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Bile Acid Oral Dissolution Therapy

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1. Bile Acid Oral Dissolution Therapy

Bile Acid Oral Dissolution Therapy Bile Acid Oral Dissolution Therapy Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Bile Acid Oral (...) Dissolution Therapy Bile Acid Oral Dissolution Therapy Aka: Bile Acid Oral Dissolution Therapy , Ursodeoxycholic Acid , Ursodiol , Actigal , Chenodeoxycholic Acid , Oral Dissolution Therapy , Gallstone Dissolving Agent II. Mechanism Decreases biliary hepatic secretion Forms unsaturated bile Promotes dissolution of crystals and s III. Indication: Cholelithiasis Comorbid condition that precludes safe and symptomatic s Symptomatic patient unwilling to undergo surgery Small s (<5mm) with functioning

2018 FP Notebook

2. Bile Acid Oral Dissolution Therapy

Bile Acid Oral Dissolution Therapy Bile Acid Oral Dissolution Therapy Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Bile Acid Oral (...) Dissolution Therapy Bile Acid Oral Dissolution Therapy Aka: Bile Acid Oral Dissolution Therapy , Ursodeoxycholic Acid , Ursodiol , Actigal , Chenodeoxycholic Acid , Oral Dissolution Therapy , Gallstone Dissolving Agent II. Mechanism Decreases biliary hepatic secretion Forms unsaturated bile Promotes dissolution of crystals and s III. Indication: Cholelithiasis Comorbid condition that precludes safe and symptomatic s Symptomatic patient unwilling to undergo surgery Small s (<5mm) with functioning

2015 FP Notebook

3. Effect of Oral Chenodeoxycholic Acid on Bile Acid Kinetics and Biliary Lipid Composition in Women with Cholelithiasis (PubMed)

Effect of Oral Chenodeoxycholic Acid on Bile Acid Kinetics and Biliary Lipid Composition in Women with Cholelithiasis Bile acid kinetics and biliary lipid composition were characterized in six women with gallstones before and after 6 mo of oral therapy with chenodeoxycholic acid, an agent that induces dissolution of cholesterol gallstones in man. Over a dosage range of 1-4 g/day, absorption varied from 0.8 to 2.3 g/day. The chenodeoxycholic acid pool expanded two-to sixfold, and bile became (...) patients, whose bile was unsaturated, it remained so. In five patients with radiolucent gallstones, chenodeoxycholic acid therapy was continued after completion of kinetic and composition measurements; the stones decreased in size or dissolved entirely during the subsequent 6 to 18 mo. Similar measurements of bile acid kinetics and biliary lipid composition were made before and after a 6-mo period without medication in a control group of six healthy women; no changes occurred.

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1973 Journal of Clinical Investigation

4. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

with a chemical name of (1S,2S,3S,4R,5S)-5-[4-Chloro-3- (4- ethoxybenzyl)phenyl]-1-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol. Ertugliflozin is included in the drug product as a cocrystal with L-pyroglutamic acid (L-PGA), known as ertugliflozin L- PGA. Ertugliflozin is formulated as an immediate-release tablet for oral administration at 5 and 15 mg strengths. The tablets are manufactured with a conventional direct compression process, utilizing conventional excipients and common blend (5% active (...) Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86941/2018 Committee for Medicinal Products

2018 European Medicines Agency - EPARs

5. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol. Ertugliflozin is included in the drug product as a cocrystal with L-pyroglutamic acid (L-PGA), known as ertugliflozin L- PGA. Ertugliflozin is formulated as an immediate-release tablet for oral administration at 5 and 15 mg Assessment report EMA/86938/2018 Page 10/139 strengths. The tablets are manufactured with a conventional direct compression process, utilizing conventional excipients and common blend (5% active). Dose strengths are expressed (...) Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86938/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report

