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Tongue Carcinoma

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1701. Stivarga - regorafenib

maximum tolerated dose NSCLC non-small cell lung cancer NOAEL no observed adverse effect level OATP Organic anion-transporting polypeptide ORR objective response rate OS overall survival OVAT One Variable At a Time PK pharmacokinetics PFS progression free survival PR partial response RECIST response evaluation criteria in solid tumours RPES Posterior reversible encephalopathy syndrome SAE serious adverse event SD stable disease SJS Stevens-Johnson-Syndrome TEN Toxic epidermal necrolysis TG (...) haemoglobin HCC hepatocellular carcinoma HCT haematocrit HFSR Hand-foot skin reaction HPLC high performance liquid chromatography HR hazard ratio KRAS Kirsten rat sarcoma 2 viral oncogene homologue LDH lactate dehydrogenase LVEF left ventricular ejection fraction MCH mean corpuscular haemoglobin Assessment report EMA/CHMP/403683/2013 Page 5/91 MCHC mean corpuscular haemoglobin concentration mCRC metastatic colorectal cancer MCV mean corpuscular volume MRP multidrug resistance-associated protein MTD

2013 European Medicines Agency - EPARs

1702. Tresiba - insulin degludec

AUC area under the curve BB basal–bolus BID twice daily BMI body mass index C max maximum plasma concentration CGM continuous glucose monitoring CHMP Committee for Medicinal Products for Human Use CI confidence interval CSII continuous subcutaneous insulin infusion CV coefficient of variation CYP cytochrome P450 DPP-4 inhib dipeptidyl peptidase-4 inhibitor ECG electrocardiogram ELISA enzyme-linked immuno sorbent assay ESRD end-stage renal disease FAS full analysis set FF fixed flexible FPG fasting (...) the results of trials with insulin degludec in: ? neonates and infants from birth to less than 12 months of age with type 1 diabetes mellitus and ? children from birth to less than 10 years of age with type 2 diabetes mellitus on the grounds that the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset. The EMA has deferred the obligation to submit the results of trials with insulin degludec in one or more subsets of the paediatric

2013 European Medicines Agency - EPARs

1703. Kadcyla - trastuzumab emtansine

be treated with curative intent; however 25%-40% of such patients will develop metastatic disease (Guarneri and Conte 2009). For metastatic breast cancer (MBC) overall, the median survival time for patients with metastatic tumors at first diagnosis is approximately 24 months, and only 18%-23% of patients (in the US and Europe) will live at least 5 years after diagnosis of MBC (Sant, Allemani et al. 2003; Howlader, Noone et al. 2011). MBC remains incurable, and an estimated 450,000 patients globally die (...) antibodies (L01XC14) Therapeutic indication: Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: • Received prior therapy for locally advanced or metastatic disease, or • Developed disease recurrence during or within six months of completing adjuvant therapy. Pharmaceutical form: Powder

2013 European Medicines Agency - EPARs

1704. Istodax - romidepsin

Response Evaluation Criteria in Solid Tumors REAL Revised European-American Lymphoma RH relative humidity RMP resting membrane potential RRT relative retention time SAE serious adverse event SD stable disease SC subcutaneously SCID severe combined immunodeficiency TEAE treatment-emergent adverse event TBA tert-butyl alcohol TLC thin layer chromatography TTP time to progression ULN upper limit of normal VEGF vascular endothelial growth factor VTE venous thromboembolism event WBC white blood cells WFI (...) -diphenyltetrazolium bromide MWCB master working cell bank NADPH nicotinamide adenine dinucleotide phosphate-oxidase NCE normochromatic erythrocytes NCI National Cancer Institute ND not determined NHL non-Hodgkin’s lymphoma NK natural killer NMR nuclear magnetic resonance NOAEL no observable adverse effect level NOS not otherwise specified NYHA New York Heart Association OATP organic anion-transporting polypeptide ORR overall response rate OS overall survival Papp permeability coefficient PBT persistent

2013 European Medicines Agency - EPARs

1705. Relvar Ellipta - fluticasone furoate / vilanterol

-therapeutic group (ATC Code): Adrenergics and other drugs for obstructive airway diseases (R03AK10) Therapeutic indications: Asthma Indication: Relvar Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta 2 -agonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta 2 -agonists. COPD Indication: Relvar (...) at the first sampling time (5 minutes) following iv administration. Highest concentrations were observed in the liver, tongue, kidney cortex, myocardium, pineal body, lung and bulbo-urethral gland. With the exception of various components of the gastrointestinal tract, all tissues attained their highest observed concentrations of DRM at 5 minutes after dosing. Tissue concentrations of DRM declined rapidly such that by 3 days post dose, concentrations in all tissues were generally below or close

