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Clinical Index of Stable Febrile Neutropenia

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141. Management of Multiple Sclerosis

Sclerosis 27 11. MONITORING DISEASE ACTIVITY AND RISK OF PROGRESSION Disease activity and risk of progression in MS can be measured by looking at: 82 - 83, level II-2; 84, level II-3; 85, level I • clinical relapses • change in disability over a given time period assessed at two time points as measured by the EDSS • neuroimaging (presence of new or enlarging T2-weighted lesions and Gd-enhancing lesions) These measures help in assessing whether a patient is truly stable or a change or escalation (...) and the content is not changed, not sold, nor used to promote or endorse any product or service, and not used in an inappropriate or misleading context. ISBN: 978-967-0769-28-8 Available on the following websites: http://www.moh.gov.my http://www.acadmed.org.my http://www.neuro.org.my Also available as a mobile app for Android and IOS platform: MyMaHTAS STATEMENT OF INTENT These clinical practice guidelines (CPG) are meant to be guides for clinical practice, based on the best available evidence at the time

2015 Ministry of Health, Malaysia

142. Procalcitonin Levels in Patients With Fever and a Central Line

and Central Venous Catheter". Diagnosis of sepsis will be made by clinical findings (fever, chills, altered mental status…) and confirmed by laboratory findings (leukocytosis or leucopenia with neutropenia, and later positive blood cultures). Management of each individual patient was determined by the pediatric emergency medicine physician in consult with a pediatric hematologist-oncologist and, in required cases, by an intensivist. On presentation to the ED, all patients will have a CBC with differential (...) with fever and a central line, most often secondary to an oncologic disease. These patients are often neutropenic and unable to fight off infection, thereby rendering them extremely vulnerable to rapid declines in clinical status. By identifying a level of procalcitonin which is significant as a threshold for serious bacterial infection, the investigators can very early on identify the sickest patients and those who could potentially have a worse clinical course and/or outcome. The primary study goal

2010 Clinical Trials

143. Remsima - infliximab

Azathioprine BASDAI Bath Ankylosing Spondylitis Disease Activity Index BASFI Bath Ankylosing Spondylitis Functional Index BASMI Bath Ankylosing Spondylitis Metrology Index biw Twice a week BLA Biologic License Application BMWP Biosimilar Medicinal Products Working Party bw Body weight CD Crohn’s disease CDAI Clinical disease activity index CDC Complement-dependent cytotoxicity cfu Colony forming unit CHMP Committee for Medicinal Products for Human Use CI Confidence Interval CL Total body clearance C max (...) exercise between the two products were presented. Demonstration of comparability via a thorough development programme included quality, nonclinical and clinical data and is key to the evaluation of a biosimilar medicinal product. As part of the comparability exercise it was shown that all major physicochemical characteristics and biological activities of Remsima were comparable to those of Remicade. The CHMP noted a small difference in the amount of afucosylated infliximab, translating into a lower

2013 European Medicines Agency - EPARs

144. Xtandi - enzalutamide

Bono, 2010). This intravenous chemotherapy is complicated by febrile neutropenia, neutropenic deaths, and serious gastrointestinal side effects including diarrhoea. Recently, abiraterone acetate, an oral inhibitor of androgen biosynthesis, has been approved for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel after demonstrating a 3.9-month survival advantage over placebo (de Bono, 2011). Treatment with abiraterone acetate requires the co (...) . Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 Pharmacodynamic drug interactions 22 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 23 Single dose toxicity 23 Repeat dose toxicity 24 Genotoxicity 26 Carcinogenicity 26 Reproduction Toxicity 26 Toxicokinetic data 27 Local Tolerance 27 Other toxicity studies 27 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 32 2.4. Clinical aspects 32