2018 European Medicines Agency - EPARs

6. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

(T2DM). It possesses a high selectivity for SGLT2 versus SGLT1 and other glucose transporters (GLUT1-4). Ertugliflozin is a new chemical entity with a chemical name of (1S,2S,3S,4R,5S)-5-[4-Chloro-3- (4- ethoxybenzyl)phenyl]-1-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol. Ertugliflozin is included in the drug product as a cocrystal with L-pyroglutamic acid (L-PGA), known as ertugliflozin L- PGA. Ertugliflozin is formulated as an immediate-release tablet for oral administration at 5 and 15 (...) Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86928/2018 Committee for Medicinal Products for Human Use

2018 European Medicines Agency - EPARs

7. Chenodeoxycholic acid sigma-tau - cerebrotendinous xanthomatosis

CDCA and other medicines originate from the use of CDCA in dissolution of gallstones. CDCA is known to bind with colestyramine, colestipol (both bile acid sequestrants) or antacid drugs containing aluminium hydroxide and/or smectite (aluminium oxide) in the intestine, thus preventing its reabsorption and efficacy. Consequently, the above listed medicines should not be administered together with CDCA. Additionally, oral contraceptives, drugs containing oestrogens and clofibrate may increase (...) and was considered acceptable. Therefore, the CHMP agreed that no further non-clinical studies are required. 2.3.2. Pharmacology The effects of chenodeoxycholic acid on the metabolism and secretion of bile acids are well known. Metabolism of bile acids is tightly controlled via a negative feedback regulation of bile acid synthesis. The applicant has provided a review of the pharmacological properties of CDCA. When given orally Assessment report EMA/650359/2016 Page 14/47 CDCA reduces biliary cholesterol

2017 European Medicines Agency - EPARs

8. Kolbam - cholic acid

(cholic acid) was granted a marketing authorisation in the EU for the treatment of treatment of inborn errors in primary bile acid synthesis due to 3ß-Hydroxy-? 5 -C 27 -steroid oxidoreductase deficiency or ? 4 -3-Oxosteroid-5ß-reductase deficiency in infants, children and adolescents aged 1 month to 18 years and adults. Deficiencies in 3ß-HSD and ? 4 -3-oxoR are two of the nine indications initially claimed by the applicant. Oral administration of cholic acid, the substance missing in affected (...) substance of Kolbam is cholic acid. Cholic acid is a primary bile acid and is classified as a bile and liver therapy, bile acid preparations. Primary bile acids are biosynthesised in the liver of healthy men and are key constituents of normal bile. The two primary bile acids synthesised by the human liver, cholic acid and chenodeoxycholic acid, serve several important physiological functions (Setchell and O’Connell 2007). Cholic acid represents between approximately half and two thirds of the primary

2015 European Medicines Agency - EPARs

9. Orphacol - cholic acid

in severely affected cases is liver transplant. Currently there is no causal treatment. Treatment is limited to correcting the biochemical abnormalities, including the administration of bile acids and vitamin preparations. No medicinal product containing cholic acid as sole active substance has a marketing authorisation in the EU. Oral administration of cholic acid, the substance missing in affected patients, inhibits the production of the hepatotoxic bile acid precursors by down-regulating cholesterol 7a (...) as a suspension for oral administration, palatibility and compatibility of the formulation when mixed with some types of foods and drinks was investigated. This has been reflected in the SmPC. Adventitious agents Cholic acid is manufactured using bovine and ovine bile as a source material. The safety of the bile with regard to TSE is assured by the Ph Eur Certificate of Suitability. Among excipients used in the drug product only gelatin (component of the capsule shell) and lactose monohydrate (capsule filling