2013 European Medicines Agency - EPARs

1706. Abilify Maintena (aripiprazole)

in adults. Schizophrenia is a chronic, disabling, and progressive disease characterized by delusions, hallucinations, and cognitive impairment; symptoms and disease course differ across patients. Lifetime prevalence may vary across countries but, overall, adult schizophrenia affects 0.8 to 1% of the general population 1 . The course of schizophrenia is typically characterized by episodes of psychotic behaviours occurring at varying intervals between periods of relative symptomatic stability. Following

2013 European Medicines Agency - EPARs

1707. Cannabis and Cannabinoids (PDQ®): Patient Version

, including the and the (see ). The main psychoactive cannabinoid in Cannabis is delta-9-THC. Another active cannabinoid is cannabidiol (CBD), which may relieve pain, lower , and decrease without causing the "high" of delta-9-THC (see ). Cannabinoids can be taken by mouth, , or sprayed under the tongue (see ). Cannabis and cannabinoids have been studied for relief of pain, and , , and loss of caused by cancer or the of cancer (see ). Two cannabinoid drugs ( and ) are approved by the (FDA (...) into a different psychoactive chemical (11-OH-THC). When Cannabis is smoked and inhaled, cannabinoids quickly enter the bloodstream. The psychoactive chemical (11-OH-THC) is made in smaller amounts than when taken by mouth. A growing number of are studying a made from an of Cannabis that contains specific amounts of cannabinoids. This medicine is sprayed under the tongue. Have any laboratory or animal studies been done using Cannabis or cannabinoids? In , tumor cells are used to test a substance to find out

2017 PDQ - NCI's Comprehensive Cancer Database

1708. Candida - oral

in nodular form or as white plaques on the cheek or tongue, that are not easily removed. In this form of the disease, the Candida hyphae are not only found at epithelial surface level but also invade deeper levels where epithelial dysplasia can be observed. It presents with mild symptoms, but has an associated increased risk of malignancy. It is most common in men older than 30 years of age and in smokers. Median rhomboid glossitis presents with a central, red, demarcated area of papillary atrophy (...) (burning and itching sensation); however, chronic forms may involve the oesophageal mucosa, leading to dysphagia and chest pains. It most commonly occurs in neonates, elderly people, people who are immunocompromised (especially people with AIDS, diabetes, cancer, or taking broad spectrum antibiotics), and people with xerostomia. Acute erythematous oral candidiasis (acute atrophic oral candidiasis) presents with marked soreness and erythema, particularly on the palate and dorsum of the tongue

2017 NICE Clinical Knowledge Summaries

1709. Antibiotic Prophylaxis for Dental Patients at Risk for Infection

: BEST PRACTICES 389 with compromised immunity at risk for distant-site infection from a dental procedure. 10 This category includes, but is not limited to, patients with the following medical conditions 10 : 1. Immunosuppression secondary to: a. human immunodeficiency virus (HIV); b. severe combined immunodeficiency (SCIDS); c. neutropenia; d. cancer chemotherapy; and e. hematopoietic stem cell or solid organ transplantation. 2. Head and neck radiotherapy. 3. Autoimmune disease (e.g., juvenile (...) endocarditis from tongue piercing. J Emerg Med 2005;29(1):57-9. 17. Akhondi H, Rahimi AR. Haemophilus aphrophilus endo- carditis after tongue piercing. Emerg Infect Dis 2002;8 (8):850-1. 18. Tronel H, Chaudemanche H, Pechier N, Doutrelant L, Hoen B. Endocarditis due to Neisseria mucosa after tongue piercing. Clin Microbiol Infect 2001;7:275–6. 19. Tate AR, Norris CK, Minniti CP . Antibiotic prophylaxis for children with sickle cell disease: A survey of pediatric dentistry residency program directors

2014 American Academy of Pediatric Dentistry

1710. Aloe vera for treatment of oral submucous fibrosis?

Aloe vera for treatment of oral submucous fibrosis? Aloe vera for treatment of oral submucous fibrosis? - National Elf Service Search National Elf Service Search National Elf Service » » » » Aloe vera for treatment of oral submucous fibrosis? Dec 5 2018 Posted by Oral submucous fibrosis (OSF) is an oral potential malignant disorder that commonly involves the buccal mucosa and results in a loss of tissue mobility and rigidity and eventually an inability to open the mouth. It is mainly seen (...) opening, change in tongue movement and cheek flexibility. Two reviewers independently selected studies extracted data and assessed risk of bias using the Cochrane assessment tool. Meta‐analysis was undertaken where studies of similar comparisons reported the same outcome measures. Mean difference (MD) for the burning sensation, mouth opening, tongue protrusion, and cheek flexibility was calculated and compared between the two studied interventions. Results 6 RCTs involving a total of 413 patients were

