)
            3kg -> 90-150 mg/day                     4kg -> 120-200 mg/day
            5kg -> 150-250 mg/day                    6kg -> 180-300 mg/day
            7kg -> 210-350 mg/day                    8kg -> 240-400 mg/day
            9kg -> 270-450 mg/day                    10kg -> 300-500 mg/day
            11kg -> 330-550 mg/day                   12kg -> 360-600 mg/day
            13kg -> 390-650 mg/day                   14kg -> 420-700 mg/day
            15kg -> 450-750 mg/day                   16kg -> 480-800 mg/day
            17kg -> 510-850 mg/day                   18kg -> 540-900 mg/day
            19kg -> 570-950 mg/day                   20kg -> 600-1000 mg/day
            21kg -> 630-1050 mg/day                  22kg -> 660-1100 mg/day
            23kg -> 690-1150 mg/day                  24kg -> 720-1200 mg/day
            25kg -> 750-1250 mg/day                  26kg -> 780-1300 mg/day
            27kg -> 810-1350 mg/day                  28kg -> 840-1400 mg/day
            29kg -> 870-1450 mg/day                  30kg -> 900-1500 mg/day
            31kg -> 930-1550 mg/day                  32kg -> 960-1600 mg/day
            33kg -> 990-1650 mg/day                  34kg -> 1020-1700 mg/day
            35kg -> 1050-1750 mg/day                 36kg -> 1080-1800 mg/day
            37kg -> 1110-1850 mg/day                 38kg -> 1140-1900 mg/day
            39kg -> 1170-1950 mg/day                 40kg -> 1200-2000 mg/day
            41kg -> 1230-2050 mg/day                 42kg -> 1260-2100 mg/day
            43kg -> 1290-2150 mg/day                 44kg -> 1320-2200 mg/day
            45kg -> 1350-2250 mg/day                 46kg -> 1380-2300 mg/day
            47kg -> 1410-2350 mg/day                 48kg -> 1440-2400 mg/day
            49kg -> 1470-2400 mg/day (upper capped)  50kg -> 1500-2400 mg/day (upper capped)
   Choice   Mesalazine is the first choice here; sulfasalazine is an alternative.
   Source   ACG Clinical Guideline: Ulcerative Colitis in Adults 2019
   Why      First-line 5-ASA maintenance agent for mild-to-moderate ulcerative colitis available in
            Egypt
   Caution  SPECIALIST REFERRAL REQUIRED: All IBD patients require regular gastroenterologist
            follow-up and surveillance colonoscopy.
            Check baseline renal function (creatinine) before starting and at 3 months, then
            annually (risk of interstitial nephritis).
            Unexplained bleeding, bruising, fever, or sore throat requires immediate FBC to check
            for blood dyscrasias.
   Egypt    SALAZINE 500MG 30 CAPS.          PHAROPHARMA         63.00 EGP (2.10/unit)
                -> ? strength differs
            MESALA 400MG 50 CAPS.            MASH PREMIERE      230.00 EGP (4.60/unit)
                -> ? strength differs
            SALOFALK 500MG 20 TAB.           MINA PHARM > ...   116.00 EGP (5.80/unit)
                -> ? strength differs
            SALCROZINE 1GM  100TABLETS       FAES FARMA > ...  1250.00 EGP (12.50/unit)
                -> ? strength differs
            IMZACOL 500MG 50 S.R F.C. TAB    AMRIYA             120.00 EGP  [? strength differs]
            PENTASA 1 GM 50 SACHETS          FERRING PHARM...  1000.00 EGP  [? strength differs]
            PENTASA 4 GM 30 SACHETS          FERRING PHARM...  1590.00 EGP  [? strength differs]
            PENTASA XTEND 2 GM 60 SACHETS    FERRING PHARM...  1980.00 EGP  [? strength differs]
            PENTASA 1GM/100ML 7 ENEMAS       FERRING PHARM...   248.50 EGP
                -> ? strength differs, ? different route - not oral solid

2. REFERRAL & SAFETY-NETTING (NO DRUG THERAPY)            [1st line]
   Adult    
   Source   Ulcerative Colitis - disease-level clinical article (ulcerative-colitis-referral-
            clinical.txt)
   Why      Carries the referral criteria and warning signs for this condition, which apply
            whichever treatment is chosen.