2013 European Medicines Agency - EPARs

145. Bosulif (bosutinib (as monohydrate))

and biological aspects 15 2.3. Non-clinical aspects 16 2.3.1. Introduction 16 2.3.2. Pharmacology 16 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 18 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 29 2.3.7. Conclusion on the non-clinical aspects 30 2.4. Clinical aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 35 2.4.3. Pharmacodynamics 40 2.4.4. Discussion on clinical pharmacology 41 2.4.5. Conclusions on clinical pharmacology 43 2.5. Clinical efficacy (...) 43 2.5.1. Dose response studies 44 2.5.2. Main studies 45 Supportive studies 56 2.5.3. Discussion on clinical efficacy 60 2.5.4. Conclusions on the clinical efficacy 64 2.6. Clinical safety 65 2.6.1. Discussion on clinical safety 75 2.6.2. Conclusions on the clinical safety 78 2.7. Pharmacovigilance 78 2.8. User consultation 81 3. Benefit-Risk Balance 81 4. Recommendations 85 Bosulif CHMP assessment report Page 3/87 List of abbreviations AE adverse event ALT aspartate aminotransferase AP

2013 European Medicines Agency - EPARs

146. Perjeta - pertuzumab

) although the proportion of patients with severe or life-threatening febrile neutropenia and diarrhoea was higher in the pertuzumab group compared to the placebo group. Adverse events resulting in death were observed in 2.5% of patients in the placebo arm and in 2.0% of patients in the pertuzumab arm. In terms of balance of benefits and risks, the totality of data indicated that pertuzumab was associated with clinically and statistically significant benefits in a patient population with limited (...) Target Range CR Complete response CRC Cardiac Review Committee CrCL Creatinine clearance CRO Clinical Research Organization CTD Common Technical Document CYP450 Cytochrome P450 DDI Drug-drug interactions DMA Danish Medicines Agency EBC Early breast cancer ECG Electrocardiogram ECOG Eastern Cooperative Oncology Group ECLA Electrochemiluminescence assay ELISA Enzyme-linked Immunosorbent Assay EMA European Medicines Agency FACT-TOI-PFB Functional Assessment of Cancer Therapy – Trial Outcome Index

2013 European Medicines Agency - EPARs

147. Lonquex - lipegfilgrastim

Electrochemiluminescence E. Coli Escherichia coli ELISA Enzyme-linked immunosorbent assay EMA European Medicines Agency EMEA European Medicines Agency EORTC European Organisation for Research and Treatment of Cancer EU European Union FDA Food and Drug Administration FN Febrile neutropenia GCP Good clinical practice GGT Gamma-glutamyltransferase G-CSF Granulocyte colony stimulating factor GLP Good laboratory practice GM-CSF Granulocyte-Macrophage colony-stimulating factor hG-CSF human Granulocyte colony-stimulating (...) Products CI Confidence interval CL/f Total body clearance C max Maximum drug concentration in plasma/serum COPD Chronic obstructive pulmonary disease CPA Cyclophosphamide CPMP Committee for Proprietary Medicinal Products CRF Case report form CSR Clinical study report CTX Chemortherapy CV coefficient of variation DDL Drug dispensation log DIC Disseminated Intravascular Coagulopathy DSMB Data safety monitoring board DSN Duration of severe neutropenia DVT Deep vein thrombosis ECG Electrocardiogram ECL

2013 European Medicines Agency - EPARs

148. Kadcyla - trastuzumab emtansine

. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 22 Methods of analysis 22 2.3.4. Toxicology 24 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 35 2.3.7. Conclusion on the non-clinical aspects 37 2.4. Clinical aspects 37 2.4.1. Introduction 37 2.4.2. Pharmacokinetics 38 2.4.3. Pharmacodynamics 43 Assessment report Page 3/121 EMA/749228/2013 2.4.4. Discussion on clinical pharmacology 44 2.4.5. Conclusions (...) on clinical pharmacology 45 2.1. Clinical efficacy 45 2.1.1. Dose response studies 45 2.1.2. Main studies 47 2.1.3. Discussion on clinical efficacy 75 2.1.4. Conclusions on the clinical efficacy 78 2.2. Clinical safety 78 Use in Pregnancy and Lactation 90 2.2.1. Discussion on clinical safety 91 2.2.2. Conclusions on the clinical safety 97 2.3. Pharmacovigilance 97 2.4. Risk Management Plan 98 2.5. User consultation 116 3. Benefit-Risk Balance 116 4. Recommendations 118 Assessment report Page 4/121 EMA

