{ "schema_version": 1, "kind": "condition", "id": "fatty-liver-disease-masld", "name": "Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)", "category": "chronic", "sources": "AASLD Practice Guidance on MASLD 2023 · EASL-EASD-EASO Clinical Practice Guidelines for MASLD 2021 · Egyptian National Drug Formulary - Endocrine System 2024 (pioglitazone monograph); indication per Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - StatPearls (NCBI Bookshelf NBK541033) - https://www.ncbi.nlm.nih.gov/books/NBK541033/: \"pioglitazone, which improves steatohepatitis without clear fibrosis regression\" · Egyptian National Drug Formulary - Endocrine System 2024 (semaglutide monograph, oral dosing) · Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - disease-level clinical article (fatty-liver-disease-masld-full.txt) · REZDIFFRA (resmetirom) tablets US prescribing information, section 1 Indications and Usage, section 2 Dosage and Administration, section 5 Warnings and Precautions and section 8 Use in Specific Populations (DailyMed SetID e67ea09f-a840-439c-86c8-f98585f978b2)", "review_status": "reviewed", "verified_against": "AASLD Practice Guidance on MASLD 2023 · Egyptian National Drug Formulary - Endocrine System 2024 (pioglitazone monograph); indication per Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - StatPearls (NCBI Bookshelf NBK541033) - https://www.ncbi.nlm.nih.gov/books/NBK541033/: \"pioglitazone, which improves steatohepatitis without clear fibrosis regression\" · Egyptian National Drug Formulary - Endocrine System 2024 (semaglutide monograph, oral dosing) · Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - disease-level clinical article (fatty-liver-disease-masld-full.txt) · REZDIFFRA (resmetirom) tablets US prescribing information, section 1 Indications and Usage, section 2 Dosage and Administration, section 5 Warnings and Precautions and section 8 Use in Specific Populations (DailyMed SetID e67ea09f-a840-439c-86c8-f98585f978b2)", "verified_date": "2026-08", "treatments": [ { "id": 704, "generic": "Vitamin E", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 400.0, "adult_dose": "800 IU (approx 530 mg) once daily", "adult_duration": "6-12 months under monitoring", "dose_source": "AASLD Practice Guidance on MASLD 2023", "rationale": "Antioxidant therapy recommended by AASLD for non-diabetic adults with biopsy-proven NASH", "cautions": [ "Primary therapeutic intervention is weight loss (7-10%) via diet and aerobic exercise.", "Avoid high-dose Vitamin E in patients with prostate cancer or heavy haemorrhagic risk.", "Not recommended in diabetic MASLD without specialist advice." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Specialist pediatric hepatology evaluation required", "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": "TOCO 400MG 20 CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SEDICO", "price_egp": 13.2, "pack_count": 20, "unit_price": 0.66, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "VITAMIN E 400 MG 24 S.G. CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SAFE PHARMA > PHARCO", "price_egp": 50.0, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "fatty-liver-disease-masld" }, { "id": 706, "generic": "Pioglitazone", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 30.0, "adult_dose": "15 mg or 30 mg once daily, increased to 45 mg once daily if needed", "adult_duration": "Review response at 3-6 months and discontinue if there is no adequate response", "dose_source": "Egyptian National Drug Formulary - Endocrine System 2024 (pioglitazone monograph); indication per Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) - StatPearls (NCBI Bookshelf NBK541033) - https://www.ncbi.nlm.nih.gov/books/NBK541033/: \"pioglitazone, which improves steatohepatitis without clear fibrosis regression\"", "rationale": "19 live products. NICE NG49 says 'Consider pioglitazone or vitamin E for adults with advanced liver fibrosis, whether they have diabetes or not' - the vitamin E half of that sentence is already the line 1 row here and the pioglitazone half is missing. The dose comes from the Egyptian formulary because NG49 does not state one.", "cautions": [ "NICE restricts pioglitazone in this disease to adults with ADVANCED liver fibrosis and to secondary or tertiary care - it is not a primary-care initiation for a fatty liver on ultrasound.", "Not licensed for fatty liver disease anywhere - the marketing authorisation is for type 2 diabetes only.", "CONTRAINDICATED in cardiac failure or any history of it (NYHA I to IV), in hepatic impairment, in diabetic ketoacidosis, and in current or previous bladder cancer or uninvestigated macroscopic haematuria.", "Hepatic impairment is a contraindication, which cuts across this very indication - it is for fibrosis, not for decompensated disease.", "Causes fluid retention, oedema in up to 27%, weight gain, and distal fractures in women.", "NICE advises stopping pioglitazone and considering vitamin E instead if the ELF test score has risen.", "Stop if there is no adequate HbA1c or clinical response by 3-6 months." