[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$f2k5ww3whsamc0":3},{"data":4,"error":10},{"id":5,"documentId":6,"heading":7,"body":8,"slug":9,"name":9,"name_ar":10,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":46,"available_strengths":58,"label_statements":66,"drug_classes":90,"specialties":97,"medical_conditions":98,"animal_species":105},1977,"pu9y18maeolfw5mbum2e1wn9","موليدوستات","الموليدوستات (molidustat) دواء يُستعمل في القطط المصابة بفقر دم غير تجددي مرتبط بـ[داء الكلى المزمن](\u002Fmedical-conditions\u002Fchronic-kidney-disease)، ويعمل برفع مستويات الإريثروبويتين الداخلي، وهو عامل نمو مهم لتكوين الدم، بحسب استعراض نُشر عام 2025 في مجلة J Feline Med Surg. يصف استعراض منشور عام 2026 في مجلة Tierarztl Prax Ausg K هذا الدواء بأنه مثبّط لإنزيم هيدروكسيلاز البرولين المرتبط بعامل الحث بنقص الأكسجة (HIF-PHI)، وبأنه دواء فموي جديد ينشّط تخليق الإريثروبويتين الداخلي.\n\n## آلية العمل\n\nيذكر استعراض نُشر عام 2026 في مجلة Tierarztl Prax Ausg K أن الموليدوستات يعمل بتثبيط إنزيمات هيدروكسيلاز البرولين، وهي الإنزيمات التي تستهدف عوامل الحث بنقص الأكسجة (HIFs) بالتحلل ما دام الأكسجين في مستواه الطبيعي. بحسب استعراض Tierarztl Prax Ausg K لعام 2026، تنتقل عوامل HIF بعد استقرارها إلى النواة فتحفّز نسخ جينات، من بينها جين الإريثروبويتين. تشير دراسة نُشرت عام 2026 في مجلة J Vet Intern Med إلى أن قدرة الكلى على إنتاج الإريثروبويتين قد تنخفض في داء الكلى المزمن، لكنها تظل قادرة على الاستجابة للتأثير الدوائي لمثبّط HIF-PH.\n\n## الاستعمالات البيطرية\n\nأفادت إدارة الغذاء والدواء الأمريكية (FDA) في بيانها الصحفي بأن فقر الدم غير التجددي ينشأ لدى القطط المصابة بداء الكلى المزمن حين تنتج الكلى قدراً أقل من الإريثروبويتين، وبأنه لم يكن ثمة علاج بالإريثروبويتين معتمد للاستعمال في القطط. يصنّف ملخص حرية المعلومات الصادر عن مركز الطب البيطري في إدارة الغذاء والدواء الأمريكية (FDA CVM) فقر الدم غير التجددي المرتبط بداء الكلى المزمن ضمن الحالات المقترنة بالوفيات والمراضة لدى القطط. تلاحظ دراسة منشورة عام 2026 أن الموليدوستات يتناول فقر الدم، لكن لا يُعرف إن كان قادراً على المساعدة في تدبير داء الكلى المزمن الكامن نفسه.\n\n## السلامة\n\nخلص FDA CVM في ملخص حرية المعلومات، استناداً إلى بيانات الشركة المقدِّمة للطلب، إلى أن الدواء آمن وله توقع معقول للفعالية عند استعماله وفق الملصق.\n\n## الوضع التنظيمي\n\nأعلنت إدارة الغذاء والدواء الأمريكية (FDA) في بيانها الصحفي الصادر في الأول من مايو 2023 موافقتها المشروطة على مستحضر معلّق فموي يحتوي الموليدوستات، بوصفه أول دواء للسيطرة على فقر الدم غير التجددي المرتبط بداء الكلى المزمن لدى القطط. تذكر FDA أن الموافقة المشروطة الأولية سارية لمدة سنة واحدة مع إمكانية أربع تجديدات سنوية. ربط ملخص حرية المعلومات الصادر عن FDA CVM أهلية الموافقة المشروطة بأن يعالج الدواء مرضاً خطيراً أو حاجة صحية غير ملباة يصعب إثبات الفعالية فيها، وعدّ السيطرة على فقر الدم المرتبط بداء الكلى المزمن لدى القطط حاجة من هذا النوع لغياب دواء بيطري معتمد مسوّق في الولايات المتحدة لهذا الاستعمال. تفيد FDA بأن المستحضر لا يُتاح إلا بوصفة من طبيب بيطري مرخّص، لأن تشخيص داء الكلى المزمن وفقر الدم غير التجددي لدى القطط يتطلب خبرة مهنية.","molidustat",null,[],[13,19,23,27,34,37,40,43],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",{"claims":28,"source":29,"licence":30,"source_url":31,"harvested_by":32,"retrieved_at":33},"Arabic article (body)","FDA press announcement, 1 May 2023 (Varenzin-CA1)","facts cited; the Arabic article is original text","https:\u002F\u002Fwww.fda.gov\u002Fnews-events\u002Fpress-announcements\u002Ffda-conditionally-approves-first-drug-anemia-cats-chronic-kidney-disease","apply-chain-articles.cjs","2026-10-23",{"claims":28,"source":35,"licence":30,"source_url":36,"harvested_by":32,"retrieved_at":33},"FDA CVM, Freedom of Information Summary application 141-571 (Varenzin-CA1)","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002Fdocument\u002FdownloadFoi\u002F13903",{"claims":28,"source":38,"licence":30,"source_url":39,"harvested_by":32,"retrieved_at":33},"Tierarztl Prax Ausg K 2026, HIF-PH inhibitor for anemia in feline CKD (PMC13322753)","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC13322753\u002F",{"claims":28,"source":41,"licence":30,"source_url":42,"harvested_by":32,"retrieved_at":33},"J