2013 European Medicines Agency - EPARs

10. Paediatric Urology

genitalia in boys. In: Campbell-Walsh Urology. 11th ed. Vol. 4. 2016, Philadelphia. 14. Liu, J., et al. Is steroids therapy effective in treating phimosis? A meta-analysis. Int Urol Nephrol, 2016. 48: 335. 15. Chu, C.C., et al. Topical steroid treatment of phimosis in boys. J Urol, 1999. 162: 861. 16. ter Meulen, P.H., et al. A conservative treatment of phimosis in boys. Eur Urol, 2001. 40: 196. 17. Elmore, J.M., et al. Topical steroid therapy as an alternative to circumcision for phimosis in boys (...) younger than 3 years. J Urol, 2002. 168: 1746. 18. Zavras, N., et al. Conservative treatment of phimosis with fluticasone proprionate 0.05%: a clinical study in 1185 boys. J Pediatr Urol, 2009. 5: 181. 19. Reddy, S., et al. Local steroid therapy as the first-line treatment for boys with symptomatic phimosis - a long-term prospective study. Acta Paediatr, 2012. 101: e130. 20. Golubovic, Z., et al. The conservative treatment of phimosis in boys. Br J Urol, 1996. 78: 786. 21. Pileggi, F.O., et al

2019 European Association of Urology

11. Practice Guidelines for the Diagnosis and Management of Aspergillosis

recommendation; high-quality evidence) ; posaconazole is a useful third-line agent for those with adverse events or clinical failure (strong recommendation; moderate-quality evidence) . 85. Hemoptysis may be managed with oral tranexamic acid (weak recommendation; low-quality evidence) , bronchial artery embolization (strong recommendation; moderate-quality evidence) , or antifungal therapy to prevent recurrence (strong recommendation; low-quality evidence) . Patients failing these measures may require (...) to IPA Similar to IPA Innate immune defects demonstrated in most of these patients; long-term therapy may be needed; surgical resection may lead to significant complications; anecdotal response to IFN-γ. Tranexamic acid may be helpful in management of hemoptysis Allergic syndromes of Aspergillosis ABPA Itraconazole Oral voriconazole (200 mg PO every 12 h) or posaconazole (dosage depends on formulation) Corticosteroids are a cornerstone of therapy for exacerbations; itraconazole has a demonstrable

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2016 Infectious Diseases Society of America

12. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

and finished product specifications, including blend uniformity, tablet content uniformity, and dissolution performance. Pharmaceutical development of the finished product contains QbD elements. The quality target product profile (QTPP) was defined as an oral immediate release solid dosage form containing 240 mg or 480 mg of letermovir, providing adequate bioavailability to maintain desired plasma levels and consistency in oral absorption (e.g. lack of food effect), all impurities controlled in line (...) , in light of the whole generated data package. Data from the clinical supratherapeutic QTc study did not result in QTc prolongation. Assessment report EMA/CHMP/490007/2017 Page 32/124 The absorption of letermovir was adequately characterised in rats and monkeys following IV and oral administration. In rat distribution studies, letermovir was rapidly and widely distributed in tissues with the highest levels of radioactivity observed in the gastrointestinal tract, bile duct and liver. Elimination

2018 European Medicines Agency - EPARs

13. Rucaparib camsylate - Ovarian Neoplasms

2.10. Product information 157 2.10.1. User consultation 157 2.10.2. Additional monitoring 158 3. Benefit-Risk Balance 158 3.1. Therapeutic Context 158 3.1.1. Disease or condition 158 3.1.2. Available therapies and unmet medical need 158 3.2. Favourable effects 158 3.3. Uncertainties and limitations about favourable effects 159 3.4. Unfavourable effects 159 3.5. Uncertainties and limitations about unfavourable effects 160 3.6. Effects Table 160 3.7. Benefit-risk assessment and discussion 161 3.7.1 (...) acid DSB double-strand breaks DSC differential scanning calorimetry DVS dynamic vapour sorption EC European Commission ECG(s) electrocardiogram(s) ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EOC epithelial ovarian cancer ESMO European Society for Medical Oncology EU European Union EU-RMP European Union Risk Management Plan FDA Food and Drug Administration FeSSIF Fed state simulated intestinal fluid Assessment report EMA/CHMP/238139/2018 Page 5/167 FFPE formalin-fixed

