DOCSLIB.ORG

LIXISENATIDE and Iglarlixi (Insulin Glargine/Lixisenatide Fixed-Ratio Combination)

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
LIXISENATIDE and Iglarlixi (Insulin Glargine/Lixisenatide Fixed-Ratio Combination) Lixisenatide and Insulin Glargine/Lixisenatide Briefing Document EMDAC Advisory Committee Meeting LIXISENATIDE and iGlarLixi (insulin glargine/lixisenatide fixed-ratio combination) FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS BRIEFING DOCUMENT FOR THE ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE MEETING DATE: 25 May 2016 ADVISORY COMMITTEE BRIEFING MATERIALS: AVAILABLE FOR PUBLIC RELEASE Available for Public Release Page 1 of 217 Lixisenatide and Insulin Glargine/Lixisenatide Briefing Document EMDAC Advisory Committee Meeting TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................................................. 2 LISTING OF TABLES ..................................................................................................................................... 7 LISTING OF FIGURES ................................................................................................................................. 11 ABBREVIATIONS ......................................................................................................................................... 14 1 READERS GUIDE TO THE BRIEFING BOOK ............................................................................. 16 2 EXECUTIVE SUMMARY ............................................................................................................... 17 2.1 MANAGEMENT OF T2DM IN 2016 ............................................................................................... 17 2.2 INTRODUCTION TO LIXISENATIDE AND IGLARLIXI ................................................................. 18 2.2.1 Lixisenatide .................................................................................................................................... 18 2.2.2 Insulin glargine (100 U/mL) ............................................................................................................ 18 2.2.3 iGlarLixi .......................................................................................................................................... 19 2.3 REGULATORY HISTORY ............................................................................................................. 20 2.4 UNMET NEED IN T2DM - RELATIVE ROLES OF FPG AND PPG .............................................. 20 2.5 MECHANISM OF ACTION ............................................................................................................ 23 2.5.1 Mechanism of action: lixisenatide .................................................................................................. 23 2.5.2 Complementary actions of iGlarLixi ............................................................................................... 31 2.6 CLINICAL PHARMACOLOGY ....................................................................................................... 31 2.6.1 Lixisenatide .................................................................................................................................... 31 2.6.2 iGlarLixi .......................................................................................................................................... 32 2.7 DOSING AND ADMINISTRATION ................................................................................................ 33 2.7.1 Lixisenatide .................................................................................................................................... 33 2.7.2 iGlarLixi .......................................................................................................................................... 33 2.8 OVERVIEW OF EFFICACY IN THE LIXISENATIDE PROGRAM ................................................. 36 Available for Public Release Page 2 of 217 Lixisenatide and Insulin Glargine/Lixisenatide Briefing Document EMDAC Advisory Committee Meeting 2.8.1 Introduction .................................................................................................................................... 36 2.8.2 Efficacy in placebo-controlled trials ................................................................................................ 36 2.8.3 Efficacy of lixisenatide versus placebo added on to basal insulin ................................................. 38 2.8.4 Efficacy of lixisenatide versus prandial insulin added on to insulin glargine.................................. 38 2.8.5 Anti-lixisenatide antibodies and efficacy ........................................................................................ 41 2.8.6 Efficacy conclusions for lixisenatide ............................................................................................... 42 2.9 OVERVIEW OF EFFICACY IN THE IGLARLIXI DEVELOPMENT PROGRAM ............................ 42 2.9.1 Study EFC12404 (insulin-naïve) .................................................................................................... 42 2.9.2 Study EFC12405 (previously insulin-treated) ................................................................................ 45 2.9.3 iGlarLixi: Consistency of findings across subgroups ..................................................................... 48 2.9.4 Efficacy of iGlarLixi by daily insulin glargine dose levels ............................................................... 50 2.9.5 Robustness of efficacy findings ..................................................................................................... 55 2.10 OVERVIEW OF SAFETY ............................................................................................................... 57 2.10.1 Safety findings: lixisenatide ............................................................................................................ 57 2.10.2 Safety findings: iGlarLixi ................................................................................................................ 63 2.11 BENEFIT/RISK: LIXISENATIDE AND IGLARLIXI ......................................................................... 65 3 LIXISENATIDE EFFICACY IN 9 PHASE 3 PLACEBO-CONTROLLED STUDIES ..................... 