DOCSLIB.ORG

Symlin) Reference Number: ERX.ST.20 Effective Date: 06.01.15 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Symlin) Reference Number: ERX.ST.20 Effective Date: 06.01.15 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log Clinical Policy: Pramlintide (Symlin) Reference Number: ERX.ST.20 Effective Date: 06.01.15 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Pramlintide (Symlin®) is an amylin analog. FDA approved indication Symlin is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Symlin is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Step Therapy for Symlin (must meet all): 1. Age ≥ 18 years; 2. Previous use of mealtime insulin therapy (e.g., Apidra, Humalog, Humulin, Novolin, Novolog) or an insulin pump in the last 30 days; 3. Dose does not exceed 120 mcg/injection (1 pen/injection). Approval duration: 6 months II. Continued Therapy A. Step Therapy for Symlin (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met all initial approval criteria; 2. Current use of mealtime insulin therapy or an insulin pump; 3. If request is for a dose increase, new dose does not exceed 120 mcg/injection (1 pen/injection). Approval duration: 12 months III. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose Novolog® (insulin aspart) Diabetes See regimen Varies (dosage is individualized) Apidra® (insulin glulisine) Diabetes See regimen Varies (dosage is individualized) Humalog® (insulin lispro) Diabetes See regimen Varies (dosage is individualized) Page 1 of 3 CLINICAL POLICY Pramlintide Drug Dosing Regimen Dose Limit/ Maximum Dose Novolin® N, Humulin® N Diabetes See regimen (isophane insulin) Varies (dosage is individualized) Novolin® R, Humulin® R Diabetes See regimen (regular insulin) Varies (dosage is individualized) IV. Dosage and Administration Indication Dosing Regimen Maximum Dose Diabetes 1 injection subcutaneously prior to each major 120 mcg/injection meal (≥ 250 kcal or containing ≥ 30 g of carbohydrate) V. Product Availability 1.5 mL SymlinPen disposable multidose pen-injector: 15 mcg, 30 mcg, 45 mcg, 60 mcg 2.7 mL SymlinPen disposable multidose pen-injector: 60 mcg, 120 mcg VI. References 1. Symlin Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2015. Available at: www.symlin.com. Accessed January 11, 2017. 2. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017; 40(suppl 1): S1-S133. Reviews, Revisions, and Approvals Date P&T Approval Date Policy created 06/15 06/15 Updated to new template (converted algorithm to bulleted 07/16 09/16 criteria). Clarified trial/failure requirement from basal insulin and either metformin or sulfonylurea to combination metformin + insulin (removed option for trial/failure of sulfonylurea as sulfonylurea + insulin combination therapy is not recommended due to limited efficacy and increased weight gain). Converted to new template. Initial: Modified mealtime 06/17 08/17 insulin/insulin pump requirement to indicate that this therapy must have been used in the last 30 days. Removed requirement for trial/failure of combination metformin + insulin per FDA labeling which requires only insulin therapy. Modified max dose requirement from generic statement to actual dose. Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to Page 2 of 3 CLINICAL POLICY Pramlintide be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions. ©2015 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 3 of 3 .
Load more

Recommended publications
  • 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]
  • 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]
  • Effective Switch from Twice-Daily Pre-Mixed Insulin 50/50 to Liraglutide to Achieve a Good Glycemic Control in Type 2 Diabetes
    Elmer ress Case Report J Med Cases • 2011;2(2):76-80 Effective Switch From Twice-Daily Pre-Mixed Insulin 50/50 to Liraglutide to Achieve a Good Glycemic Control in Type 2 Diabetes Hidekatsu Yanaia, c, Taro Yoshimia, Ritsuko Hondab such gastrointestinal hormones. GLP-1 is produced mainly Abstract by L-cells in the ileum. GLP-1 is released into the blood from intestinal L-cells in response to meal ingestion, and GLP-1 The glucagon-like peptide 1 (GLP-1) stimulates insulin secretion stimulates insulin secretion from pancreatic β-cells in a glu- from pancreatic β-cells in a glucose-dependent manner. Therapeu- cose-dependent manner [1]. GLP-1 slows gastric emptying, tic strategies for type 2 diabetes mellitus are focused on the use which may aid weight loss, and inhibits glucagon release of GLP-1 analogues. Liraglutide, an acylated analogue of human from the pancreatic α-cells [1], improving insulin sensitivity. GLP-1, has been introduced in Japan in 2010. We will show a Therefore, therapeutic strategies for type 2 diabetes mel- 70-year-old woman with type 2 diabetes mellitus achieving a good litus are focused on the use of GLP-1 analogues. Exenatide glycemic control by switching from twice-daily pre-mixed insulin 50/50 to liraglutide. Measurements of plasma glucose and serum was introduced to the market in the United States in 2005 C-peptide levels before and after each meal ingestion and daily uri- and in Europe in 2007. Liraglutide has been introduced to nary C-peptide levels suggested that liraglutide ameliorates glucose the market in Europe in 2009 and in the United States and metabolism mainly not by the glucose-dependent insulinotropic Japan in 2010 [2].