   Caution  RED FLAG - The trigger for escalating from mesalazine to glucocorticoids is failure to
            achieve remission within two weeks.
            RED FLAG - The indications for surgical referral are failure of medical therapy,
            intractable fulminant colitis, toxic megacolon, perforation, uncontrollable bleeding,
            intolerable medication side effects, strictures, high-grade/multifocal dysplasia,
            cancer, or growth retardation in children.
            RED FLAG - Toxic megacolon is the leading cause of death in ulcerative colitis.
            RED FLAG - Severe disease requiring escalated or urgent care is defined as more than
            four rectal bleeding episodes per day with systemic features and hypoalbuminemia.

3. SULFASALAZINE                                          [1st line]
   Adult    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
   Peds     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)
            Over 2 years: Attacks: 40 to 60 mg/kg daily, divided into 3 to 6 doses. Maintenance: 20
            to 30 mg/kg daily, divided into 4 doses.
            3kg -> 120-180 mg/day                    4kg -> 160-240 mg/day
            5kg -> 200-300 mg/day                    6kg -> 240-360 mg/day
            7kg -> 280-420 mg/day                    8kg -> 320-480 mg/day
            9kg -> 360-540 mg/day                    10kg -> 400-600 mg/day
            11kg -> 440-660 mg/day                   12kg -> 480-720 mg/day
            13kg -> 520-780 mg/day                   14kg -> 560-840 mg/day
            15kg -> 600-900 mg/day                   16kg -> 640-960 mg/day
            17kg -> 680-1020 mg/day                  18kg -> 720-1080 mg/day
            19kg -> 760-1140 mg/day                  20kg -> 800-1200 mg/day
            21kg -> 840-1260 mg/day                  22kg -> 880-1320 mg/day
            23kg -> 920-1380 mg/day                  24kg -> 960-1440 mg/day
            25kg -> 1000-1500 mg/day                 26kg -> 1040-1560 mg/day
            27kg -> 1080-1620 mg/day                 28kg -> 1120-1680 mg/day
            29kg -> 1160-1740 mg/day                 30kg -> 1200-1800 mg/day
            31kg -> 1240-1860 mg/day                 32kg -> 1280-1920 mg/day
            33kg -> 1320-1980 mg/day                 34kg -> 1360-2040 mg/day
            35kg -> 1400-2100 mg/day                 36kg -> 1440-2160 mg/day
            37kg -> 1480-2220 mg/day                 38kg -> 1520-2280 mg/day
            39kg -> 1560-2340 mg/day                 40kg -> 1600-2400 mg/day
            41kg -> 1640-2400 mg/day (upper capped)  42kg -> 1680-2400 mg/day (upper capped)
            43kg -> 1720-2400 mg/day (upper capped)  44kg -> 1760-2400 mg/day (upper capped)
            45kg -> 1800-2400 mg/day (upper capped)  46kg -> 1840-2400 mg/day (upper capped)
            47kg -> 1880-2400 mg/day (upper capped)  48kg -> 1920-2400 mg/day (upper capped)
            49kg -> 1960-2400 mg/day (upper capped)  50kg -> 2000-2400 mg/day (upper capped)
   Source   Egyptian National Drug Formulary - Gastrointestinal
   Why      First-line 5-ASA agent for mild-to-moderate ulcerative colitis; the source lists
            sulfasalazine as an equivalent first-line option to mesalazine.
   Caution  Treatment should be discontinued if renal function deteriorates.
            Patients with G-6-PD deficiency should be monitored closely for hemolytic anemia.
            Folic acid deficiency may occur due to inhibition of absorption and metabolism of folic
            acid.
            Reactions may include severe cutaneous reactions, myocarditis, pericarditis, nephritis,
            hepatitis, pneumonitis, and hematologic abnormalities.