69 3.1 STUDY DESIGN ............................................................................................................................ 69 3.1.1 Inclusion and exclusion criteria ...................................................................................................... 71 3.1.2 Endpoints ....................................................................................................................................... 71 3.1.3 Statistical methodology .................................................................................................................. 72 3.2 RESULTS ....................................................................................................................................... 73 3.2.1 Patient disposition .......................................................................................................................... 73 3.2.2 Baseline demographics and disease characteristics ..................................................................... 73 3.2.3 Change in HbA1c from baseline to the primary efficacy time point ............................................... 74 3.2.4 HbA1c responder analysis ............................................................................................................. 79 3.2.5 Mean change from baseline in 2-hour postprandial glucose ......................................................... 81 3.2.6 Mean change from baseline in fasting plasma glucose ................................................................. 82 3.2.7 Mean change from baseline in body weight .................................................................................. 83 3.3 DURABILITY OF EFFECT ............................................................................................................. 86 3.4 STUDY EFC12626: EFFICACY OF LIXISENATIDE VERSUS PRANDIAL INSULIN ADDED ON TO INSULIN GLARGINE ........................................................................................... 86 3.4.1 Study design and methods ............................................................................................................ 86 3.4.2 Patient disposition .......................................................................................................................... 87 Available for Public Release Page 3 of 217 Lixisenatide and Insulin Glargine/Lixisenatide Briefing Document EMDAC Advisory Committee Meeting 3.4.3 Demographics and baseline characteristics .................................................................................. 88 3.4.4 Primary endpoint: change from baseline in HbA1c ........................................................................ 89 3.4.5 Secondary endpoints ..................................................................................................................... 91 3.5 LIXISENATIDE EFFICACY CONCLUSIONS ................................................................................ 92 4 EFFICACY OF IGLARLIXI – STUDIES EFC12404 AND EFC12405 ........................................... 94 4.1 OVERVIEW OF STUDY DESIGN .................................................................................................. 94 4.1.1 Endpoints ....................................................................................................................................... 95 4.1.2 Statistical methodology .................................................................................................................
Load more

Recommended publications
  • GLP-1 Receptor Agonists
    Cognitive Vitality Reports® are reports written by neuroscientists at the Alzheimer’s Drug Discovery Foundation (ADDF). These scientific reports include analysis of drugs, drugs-in- development, drug targets, supplements, nutraceuticals, food/drink, non-pharmacologic interventions, and risk factors. Neuroscientists evaluate the potential benefit (or harm) for brain health, as well as for age-related health concerns that can affect brain health (e.g., cardiovascular diseases, cancers, diabetes/metabolic syndrome). In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. GLP-1 Receptor Agonists Evidence Summary GLP-1 agonists are beneficial for patients with type 2 diabetes and obesity. Some evidence suggests benefits for Alzheimer’s disease. It is unclear whether it is beneficial for individuals without underlying metabolic disease. Semaglutide seems to be most effective for metabolic dysfunction, though liraglutide has more preclinical data for Alzheimer’s disease. Neuroprotective Benefit: Evidence from many preclinical studies and a pilot biomarker study suggest some neuroprotective benefits with GLP-1 agonists. However, whether they may be beneficial for everyone or only a subset of individuals (e.g. diabetics) is unclear. Aging and related health concerns: GLP-1 agonists are beneficial for treating diabetes and cardiovascular complications relating to diabetes. It is not clear whether they have beneficial effects in otherwise healthy individuals. Safety: GLP-1 agonists are generally safe for most people with minor side effects. However, long-term side effects are not known. 1 Availability: Available Dose: Varies - see Chemical formula: C172H265N43O51 (Liraglutide) as a prescription chart at the end of MW: 3751.262 g/mol medicine.
    [Show full text]
  • 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.
    [Show full text]
  • Insulin Aspart Sanofi, If It Is Coloured Or It Has Solid Pieces in It
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Insulin aspart Sanofi 100 units/ml solution for injection in vial Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). Insulin aspart Sanofi 100 units/ml solution for injection in vial Each vial contains 10 ml equivalent to 1,000 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in cartridge Each cartridge contains 3 ml equivalent to 300 units insulin aspart. Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen Each pre-filled pen contains 3 ml equivalent to 300 units insulin aspart. Each pre-filled pen delivers 1-80 units in steps of 1 unit. *produced in Escherichia coli by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. 4.2 Posology and method of administration Posology The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency of human insulin is expressed in international units.