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Safety and efficacy in children have not been established. NICE restricts pharmacological therapy for children with advanced fibrosis to vitamin E in tertiary 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": null, "brands": [ { "trade_name": "GLITAZEN 30 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL-OBOUR MODERN PHARM. IND. > HYGINT PHARMACEUTICALS", "price_egp": 33.0, "pack_count": 30, "unit_price": 1.1, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "HI-GLITAZONE 30MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HI-PHARM", "price_egp": 33.0, "pack_count": 30, "unit_price": 1.1, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "GLUSTAZON 30MG 21 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "CHEMIPHARM", "price_egp": 28.5, "pack_count": 21, "unit_price": 1.36, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DIABETIN 30 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "UNIPHARMA", "price_egp": 35.0, "pack_count": 10, "unit_price": 3.5, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DIABETIN 30 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "UNIPHARMA", "price_egp": 105.0, "pack_count": 30, "unit_price": 3.5, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PIOJET 30MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EUROPEAN EGYPTIAN PHARM. IND.", "price_egp": 37.0, "pack_count": 10, "unit_price": 3.7, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "GLUSTIN 30MG 7 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "TAKEDA", "price_egp": 55.5, "pack_count": 7, "unit_price": 7.93, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ACTOS 30MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ARAB PHARMACEUTICAL MANUFACTURING CO. > HIKMA PHARMA", "price_egp": 372.0, "pack_count": 30, "unit_price": 12.4, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "fatty-liver-disease-masld" }, { "id": 707, "generic": "Semaglutide", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 7.0, "adult_dose": "Initially 3 mg once daily for 1 month, then increased to 7 mg once daily for at least 1 month, and then increased if necessary to 14 mg once daily, taken on an empty stomach", "adult_duration": null, "dose_source": "Egyptian National Drug Formulary - Endocrine System 2024 (semaglutide monograph, oral dosing)", "rationale": "An earlier review refused this because the formulary indicates GLP-1 receptor agonists for type 2 diabetes and for weight management, never for fatty liver. Under the August 2026 ruling that silence is not prohibition, and with the indication claim coming from the card's own article, it stands. The article's reasoning: metformin is first-line for type 2 diabetes, while pioglitazone and the GLP-1 receptor agonists - liraglutide, semaglutide - are reasonable alternatives where more glucose control is needed or metformin cannot be taken, and may improve liver histology into the bargain. Semaglutide rather than liraglutide because the Egyptian register carries 14 semaglutide products against 3 liraglutide, including the oral tablets dosed here. The metformin and pioglitazone rows are the same shape and stay: the same article names both by name.", "cautions": [ "CONTRAINDICATED on the formulary's own list: hypersensitivity to semaglutide or to anything else in the product; medullary thyroid carcinoma, whether in the patient or in the family, and thyroid C-cell tumours; and multiple endocrine neoplasia type 2 (MEN 2).", "The formulary's indication is diabetes, not fatty liver: it licenses the drug in type 2 diabetes, alongside diet and exercise, to bring the blood glucose under better control in adults. The liver indication comes from the disease article, which is also honest about the limit of the benefit - a GLP-1 agonist can clear the steatohepatitis while leaving the fibrosis where it was.", "The formulary also gives a subcutaneous regimen: initially 0.25 mg once weekly for 4 weeks, then doubled at 4-week intervals up to 1 mg once weekly if necessary. The oral regimen is on this row because the card's other options are oral and both forms are registered in Egypt.", "Cost is a real barrier in Egypt - the oral tablets and the pens are among the most expensive items on this card by a wide margin.", "Weight loss and sustained lifestyle change remain the primary treatment for MASLD; a drug does not replace them." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "The formulary states adult dosing only for this indication. Not for paediatric use here.", "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": "RYBELSUS 7 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NOVO NORDISK > NOVO NORDISK SCIENTIFIC OFFICE", "price_egp": 3150.0, "pack_count": 30, "unit_price": 105.0, "strength_mg": 7.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "RYBELSUS 7 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NOVO NORDISK > NOVO NORDISK SCIENTIFIC OFFICE", "price_egp": 1575.0, "pack_count": 10, "unit_price": 157.5, "strength_mg": 7.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "fatty-liver-disease-masld" }, { "id": 708, "generic": "Resmetirom", "line": 3, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "Dosed by actual body weight, taken once daily. Per the US label: below 100 kg the dose is 80 mg by mouth once daily, and at 100 kg or above it is 100 mg once daily. It can be taken with or without food; swallow tablets whole - they must not be divided, crushed or chewed. Combined with a moderate CYP2C8 inhibitor - clopidogrel is the label's example - dosing drops to 60 mg once daily under 100 kg and 80 mg once daily at 100 kg or above. StatPearls gives the same two weight-based doses.", "adult_duration": "Long-term, on an approval that is itself provisional. US label verbatim: \"This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.