   Egypt    SALAZOSIN 500MG 10 ENTERIC F.C. TAB. DELTA PHARMA > SCIENCE PHARMA              7.50 EGP
            SALAZOPYRINE 500MG 20 EN-TAB.    KAHIRA > PFIZER     19.00 EGP
            SALAZO-SULPH PYRINE 500MG 20 EN-TAB. KAHIRA                                    60.00 EGP
            COLOSALAZINE-EC 500 MG 20 E.C.TABS. ALEXANDRIA > ACDIMA INTERNATIONAL TR...    67.00 EGP

4. PREDNISOLONE                                           [add-on - not a substitute]
   Adult    40 mg once daily in the morning for 1-2 weeks, then taper by 5 mg weekly x 8 weeks
            tapering course
   Peds     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)
            3kg -> 3-4.5 mg/day                  4kg -> 4-6 mg/day
            5kg -> 5-7.5 mg/day                  6kg -> 6-9 mg/day
            7kg -> 7-10.5 mg/day                 8kg -> 8-12 mg/day
            9kg -> 9-13.5 mg/day                 10kg -> 10-15 mg/day
            11kg -> 11-16.5 mg/day               12kg -> 12-18 mg/day
            13kg -> 13-19.5 mg/day               14kg -> 14-21 mg/day
            15kg -> 15-22.5 mg/day               16kg -> 16-24 mg/day
            17kg -> 17-25.5 mg/day               18kg -> 18-27 mg/day
            19kg -> 19-28.5 mg/day               20kg -> 20-30 mg/day
            21kg -> 21-31.5 mg/day               22kg -> 22-33 mg/day
            23kg -> 23-34.5 mg/day               24kg -> 24-36 mg/day
            25kg -> 25-37.5 mg/day               26kg -> 26-39 mg/day
            27kg -> 27-40 mg/day (upper capped)  28kg -> 28-40 mg/day (upper capped)
            29kg -> 29-40 mg/day (upper capped)  30kg -> 30-40 mg/day (upper capped)
            31kg -> 31-40 mg/day (upper capped)  32kg -> 32-40 mg/day (upper capped)
            33kg -> 33-40 mg/day (upper capped)  34kg -> 34-40 mg/day (upper capped)
            35kg -> 35-40 mg/day (upper capped)  36kg -> 36-40 mg/day (upper capped)
            37kg -> 37-40 mg/day (upper capped)  38kg -> 38-40 mg/day (upper capped)
            39kg -> 39-40 mg/day (upper capped)  40kg -> 40 mg/day (capped)
            41kg -> 40 mg/day (capped)           42kg -> 40 mg/day (capped)
            43kg -> 40 mg/day (capped)           44kg -> 40 mg/day (capped)
            45kg -> 40 mg/day (capped)           46kg -> 40 mg/day (capped)
            47kg -> 40 mg/day (capped)           48kg -> 40 mg/day (capped)
            49kg -> 40 mg/day (capped)           50kg -> 40 mg/day (capped)
   Source   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.
   Why      Oral corticosteroid for acute moderate-to-severe flare induction of remission under
            specialist guidance
   Caution  Do NOT use for maintenance therapy in ulcerative colitis.
            Taper gradually to avoid adrenal crisis.
            Monitor blood pressure, blood glucose, and bone density.
   Egypt    HOSTACORTIN H 5MG 30 TAB.        SANOFI              12.00 EGP (0.40/unit)
            PREDNISOLONE 5 MG 20 TABS.       ARAB DRUG COM...    24.00 EGP (1.20/unit)
            PREDILONE 5MG 10 TAB. (25 STRIPS PACK) KAHIRA                    250.00 EGP (25.00/unit)
            EPICOPRED 5 MG 30 ORODISPERSIBLE TABS. EIPICO                                  69.00 EGP
            PREDNISOLONE-EVA 5 MG 30 ORODISPERSIBLE TABS. EVA PHARMA                       79.50 EGP
            DISPRELONE-OD 5 MG 30 ORODISPERSABLE TABS. ANDALOUS PHARMA                     84.00 EGP
            SOLUPRED ORO 5 MG 30 ORODISPERSIBLE TABS. SANOFI WINTHROP > SANOFI             84.00 EGP
            ACETASEE 1% EYE DROPS (SUSP.) 5 ML RAMEDA                                       7.50 EGP
                -> ? strength differs, ? different route - not oral solid
            PREDNIS 5MG/5ML SYRUP 100 ML     PHAROPHARMA          9.50 EGP
                -> ? strength differs, ? different route - not oral solid


THIOPURINE STEROID-SPARING MAINTENANCE - SPECIALIST-INITIATED (GASTROENTEROLOGY)
5. AZATHIOPRINE                                           [2nd line]
   Adult    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."
   Peds     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".)
