{ "schema_version": 1, "kind": "condition", "id": "ulcerative-colitis-referral", "name": "Ulcerative Colitis Primary Care Support & Referral", "category": "chronic", "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", "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)", "verified_date": "2026-08", "treatments": [ { "id": 1787, "generic": "Mesalazine", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 800.0, "adult_dose": "Maintenance: 1.6-2.4 g daily once daily or in divided doses; Acute flare: 2.4-4.8 g once daily", "adult_duration": "long-term", "dose_source": "ACG Clinical Guideline: Ulcerative Colitis in Adults 2019", "rationale": "First-line 5-ASA maintenance agent for mild-to-moderate ulcerative colitis available in Egypt", "cautions": [ "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." ], "peds_mgkg_low": 30.0, "peds_mgkg_high": 50.0, "peds_max_mg": 2400.0, "peds_basis": "day", "peds_unit": "mg", "peds_note": "30-50 mg/kg daily in divided doses (max 2.4 g daily) under pediatric gastroenterology care", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": [ { "weight_kg": 10, "low_mg": 300, "high_mg": 500, "capped": false }, { "weight_kg": 20, "low_mg": 600, "high_mg": 1000, "capped": false }, { "weight_kg": 30, "low_mg": 900, "high_mg": 1500, "capped": false }, { "weight_kg": 40, "low_mg": 1200, "high_mg": 2000, "capped": false } ], "brands": [ { "trade_name": "SALAZINE 500MG 30 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PHAROPHARMA", "price_egp": 63.0, "pack_count": 30, "unit_price": 2.1, "strength_mg": 500.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "MESALA 400MG 50 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MASH PREMIERE", "price_egp": 230.0, "pack_count": 50, "unit_price": 4.6, "strength_mg": 400.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SALOFALK 500MG 20 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MINA PHARM > DR.FALK-GERMANY", "price_egp": 116.0, "pack_count": 20, "unit_price": 5.8, "strength_mg": 500.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SALCROZINE 1GM 100TABLETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FAES FARMA > RX HEALTHCARE", "price_egp": 1250.0, "pack_count": 100, "unit_price": 12.5, "strength_mg": 1000.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMZACOL 500MG 50 S.R F.C. TAB", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMRIYA", "price_egp": 120.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PENTASA 1 GM 50 SACHETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FERRING PHARMACEUTICALS > MULTIPHARMA", "price_egp": 1000.0, "pack_count": null, "unit_price": null, "strength_mg": 1000.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PENTASA 4 GM 30 SACHETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FERRING PHARMACEUTICALS > MULTIPHARMA", "price_egp": 1590.0, "pack_count": null, "unit_price": null, "strength_mg": 4000.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PENTASA XTEND 2 GM 60 SACHETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FERRING PHARMACEUTICALS > MULTIPHARMA", "price_egp": 1980.0, "pack_count": null, "unit_price": null, "strength_mg": 2000.0, "exact_strength": false, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PENTASA 1GM/100ML 7 ENEMAS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FERRING PHARMACEUTICALS > MULTIPHARMA", "price_egp": 248.5, "pack_count": null, "unit_price": null, "strength_mg": 1000.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1789, "generic": "Referral & safety-netting (no drug therapy)", "line": 1, "is_adjunct": false, "form": null, "strength_mg": null, "adult_dose": null, "adult_duration": null, "dose_source": "Ulcerative Colitis - disease-level clinical article (ulcerative-colitis-referral-clinical.txt)", "rationale": "Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": null, "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "ulcerative-colitis-referral" }, { "id": 1790, "generic": "Sulfasalazine", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 500.0, "adult_dose": "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.", "adult_duration": "long-term", "dose_source": "Egyptian National Drug Formulary - Gastrointestinal", "rationale": "First-line 5-ASA agent for mild-to-moderate ulcerative colitis; the source lists sulfasalazine as an equivalent first-line option to mesalazine.", "cautions": [ "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." ], "peds_mgkg_low": 40.0, "peds_mgkg_high": 60.0, "peds_max_mg": 2400.0, "peds_basis": "day", "peds_unit": "mg", "peds_note": "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", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "Over 2 years", "age_min_months": 24, "age_max_months": 216, "dose_text": "Attacks: 40 to 60 mg/kg daily, divided into 3 to 6 doses. Maintenance: 20 to 30 mg/kg daily, divided into 4 doses." } ], "peds_doses": [ { "weight_kg": 10, "low_mg": 400, "high_mg": 600, "capped": false }, { "weight_kg": 20, "low_mg": 800, "high_mg": 1200, "capped": false }, { "weight_kg": 30, "low_mg": 1200, "high_mg": 1800, "capped": false }, { "weight_kg": 40, "low_mg": 1600, "high_mg": 2400, "capped": false } ], "brands": [ { "trade_name": "SALAZOSIN 500MG 10 ENTERIC F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA > SCIENCE PHARMA", "price_egp": 7.5, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SALAZOPYRINE 500MG 20 EN-TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA > PFIZER", "price_egp": 19.