2013 European Medicines Agency - EPARs

149. Istodax - romidepsin

Licensing status 7 1.2. Steps taken for the assessment of the product 8 1.3. Steps taken for the re-examination procedure 9 2. Scientific discussion 10 2.1. Introduction 10 2.2. Quality aspects 12 Manufacture 13 Specification 13 Stability 14 Pharmaceutical Development 14 Adventitious agents 15 Manufacture of the product 15 Product specification 16 Stability of the product 16 2.3. Non-clinical aspects 19 Primary pharmacodynamic studies 19 Secondary pharmacodynamic studies 24 Safety pharmacology programme (...) 24 Pharmacodynamic drug interactions 26 Single dose toxicity 28 Repeat dose toxicity 29 Genotoxicity 34 Carcinogenicity 34 Reproduction Toxicity 34 Toxicokinetic data 35 Local Tolerance 35 Other toxicity studies 35 2.4. Clinical aspects 43 GCP 43 Absorption 45 Distribution 45 Elimination 46 Dose proportionality and time dependencies 46 Special populations 46 Pharmacokinetic interaction studies 46 Pharmacokinetics using human biomaterials 47 Mechanism of action 47 Primary and Secondary

2013 European Medicines Agency - EPARs

150. Abilify Maintena (aripiprazole)

69 Abilify Maintena EMA/737723/2013 Page 2/70 List of abbreviations Acc Nucleus Accumbens ADP Action Potential Duration AE Adverse Event ALT Alanine transaminase/Alanine Aminotransferase ANCOVA Analysis of covariance AST Aspartate transaminase/Aspartate Aminotransferase AUC Area Under Curve BMI Body Mass Index CGI-I Clinical Global Impression - Improvement Scale CGI-SS Clinical Global Impression – Severity of Suicide CGI-S Clinical Global Impression – Severity Scale CHL Chinese Hamster Lung CHMP (...) and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 14 2.2.6. Recommendation(s) for future quality development 14 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 15 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 18 2.3.5. Ecotoxicity/environmental risk assessment 25 2.3.6. Discussion on non-clinical aspects 26 2.3.7. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 27 2.4.3

2013 European Medicines Agency - EPARs

151. Inflectra - infliximab

under the concentration-time curve over the dosing interval AZA Azathioprine BASDAI Bath Ankylosing Spondylitis Disease Activity Index BASFI Bath Ankylosing Spondylitis Functional Index BASMI Bath Ankylosing Spondylitis Metrology Index biw Twice a week BLA Biologic License Application BMWP Biosimilar Medicinal Products Working Party bw Body weight CD Crohn’s disease CDAI Clinical disease activity index CDC Complement-dependent cytotoxicity cfu Colony forming unit CHMP Committee for Medicinal (...) of an extensive comparability exercise between the two products were presented. Demonstration of comparability via a thorough development programme included quality, nonclinical and clinical data and is key to the evaluation of a biosimilar medicinal product. As part of the comparability exercise it was shown that all major physicochemical characteristics and biological activities of Inflectra were comparable to those of Remicade. The CHMP noted a small difference in the amount of afucosylated infliximab

2013 European Medicines Agency - EPARs

152. Belinostat (Beleodaq)

%), mucositis (21%), neutropenia (20%), and anemia (17%). The most frequently reported adverse reactions with romidepsin (=30%) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%) pyrexia (35%), neutropenia (30%) and constipation (30%). The most common grade 3 or 4 AEs with romidepsin included thrombocytopenia (24%), neutropenia (20%), and anemia (11%). Belinostat is a histone deacetylase (HDAC) inhibitor. Commercially available HDAC inhibitors include Zolinza (...) Belinostat (Beleodaq) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206256Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number 206256 Priority or Standard Priority Submit Date December 8, 2013 Received Date December 9, 2013 PDUFA Goal Date August 8, 2014 Division / Office DHP/OHOP Reviewer Name Hyon-Zu Lee, Pharm.D. Review Completion Date May 16, 2014 Established Name Belinostat Trade Name Beleodaq Therapeutic Class Histone deacetylase inhibitor