            3kg -> 3-9 mg/day      4kg -> 4-12 mg/day     5kg -> 5-15 mg/day
            6kg -> 6-18 mg/day     7kg -> 7-21 mg/day     8kg -> 8-24 mg/day
            9kg -> 9-27 mg/day     10kg -> 10-30 mg/day   11kg -> 11-33 mg/day
            12kg -> 12-36 mg/day   13kg -> 13-39 mg/day   14kg -> 14-42 mg/day
            15kg -> 15-45 mg/day   16kg -> 16-48 mg/day   17kg -> 17-51 mg/day
            18kg -> 18-54 mg/day   19kg -> 19-57 mg/day   20kg -> 20-60 mg/day
            21kg -> 21-63 mg/day   22kg -> 22-66 mg/day   23kg -> 23-69 mg/day
            24kg -> 24-72 mg/day   25kg -> 25-75 mg/day   26kg -> 26-78 mg/day
            27kg -> 27-81 mg/day   28kg -> 28-84 mg/day   29kg -> 29-87 mg/day
            30kg -> 30-90 mg/day   31kg -> 31-93 mg/day   32kg -> 32-96 mg/day
            33kg -> 33-99 mg/day   34kg -> 34-102 mg/day  35kg -> 35-105 mg/day
            36kg -> 36-108 mg/day  37kg -> 37-111 mg/day  38kg -> 38-114 mg/day
            39kg -> 39-117 mg/day  40kg -> 40-120 mg/day  41kg -> 41-123 mg/day
            42kg -> 42-126 mg/day  43kg -> 43-129 mg/day  44kg -> 44-132 mg/day
            45kg -> 45-135 mg/day  46kg -> 46-138 mg/day  47kg -> 47-141 mg/day
            48kg -> 48-144 mg/day  49kg -> 49-147 mg/day  50kg -> 50-150 mg/day
   Source   Azathioprine 50mg Film-Coated Tablets SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143)
   Why      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.
   Caution  RED FLAG - bone marrow suppression. Stop the drug the moment blood counts begin to fall
            abnormally: white cells and platelets can keep dropping even after it has been stopped.
            Tell every patient taking azathioprine to report at once any sign of infection,
            unexplained bruising or bleeding, or anything else suggesting the marrow is failing.
            Blood counts on a schedule, not on suspicion. For the first 8 weeks, check a full blood
            count including platelets every week - more often on a high dose, or where renal or
            liver function is badly impaired. After that, monthly, and never with more than 3 months
            between counts.
            Long-term cancer risk. Immunosuppression, azathioprine among it, raises the risk of
            lymphoproliferative disease and of other cancers - skin cancers of both melanoma and
            non-melanoma type; sarcomas, whether Kaposi's or not; and carcinoma in situ of the
            cervix. Sun protection and skin surveillance matter.
            No live vaccines. Withhold any live vaccine until 3 months or more have passed since the
            last dose of azathioprine.
            Pregnancy is a specialist conversation, not a clinic decision. Do not give azathioprine
            to a woman who is pregnant, or who may become pregnant before long, without a careful
            weighing of the risk against the benefit.
            Allopurinol raises azathioprine levels sharply; the combination needs the azathioprine
            dose cut and specialist supervision.
   Egypt    AZATHIOPRINE RPG 50 MG 100 TABS. RPG LIFE SCIE...   156.00 EGP (1.56/unit)
            AZATHIOPRINE-MYLAN 50 MG 100 TABS. MYLAN S.A.S > ONE PHARMA ...   198.00 EGP (1.98/unit)
            AZATHIOPRINE-EVAPHARMA 25 MG 30 F.C.TABS. EVA PHARMA               60.00 EGP (2.00/unit)
            AZATHIOPRINE RPG 50 MG 30 TABS.  RPG LIFE SCIE...    68.00 EGP (2.27/unit)
            AZATHIOPRINE-EVAPHARMA 50 MG 30 F.C.TABS. EVA PHARMA               96.00 EGP (3.20/unit)
            AZATHIOPRINE-EVAPHARMA 75 MG 30 F.C.TABS. EVA PHARMA              123.00 EGP (4.10/unit)
            IMURAN 50 MG 100 F.C.TABS.       ASPEN PHARMA ...   508.00 EGP (5.08/unit)
            AZATHIOPRINE-EVAPHARMA 100 MG 30 F.C.TABS. EVA PHARMA             153.00 EGP (5.10/unit)


ANTI-TNF BIOLOGIC FOR GLUCOCORTICOID-REFRACTORY DISEASE - HOSPITAL-INITIATED - choose one
6. ADALIMUMAB                                             [3rd line]
   Adult    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."