2018 European Medicines Agency - EPARs

14. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

concentration prior to the beginning of a dosing C 24h Plasma concentration after 24 hours CAR Current antiretroviral regimen cART Combination antiretroviral therapy CFU Colony forming units CHMP Committee for Medicinal Products for Human use CI Confidence interval CL Systemic clearance of parent drug CL/F Apparent clearance following oral dosing CL/F/kg Apparent oral clearance adjusted for body weight C max Maximum concentration CMH Cochran-Mantel Haenszel C min Minimum observed concentration CPP (...) , less than 4% in rat and 4 - 6% in monkey. In bile duct cannulated animals, biliary excretion accounted for approximately 2.5% of dose in mouse, 7% of the dose in rat and 12% of dose in monkey. Assessment report EMA/243517/2018 Page 23/109 The predominant route of elimination of rilpivirine drug-related material in all species following oral administration was via faeces (>85%), with a small contribution eliminated in urine ( 0.01 threshold YES Refined PEC accepted for Phase II Other concerns (e.g

2018 European Medicines Agency - EPARs

15. Plitidepsin (Aplidin) - Multiple Myeloma

Active Substance 133 2.10. Product information 133 Assessment report EMA/249101/2018 Page 4/156 2.10.1. User consultation 133 2.10.2. Additional monitoring 133 3. Benefit-Risk Balance 134 3.1. Therapeutic Context 134 3.1.1. Disease or condition 134 3.1.2. Available therapies and unmet medical need 134 3.1.3. Main clinical studies 134 3.2. Favourable effects 134 3.3. Uncertainties and limitations about favourable effects 135 3.4. Unfavourable effects 135 3.5. Uncertainties and limitations about (...) unfavourable effects 135 3.6. Effects Table 136 3.7. Benefit-risk assessment and discussion 136 3.7.1. Importance of favourable and unfavourable effects 136 3.7.2. Balance of benefits and risks 137 3.7.3. Additional considerations on the benefit-risk balance 137 3.8. Conclusions 137 4. Recommendations 137 5. Re-examination of the CHMP opinion of 14 December 2017 138 6. Benefit-risk balance following re-examination 146 6.1. Therapeutic Context 146 6.1.1. Disease or condition 146 6.1.2. Available therapies

2018 European Medicines Agency - EPARs

16. Allopurinol / lesinurad (Duzallo) - Gout

Characteristics SOC System Organ Class sUA Serum uric acid (also referred to as serum urate) SURI Selective UA reabsorption inhibitor TEAE Treatment emergent adverse event TTC Threshold of Toxicological Concern UA Uric acid ULT Urate-lowering therapy URAT1 Uric acid transporter 1 US United States USP United States Pharmacopoeia UV Ultraviolet XOI Xanthine oxidase inhibitor XRPD X-ray powder diffraction Assessment report EMA/474026/2018 Page 6/100 1. Background information on the procedure 1.1. Submission (...) skin (“leaking tophi”). Tophus forming in the kidney may lead to lithiasis and inflammation, and if uncontrolled, to renal failure. 2.1.5. Management Several urate lowering therapies (ULTs) are available for the prophylaxis of recurrent gouty attacks and reduction of tophi, which include: a) oral xanthine-oxidase inhibitors (XOI), allopurinol and febuxostat, which decrease the de novo synthesis of urate. b) oral uricosuric agents probenecid, benzbromarone, and sulphinpyrazone. Uricosuric agents