    [Show full text]
  • Combining a Glucagon-Like Peptide-1 Receptor Agonist with Basal Insulin: the Why and How
    Combining a Glucagon-like Peptide-1 Receptor Agonist with Basal Insulin: The Why and How Case Study Mary is a 61 year-old female diagnosed with type 2 diabetes mellitus (T2DM) 8 years ago. She was initially managed with the combination of lifestyle modification and metformin. Since that time she was treated with a sulfonylurea, but it was discontinued due to symptomatic hypoglycemia. She was also treated with pioglitazone, but significant fluid retention led to it discontinuation. A year-and-a- half ago, basal insulin was added to her lifestyle and metformin management. She now administers 52 units (0.62 units/kg) once daily at bedtime. Since starting basal insulin, she has experienced 3 episodes of mild hypoglycemia. Since her diagnosis, Mary’s HbA1c has never been <7.0%; her current HbA1c is 7.9%. Over the past month, her fasting plasma glucose (FPG) has ranged from 103 mg/dL to 136 mg/dL and her postprandial glucose (PPG) from 164 mg/dL to 213 mg/dL. She has gained 2.6 kg since starting basal insulin and her body mass index is now 31 kg/m2. Her blood pressure is 134/82 mmHg. She experiences occasional tingling in her feet. Eye examination reveals grade 1 retinopathy. Current medications are: metformin 1000mg twice daily, basal insulin 52 units once daily at bedtime, and hydrochlorothiazide 25 mg once daily. Her family physician notes that Mary’s FPG is reasonably well-controlled, yet her HbA1c and PPG remain elevated. He is also concerned about her episodes of hypoglycemia and weight gain and the evidence indicating microvascular damage.
    [Show full text]
  • A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D
    Drugs 2005; 65 (3): 325-340 REVIEW ARTICLE 0012-6667/05/0003-0325/$39.95/0 2005 Adis Data Information BV. All rights reserved. A Critical Appraisal of the Role of Insulin Analogues in the Management of Diabetes Mellitus Ralph Oiknine, Marla Bernbaum and Arshag D. Mooradian Division of Endocrinology, Department of Internal Medicine, Diabetes, and Metabolism, St Louis University School of Medicine, St Louis, Missouri, USA Contents Abstract ....................................................................................325 1. Physiology of Insulin Secretion .............................................................326 2. Conventional Insulin Preparations ..........................................................327 3. Insulin Analogues ........................................................................328 3.1 Rapid-Acting Insulin Analogues .......................................................328 3.1.1 Insulin Lispro ...................................................................328 3.1.2 Insulin Aspart ..................................................................329 3.1.3 Insulin Glulisine .................................................................329 3.1.4 Clinical Utility of Rapid-Acting Insulin Analogues ...................................330 3.2 Premixed Insulins and Insulin Analogues ................................................331 3.3 Basal Insulin Analogues ...............................................................331 3.3.1 Insulin Glargine ................................................................331
    [Show full text]
  • (Pram) and Insulin A21G Improves Post-Prandial Glucose Vs Novolog
    ADO09, A Co-Formulation Of Pramlintide (Pram) and Insulin A21G improves Post-Prandial Glucose Vs Novolog® in Type 1 Diabetes (T1DM) G.Meiffren¹, G.Andersen², R.Eloy¹, C.Seroussi¹, C.Mégret¹, S.Famulla², Y.-P Chan¹, M.Gaudier¹, O.Soula¹, J.H. DeVries²,T.Heise² (1 Adocia, Lyon, France ; 2 Profil, Neuss, Germany) Introduction & Background Overall safety Outpatient period results - CGM metrics o ADO09 (M1Pram) is a co-formulation of pramlintide and insulin A21G o Both treatments were well tolerated without any treatment-related serious adverse events o Most of the CGM metrics (TiR [70-180], TiR [80-140], mean blood glucose per day), were significantly improved developed to leverage the beneficial effects of pramlintide on post-prandial (Table 2). As expected M1Pram had numerically more, mostly gastrointestinal adverse events with M1Pram (Table 4). Postprandial and mean 24-hour glucose profiles were improved with M1Pram (Fig. 3) glucose without additional injections than insulin aspart Table 4: CGM metrics, all days. Significant differences are marked in bold Objective and design o No severe hypoglycemia were seen, slightly more hypoglycemic events occurred with M1Pram Ratio of LSMean* o To compare the effect of M1Pram and insulin aspart (Novolog®, Novo than with aspart (Table 3) Difference Parameter Treatment LS Mean M1Pram / Aspart P-value Nordisk) on post-prandial glucose control, glycemic control assessed by Table 2: Incidence of adverse events throughout the trial (M1Pram-Aspart) (95% CI) CGM and safety/tolerability M1Pram Aspart M1Pram