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SALAZO-SULPH PYRINE 500MG 20 EN-TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA", "price_egp": 60.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "COLOSALAZINE-EC 500 MG 20 E.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ALEXANDRIA > ACDIMA INTERNATIONAL TRADING", "price_egp": 67.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1791, "generic": "Azathioprine", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "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.\"", "adult_duration": "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.\"", "dose_source": "Azathioprine 50mg Film-Coated Tablets SmPC sections 4.1, 4.2 and 4.4 (eMC product 11143)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": 1.0, "peds_mgkg_high": 3.0, "peds_max_mg": null, "peds_basis": "day", "peds_unit": "mg", "peds_note": "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\".", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": [ { "weight_kg": 10, "low_mg": 10, "high_mg": 30, "capped": false }, { "weight_kg": 20, "low_mg": 20, "high_mg": 60, "capped": false }, { "weight_kg": 30, "low_mg": 30, "high_mg": 90, "capped": false }, { "weight_kg": 40, "low_mg": 40, "high_mg": 120, "capped": false } ], "brands": [ { "trade_name": "AZATHIOPRINE RPG 50 MG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RPG LIFE SCIENCES-INDIA > INTERNATIONAL TRADING OFFICE", "price_egp": 156.0, "pack_count": 100, "unit_price": 1.56, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE-MYLAN 50 MG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MYLAN S.A.S > ONE PHARMA MEDICS", "price_egp": 198.0, "pack_count": 100, "unit_price": 1.98, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE-EVAPHARMA 25 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 60.0, "pack_count": 30, "unit_price": 2.0, "strength_mg": 25.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE RPG 50 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RPG LIFE SCIENCES-INDIA > INTERNATIONAL TRADING OFFICE", "price_egp": 68.0, "pack_count": 30, "unit_price": 2.27, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE-EVAPHARMA 50 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 96.0, "pack_count": 30, "unit_price": 3.2, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE-EVAPHARMA 75 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 123.0, "pack_count": 30, "unit_price": 4.1, "strength_mg": 75.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMURAN 50 MG 100 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ASPEN PHARMA TRADING LIMITED > PHOENIX GROUP", "price_egp": 508.0, "pack_count": 100, "unit_price": 5.08, "strength_mg": 50.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AZATHIOPRINE-EVAPHARMA 100 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 153.0, "pack_count": 30, "unit_price": 5.1, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1792, "generic": "Adalimumab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "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.\"", "adult_duration": "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.\"", "dose_source": "Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "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.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "6 to 17 years", "age_min_months": 72, "age_max_months": 215, "dose_text": "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." } ], "peds_doses": null, "brands": [ { "trade_name": "ADALIMAB-EIPICO 40 MG/0.8ML PREFILLED SYRINGE", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RELIANCE LIFE SCIENCES > EIPICO", "price_egp": 4675.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ADALIMAB-EVA 40 MG/0.4ML 2 PREFILLED SYRINGE", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ALVOTECH > EVA PHARMA", "price_egp": 7000.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HYRIMOZ 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANDOZ > NOVARTIS PHARMA SANDOZ DIVISION", "price_egp": 8435.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AMGEVITA 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMGEN MANUFACTURING LIMITED > AMGEN SCIENTIFIC OFFICE", "price_egp": 11680.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HULIO 40MG/0.8ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "TERUMO > ONE PHARMA MEDICS", "price_egp": 11680.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HUMIRA 40MG/0.4ML 2 PREF. SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ABBVIE LTD. > MULTIPHARMA", "price_egp": 14113.0, "pack_count": null, "unit_price": null, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1793, "generic": "Golimumab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "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.\"", "adult_duration": "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.