{ "schema_version": 1, "kind": "condition", "id": "polymyalgia-rheumatica-referral", "name": "Polymyalgia rheumatica (PMR referral & management)", "category": "chronic", "sources": "BSR/BHPR Guideline for Polymyalgia Rheumatica for the regimen, with the dose from Egyptian National Drug Formulary - Endocrine System Drugs 2024, Prednisolone monograph (printed pages 169-170): \"Oral: Usual Initial doses: 5 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses.\" and \"Abrupt withdrawal is not recommended particularly with doses 40 mg or more or 3 weeks of treatment or more.\" The formulary states a general adult range rather than a polymyalgia regimen; the 15 mg start and the taper are from the BSR/BHPR guideline, which is not held in this corpus. · BSR/BHPR Guideline for Polymyalgia Rheumatica · KEVZARA (sarilumab) injection US prescribing information, boxed warning, section 1.2 Polymyalgia Rheumatica, section 2.1 General Considerations Prior to Administration and section 2.3 Recommended Dosage for Polymyalgia Rheumatica (DailyMed SetID 827bc01c-d379-4266-a18c-c7f904b76af3) · Methotrexate 2.5mg Tablets BP SmPC sections 4.3 and 4.4 (eMC product 4608) · Accrete D3 film-coated tablets SmPC sections 2 and 4.2 (eMC product 2766)", "review_status": "reviewed", "verified_against": "BSR/BHPR Guideline for Polymyalgia Rheumatica for the regimen, with the dose from Egyptian National Drug Formulary - Endocrine System Drugs 2024, Prednisolone monograph (printed pages 169-170): \"Oral: Usual Initial doses: 5 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses.\" and \"Abrupt withdrawal is not recommended particularly with doses 40 mg or more or 3 weeks of treatment or more.\" The formulary states a general adult range rather than a polymyalgia regimen; the 15 mg start and the taper are from the BSR/BHPR guideline, which is not held in this corpus. · BSR/BHPR Guideline for Polymyalgia Rheumatica · Polymyalgia Rheumatica - disease-level clinical article (polymyalgia-rheumatica-referral-full.txt) · Polymyalgia rheumatica (PMR referral & management) - disease-level clinical article (polymyalgia-rheumatica-referral-clinical.txt) · KEVZARA (sarilumab) injection US prescribing information, boxed warning, section 1.2 Polymyalgia Rheumatica, section 2.1 General Considerations Prior to Administration and section 2.3 Recommended Dosage for Polymyalgia Rheumatica (DailyMed SetID 827bc01c-d379-4266-a18c-c7f904b76af3) · Methotrexate 2.5mg Tablets BP SmPC sections 4.3 and 4.4 (eMC product 4608)", "verified_date": "2026-08", "treatments": [ { "id": 1482, "generic": "Prednisolone", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 5.0, "adult_dose": "15 mg once daily in morning with breakfast for 3-4 weeks (until symptoms resolve and ESR/CRP normalize), then taper by 2.5 mg every 2-4 weeks to 10 mg/day, then by 1 mg monthly", "adult_duration": "long-term (1-2 years tapering course)", "dose_source": "BSR/BHPR Guideline for Polymyalgia Rheumatica for the regimen, with the dose from Egyptian National Drug Formulary - Endocrine System Drugs 2024, Prednisolone monograph (printed pages 169-170): \"Oral: Usual Initial doses: 5 to 60 mg/day given in a single daily dose or in 2 to 4 divided doses.\" and \"Abrupt withdrawal is not recommended particularly with doses 40 mg or more or 3 weeks of treatment or more.\" The formulary states a general adult range rather than a polymyalgia regimen; the 15 mg start and the taper are from the BSR/BHPR guideline, which is not held in this corpus.", "rationale": "Rapid symptomatic relief within 48-72 hours confirms diagnosis; exclude Giant Cell Arteritis", "cautions": [ "ALWAYS screen for Giant Cell Arteritis (headache, jaw claudication, visual loss); GCA is a medical emergency requiring high-dose steroids (40-60 mg daily).", "Co-prescribe bone protection (bisphosphonate + calcium/vitamin D) and PPI gastroprotection.", "Never stop steroids abruptly (risk of adrenal crisis).", "Monitor blood pressure, blood glucose, weight, and bone density during long-term therapy." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Polymyalgia rheumatica occurs exclusively in adults >50 years", "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": "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": "polymyalgia-rheumatica-referral" }, { "id": 1483, "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": "Polymyalgia Rheumatica - disease-level clinical article (polymyalgia-rheumatica-referral-full.txt)", "rationale": "Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.", "cautions": [ "RED FLAG - The GCA (giant cell arteritis) red flags requiring urgent evaluation are new headache, visual or jaw symptoms, temporal artery tenderness or pulse loss, persistent inflammatory markers, high-grade fever, and refractory symptoms.", "RED FLAG - The rheumatology referral criteria are atypical features, inadequate response to initial GC treatment, prominent peripheral arthritis, and tapering difficulty." ], "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": "polymyalgia-rheumatica-referral" }, { "id": 1485, "generic": "Sarilumab", "line": 3, "is_adjunct": false, "form": "injection", "strength_mg": 200.0, "adult_dose": "200 mg subcutaneously every two weeks, and the steroid comes down alongside it. US label verbatim: \"The recommended dosage of KEVZARA is 200 mg once every two weeks given as a subcutaneous injection, in combination with a tapering course of systemic corticosteroids. KEVZARA can be used as monotherapy following discontinuation of corticosteroids.