LILLY CARES® FOUNDATION Patient Assistance Program Application the Lilly Cares Foundation, Inc
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LANTUS® (Insulin Glargine [Rdna Origin] Injection)
Rev. March 2007 Rx Only LANTUS® (insulin glargine [rDNA origin] injection) LANTUS® must NOT be diluted or mixed with any other insulin or solution. DESCRIPTION LANTUS® (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent. (See CLINICAL PHARMACOLOGY). LANTUS is produced by recombinant DNA technology utilizing a non- pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A- B B Gly-30 a-L-Arg-30 b-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063. It has the following structural formula: LANTUS consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine injection) contains 100 IU (3.6378 mg) insulin glargine. Inactive ingredients for the 10 mL vial are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection. Inactive ingredients for the 3 mL cartridge are 30 mcg zinc, 2.7 mg m-cresol, 20 mg glycerol 85%, and water for injection. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4. CLINICAL PHARMACOLOGY Mechanism of Action: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. -
Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Galcanezumab-Gnlm) Injection, for Subcutaneous Use
1 HIGHLIGHTS OF PRESCRIBING INFORMATION • Administer in the abdomen, thigh, back of the upper arm, or These highlights do not include all the information needed to use buttocks subcutaneously. (2.3) EMGALITY safely and effectively. See full prescribing information for EMGALITY. ---------------------- DOSAGE FORMS AND STRENGTHS -------------------- • Injection: 120 mg/mL solution in a single-dose prefilled pen (3) EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use Initial U.S. Approval: 2018 • Injection: 120 mg/mL solution in a single-dose prefilled syringe (3) • Injection: 100 mg/mL solution in a single-dose prefilled syringe (3) --------------------------- RECENT MAJOR CHANGES ------------------------- Indications and Usage, Episodic Cluster Headache (1.2) 06/2019 ------------------------------- CONTRAINDICATIONS ----------------------------- Dosage and Administration, Recommended Dosing for Episodic EMGALITY is contraindicated in patients with serious hypersensitivity Cluster Headache (2.2) 06/2019 to galcanezumab-gnlm or to any of the excipients. (4) ---------------------------- INDICATIONS AND USAGE -------------------------- ------------------------ WARNINGS AND PRECAUTIONS ---------------------- EMGALITY® is a calcitonin-gene related peptide antagonist indicated in Hypersensitivity Reactions: If a serious hypersensitivity reaction adults for the: occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions could occur days after • preventive treatment of migraine. (1.1) -
Baqsimi, INN-Glucagon
17 October 2019 EMA/CHMP/602404/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report BAQSIMI International non-proprietary name: glucagon Procedure No. EMEA/H/C/003848/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union Table of contents 1. Background information on the procedure .............................................. 7 1.1. Submission of the dossier ...................................................................................... 7 1.2. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ................................................................................ 9 2.1. Problem statement ............................................................................................... 9 2.1.1. Disease or condition ........................................................................................... 9 2.1.2. Epidemiology .................................................................................................. 10 2.1.3. Biologic features, Aetiology and pathogenesis ..................................................... 10 2.1.4. Clinical presentation, diagnosis ......................................................................... -
Type 2 Diabetes Adult Outpatient Insulin Guidelines