2018 The Dental Elf

1711. Breastfeeding problems

skin conditions or other underlying causes of symptoms, if present. Arranging a paediatric referral for the infant if there are concerns about dehydration, faltering growth, infant development, or the presence of an anatomical abnormality such as ankyloglossia (tongue-tie) that may be affecting infant attachment and feeding. Considering specialist referral for possible drug treatment if Raynaud's disease of the nipple, or prolactin deficiency causing a low milk supply, is suspected, and other (...) to a breast specialist using a suspected cancer pathway. See the CKS topic on for more information. Nipple vasospasm or Raynaud's disease of the nipple: Advise on avoiding exposure to the cold, wearing warm clothing, and breastfeeding in a warm environment. Advise on self-management techniques such as the use of heat packs or a warm shower following a breastfeed or when there is breast pain. Advise on avoiding caffeine and stopping smoking which can cause vasoconstriction, if appropriate. See the CKS

2017 NICE Clinical Knowledge Summaries

1712. Aphthous ulcer

with circumscribed margins, typically presenting first in childhood or adolescence, and not associated with systemic disease. Aphthous ulcers are often recurrent, with a natural history of spontaneous resolution with age. Aphthous ulcers occur in three different clinical morphological variants that can occasionally occur simultaneously. Minor ulcers are less than 1 cm in diameter (usually 2–5 mm) and heal spontaneously in less than 14 days. They account for around 85% of all recurrent oral aphthous ulcers. Major (...) Aphthous ulcer Aphthous ulcer - NICE CKS Share Aphthous ulcer: Summary Aphthous ulcers are painful, clearly defined, round or ovoid, shallow ulcers that are confined to the mouth and are not associated with systemic disease. They are often recurrent, with onset usually in childhood. Single ulcers, or recurrent ulcers in the same place, may be caused by damage to the mouth, for example biting the cheek, or damage to the buccal mucosa with a toothbrush, sharp tooth, or filling. People

2017 NICE Clinical Knowledge Summaries

1713. Stroke and TIA

of cardiovascular disease . Scottish Intercollegiate Guidelines Network. [ ] AHA/ASA (2018) 2018 guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American heart association/American stroke association . AHA/ASA. [ ] Mulder, M. J., Jansen, I. V., Goldhoorn, R-B. (2018) Time to endovascular treatment and outcome in acute ischemic stroke: MR CLEAN registry results. Circulation. [ ] Zerna, C., et al (2018) Current practice and future (...) national database study of 795 869 adults. The British Medical Journal. [ ] Mehra, M., Vaduganathan, M., Fu, M., et al. (2019) A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. European Society of Cardiology. [ ] Jame, S. and Barnes, G. (2019) Stroke and thromboembolism prevention in atrial fibrillation . Heart BMJ. [ ] Primary evidence Johnston, S. et al

2017 NICE Clinical Knowledge Summaries

1714. Hiccups

than females, with a ratio of 4:1. Persistent intractable hiccups are rare and affect women and men equally. Hiccups of psychogenic origin are more common in women, while those originating from an underlying cause occur more commonly in men. Hiccups may occur in up to 9% of patients with advanced cancer. Up to 20% of people with Parkinson’s disease and 10% of people with reflux symptoms report recurrent hiccups compared to approximately 3% of controls. [ ; ; ] Causes What are the causes? Benign (...) cyst, pneumonia, empyema, bronchitis, asthma, pleuritis, oesophagitis, aortic aneurysm, tuberculosis, lung cancer, cor pulmonale, mediastinitis, gastric atony, gastric cancer, gastritis, duodenal ulcer, pancreatitis, pancreatic cancer, intra-abdominal abscess, bowel obstruction, cholecystitis, cholelithiasis, ulcerative colitis, Crohn's disease, gastrointestinal haemorrhage, appendicitis, hepatitis, or prostatic disease. Central nervous pathologies , including: Structural lesions — intracranial

2017 NICE Clinical Knowledge Summaries

1715. Meniere's disease

[ ]. Expert opinion in diagnostic and therapeutic guidelines from the French Otorhinolaryngology Head and Neck Surgery Society [ ] and review articles [ ; ; ] suggests people with suspected Meniere's disease should undergo MRI scanning to exclude acoustic neuroma, cerebellopontine angle or endolymphatic sac tumour, Chiari malformation, or multiple sclerosis. Specialist investigations that may also be used in the diagnosis of Meniere's disease include vestibular testing using electronystagmography (...) or videonystagmography [ ; ]. Differential diagnosis What else might it be? The diagnosis of Meniere's disease should only be made once conditions such as tumours (for example acoustic neuroma), multiple sclerosis, perilymph fistula, vascular events (for example transient ischaemic attack), migraine, benign paroxysmal positional vertigo, vestibular neuronitis, and acute labyrinthitis have been ruled out. For more information on conditions which may present in a similar way to Meniere's disease, see the CKS topics