Feline Med Surg 2025, clinical therapeutics in feline medicine (PMC12501467)","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC12501467\u002F",{"claims":28,"source":44,"licence":30,"source_url":45,"harvested_by":32,"retrieved_at":33},"J Vet Intern Med 2026, molidustat for anemia in cats with CKD (PMC12883063)","https:\u002F\u002Fpmc.ncbi.nlm.nih.gov\u002Farticles\u002FPMC12883063\u002F",[47,53],{"id":48,"dose_text":49,"species":50,"administration_route":51,"limitation":10,"source_label":52},15132,"Administer orally at a dosage of 5 mg\u002Fkg of body weight (2.3 mg\u002Flb) daily for up to 28 consecutive days. Treatment may be repeated after a minimum 7-day pause.","Cats","Oral","Varenzin™-CA1",{"id":54,"dose_text":55,"species":10,"administration_route":56,"limitation":10,"source_label":57},15133,"Shake well before use.\nThe dosage of Varenzin-CA1 is 2.3 mg\u002Flb (5 mg\u002Fkg) body weight (bw) administered orally once daily for up to 28 consecutive days. Treatment may be repeated after a minimum 7-day pause (see\nMonitoring and Repeating Treatment\n). Varenzin-CA1 should be administered using the dosing syringe provided in the package. The dosing syringe is marked in increments of 0.1 mL. The dose should be rounded up to the nearest 0.1 mL.\nDosing Information\nTo ensure the correct dose is administered, body weight should be determined prior to starting each treatment cycle.\nTable 1. Dosing Chart\nWeight Range in\npounds (lb)\nVolume of\nVarenzin-CA1 (mL)\n3.4 to 4.4\n0.4\n4.5 to 5.5\n0.5\n5.6 to 6.6\n0.6\n6.7 to 7.7\n0.7\n7.8 to 8.8\n0.8\n8.9 to 9.9\n0.9\n10 to 11\n1\n11.1 to 12.1\n1.1\n12.2 to 13.2\n1.2\nNote: The syringe included with the Varenzin-CA1 product cannot be used to accurately dose cats weighing under 3.4 pounds. Cats greater than 13.2 lb bw should be treated with a dose of 2.3 mg\u002Flb bw rounded up to the nearest 0.1 mL.\nAdministration\nShake well before use. Remove screw cap. Use the enclosed syringe for each treatment. Place the syringe nozzle firmly into the opening of the bottle. Turn the bottle upside down and withdraw the necessary volume. Turn the bottle back into an upright position before removing the syringe. The product should be administered with the syringe into the cat’s mouth. See illustrations 1 through 4 below for administration steps:\nAfter administration, close bottle tightly with cap and store syringe in the carton together with the product. Do not disassemble or wash the syringe.\nThe product should be given once daily for up to 28 consecutive days. If the cat vomits after consuming any portion of the dose, the cat should not be re-dosed and should be considered as dosed for the day.\nMonitoring and Repeating Treatment\nTreated cats should initially have their hematocrit (HCT) or packed cell volume (PCV) levels monitored weekly beginning about the 14th day of the 28-day treatment cycle to ensure HCT or PCV does not exceed the upper limit of the reference range. Discontinue Varenzin-CA1 if HCT or PCV exceeds the upper limit of the reference range.\nAfter treatment cessation the hematocrit level should be periodically checked (for example, weekly, every 2 weeks or monthly). When the HCT or PCV level declines below the lower limit of the reference range, a new treatment cycle should be started. The interval between treatment cycles will vary between cats and may change over time for an individual cat but should be at least 7 days.