Diabetes Coalition of California TYPE 2 DIABETES ADULT OUTPATIENT INSULIN GUIDELINES GENERAL RECOMMENDATIONS Start insulin if A1C and glucose levels are above goal despite optimal use of other diabetes 6,7,8 medications. (Consider insulin as initial therapy if A1C very high, such as > 10.0%) 6,7,8 Start with BASAL INSULIN for most patients 1,6 Consider the following goals ADA A1C Goals: A1C < 7.0 for most patients A1C > 7.0 (consider 7.0-7.9) for higher risk patients 1. History of severe hypoglycemia 2. Multiple co-morbid conditions 3. Long standing diabetes 4. Limited life expectancy 5. Advanced complications or 6. Difficult to control despite use of insulin ADA Glucose Goals*: Fasting and premeal glucose < 130 Peak post-meal glucose (1-2 hours after meal) < 180 Difference between premeal and post-meal glucose < 50 *for higher risk patients individualize glucose goals in order to avoid hypoglycemia BASAL INSULIN Intermediate-acting: NPH Note: NPH insulin has elevated risk of hypoglycemia so use with extra caution6,8,15,17,25,32 Long-acting: Glargine (Lantus®) Detemir (Levemir®) 6,7,8 Basal insulin is best starting insulin choice for most patients (if fasting glucose above goal). 6,7 8 Start one of the intermediate-acting or long-acting insulins listed above. Start insulin at night. When starting basal insulin: Continue secretagogues. Continue metformin. 7,8,20,29 Note: if NPH causes nocturnal hypoglycemia, consider switching NPH to long-acting insulin. 17,25,32 STARTING DOSE: Start dose: 10 units6,7,8,11,12,13,14,16,19,20,21,22,25 Consider using a lower starting dose (such as 0.1 units/kg/day32) especially if 17,19 patient is thin or has a fasting glucose only minimally above goal. -
Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach Applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer”
Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” María García-Cremades Mira Pamplona, 2017 Departamento de Farmacia y Tecnología Farmacéutica Facultad de Farmacia y Nutrición UNIVERSIDAD DE NAVARRA TESIS DOCTORAL “Pharmacokinetic/Pharmacodynamic Modelling-Based Translational Approach applied to the Anticancer Drug Gemcitabine in Advanced Pancreatic and Ovarian Cancer” Trabajo presentado por María García-Cremades Mira para obtener el Grado de Doctor Fdo. María García-Cremades Mira Pamplona, 2017 UNIVERSIDAD DE NAVARRA FACULTAD DE FARMACIA Y NUTRICIÓN Departamento de Farmacia y Tecnología Farmacéutica D. JOSÉ IGNACIO FERNÁNDEZ DE TROCÓNIZ FERNÁNDEZ, Doctor en Farmacia y Catedrático del Departamento de Farmacia y Tecnología Farmacéutica. Certifica: Que el presente trabajo, titulado “Pharmacokinetic/pharmacodynamic modelling-based translational approach applied to the anticancer drug gemcitabine in advanced pancreatic and ovarian cancer”, presentado por DÑA. MARÍA GARCÍA-CREMADES MIRA para optar al grado de Doctor en Farmacia, ha sido realizado bajo su dirección en los Departamentos de Farmacia y Tecnología Farmacéutica. Considerando finalizado el trabajo autorizan su presentación a fin de que pueda ser juzgado y calificado por el Tribunal correspondiente. Y para que así conste, firma la presente: Fdo.: Dr. José Ignacio F Trocóniz Pamplona, 2017 “El mundo es de los que hacen de cada momento una gran aventura” AGRADECIMIENTOS Quisiera comenzar expresando mi agradecimiento a la Universidad de Navarra y al Departamentos de Farmacia y Tecnología Farmacéutica por haberme posibilitado la realización de esta tesis doctoral. Al Dr. Iñaki Trocóniz me gustaría agradecerle la confianza y motivación que desde el primer día me ha dado. -
761063Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761063Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) Office of Clinical Pharmacology Review BLA Number 761063 Link to EDR \\cdsesub1\evsprod\bla761063\0001\m1\us\cover.pdf Submission Date 10/27/2017 Submission Type NME, Standard Review Brand Name EMGALITYTM Generic Name Galcanezumab Dosage Form and Strength 120 mg/mL Prefilled auto-injector pen and Pre-filled syringe Route of Administration Subcutaneous injection Proposed Dose/Regimen: 120 mg once monthly, with a 240 mg loading dose as the initial dose Proposed Indication preventive treatment of migraine Applicant Eli Lilly and Company Associated IND 111295 OCP Review Team Bilal AbuAsal, Ph.D., Gopichand Gottipati, Ph.D., Kevin Krudys, Ph.D., Sreedharan Sabarinath, Ph.D. OCP Final Signatory Ramana Uppoor, Ph.D. 1 Reference ID: 4278873 Table of Contents 1. EXECUTIVE SUMMARY .......................................................................................................................... 3 1.1 Recommendations ........................................................................................................................ 3 1.2 Post-Marketing Requirements and Commitments ....................................................................... 4 2. SUMMARY OF CLINICAL PHARMACOLOGY ASSESSMENT ..................................................................... 5 2.1 Pharmacology and Clinical Pharmacokinetics............................................................................... 5 2.2 Dosing and -
Does Treatment with Duloxetine for Neuropathic Pain Impact Glycemic Control?