    [Show full text]
  • Effects of Exenatide on Cardiac Function, Perfusion, and Energetics
    Chen et al. Cardiovasc Diabetol (2017) 16:67 DOI 10.1186/s12933-017-0549-z Cardiovascular Diabetology ORIGINAL INVESTIGATION Open Access Efects of exenatide on cardiac function, perfusion, and energetics in type 2 diabetic patients with cardiomyopathy: a randomized controlled trial against insulin glargine Weena J. Y. Chen1*, Michaela Diamant1^, Karin de Boer2, Hendrik J. Harms3, Lourens F. H. J. Robbers2, Albert C. van Rossum2, Mark H. H. Kramer1, Adriaan A. Lammertsma3 and Paul Knaapen2 Abstract Background: Multiple bloodglucose-lowering agents have been linked to cardiovascular events. Preliminary studies showed improvement in left ventricular (LV) function during glucagon-like peptide-1 receptor agonist administration. Underlying mechanisms, however, are unclear. The purpose of this study was to investigate myocardial perfusion and oxidative metabolism in type 2 diabetic (T2DM) patients with LV systolic dysfunction as compared to healthy controls. Furthermore, efects of 26-weeks of exenatide versus insulin glargine administration on cardiac function, perfusion and oxidative metabolism in T2DM patients with LV dysfunction were explored. Methods and results: Twenty-six T2DM patients with LV systolic dysfunction (cardiac magnetic resonance (CMR) derived LV ejection fraction (LVEF) of 47 13%) and 10 controls (LVEF of 59 4%, P < 0.01 as compared to patients) were analyzed. Both myocardial perfusion± during adenosine-induced hyperemia± (P < 0.01), and coronary fow reserve 15 (P < 0.01), measured by ­[ O]H2O positron emission tomography (PET), were impaired in T2DM patients as compared to healthy controls. Myocardial oxygen consumption and myocardial efciency, measured using ­[11C]acetate PET and CMR derived stroke volume, were not diferent between the groups.
    [Show full text]
  • OZEMPIC (Semaglutide) Injection, for Subcutaneous Use Initial U.S
    HIGHLIGHTS OF PRESCRIBING INFORMATION ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙CONTRAINDICATIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ These highlights do not include all the information needed to use Personal or family history of medullary thyroid carcinoma or in patients OZEMPIC® safely and effectively. See full prescribing information with Multiple Endocrine Neoplasia syndrome type 2 (4). for OZEMPIC. Known hypersensitivity to OZEMPIC or any of the product components (4). OZEMPIC (semaglutide) injection, for subcutaneous use Initial U.S. Approval: 2017 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙WARNINGS AND PRECAUTIONS∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ Pancreatitis: Has been reported in clinical trials. Discontinue promptly if WARNING: RISK OF THYROID C-CELL TUMORS pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2). See full prescribing information for complete boxed warning. Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored (5.3). In rodents, semaglutide causes thyroid C-cell tumors. It is Never share an OZEMPIC pen between patients, even if the needle is unknown whether OZEMPIC causes thyroid C-cell tumors, changed (5.4). including medullary thyroid carcinoma (MTC), in humans as Hypoglycemia: When OZEMPIC is used with an insulin secretagogue or the human relevance of semaglutide-induced rodent thyroid C- insulin, consider lowering the dose of the secretagogue or insulin to reduce cell tumors has not been determined (5.1, 13.1). the risk of hypoglycemia (5.5). OZEMPIC is contraindicated in patients with a personal or Acute Kidney Injury: Monitor renal function in patients with renal family history of MTC or in patients with Multiple Endocrine impairment reporting severe adverse gastrointestinal reactions (5.6). Neoplasia syndrome type 2 (MEN 2).