    [Show full text]
  • Inpatient Care | Lantus (Insulin Glargine Injection) 100 Units/Ml
    For noncritically ill hospitalized patients with diabetes Lantus® as part of a basal-prandial dosing regimen ARA basal-prandialBBIT 2 BASAL-PRA dosing NDoptionIAL forDOS nonintensiveING care inpatients with type 2 diabetes from the RABBIT 2 Study1,a A basal-prandial dosing option for inpatients with type 2 diabetes from the RABBIT 2 Study 31 Calculate total daily dose based Total daily dose on BG and weight at the time of • For BG 140-200 mg/dL, use 0.4 Units/kg admission • For BG 201-400 mg/dL, use 0.5 Units/kg Dose administration Divide the calculated dose into basal and prandial components • Administer 50% of daily dose as basal insulin • Administer the other 50% as rapid-acting prandial 50:50 insulin divided into 3 mealtime injections basal prandial Dose administration Monitor BG, add supplemental • If fasting or mean BG during the day >140 mg/dL, increase basal insulin dose by 20% rapid-acting insulin, and adjust doses as needed • If fasting and premeal BG >140 mg/dL, add supplemental rapid-acting insulin • If BG <70 mg/dL, reduce basal insulin dose by 20% • Hold prandial insulin doses in patients not eating RABBIT 2 was a multicenter, prospective, open-label, randomized study (N=130) to compare the efficacy of a basal-prandial regimen of insulin glargine + insulin glulisine with SSI monotherapy (regular human insulin) in insulin-naive nonsurgical patients aged 18 to 80 years with type 2 diabetes. Patients in the basal-prandial group received glargine once daily and glulisine before meals. SSI was given 4 times per Aday basal-prandialfor BG >140 mg/dL.
    [Show full text]
  • What to Do After Basal Insulin
    BASALINSULIN What to Do After Basal Insulin 3 Treatment Strategies for Type 2 Diabetes These strategies can help you optimize glucose control in your patient with type 2 diabetes when basal insulin alone is insufficient. Lubaina Presswala, DO, Jay Shubrook, DO, FAAFP, FACOFP, BC-ADM iabetes mellitus is a complex, progressive disease that af- Practice fects every primary care provider’s practice. Major diabe- recommendations tes organizations recommend that treatment be ongoing • Intensify diabetes treatment D and progressive in order to control the disease. The American Dia- for patients who have a normal betes Association (ADA), the European Association for the Study fasting glucose but an A1C > 7% of Diabetes (EASD), and the American Association of Clinical En- and daytime hyperglycemia, and for those who are not at goal docrinologists recommend that patients be assessed every two to despite basal insulin doses three months after diagnosis and that treatment should be intensi- 1,2 > 0.5 U/kg/d. B fied if the patient is not meeting treatment goals. Using this ap- • Consider intensifying diabetes proach, all people with type 2 diabetes could be on insulin one management beyond basal insulin year after diagnosis.1,2 therapy by adding a glucagon-like While many clinicians have become comfortable with using peptide 1 receptor agonist, insulin once-daily basal insulin, such as glargine or detemir, what to do prior to one meal each day, or after basal insulin is much more complex. This review explains insulin prior to all meals. C three strategies to consider when basal insulin alone isn’t enough.