2013 FDA - Drug Approval Package

153. Ibrutinib (Imbruvica)

and pulmonary embolism with IVC filter placement, and presented to the hospital with fever, diarrhea and hypotension on study day Her CBC was significant for a WBC Reference ID: 3402723 (b) (6)Clinical Review Karen McGinn, M.S.N., C.R.N.P. NDA 205552 Ibrutinib 65 count of 28.8 K/µL, platelet count of l89 K/µL, and ANC of 27.68 K/µL. She was admitted with a diagnosis of sepsis which required vasopressors and antibiotics. She had a run of Torsades de Pointes, but did not have any cardiac hemodynamic (...) Ibrutinib (Imbruvica) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205552Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type New Molecular Entity Application Numbers 205552 Priority or Standard Priority Submit Date June 28, 2013 Received Date June 28, 2013 PDUFA Goal Date February 28, 2014 Division / Office DHP/OHOP Reviewer Name Karen McGinn, M.S.N., C.R.N.P. Review Completion Date October 31, 2013 Established Name Ibrutinib Trade Name Imbruvica Therapeutic Class Kinase

2013 FDA - Drug Approval Package

154. Telavancin (Vibativ)

infiltrate plus at least two of three clinical features (fever >38°C, leukocytosis or leucopenia, and purulent secretions) at baseline Analysis Subgroups Modified All-Treated (MAT) All patients in the AT population who also had a baseline pathogen identified. MAT, Any Gram Positive Subgroup of all patients in the MAT population who also had a baseline Gram positive pathogen identified (I.e. patients with Gram positive or mixed gram positive, Gram negative infections) MAT, Only Gram Positive Subgroup (...) HABP/VABP. The trials were randomized, double-blind, active-controlled, multicenter, and multinational. Subjects with Gram-positive HABP/VABP were randomized 1:1 to receive either TLV 10 mg/kg IV q 24 h or VAN 1 g IV q 12 h for 7 to 21 days. Study 0015 enrolled 761 subjects and Study 0019 enrolled 771 subjects. The prespecified primary efficacy analysis was clinical response at the test- of-cure (TOC) assessment, which occurred 7-14 days after the last dose of study drug. The noninferiority margin

2013 FDA - Drug Approval Package

155. Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Treatment (PDQ®): Health Professional Version

a better outcome in JMML.[ ] These results suggest that MDS and JMML in children may be significantly different disorders than adult-type MDS. Pediatric MDS can be grouped into several general categories, each with distinctive clinical and biological characteristics, as follows:[ ] MDS arising from an inherited bone marrow failure syndrome, such as Fanconi anemia, severe congenital neutropenia, and Shwachman-Diamond syndrome. MDS arising from severe aplastic anemia. Secondary MDS arising from cytotoxic (...) transformation to AML. (Refer to the section of this summary for more information.) Juvenile myelomonocytic leukemia (JMML). JMML represents the most common myeloproliferative syndrome observed in young children. JMML occurs at a median age of 1.8 years. JMML characteristically presents with hepatosplenomegaly, lymphadenopathy, fever, and skin rash along with an elevated white blood cell (WBC) count and increased circulating monocytes.[ ] In addition, patients often have an elevated hemoglobin F

2017 PDQ - NCI's Comprehensive Cancer Database

156. Cancer Pain (PDQ®): Health Professional Version

-based analysis. Pain Med 11 (10): 1525-36, 2010. [ ] Gutgsell T, Walsh D, Zhukovsky DS, et al.: A prospective study of the pathophysiology and clinical characteristics of pain in a palliative medicine population. Am J Hosp Palliat Care 20 (2): 140-8, 2003 Mar-Apr. [ ] Caraceni A, Portenoy RK: An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain. Pain 82 (3): 263-74, 1999. [ ] Barbera L, Molloy S, Earle (...) CC: Frequency of non-cancer-related pain in patients with cancer. J Clin Oncol 31 (22): 2837, 2013. [ ] Childers JW, King LA, Arnold RM: Chronic Pain and Risk Factors for Opioid Misuse in a Palliative Care Clinic. Am J Hosp Palliat Care 32 (6): 654-9, 2015. [ ] Massaccesi M, Deodato F, Caravatta L, et al.: Incidence and management of noncancer pain in cancer patients referred to a radiotherapy center. Clin J Pain 29 (11): 944-7, 2013. [ ] Kim N, Matzon JL, Abboudi J, et al.: A Prospective