   Peds     6 to 17 years: By body weight. Under 40 kg: 80 mg at Week 0, 40 mg at Week 2, then 40 mg
            every other week. 40 kg and over: 160 mg at Week 0, 80 mg at Week 2, then 80 mg every
            other week.
            (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.")
   Choice   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.
   Source   Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4
            (eMC product 7986)
   Why      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.
   Caution  Screen for tuberculosis and treat active infection before the first dose. TNF
            antagonists leave a patient more open to serious infection, so watch for infection -
            tuberculosis above all - before treatment, during it, and after it. Egypt is a country
            where latent tuberculosis is common, so this screen is not a formality.
            Contraindicated outright in some patients: active tuberculosis; other severe infection
            such as sepsis; opportunistic infection; and moderate or severe heart failure, NYHA
            class III or IV.
            Hold the dose during an acute infection and restart only once it is controlled. Do not
            start Humira in anyone carrying an active infection, chronic or localised included,
            until that infection is under control.
            The drug lingers. Clearing adalimumab from the body can take as long as four months, so
            stay alert for infection well past the last injection.
            Started and reviewed by a gastroenterology service. Humira is begun and supervised by
            specialists experienced in the conditions it is licensed for.
   Egypt    ADALIMAB-EIPICO 40 MG/0.8ML PREFILLED SYRINGE RELIANCE LIFE SCIENCES > E...  4675.00 EGP
            ADALIMAB-EVA 40 MG/0.4ML 2 PREFILLED SYRINGE ALVOTECH > EVA PHARMA           7000.00 EGP
            HYRIMOZ 40MG/0.8ML 2 PREF. SYRINGES SANDOZ > NOVARTIS PHARMA SANDOZ DIVI...  8435.00 EGP
            AMGEVITA 40MG/0.8ML 2 PREF. SYRINGES AMGEN MANUFACTURING LIMITED > AMGEN... 11680.00 EGP
            HULIO 40MG/0.8ML 2 PREF. SYRINGES TERUMO > ONE PHARMA MEDICS                11680.00 EGP
            HUMIRA 40MG/0.4ML 2 PREF. SYRINGES ABBVIE LTD. > MULTIPHARMA                14113.00 EGP

7. GOLIMUMAB                                              [3rd line]
   Adult    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."
   Peds     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.
   Source   Simponi 50 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3
            (eMC product 8122)
   Why      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.
   Caution  Screen for tuberculosis and treat active infection before the first dose. TNF
            antagonists leave a patient more open to serious infection, so watch for infection -
            tuberculosis above all - before treatment, during it, and after it. Egypt is a country
            where latent tuberculosis is common, so this screen is not a formality.
            Contraindicated outright in some patients: active tuberculosis; other severe infection
            such as sepsis; opportunistic infection; and heart failure that is moderate or severe,
            meaning NYHA class III or IV.
            Colorectal surveillance continues on treatment. Anyone with ulcerative colitis at raised
            risk of dysplasia or colon cancer - long-standing disease, primary sclerosing
            cholangitis, or a past dysplasia or colon cancer - needs surveillance at regular
            intervals, both before therapy begins and throughout the course of the illness.
            Started and supervised by a gastroenterology service - a qualified physician experienced
            in the licensed indications, ulcerative colitis among them, begins it and oversees it.
   Egypt    SIMPONI 50MG/0.5 ML PREFILLED PEN BAXTER AG > JANSSEN CILAG                 13597.00 EGP
                -> ? different route - not injection

8. INFLIXIMAB                                             [3rd line]
   Adult    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."
   Peds     Age restriction: minimum 72 months
            6 to 17 years: 5 mg/kg as an intravenous infusion, then 5 mg/kg at 2 and 6 weeks after
            the first infusion, then every 8 weeks. Below 6 years no posology can be recommended.
            (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".)
   Source   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)
   Why      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.
   Caution  RED FLAG - tuberculosis is excluded before the first infusion, not after it. Every
            patient must be assessed for tuberculosis, active and latent alike, before infliximab is
            started, using appropriate screening - a tuberculin skin test, a chest X-ray, an
            interferon gamma release assay, or some combination of them. Note too that most of the
            reported cases lay outside the lungs. Latent tuberculosis is common in Egypt, so this is
            a real gate rather than a formality.