\"", "dose_source": "Simponi 50 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.3 (eMC product 8122)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "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.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "SIMPONI 50MG/0.5 ML PREFILLED PEN", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BAXTER AG > JANSSEN CILAG", "price_egp": 13597.0, "pack_count": null, "unit_price": null, "strength_mg": 50.0, "exact_strength": true, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1794, "generic": "Infliximab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": null, "adult_dose": "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.\"", "adult_duration": "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.\"", "dose_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)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "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\".", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": 72.0, "peds_age_max_months": null, "peds_age_bands": [ { "label": "6 to 17 years", "age_min_months": 72, "age_max_months": 215, "dose_text": "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." } ], "peds_doses": null, "brands": [ { "trade_name": "REMICADE 100 MG PD. VIAL FOR I.V. INF. 10 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "JANSSEN CILAG > SOFICOPHARM", "price_egp": 5936.0, "pack_count": null, "unit_price": null, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1795, "generic": "Vedolizumab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": 300.0, "adult_dose": "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.\"", "adult_duration": "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.\"", "dose_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)", "rationale": "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.", "cautions": [ "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." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "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.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "ENTYVIO 300 MG VIAL FOR INF.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "TAKEDA > PHARMA OVER SEAS", "price_egp": 48824.0, "pack_count": null, "unit_price": null, "strength_mg": 300.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" }, { "id": 1788, "generic": "Prednisolone", "line": 1, "is_adjunct": true, "form": "oral.solid", "strength_mg": 5.0, "adult_dose": "40 mg once daily in the morning for 1-2 weeks, then taper by 5 mg weekly", "adult_duration": "8 weeks tapering course", "dose_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.", "rationale": "Oral corticosteroid for acute moderate-to-severe flare induction of remission under specialist guidance", "cautions": [ "Do NOT use for maintenance therapy in ulcerative colitis.", "Taper gradually to avoid adrenal crisis.", "Monitor blood pressure, blood glucose, and bone density." ], "peds_mgkg_low": 1.0, "peds_mgkg_high": 1.5, "peds_max_mg": 40.0, "peds_basis": "day", "peds_unit": "mg", "peds_note": "1-1.5 mg/kg once daily in the morning (max 40 mg) tapering over 6-8 weeks under specialist care", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": [ { "weight_kg": 10, "low_mg": 10, "high_mg": 15, "capped": false }, { "weight_kg": 20, "low_mg": 20, "high_mg": 30, "capped": false }, { "weight_kg": 30, "low_mg": 30, "high_mg": 40, "capped": true }, { "weight_kg": 40, "low_mg": 40, "high_mg": 40, "capped": true } ], "brands": [ { "trade_name": "HOSTACORTIN H 5MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI", "price_egp": 12.0, "pack_count": 30, "unit_price": 0.4, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PREDNISOLONE 5 MG 20 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ARAB DRUG COMPANY (ADCO)", "price_egp": 24.0, "pack_count": 20, "unit_price": 1.2, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PREDILONE 5MG 10 TAB. (25 STRIPS PACK)", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA", "price_egp": 250.0, "pack_count": 10, "unit_price": 25.0, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "EPICOPRED 5 MG 30 ORODISPERSIBLE TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EIPICO", "price_egp": 69.0, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PREDNISOLONE-EVA 5 MG 30 ORODISPERSIBLE TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 79.5, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DISPRELONE-OD 5 MG 30 ORODISPERSABLE TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ANDALOUS PHARMA", "price_egp": 84.0, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SOLUPRED ORO 5 MG 30 ORODISPERSIBLE TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI WINTHROP > SANOFI", "price_egp": 84.0, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ACETASEE 1% EYE DROPS (SUSP.) 5 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "RAMEDA", "price_egp": 7.5, "pack_count": null, "unit_price": null, "strength_mg": null, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "PREDNIS 5MG/5ML SYRUP 100 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PHAROPHARMA", "price_egp": 9.5, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "ulcerative-colitis-referral" } ] }