    [Show full text]
  • Lixisenatide Injection, Subcutaneous
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 New Drug Evaluation: lixisenatide injection, subcutaneous Date of Review: January 2017 End Date of Literature Search: Generic Name: lixisenatide Brand Name (Manufacturer): Adlyxin (Sanofi-Aventis) PDL Class: GLP-1 receptor agonists AMCP Dossier Received: Yes Current Status of PDL Class: See Appendix 1. Research Questions: Is there evidence that lixisenatide improves outcomes versus other GLP-1 receptor agonists in patients with type 2 diabetes mellitus (T2DM), including hemoglobin A1c (A1C) reduction, microvascular and macrovascular outcomes and mortality? Is there evidence that lixisenatide is safer than other GLP-1 receptor agonists in patients with T2DM? Are there subpopulations of patients with T2DM for which lixisenatide may be more effective or associated with less harm? Conclusions: Lixisenatide approval was based on 11 phase 3 clinical trials.1- 11 Eight trials were placebo-controlled and 3 were active treatment comparisons to either sitagliptin, exenatide or insulin glulisine. All trials were designed and funded by the manufacture Sanofi-Aventis. Limitations to the data include short trial durations (12-26 weeks for most) and insufficient evidence for improvement in any health outcomes. The studies are most applicable to patients with moderately uncontrolled T2DM (HbA1c around 8%) with few comorbidities. There is insufficient evidence to determine if lixisenatide has any effect on microvascular outcomes. One study provides moderate strength evidence that lixisenatide is not associated with increased risk for macrovascular outcomes compared to placebo.
    [Show full text]
  • New Pharmacological Strategies for Protecting Kidney Function in Type 2 Diabetes
    Manuscript Muskiet, Wheeler & Heerspink New renoprotective drugs REVIEW New Pharmacological Strategies for Protecting Kidney Function in Type 2 Diabetes Marcel H.A. Muskiet MD1 David C. Wheeler MD2 Hiddo J.L. Heerspink PharmD PhD3 1 Diabetes Centre, Department of Internal Medicine, VU University Medical Centre, Amsterdam, The Netherlands 2 Centre for Nephrology, University College London, London, United Kingdom 3 Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands Corresponding Author: David C. Wheeler MD Centre for Nephrology, University College London Rowland Hill Street, London NW3 2PF, UK Email: [email protected] Running head: New renoprotective drugs Key words: Type 2 diabetes, diabetic kidney disease, end-stage kidney disease, renoprotection, SGLT2 inhibitors, incretin-based therapies, GLP-1 receptor agonists, DPP-4 inhibitors, mineralocorticoid receptor antagonists, endothelin receptor antagonists Word count: Summary: 164; Manuscript: 5343 Figures: 2; Tables: 3; Boxes: 2; Supplemental 0 References: 117 The Lancet Diabetes & Endocrinology Page: 1/26 Muskiet, Wheeler & Heerspink New renoprotective drugs [H1]Summary Diabetes is the leading cause of impaired kidney function, albuminuria and renal replacement therapy in virtually all regions of the world and places a large burden on health care systems. Current treatment strategies rely on intensive glucose-lowering and strict blood pressure control, targeting blockade of the renin-angiotensin-aldosterone system. Such approaches may slow decline in kidney function, but many patients progress to end-stage kidney failure despite optimal therapy. In recent clinical trials, two new-generation glucose-lowering drug classes; the sodium-glucose co-transporter (SGLT)2 inhibitors and glucagon-like peptide (GLP)-1 receptor agonists have been shown to improve both kidney and cardiovascular outcomes in patients with type 2 diabetes.