2018 European Medicines Agency - EPARs

17. Vyndaqel (tafamidis meglumine)

substance during development and it has been confirmed that there are no major differences in the dissolution profile etc. between the pre-change and post-change drug product. Some of foreign clinical studies were conducted with hard capsule and oral solution formulations whose bioequivalence with the proposed commercial formulation has not been demonstrated. 2.A.(2).2) Manufacturing process The manufacturing process for the drug product consists of **************, **************, ******, and packaging (...) studies are of clinical relevance. The applicant explained as follows: In a rat study (4.2.1.3.1), body weight loss was observed at ?30 mg/kg in females and at 100 mg/kg in males. In a 28-day repeated oral dose toxicity study in rats, reduced body weight associated with reduced food consumption was observed at ?100 mg/kg/day. These findings are considered attributable to decreased appetite caused by the precipitation and accumulation of tafamidis in the acidic gastric environment. In a dog study

2013 Pharmaceuticals and Medical Devices Agency, Japan

18. Nouriast (istradefylline)

for the following indication and dosage and administration. [Indication] Improvement of the “wearing-off” phenomenon in patients with Parkinson’s disease on levodopa-containing preparations [Dosage and administration] The product should be used in combination with levodopa-containing preparations. The usual adult dosage is 20 mg of Istradefylline orally administered once daily. According to symptoms, 40 mg of Istradefylline may be orally administered once daily. 3 Review Report (1) January 8, 2013 I. Product (...) . The usual adult dosage is 20 mg of Istradefylline orally administered once daily. The dose should be increased as appropriate according to symptoms and 40 mg of Istradefylline may be orally administered once daily. II. Summary of the Submitted Data and Outline of the Review by the Pharmaceuticals and Medical Devices Agency The data submitted in the application and the outline of a review by the Pharmaceuticals and Medical Devices Agency (PMDA) are as shown below. 1. Origin or history of discovery

2013 Pharmaceuticals and Medical Devices Agency, Japan

19. Acofide (acotiamide hydrochloride hydrate)

in acid secretion is unlikely to cause any serious safety concerns in humans. 3.(i).A.(3) Safety pharmacology 3.(i).A.(3).1) Effect on central nervous system (4.2.1.3-1: Study 611**509) The vehicle (0.5 w/v% MC solution) or acotiamide (10, 100, 1000 mg/kg) was administered in a single oral dose to rats, and the effect on general symptoms and behavior was evaluated using the functional observational battery. Miosis was observed within 4 hours after administration in the acotiamide ?100 mg/kg groups (...) hydrochloride hydrate administered orally three times daily before a meal. 4 Review Report (1) December 10, 2012 I. Product Submitted for Registration [Brand name] Acofide Tablets 100 mg [Non-proprietary name] Acotiamide Hydrochloride Hydrate [Applicant] Zeria Pharmaceutical Co., Ltd. [Date of application] September 29, 2010 [Dosage form/Strength] Each tablet, containing 100 mg Acotiamide Hydrochloride Hydrate [Proposed indication] Functional dyspepsia (gastrointestinal symptoms such as postprandial

2013 Pharmaceuticals and Medical Devices Agency, Japan

20. Stivarga (regorafenib hydrate)

cancer [Dosage and administration] The usual adult dosage is 160 mg of regorafenib orally administered once daily after a meal for 3 weeks followed by 1- week off therapy. The above regimen should be repeated in a 4- week cycle. The dose may be reduced according to the patient's condition. 4 Review Report (1) December 28, 2012 I. Product Submitted for Registration [Brand name] Stivarga Tablets 40 mg [Non-proprietary name] Regorafenib Hydrate [Applicant] Bayer Yakuhin, Ltd. [Date of application] July (...) 31, 2012 [Dosage form/strength] Each tablet contains 40 mg of regorafenib (41.49 mg as regorafenib hydrate). [Proposed indication] Incurable, unresectable, advanced/recurrent colorectal cancer [Proposed dosage and administration] The usual adult dosage is 160 mg of regorafenib orally administered once daily for 3 weeks followed by 1-week off therapy. The above regimen should be repeated in a 4-week cycle. The dose may be reduced according to the patient's condition. II. Summary of the Submitted

2013 Pharmaceuticals and Medical Devices Agency, Japan

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