\nIf a cat does not respond to treatment after 3 weeks (see\nREASONABLE EXPECTATION OF EFFECTIVENESS\n), it is recommended to re-examine the animal for any other underlying condition that may contribute to anemia, such as iron deficiency, inflammatory diseases or blood loss. It is advised to treat the underlying condition before restarting treatment with Varenzin-CA1.","ORAL","FDA application 141-571",[59,63],{"id":60,"strength_text":61,"dosage_form":62,"proprietary_name":52,"species":50,"source_label":52},13047,"25 mg\u002FmL","Suspension",{"id":64,"strength_text":65,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":57},13048,"25 mg \u002F 1 mL",[67,71,74,78,82,86],{"id":68,"kind":69,"statement":70,"species":50,"limitation":10,"source_label":52},22480,"indication","Conditionally approved for the control of nonregenerative anemia associated with chronic kidney disease (CDK) in cats.",{"id":72,"kind":69,"statement":73,"species":10,"limitation":10,"source_label":57},22481,"Varenzin-CA1 is indicated for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.",{"id":75,"kind":76,"statement":77,"species":10,"limitation":10,"source_label":57},22482,"contraindication","Varenzin-CA1 should not be administered to cats with known hypersensitivity to molidustat or to any of the inactive ingredients.\nVarenzin-CA1 should not be administered to cats that are pregnant, lactating, or intended for breeding. In an embryo-fetal-developmental toxicity study in rats, an increase incidence of ocular malformations such as flat eye rudiments and microphthalmia were observed at doses of 30 mg\u002Fkg bw per day. These effects may be due to an increase in oxygen availability, caused by molidustat-induced polycythemia. Localized hypoxia is an important factor in normal eye development. Developmental toxicity studies have not been conducted in cats. Available animal data have shown excretion of other HIF-PH inhibitors into milk. It is unknown whether molidustat is excreted into the milk of lactating cats.",{"id":79,"kind":80,"statement":81,"species":10,"limitation":10,"source_label":57},22483,"warning","User Safety Warnings\nNot for use in humans.\nKeep this drug, including used syringes, out of reach of children. Wash hands immediately after use and\u002For spillage.\nIn case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Symptoms of exposure to molidustat may include the following: gastrointestinal effects (nausea, vomiting, diarrhea), blood and clotting effects (increases in reticulocytes, erythropoietin, and hemoglobin), dizziness, fainting, hypertension, changes in cardiac output and cardiac index, and increases in heart rate.\nSymptoms may not occur immediately; therefore, the exposed individual should be monitored. People with known hypersensitivity to molidustat sodium should avoid direct contact with this product and should administer the product with caution.\nWomen who are pregnant or may become pregnant should administer the product with caution. Molidustat administered orally to pregnant rats during the period of organogenesis was associated with adverse fetal outcomes (see\nCONTRAINDICATIONS\n).\nDo not eat, drink, or smoke while handling this product.\nAnimal Safety Warnings\nKeep Varenzin-CA1 in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":83,"kind":84,"statement":85,"species":10,"limitation":10,"source_label":57},22484,"adverse_reaction","The safety of Varenzin-CA1 was evaluated in a masked, controlled 28-day field study to evaluate the effectiveness of molidustat oral suspension (not commercial formulation) for the control of nonregenerative anemia associated with CKD in cats (see\nREASONABLE EXPECTATION OF EFFECTIVENESS\n). Enrollment included 21 cats; 15 cats were treated with Varenzin-CA1, and 6 cats were administered a vehicle control. Eight of these cats were subsequently enrolled in an extended open-label safety study for up to 8 additional weeks. Cats were dosed daily for 28 days. Vomiting was the most frequently reported adverse event, observed in 6\u002F15 (40%) cats in the molidustat group and no cats in the control group. Increases in systolic blood pressure and mild transient increases in serum potassium were also observed. The most serious adverse event was a cat in the molidustat group that presented, after 28 days of treatment, in lateral recumbency with a cold front leg from a suspected thromboembolism and was euthanized.