    [Show full text]
  • Prandial Options to Advance Basal Insulin Glargine Therapy
    1318 Diabetes Care Volume 39, August 2016 Julio Rosenstock,1 Bruno Guerci,2 Prandial Options to Advance Basal Markolf Hanefeld,3 Sandro Gentile,4 Ronnie Aronson,5 Francisco J. Tinahones,6 Insulin Glargine Therapy: Testing Christine Roy-Duval,7 Elisabeth Souhami,7 Marek Wardecki,8 Jenny Ye,9 Lixisenatide Plus Basal Insulin Riccardo Perfetti,9 and Simon Heller,10 on behalf of the GetGoal Duo-2 Trial Versus Insulin Glulisine Either as Investigators Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial Diabetes Care 2016;39:1318–1328 | DOI: 10.2337/dc16-0014 CLIN CARE/EDUCATION/NUTRITION/PSYCHOSOCIAL OBJECTIVE To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1–3 oral antidi- 1Dallas Diabetes and Endocrine Center at Medi- abetic agents (OADs). cal City, Dallas, TX 2University of Lorraine and the Department of RESEARCH DESIGN AND METHODS Diabetology, Metabolic Diseases and Nutrition, Brabois Adult Hospital, Vandœuvre-les-Nancy,` Patients were randomized to lixisenatide once daily or insulin glulisine given once France 3 or thrice daily, added to glargine, with or without metformin, if HbA1c remained GWT-TUD, Study Centre Prof. Hanefeld, Dres- ‡7to£9% (‡53 to £75 mmol/mol) after 12 weeks of glargine optimization with den Technical University, Dresden, Germany 4Department of Clinical and Experimental Med- OADs other than metformin stopped at the start
    [Show full text]
  • New Tools in the Toolbox for Type 2 Diabetes
    9/5/2019 Statement of disclosure NEW TOOLS IN THE • S. Mimi Mukherjee is an academic preceptor for an TOOLBOX FOR TYPE 2 industry fellowship program at Sanofi-Genzyme DIABETES S. Mimi Mukherjee PharmD, CDE, BCPS Objectives After attending this educational session, participants will be able to: • Recommend appropriate treatment based on patient characteristics. • Summarize the considerations when deciding whether to recommend sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 agonists or thiazolidinediones to metformin therapy THE BASICS Type 2 Diabetes Mellitus • Explain how to use insulin in combination with non-insulin medications • Identify the roles of the different types of insulin What do we hope to achieve when treating patients with T2DM? 1 9/5/2019 ABCs Individualizing A1c goals A – B – C – Why are certain medications for T2DM Metformin is 1st line in patients with type 2 diabetes mellitus. more likely to cause hypoglycemia? But sometimes patients aren’t on it… Medications that increase insulin levels without regard to meals tend to cause hypoglycemia What is the most common reason for a patient not being on metformin? Guidelines • American Diabetes Association. Standards of medical care in diabetes – 2019. Diabetes Care.2019; 42(S1) 1- 193. • Davies MJ, D’Alessio DA, Fradkin J, et al. Management of HOW TO DECIDE WHAT TO hyperglycemia in type 2 diabetes, 2018 – a consensus ADD AFTER METFORMIN report by the American Diabetes Association for the Study of Diabetes (EASD). Diabetes Care. 2018; 41(12):2669- Focus on sulfonylureas, DPP-4 inhibitors, SGLT2 2701. inhibitors, GLP-1 agonists, and thiazolidinediones 2 9/5/2019 Questions to ask when adding History of ASCVD to metformin Does the patient have…? • ASCVD GLP-1 RA SGLT2i • HF • CKD (“tide”) (“flozin”) Is the patient at risk of falls or other complications due to 1.