Clinical Care/Education/Nutrition ORIGINAL ARTICLE Does Treatment With Duloxetine for Neuropathic Pain Impact Glycemic Control? 1 1 THOMAS HARDY, MD, PHD MARY ARMBRUSTER, MSN, CDE betic peripheral neuropathic pain (DPNP) 2 3,4 RICHARD SACHSON, MD ANDREW J.M. BOULTON, MD, FRCP vary from 3% to Ͼ20% (4). 1 SHUYI SHEN, PHD For many agents, the data supporting effectiveness is limited. In addition, nearly all treatments are associated with OBJECTIVE — We examined changes in metabolic parameters in clinical trials of duloxetine safety or tolerability issues. One category for diabetic peripheral neuropathic pain (DPNP). of side effects common to a number of the antidepressant and anticonvulsant drugs RESEARCH DESIGN AND METHODS — Data were pooled from three similarly de- is related to metabolic changes. Weight signed clinical trials. Adults with diabetes and DPNP (n ϭ 1,024) were randomized to 60 mg ϭ gain is seen with tricyclic antidepressants duloxetine q.d., 60 mg b.i.d., or placebo for 12 weeks. Subjects (n 867) were re-randomized (TCAs) (5) and anticonvulsants (e.g., val- to 60 mg duloxetine b.i.d. or routine care for an additional 52 weeks. Mean changes in plasma glucose, lipids, and weight were evaluated. Regression and subgroup analyses were used to proate, gabapentin, pregabalin) (6). identify relationships between metabolic measures and demographic, clinical, and electrophys- Changes in plasma glucose have also been iological parameters. reported with TCAs (7,8) and phenytoin (9), and dyslipidemia can be seen with RESULTS — Duloxetine treatment resulted in modest increases in fasting plasma glucose carbamazepine (10). in short- and long-term studies (0.50 and 0.67 mmol/l, respectively). -
Baricitinib Counteracts Metaflammation, Thus Protecting Against Diet-Induced Metabolic Abnormalities in Mice
Original Article Baricitinib counteracts metaflammation, thus protecting against diet-induced metabolic abnormalities in mice Debora Collotta 1,5, William Hull 2,5, Raffaella Mastrocola 3, Fausto Chiazza 1, Alessia Sofia Cento 3, Catherine Murphy 2, Roberta Verta 1, Gustavo Ferreira Alves 1, Giulia Gaudioso 4, Francesca Fava 4, Magdi Yaqoob 2, Manuela Aragno 3, Kieran Tuohy 4, Christoph Thiemermann 2,5,**, Massimo Collino 1,5,* ABSTRACT Objective: Recent evidence suggests the substantial pathogenic role of the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway in the development of low-grade chronic inflammatory response, known as “metaflammation,” which contributes to obesity and type 2 diabetes. In this study, we investigated the effects of the JAK1/2 inhibitor baricitinib, recently approved for the treatment of rheumatoid arthritis, in a murine high-fat-high sugar diet model. Methods: Male C57BL/6 mice were fed with a control normal diet (ND) or a high-fat-high sugar diet (HD) for 22 weeks. A sub-group of HD fed mice was treated with baricitinib (10 mg/kg die, p.o.) for the last 16 weeks (HD þ Bar). Results: HD feeding resulted in obesity, insulin-resistance, hypercholesterolemia and alterations in gut microbial composition. The metabolic abnormalities were dramatically reduced by chronic baricitinib administration. Treatment of HD mice with baricitinib did not change the diet- induced alterations in the gut, but restored insulin signaling in the liver and skeletal muscle, resulting in improvements of diet-induced myo- steatosis, mesangial expansion and associated proteinuria. The skeletal muscle and renal protection were due to inhibition of the local JAK2- STAT2 pathway by baricitinib. -