\" The label stops it rather than reducing it if the blood tests turn: \"Discontinue KEVZARA if the patient develops neutropenia (using ANC results obtained at the end of the dosing interval), thrombocytopenia, or liver enzyme abnormalities.\"", "adult_duration": "Continued while the steroid is being withdrawn, then reviewed. The label's own framing is that it can carry on as monotherapy \"following discontinuation of corticosteroids\", so the end point is a patient off prednisolone rather than a fixed number of weeks.", "dose_source": "KEVZARA (sarilumab) injection US prescribing information, boxed warning, section 1.2 Polymyalgia Rheumatica, section 2.1 General Considerations Prior to Administration and section 2.3 Recommended Dosage for Polymyalgia Rheumatica (DailyMed SetID 827bc01c-d379-4266-a18c-c7f904b76af3)", "rationale": "The disease article names the drug and the exact patient, verbatim: \"Sarilumab is a biologic medication approved for treating polymyalgia rheumatica in adults who have not responded adequately to corticosteroids or cannot tolerate corticosteroid tapers.\" The US label's indication section names the same disease in almost the same words, verbatim: \"KEVZARA is indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.\" The card carried prednisolone and methotrexate; sarilumab is the only drug licensed for this disease by name, and it is the one the article reaches for when the taper fails. Egypt registers KEVZARA 200 mg pre-filled syringes at about 14,050 EGP for two, so cost is part of the conversation. Rheumatology starts it; the regimen is printed so a shared-care clinic can recognise it and knows to hold it during infection.", "cautions": [ "RED FLAG - boxed warning, serious infection. US label verbatim: \"Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA in patients with an active infection.\" That last clause matters here because almost every patient on this card is also on prednisolone.", "Tuberculosis is screened for before the first injection, not after. US label verbatim: \"Prior to initiating KEVZARA, test patients for active and latent tuberculosis (TB). KEVZARA should not be administered to patients with active TB. If positive for latent infection, consider treating for TB prior to KEVZARA use.\" The boxed warning adds that TB \"may present with pulmonary or extrapulmonary disease\". Latent tuberculosis is common in Egypt.", "Baseline bloods gate the first dose. US label verbatim: \"Treatment initiation with KEVZARA is not recommended in patients with an absolute neutrophil count (ANC) below 2000 per mm3, or platelet count below 150,000 per mm3.\" and \"Treatment initiation with KEVZARA is not recommended in patients with or who have alanine transaminase (ALT) or aspartate aminotransferase (AST) above 1.5 times the upper limit of normal (ULN).\" Lipids are measured at baseline too.", "IL-6 blockade blunts the inflammatory markers you would otherwise use to judge the disease and to detect infection. A normal CRP on this drug does not exclude sepsis, and the fever may be absent.", "Not to be stacked on another biologic. US label verbatim: \"Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection.\"", "The steroid-related work does not stop. Disease article verbatim: \"Vitamin D and calcium supplementation are routine recommendations for patients on long-term steroids. Bisphosphonate prophylaxis is recommended for patients in moderate to high fracture risk categories\".", "New headache, jaw claudication or visual loss in a patient with polymyalgia is giant cell arteritis until proved otherwise, and that is a same-day, high-dose-steroid emergency - not a reason to bring the biologic forward." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Polymyalgia rheumatica is a disease of people over 50. The label's only paediatric indication is a different one - juvenile idiopathic arthritis in patients \"who weigh 63 kg or greater\" - and it does not belong on this card.", "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": "KEVZARA 200 MG 2 PRE-FILLED SYRINGES", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI > EGYPTIAN PHARMACEUTICAL TRADING COMPANY", "price_egp": 14050.0, "pack_count": null, "unit_price": null, "strength_mg": 200.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "polymyalgia-rheumatica-referral" }, { "id": 1486, "generic": "Calcium carbonate", "line": 1, "is_adjunct": true, "form": "oral.solid", "strength_mg": 600.0, "adult_dose": "600 mg of calcium (as calcium carbonate 1500 mg) with 400 IU vitamin D3, one combined tablet twice a day, morning and evening", "adult_duration": "For as long as the prednisolone course lasts", "dose_source": "Accrete D3 film-coated tablets SmPC sections 2 and 4.2 (eMC product 2766) - verbatim: \"Each film-coated tablet contains 600 mg calcium (as calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent to 400 IU vitamin D 3 )\" and \"One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening).\"", "rationale": "Polymyalgia rheumatica is treated with a year or more of prednisolone, which strips bone from the start. Calcium with vitamin D is the floor of steroid bone protection and belongs on the card next to the steroid that causes the problem.", "cautions": [ "Egypt sells this mostly as a combined calcium-with-vitamin-D3 tablet; if plain calcium carbonate is used, vitamin D has to be given as well.", "Bone protection is not only calcium: assess fracture risk and add a bisphosphonate for anyone at moderate or high risk, which most patients on a long steroid course will be.", "Do not use it where calcium is already high or being lost in the urine - myeloma, bone metastases, sarcoidosis, primary hyperparathyroidism.", "Check serum calcium and creatinine periodically on long treatment, especially in a patient also on a thiazide or digoxin.", "Calcium blocks tetracycline absorption - give a tetracycline well before the calcium dose, or several hours after it." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Not applicable - polymyalgia rheumatica is a disease of older adults, and this preparation is not intended for children and adolescents.", "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": "OKTAL 600 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "INTERNATIONAL DRUG AGENCY (IDI) > NOVELL PHARMA", "price_egp": 31.2, "pack_count": 30, "unit_price": 1.04, "strength_mg": 600.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "USKADE 600 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HOCHSTER PHARMACEUTICAL INDUSTRIES", "price_egp": 36.0, "pack_count": 30, "unit_price": 1.2, "strength_mg": 600.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CALCINEX PLUS SYRUP 120 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FAMILY PHARMACIA > SPHINX PHARMA", "price_egp": 59.0, "pack_count": null, "unit_price": null, "strength_mg": null, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "polymyalgia-rheumatica-referral" }, { "id": 1484, "generic": "Methotrexate", "line": 2, "is_adjunct": true, "form": "oral.solid", "strength_mg": null, "adult_dose": "7.5 to 10 mg/week", "adult_duration": null, "dose_source": "Polymyalgia rheumatica (PMR referral & management) - disease-level clinical article (polymyalgia-rheumatica-referral-clinical.txt)", "rationale": "Steroid-sparing immunosuppressive adjunct for PMR patients at high risk of relapse or prolonged glucocorticoid therapy.", "cautions": [ "Monitor blood counts and renal and liver function. Methotrexate 2.5 mg Tablets SmPC section 4.4 (eMC product 511) says \"Before beginning or reinstituting methotrexate after a rest period, the patient's renal, liver and bone marrow function should be assessed by history, physical examination and laboratory tests\", and \"Full blood count (including haematocrit), hepatic and renal function tests (including urinalysis) should be carried out every week until treatment is stabilized, thereafter every 2 to 3 months throughout treatment\".", "Co-prescribe folic acid to reduce toxicity. Methotrexate 2.5 mg Tablets SmPC section 4.4 (eMC product 511) says \"In patients with rheumatoid arthritis or psoriasis, folic acid or folinic acid supplementation may reduce methotrexate toxicity, such as gastrointestinal symptoms, stomatitis, alopecia and elevated liver enzymes\", and adds \"It is recommended to check levels of vitamin B12 prior to initiating folic acid supplementation, particularly in adults aged over 50 years, as folic acid intake may mask a vitamin B12 deficiency\".", "CONTRAINDICATED, from the same label section 4.3: methotrexate is barred where hepatic function is significantly impaired; where renal function is severely or significantly impaired - a creatinine clearance under 30 ml/min - at doses below 100 mg/m2, and where renal impairment is moderate - a clearance under 60 ml/min - at doses above 100 mg/m2; and in liver disease, fibrosis and cirrhosis included, or recent or active hepatitis. It is teratogenic, and should not be given in pregnancy or to a mother who is breast-feeding." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Safety and effectiveness in children have not been established, other than in cancer chemotherapy.", "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": "METHOTREXATE 2.5MG 100 TAB (ORION)", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ORION PHARMA-FINLAND > S.M. PHARMA", "price_egp": 130.25, "pack_count": 100, "unit_price": 1.3, "strength_mg": 2.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "METHOTREXATE 2.5MG 30 TAB. (ORION)", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ORION PHARMA-FINLAND > S.M. PHARMA", "price_egp": 84.0, "pack_count": 30, "unit_price": 2.8, "strength_mg": 2.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "METHOTREXATE (ACDIMA) 2.5MG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SHANGHAI SINE PHARMACEUTICAL CORPORATION LTD > ACDIMA INTERNATIONAL TRADING", "price_egp": 333.5, "pack_count": 100, "unit_price": 3.33, "strength_mg": 2.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMUTREXATE 2.5 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 51.0, "pack_count": 10, "unit_price": 5.1, "strength_mg": 2.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMUTREXATE 5 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 77.0, "pack_count": 10, "unit_price": 7.7, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMUTREXATE 7.5 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 89.0, "pack_count": 10, "unit_price": 8.9, "strength_mg": 7.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMUTREXATE 10 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 100.0, "pack_count": 10, "unit_price": 10.0, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IMUTREXATE 15 MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 136.0, "pack_count": 10, "unit_price": 13.6, "strength_mg": 15.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "polymyalgia-rheumatica-referral" } ] }