    [Show full text]
  • APIDRA® INSULIN GLULISINE INJECTION (Monocomponent Insulin Glulisine)
    For the use only of a Registered Medical Practitioner or Hospital or a Laboratory APIDRA® INSULIN GLULISINE INJECTION (Monocomponent Insulin Glulisine) Abridged Prescribing Information COMPOSITION 1 ml contains 3.5 mg insulin glulisine, corresponding to 100 IU human insulin. Each pre-filled disposable pen (SoloStar®) contains 3 ml, equivalent to 300 IU insulin. Each vial contains 10 ml equivalent to 1000 IU. THERAPEUTIC INDICATIONS Treatment of adults, adolescents and children of 6 years or older with diabetes mellitus, where treatment with insulin is required. DOSAGE & ADMINISTRATION The dosage of Apidra should be individually adjusted. Apidra should normally be used in regimens that include a longer-acting insulin or basal insulin analogue. Blood glucose monitoring is recommended for all patients with diabetes. Apidra should be given by injection within 15 minutes before or immediately after a meal. Apidra is intended for subcutaneous administration by injection or by external infusion pump. Apidra can also be administered intravenously. There is insufficient clinical information on the use of Apidra in children younger than the age of 6 years. Hypoglycaemia may be difficult to recognize in the elderly. SAFETY-RELATED INFORMATION CONTRAINDICATIONS: Hypersensitivity to insulin glulisine or to any of the excipients. WARNINGS & PRECAUTIONS: Patients with diabetes will also require a longer-acting insulin or insulin infusion pump therapy to maintain adequate glucose control. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, species or method of manufacture may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
    [Show full text]
  • Randomized Comparison of Pramlintide Or Mealtime Insulin Added to Basal Insulin Treatment for Patients with Type 2 Diabetes
    Clinical Care/Education/Nutrition/Psychosocial Research ORIGINAL ARTICLE Randomized Comparison of Pramlintide or Mealtime Insulin Added to Basal Insulin Treatment for Patients With Type 2 Diabetes 1 2 MATTHEW RIDDLE, MD KAREN LUTZ, PHD limit postmeal hyperglycemia. Amylin 2 2 RICHARD PENCEK, PHD KEN WILHELM, MD deficiency accelerates gastric emptying, 2 2 SUPOAT CHARENKAVANICH, PHD LISA PORTER, MD increases glucagon secretion, and alters satiety mechanisms (10,11). Pramlintide, an injectable synthetic OBJECTIVE — To compare the efficacy and safety of adding mealtime pramlintide or rapid- analog of amylin, slows gastric emptying, acting insulin analogs (RAIAs) to basal insulin for patients with inadequately controlled type 2 attenuates postprandial glucagon secre- diabetes. tion, enhances satiety, and reduces food intake (12–14). Pramlintide is approved RESEARCH DESIGN AND METHODS — In a 24-week open-label, multicenter study, ␮ as adjunctive treatment for patients with 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 g) or a diabetes who use mealtime insulin with or titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs). At screening, patients were insulin naive or had been receiving Ͻ50 units/day basal insulin for Ͻ6 months. without oral antihyperglycemic drugs The basal insulin dosage was titrated from day 1, seeking fasting plasma glucose (FPG) Ն70– (OADs) and have not achieved desired Ͻ100 mg/dl. Pramlintide and an RAIA were initiated on day 1 and week 4, respectively. The glucose control. Recently, a 16-week, proportion of patients achieving A1C Յ7.0% without weight gain or severe hypoglycemia at double-blind, placebo-controlled study week 24 was the primary end point.
    [Show full text]
  • Apidraapidrasolostarinj.Pdf
    New Zealand Data Sheet Apidra - insulin glulisine NEW ZEALAND DATA SHEET 1 PRODUCT NAME Apidra 100 IU/mL solution for injection in 10 mL vials. Apidra 100 IU/mL solution for injection in 3 mL cartridges. Apidra SoloStar 100 IU/mL solution for injection in a 3 mL pre-filled pen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Apidra contains 100 IU/mL (3.49 mg/mL) insulin glulisine. Apidra 100 IU/mL solution for injection in 10 mL vials - equivalent to 1000 IU. Apidra 100 IU/mL solution for injection in 3 mL cartridges - equivalent to 300 IU. Apidra SoloStar 100 IU/mL solution for injection in a 3 mL pre-filled pen – equivalent to 300 IU. Insulin glulisine is produced by recombinant DNA technology in Escherichia coli. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Apidra is a sterile clear, colourless solution of insulin glulisine in vials and cartridges for use as an injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Apidra is indicated for the treatment of type 1 and type 2 diabetes mellitus in adults and children of 4 years or above who require insulin for the control of hyperglycaemia. api-ccdsv12-dsv9-26feb21 Page 1 New Zealand Data Sheet Apidra - insulin glulisine 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Apidra is a recombinant human insulin analogue that has been shown to be equipotent to human insulin. After subcutaneous administration it has a more rapid onset and a shorter duration of action than regular human insulin. Apidra is for single patient use only.
    [Show full text]