The Microbiota-Produced N-Formyl Peptide Fmlf Promotes Obesity-Induced Glucose
Page 1 of 230 Diabetes Title: The microbiota-produced N-formyl peptide fMLF promotes obesity-induced glucose intolerance Joshua Wollam1, Matthew Riopel1, Yong-Jiang Xu1,2, Andrew M. F. Johnson1, Jachelle M. Ofrecio1, Wei Ying1, Dalila El Ouarrat1, Luisa S. Chan3, Andrew W. Han3, Nadir A. Mahmood3, Caitlin N. Ryan3, Yun Sok Lee1, Jeramie D. Watrous1,2, Mahendra D. Chordia4, Dongfeng Pan4, Mohit Jain1,2, Jerrold M. Olefsky1 * Affiliations: 1 Division of Endocrinology & Metabolism, Department of Medicine, University of California, San Diego, La Jolla, California, USA. 2 Department of Pharmacology, University of California, San Diego, La Jolla, California, USA. 3 Second Genome, Inc., South San Francisco, California, USA. 4 Department of Radiology and Medical Imaging, University of Virginia, Charlottesville, VA, USA. * Correspondence to: 858-534-2230, [email protected] Word Count: 4749 Figures: 6 Supplemental Figures: 11 Supplemental Tables: 5 1 Diabetes Publish Ahead of Print, published online April 22, 2019 Diabetes Page 2 of 230 ABSTRACT The composition of the gastrointestinal (GI) microbiota and associated metabolites changes dramatically with diet and the development of obesity. Although many correlations have been described, specific mechanistic links between these changes and glucose homeostasis remain to be defined. Here we show that blood and intestinal levels of the microbiota-produced N-formyl peptide, formyl-methionyl-leucyl-phenylalanine (fMLF), are elevated in high fat diet (HFD)- induced obese mice. Genetic or pharmacological inhibition of the N-formyl peptide receptor Fpr1 leads to increased insulin levels and improved glucose tolerance, dependent upon glucagon- like peptide-1 (GLP-1). Obese Fpr1-knockout (Fpr1-KO) mice also display an altered microbiome, exemplifying the dynamic relationship between host metabolism and microbiota. -
Immunfarmakológia Immunfarmakológia
Gergely: Immunfarmakológia Immunfarmakológia Prof Gergely Péter Az immunpatológiai betegségek döntő többsége gyulladásos, és ennek következtében általában szövetpusztulással járó betegség, melyben – jelenleg – a terápia alapvetően a gyulladás csökkentésére és/vagy megszűntetésére irányul. Vannak kizárólag gyulladásgátló gyógyszereink és vannak olyanok, amelyek az immunreakció(k) bénításával (=immunszuppresszió révén) vagy emellett vezetnek a gyulladás mérsékléséhez. Mind szerkezetileg, mind hatástanilag igen sokféle csoportba oszthatók, az alábbi felosztás elsősorban didaktikus célokat szolgál. 1. Nem-szteroid gyulladásgátlók (‘nonsteroidal antiinflammatory drugs’ NSAID) 2. Kortikoszteroidok 3. Allergia-elleni szerek (antiallergikumok) 4. Sejtoszlás-gátlók (citosztatikumok) 5. Nem citosztatikus hatású immunszuppresszív szerek 6. Egyéb gyulladásgátlók és immunmoduláns szerek 7. Biológiai terápia 1. Nem-szteroid gyulladásgátlók (NSAID) Ezeket a vegyületeket, melyek őse a szalicilsav (jelenleg, mint acetilszalicilsav ‘aszpirin’ használatos), igen kiterjedten alkalmazzák a reumatológiában, az onkológiában és az orvostudomány szinte minden ágában, ahol fájdalom- és lázcsillapításra van szükség. Egyes felmérések szerint a betegek egy ötöde szed valamilyen NSAID készítményt. Szerkezetük alapján a készítményeket több csoportba sorolhatjuk: szalicilátok (pl. acetilszalicilsav) pyrazolidinek (pl. fenilbutazon) ecetsav származékok (pl. indometacin) fenoxiecetsav származékok (pl. diclofenac, aceclofenac)) oxicamok (pl. piroxicam, meloxicam) propionsav