            Infection risk runs for months after the last infusion. Watch closely for infection,
            tuberculosis included, before, during and after infliximab. Because clearing the drug
            can take as long as six months, keep watching for that whole period, and never give a
            further dose to a patient who has developed a serious infection or sepsis. Blocking TNF
            can also mask the signs of infection, fever among them, so the usual warning may never
            appear.
            Contraindicated outright in some patients: tuberculosis; other severe infection such as
            sepsis, abscess or opportunistic infection; and heart failure that is moderate or
            severe, meaning NYHA class III or IV.
            An intravenous hospital drug, not a prescription pad drug. The infusion is given by
            trained staff able to recognise a reaction to it, because infliximab can cause acute
            reactions during the infusion, anaphylactic shock among them, and delayed
            hypersensitivity as well.
            Record the brand and batch at every infusion. A biological medicine is traceable only if
            the trade name and the batch number of what was actually given are written down clearly.
            Infliximab biosimilars are not interchangeable without a record of which was given.
   Egypt    REMICADE 100 MG PD. VIAL FOR I.V. INF. 10 ML JANSSEN CILAG > SOFICOPHARM     5936.00 EGP


GUT-SELECTIVE ANTI-INTEGRIN BIOLOGIC WHEN CONVENTIONAL THERAPY FAILS - HOSPITAL-INITIATED
9. VEDOLIZUMAB                                            [3rd line]
   Adult    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."
   Peds     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.
   Source   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)
   Why      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.
   Caution  Tuberculosis is assessed before the first infusion. US label verbatim: "Consider
            evaluating patients for TB infection prior to initiating treatment with ENTYVIO.
            Treatment with Entyvio should not be administered to patients with active TB infection.
            Initiate treatment of latent TB prior to administering ENTYVIO." Latent tuberculosis is
            common in Egypt, so this is a real gate rather than a formality.
            Infection risk is lower than with the anti-TNF drugs but it is not absent. US label
            verbatim: "Patients treated with ENTYVIO are at increased risk for developing
            infections. Serious infections reported in clinical trials include anal abscess, sepsis
            (some fatal), tuberculosis (TB), salmonella sepsis, Listeria meningitis, giardiasis, and
            cytomegaloviral colitis." and "Treatment with ENTYVIO should not be initiated in
            patients with a clinically important active infection until the infection resolves or is
            adequately treated."
            RED FLAG - new neurological symptoms. US label verbatim: "Monitor patients on ENTYVIO
            for any new onset, or worsening, of neurological signs and symptoms. Typical signs and
            symptoms associated with PML are diverse, progress over days to weeks, and include
            progressive weakness on one side of the body or clumsiness of limbs, disturbance of
            vision, and changes in thinking, memory, and orientation leading to confusion and
            personality changes... If PML is suspected, withhold dosing with ENTYVIO and refer to a
            neurologist; if confirmed, discontinue dosing permanently."
            Infusion and hypersensitivity reactions, including anaphylaxis. US label verbatim:
            "Infusion-related reactions and hypersensitivity reactions have been reported, including
            anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood
            pressure and heart rate. These reactions may occur with the first or subsequent
            infusions of ENTYVIO and may vary in their time of onset from during infusion or up to
            several hours post-infusion." It is given by staff able to treat anaphylaxis, and a
            prior severe reaction to it is a contraindication.
            Liver injury. US label verbatim: "ENTYVIO should be discontinued in patients with
            jaundice or other evidence of significant liver injury."
            Get the vaccinations done first. US label verbatim: "Prior to initiating treatment with
            ENTYVIO, all patients should be brought up to date with all immunizations according to
            current immunization guidelines."
            A hospital drug, not a prescription-pad drug. Egypt registers one product, ENTYVIO 300
            mg vial for infusion at roughly 48,800 EGP, and an eight-weekly schedule means that cost
            recurs. The regimen is printed here so a shared-care clinic can recognise it, hold it
            during infection and know when the next infusion is due.
   Egypt    ENTYVIO 300 MG VIAL FOR INF.     TAKEDA > PHAR... 48824.00 EGP

Prices are indicative (dataset snapshot 2026-06); verify with the pharmacy.
```

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Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement.

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