\nThe safety of Varenzin-CA1 was evaluated in an interim analysis of data collected in an open label safety phase of an ongoing clinical field effectiveness and safety study. Varenzin-CA1 was administered for 28 consecutive days, followed by a treatment pause of at least 7 days, then treatment was repeated for up to 4 treatment cycles. The study evaluated 55 client-owned cats with nonregenerative anemia (PCV \u003C 28%) secondary to CKD that had received at least one dose of Varenzin-CA1 at 5 mg\u002Fkg bw in the safety phase. Cats had a mean age of 13 years (range 5.2 to 23.4) and initial body weights between 2.3 to 5.9 kilograms. At baseline just prior to enrollment into the study, 31%, 47%, and 22% of cats were in International Renal Interest Society (IRIS) Stage 2, 3, and 4 CKD, respectively (to learn more about IRIS staging, visit http:\u002F\u002Fwww.iris-kidney.com\u002Findex.html).\nVomiting was the most frequently reported adverse event, either alone or with other events, and was reported at least once in 29\u002F55 (52.7%) of the cats in the study. Vomiting was more frequent on treatment days than during treatment pause.\nTwo cats had seizures during the study. One cat had a seizure associated with severe uremia, severe anemia, and dehydration. One cat, which had a history of a seizure about 1 year prior, had a seizure during the study and severe hypertension.\nNineteen cats died or were euthanized before completion of the safety phase of the study due to worsening CKD or declining quality of life, and one cat was euthanized due to an abdominal mass.",{"id":87,"kind":88,"statement":89,"species":10,"limitation":10,"source_label":57},22485,"mechanism_of_action","Mechanism of Action\nVarenzin-CA1 (molidustat oral suspension) is a competitive and reversible inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH). The inhibition of HIF-PH induces a dose-dependent increase of endogenous erythropoietin (EPO) by stabilizing HIF, resulting in increased erythropoiesis (red blood cell production).\nPharmacokinetics\nThe pharmacokinetic parameters of Varenzin-CA1 after a single oral dose of 2.5, 5, and 10 mg\u002Fkg bw and intravenous dose of 5 mg\u002Fkg bw were evaluated in a laboratory study in which 8 healthy, young adult cats (4 neutered males, 4 spayed females) received Varenzin-CA1 orally or molidustat sodium aqueous suspension intravenously, utilizing a crossover study design. Following oral administration, molidustat was rapidly absorbed.\nTable 2: Mean (± standard deviation) pharmacokinetic parameters of molidustat following a single oral or intravenous dose of 5 mg\u002Fkg in cats:\n† Median and range are reported for Tmax instead of arithmetic mean and standard deviation\n†† C0 back-extrapolated concentration at time 0 by a log-linear regression of first 2 data points following intravenous administration\nCmax: Maximum observed plasma concentration\nTmax: Time to maximum observed plasma concentration\nAUClast: Area under the plasma concentration versus time curve from time of dosing to the last quantifiable concentration\nAUCinf: Area under the plasma concentration versus time curve from time of dosing extrapolated to infinity\nT1\u002F2: Terminal elimination half-life\nRoute\nOral\nIntravenous\nTmax\n† (hour)\n1 (0.67 – 1.5)\nNot Applicable\nCmax (µg\u002FmL)\n3.86 ± 0.495\n26.0 ± 8.42††\nAUClast\n(hour*µg\u002FmL)\n13.0 ± 2.98\n16.5 ± 2.97\nAUCinf\n(hour*µg\u002FmL)\n13.1 ± 2.99\n16.6 ± 3.01\nT1\u002F2 (hour)\n4.68 ± 0.661\n6.28 ± 4.43\nThe pharmacokinetic parameters of molidustat after 6 daily oral doses of 5 mg\u002Fkg bw were evaluated in a second laboratory study using 8 healthy, young adult cats (4 neutered males, 4 spayed females). Minimal accumulation of molidustat in the plasma pharmacokinetic profile was observed in the study.",[91],{"id":92,"documentId":93,"slug":94,"name":95,"heading":96},1219,"lq8o92d2dxlg9pu5zbhzi7jb","other-antianemic-preparations","Other antianemic preparations","مستحضرات أخرى مضادة لفقر الدم",[],[99],{"id":100,"documentId":101,"slug":102,"title":103,"heading":104},316,"jjdlvbfrxh850tibm4vz4t5w","chronic-kidney-disease","Chronic Kidney Disease","داء الكلى المزمن",[]]