\" Liver tests are monitored throughout rather than checked once.", "dose_source": "REZDIFFRA (resmetirom) tablets US prescribing information, section 1 Indications and Usage, section 2 Dosage and Administration, section 5 Warnings and Precautions and section 8 Use in Specific Populations (DailyMed SetID e67ea09f-a840-439c-86c8-f98585f978b2)", "rationale": "StatPearls names the drug, the fibrosis stage and the dose. Resmetirom, a thyroid hormone receptor-beta agonist, is licensed for MASH with F2-F3 fibrosis in patients who have not achieved significant weight loss; people with cirrhosis were excluded from the pivotal trials, and safety in that group is still under study. The doses given are 80 mg once daily under 100 kg and 100 mg once daily at 100 kg or above. The US label's indication matches the same disease and stage: adults with noncirrhotic MASH and moderate-to-advanced fibrosis (stage F2-F3), used alongside diet and exercise. It is the only drug licensed for MASH itself, rather than for the metabolic disease driving it, and the card carried none. Egypt has no registered resmetirom product, so no local brand or price can be shown; the row exists so a prescription started abroad can be recognised, with the fibrosis stage that gates it clearly stated.", "cautions": [ "It is not for cirrhosis, and that is the boundary the whole row turns on. US label verbatim: \"Avoid use of REZDIFFRA in patients with decompensated cirrhosis (consistent with moderate to severe hepatic impairment).\" and \"The safety and effectiveness of REZDIFFRA have not been established in patients with MASH cirrhosis.\" A patient with ascites, varices or a low platelet count needs hepatology, not this tablet.", "RED FLAG - it can itself injure the liver. US label verbatim: \"Hepatotoxicity has been observed with use of REZDIFFRA.\" and \"Monitor patients during treatment with REZDIFFRA for elevations in liver tests and for the development of liver-related adverse reactions. Monitor for symptoms and signs of hepatotoxicity (e.g., fatigue, nausea, vomiting, right upper quadrant pain or tenderness, jaundice, fever, rash, and/or eosinophilia [>5%]). If hepatotoxicity is suspected, discontinue REZDIFFRA and continue to monitor the patient.\" One reported case reached 58 times the upper limit of normal for ALT.", "Gallstones and their complications. US label verbatim: \"In clinical trials, cholelithiasis, acute cholecystitis, and obstructive pancreatitis (gallstone) were observed more often in REZDIFFRA-treated patients than in placebo-treated patients. If an acute gallbladder event is suspected, interrupt REZDIFFRA treatment until the event is resolved.\"", "It raises statin levels, and most of these patients are on one. US label verbatim: \"An increase in exposure of atorvastatin, pravastatin, rosuvastatin and simvastatin was observed when concomitantly administered with REZDIFFRA, which may increase the risk of adverse reactions related to these drugs. Dosage adjustment for certain statins is recommended. Monitor for statin-related adverse reactions including but not limited to elevation of liver tests, myopathy, and rhabdomyolysis.\"", "Two drug groups the disease article singles out. Resmetirom is not to be given with an OATP 1B1/1B3 inhibitor - ciclosporin is the example it gives - nor with a strong CYP2C8 inhibitor such as gemfibrozil. The label takes the same line on gemfibrozil, advising against REZDIFFRA alongside a strong CYP2C8 inhibitor.", "It does not replace the weight loss. The label ties it to diet and exercise, and the article frames it as being for MASH where significant weight loss has not happened - the patient who can lose 7% of body weight does not need 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. US label verbatim: \"The safety and effectiveness of REZDIFFRA have not been established in pediatric patients.\"", "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": "fatty-liver-disease-masld" }, { "id": 705, "generic": "Metformin", "line": 1, "is_adjunct": true, "form": "oral.solid", "strength_mg": 500.0, "adult_dose": "500 mg twice daily with meals, titrate to 1000 mg twice daily", "adult_duration": "long-term", "dose_source": "AASLD Practice Guidance on MASLD 2023", "rationale": "Targeted at underlying insulin resistance and metabolic risk factors in patients with MASLD and prediabetes/T2DM", "cautions": [ "Metformin improves glycemic control but does NOT reverse liver histology/fibrosis directly in MASLD per AASLD 2023.", "Monitor renal function (eGFR) and serum B12.", "Contraindicated in severe hepatic impairment or eGFR <30 mL/min." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Specialist endocrinology use", "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": "METFORMIN-EL NASR 500MG 200 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL NASR", "price_egp": 26.0, "pack_count": 200, "unit_price": 0.13, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DIAPHAGE 500MG 20 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PHAROPHARMA", "price_egp": 4.0, "pack_count": 20, "unit_price": 0.2, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "AMOPHAGE 500MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMOUN", "price_egp": 10.5, "pack_count": 30, "unit_price": 0.35, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CIDOPHAGE 500 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "CID", "price_egp": 11.0, "pack_count": 10, "unit_price": 1.1, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "GLUCOPHAGE 500 MG 50 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MINA PHARM > MERCK SANTE-FRANCE", "price_egp": 60.0, "pack_count": 50, "unit_price": 1.2, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "KELVAMET MR 500 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "BIOMED", "price_egp": 54.0, "pack_count": 30, "unit_price": 1.8, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ANDOGLYCEMIC XR 500MG 30 EXT. REL. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ANDALOUS PHARMA", "price_egp": 24.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "METIANORMIN 500 MG 30 EXT. REL. F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "WADI ELNEEL BENTA", "price_egp": 54.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "fatty-liver-disease-masld" } ] }