2017 NICE Clinical Knowledge Summaries

1716. Vertigo

. It is important to differentiate peripheral from central vertigo. Peripheral vertigo is more common and is usually caused by a problem with the inner ear affecting the labyrinth or vestibular nerve (for example benign paroxysmal positional vertigo, vestibular neuronitis, labyrinthitis, and Meniere’s disease). Central vertigo is uncommon and is usually caused by pathology in the brainstem and cerebellum (for example stroke, transient ischaemic attack, cerebellar tumour, and multiple sclerosis). Examination (...) . It can be difficult to distinguish from early Meniere's disease. For more information, see the CKS topic on . Stroke and transient ischaemic attack, cerebellar tumour, acoustic neuroma, and multiple sclerosis (less common causes). For more information, see the CKS topics on , , and . Vertigo may present as part of the acute vestibular syndrome , defined as acute onset dizziness and/or vertigo; intolerance of head movement; continuous dizziness of 24 hours to several weeks' duration; spontaneous

2017 NICE Clinical Knowledge Summaries

1717. Vestibular neuronitis

diagnosis of vertigo includes benign paroxysmal positional vertigo, labyrinthitis, Meniere’s disease, and central causes such as migraine, stroke, cerebellar tumour, and multiple sclerosis. Advice should be offered regarding resuming activity as soon as possible, and safety issues such as driving, work, and prevention of falls. If symptoms are severe, short-term symptomatic drug treatment can be offered. Buccal or intramuscular prochlorperazine or intramuscular cyclizine can be considered to rapidly (...) , see the CKS topic on . Labyrinthitis (similar features to vestibular neuronitis, but also involves tinnitus and hearing loss). Meniere's disease. For more information, see the CKS topic on . Central causes (for example migraine, stroke, cerebellar tumour, and multiple sclerosis). For more information on differentiating between these conditions, see the CKS topic on . Basis for recommendation Basis for recommendation This information is based on expert opinion in review articles

2017 NICE Clinical Knowledge Summaries

1718. Signifor - pasireotide

by the patient. There are no dose adjustments recommended in the elderly or in renal impairment. The recommended initial dose for patients with moderate or severe hepatic impairment is 0.3 mg twice a day, with a maximum recommended dose of 0.6 mg twice a day. Cushing’s disease Cushing’s disease is a very rare, debilitating, and life-threatening disease that is caused by an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma most commonly affecting adult females. The tumours are usually (...) microadenomas ( = 1 cm in diameter); macroadenomas are rare. The elevated levels of ACTH secreted by these tumours stimulate the adrenal glands to produce excess cortisol, thereby leading to the subsequent development of the clinical signs and symptoms of hypercortisolism. In patients with Cushing’s disease, most adenomatous cells develop a high set-point for feedback inhibition of ACTH secretion by cortisol, which may lead to loss of tumour differentiation to the point where increased cortisol levels can

2012 European Medicines Agency - EPARs

1719. NexoBrid - concentrate of proteolytic enzymes enriched in bromelain

, the Committee for Orphan Medicinal Products (COMP) reviewed the designation of NexoBrid as an orphan medicinal product in the approved indication. The outcome of the COMP review can be found on the Agency's website: ema.europa.eu/Find Medicine/Human medicines/Rare disease designations. 2. Scientific discussion 2.1. Introduction 2.1.1. Problem statement Debridement of eschar is essential to initiate the wound healing process and prevent further complications. Technology for this treatment in severe burns has

2012 European Medicines Agency - EPARs

1720. Lymphoseek - technetium complexed with tilmanocept

(manufacturing facilities’ inspections) having been resolved, this reviewer recommends approving the NDA 202207 for Lymphoseek as a radioactive diagnostic agent indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma. Clinically relevant labeling issues have been all addressed during the previous review cycle. Reference ID: 3266833 (...) - 4%) 47 (30%) (23 - 38%) 9 (6%) (3 - 11%) One B 154 108 (70%) (62 - 77 %) 146 (95%) (90 - 98%) 7 (5%) (2 – 9%) 45 (29%) (22 - 37%) 1 (1%) (0 - 4%) M 196 115 (59%) (51 - 66%) 196 (100%) (98 - 100%) 0 (0 - 2%) 81 (41%) (34 - 49%) 0 (0 - 2%) Two B 180 112 (62%) (55 - 69%) 180 100%) (98 - 100%) 0 (0 - .2%) 68 (38%) (31- 45%) 0 (0 - 2%) T = tumor; M = melanoma; B = breast cancer; The percents may not add to 100% due to rounding. 95% Confidence Intervals are based on Exact Binomial and represent

2012 FDA - Drug Approval Package

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