    [Show full text]
  • A Network Meta-Analysis Comparing Exenatide Once Weekly with Other GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus
    Diabetes Ther DOI 10.1007/s13300-016-0155-1 REVIEW A Network Meta-analysis Comparing Exenatide Once Weekly with Other GLP-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus Sheena Kayaniyil . Greta Lozano-Ortega . Heather A. Bennett . Kristina Johnsson . Alka Shaunik . Susan Grandy . Bernt Kartman To view enhanced content go to www.diabetestherapy-open.com Received: December 17, 2015 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT treatment of adults with T2DM inadequately controlled on metformin monotherapy. Introduction: Exenatide is a glucagon-like Methods: A systematic literature review was peptide-1 receptor agonist (GLP-1 RA), conducted to identify randomized controlled approved for treatment of type 2 diabetes trials (RCTs) that investigated GLP-1 RAs mellitus (T2DM). There is limited direct (albiglutide, dulaglutide, exenatide, liraglutide, evidence comparing the efficacy and and lixisenatide) at approved doses in the tolerability of exenatide 2 mg once weekly United States/Europe, added on to metformin (QW) to other GLP-1 RAs. A network only and of 24 ± 6 weeks treatment duration. meta-analysis (NMA) was conducted to A Bayesian NMA was conducted. estimate the relative efficacy and tolerability of Results: Fourteen RCTs were included in the exenatide QW versus other GLP-1 RAs for the NMA. Exenatide QW obtained a statistically significant reduction in glycated hemoglobin (HbA1c) relative to lixisenatide 20 lg once daily. No other comparisons of exenatide QW Electronic supplementary material The online version of this article (doi:10.1007/s13300-016-0155-1) to other GLP-1 RAs were statistically significant contains supplementary material, which is available to for change in HbA1c.
    [Show full text]
  • 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.
    [Show full text]
  • Byetta (Injection Pen) Usage & Safety Guide
    Byetta (Injection Pen) Usage & Safety Guide - Drugs.com 04/07/2015 Tubeless Insulin Pump Tubeless, Reliable, Safe. Try The OmniPod®. Sign-Up For A Demo Kit! Browse all medications A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Advanced Search Phonetic Search Drugs A-Z Pill Identifier Interactions Checker News Health Professionals Q & A Mednotes Apps Home → Conditions → Diabetes, Type 2 → Byetta Print Share Sign In or Register Byetta Related Information Availability Pregnancy Category Generic Name: exenatide (Byetta) (ex EN a tide) Prescription only Risk cannot be ruled out Brand Names: Byetta Prefilled Pen CSA Schedule Approval History Not a controlled drug FDA approved 2009 Overview Side Effects Dosage Interactions For Professionals More Reviews Average User Rating Prostate Cancer Stages 64 User Reviews 8.3 Rate it! See the Progression of Stages for Prostate Cancer. Get Expert Info Drug Class Incretin mimetics What is Byetta? Tubeless Byetta (exenatide) is an injectable diabetes Related Drugs medicine that helps control blood sugar levels . This medication helps Diabetes, Type 2 Insulin metformin your pancreas produce insulin more efficiently. insulin aspart Byetta is a short-acting form of exenatide. Januvia Pump Byetta is used to treat type 2 diabetes. Other glipizide Tubeless, diabetes medicines are sometimes used in glimepiride combination with Byetta if needed. Lantus Reliable, Invokana This medication guide provides information Victoza Safe. Try about the Byetta brand of exenatide. Bydureon glyburide is another brand of exenatide that is not Levemir The covered in this medication guide.
    [Show full text]
  • Insulin Aspart (Nvolog): Important Patient Information
    What is most important to remember? If you have questions: Strong Internal Medicine • Insulin aspart (Novolog®) is used to lower blood sugar. It is Ask your doctor, nurse or pharmacist for important to use this medicine as more information about insulin aspart directed by your doctor (Novolog®) • Do not start any new medicines, over-the-counter drugs or herbal remedies without talking to your doctor • Tell all doctors, dentists and pharmacists that you are using insulin aspart (Novolog®) • insulin aspart (Novolog®) can cause low blood sugar. Always Strong Internal Medicine keep a source of sugar handy for 601 Elmwood Avenue times when your blood sugar gets Ambulatory Care Facility, 5th Floor too low Rochester, NY 14642 Phone: (585) 275 -7424 Insulin Aspart • Do not use your insulin if it (Novolog®): Visit our website at: becomes cloudy or has particles www.urmc.rochester.edu/medicine/ - Important Patient Information in it general-medicine/patientcare/ • Throw away all opened insulin after 28 days, even if it is not used up What does insulin aspart (Novolog®) do? Are there any interactions with other drugs that I need What are some things that I need to be aware of when to worry about? taking insulin aspart (Novolog®)? • It is used to lower blood sugar in patient with high blood sugar (diabetes) • There are many drug interactions that may increase • Tell your doctor or pharmacist if you have an allergy to How should insulin aspart (Novolog®) be used? your risk of side effects insulin, or any other drugs, foods, or substances • Use this
    [Show full text]