2017 PDQ - NCI's Comprehensive Cancer Database

157. Nutrition in Cancer Care (PDQ®): Health Professional Version

and metabolic) that precede substantial weight loss. Cachexia: the presence of significant weight loss or sarcopenia in the absence of simple starvation. - Weight loss >5% over the past 6 months; or - Body mass index <20 and degree of weight loss >2%; or - Sarcopenia and any degree of weight loss >2%. Refractory cachexia: cachexia that is clinically refractory, usually associated with advanced-stage cancer or rapid progression of disease that is unresponsive to treatment. Although anorexia may also (...) N, Bergerson S, et al., eds.: Oncology Nutrition for Clinical Practice. Chicago, Ill: Oncology Nutrition Dietetic Practice Group, 2018, pp 25-32. Wojtaszek CA, Kochis LM, Cunningham RS: Nutrition impact symptoms in the oncology patient. Oncology Issues 17 (2): 15-7, 2002. Martin L, Birdsell L, Macdonald N, et al.: Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol 31 (12): 1539-47, 2013. [ ] Huhmann M

2017 PDQ - NCI's Comprehensive Cancer Database

158. Gastrointestinal Stromal Tumors Treatment (PDQ®): Health Professional Version

of clinical presentation, the prognosis appears to be influenced by genetic events other than kinase mutations, although a particular kinase mutation may help to define the initial clinical course of a GIST. Based on retrospective studies from time periods that predated the clinical use of kinase inhibitors, current recommendations for assessing the risk of progression for a newly diagnosed primary GIST rely on three parameters (refer to ):[ , - ] Mitotic index (mitoses per 50 high-power fields). Tumor (...) on clinical outcomes is not known. Follow-up recommendations are, therefore, based upon expert opinion and clinical judgment taking into account tumor site, size, and mitotic index. For surgically treated patients with localized disease, routine follow-up schedules may differ across institutions and may depend on the risk status of the tumor.[ ] Abdominal/pelvic CT may be performed every 3 to 6 months, but very low-risk lesions may not need routine follow-up testing.[ ] CT or 18F-FDG PET are used

2017 PDQ - NCI's Comprehensive Cancer Database

159. Zinforo - ceftaroline fosamil

on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendation for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 21 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion on non-clinical aspects 26 2.3.6. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 34 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 43 (...) 2.4.5. Conclusions on clinical pharmacology 44 2.5. Clinical efficacy 44 2.5.1. Dose response studies 44 2.5.2. Main studies 46 2.5.3. Discussion on clinical efficacy 92 2.5.4. Conclusions on the clinical efficacy 94 2.6. Clinical safety 95 2.6.1. Discussion on clinical safety 105 2.6.2. Conclusions on the clinical safety 105 2.7. Pharmacovigilance 105 2.8. User consultation 119 3. 119 Benefit-Risk Balance 4. 121 RecommendationsZinforo Assessment report Page 4/122 List of abbreviations %T>MIC

2012 European Medicines Agency - EPARs

160. Folotyn - pralatrexate

lymphoma DNA deoxyribonucleic acid dTMP deoxythymidine monophosphate EMA European Medicines Agency EU European Union FDA Food and Drug Administration FPGS folylpolyglutamyl synthetase G-CSF granulocyte colony stimulating factor GCP Good Clinical Practice GM-CSF granulocyte/macrophage colony stimulating factor HR hazard ratio HTLV human T-cell leukaemia virus ICH International Conference on Harmonisation IPI International Prognostic Index IWC International Workshop Criteria IV intravenous LFT liver (...) Prognostic Index, 5-year survival has been reported to be as low as 6%. Several clinical studies have reported a median survival of less than 2 years for patients with T-cell neoplasms and 5-year survival rates of less than 30%. Because of having an aggressive clinical course with poor outcomes, PTCL is typically treated with combination chemotherapy regimens like CHOP and its variants. The first-line response rates to CHOP chemotherapy have been reported to range between 50% and 70%. However, patients

2012 European Medicines Agency - EPARs

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