DOCSLIB.ORG

Drug Information Center Highlights of FDA Activities

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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. Propylhexedrine should only be used via inhalation, any other route can cause serious harm. Immediate medical attention is needed in people who experience severe anxiety or agitation, confusion, hallucinations, paranoia, rapid heartbeat or abnormal heart rhythm, chest pain or tightness. Serious complications from abuse/misuse can lead to death. There is no specific reversal agent in cases of acute intoxication, symptomatic and supportive care should be provided. Lamotrigine (Lamictal) Safety Communication: Increased Risk of Arrhythmias 3/31/21 FDA study review finds a potential increased risk of arrhythmias in patients with heart disease while taking lamotrigine. Safety studies are now being required on medications in the same drug class. Reports of abnormal electrocardiographic findings, chest pain, loss of consciousness, and cardiac arrest prompted further investigation into lamotrigine’s effect on the heart. The public will be updated when additional information becomes available. Providers should assess risks and benefits in patients taking lamotrigine who also have clinically important structural and functional heart disorders, including heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, Brugada syndrome or risk factors for coronary artery disease. Major Medication/Drug‐Related Product Recalls Announced Through MedWatch: Spironolactone 25 mg & 50 mg Tablets, Bryant Ranch Prepack: Recall – Mislabeled, Incorrect Strength 3/10/21 Bryant Ranch Prepack recalled 4 lots of spironolactone tablets because the products have been mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain 25 mg tablets and vice versa. The recalled products include spironolactone 25 mg tablets (NDC 63629106401 [lot 148969], NDCs 63629106402 & 63629106403 [lot 148791] and 50 mg tablets (NDC 63629106701 [lot 148992]), all with an expiration date of 7/31/2022. FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 2 Phenylephrine HCl Injection 10 mg/mL, Sagent Pharmaceuticals: Compromised Vial Seal 3/12/21 Three lots of Phenylephrine hydrochloride injection, USP 10 mg/mL vials (NDC 25021‐315‐01) manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, were recalled due to potentially loose crimped vial over‐seals which could result in non‐sterile product. Lot numbers involved are PHT8IB2, PHT9IB2, and PHT1JB2. Heal the World Hand Sanitizer 9.6 oz, PNHC: Recall – Resemble Water Bottles 3/17/21 PNHC, LLC, doing business as Heal the World, recalled all lots of Heal the World hand sanitizer packaged in 9.6 oz bottles because they resemble water bottles. No other package sizes were recalled. ChloraPrep 3 mL applicators by BD: Recall ‐ Microbial Contamination Risks 3/25/21 The FDA advised health care providers not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company) and labeled with “CareFusion, El Paso, TX” following a recall expansion to include the applicators in all U.S. states. The product is prone to microbial contamination due to product lid failure when exposed to high temperature and humidity, including the growth of Aspergillus penicillioides within the packaging. The drug is used to sanitize skin prior to surgery or catheter procedures. Telmisartan Tablets 20 mg, Alembic Pharmaceuticals: Recall ‐ Mislabeling and Incorrect Strength 3/25/21 One lot of telmisartan 20 mg, USP tablets packaged in 30‐count bottles (lot 1905005661) was recalled due to incorrect product strength in the package (40 mg). FDA advises to check tablets for shape and imprint; the 20 mg tablets should be round with an L202 imprint. Acyclovir Sodium Injection 50 mg/mL, Zydus: Recall ‐ Crystallization 3/25/21 Four lots of acyclovir sodium injection 50 mg/mL in 10 mL and 20 mL vials were recalled after complaints of crystallization in vials. Lots being recalled are L000155, L000156, L000126 and L000127. Durisan Antimicrobial Solutions Hand Sanitizer: Recall – Microbial Contamination 3/25/21 Sanit Technologies LLC, doing business as Durisan, recalled Durisan Antimicrobial Solutions Hand Sanitizer due to microbial contamination with Burkholderia cepacia complex and Ralstonia pickettii. A complete list of the recalled lots can be found on the FDA site and the product has been added to the FDA do‐not‐use list of hand sanitizers. Dietary Supplement Recalls & Public Notifications Notifications were issued regarding undeclared active ingredients or contaminants in the following products. Patients are advised not to purchase or use these products. Product Promoted Use Undeclared Ingredient(s) or Contaminants 2 Own The Knight Sexual enhancement Sildenafil and tadalafil 69MODE Blue 69* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Furious X 1350 Sexual enhancement Sildenafil and tadalafil Imperial Extreme 2000 mg* Sexual enhancement Sildenafil and tadalafil Krazy Night* Sexual enhancement Sildenafil, tadalafil and vardenafil PremierZen Black 5000* Sexual enhancement Sildenafil and tadalafil Rhino SE7EN2 Sexual enhancement Sildenafil and tadalafil Shogun‐X 15000mg* Sexual enhancement Sildenafil, tadalafil and vardenafil Shogun‐X 7000* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Stiff Rox Sexual enhancement Sildenafil and tadalafil Titanium 18K Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Black 25K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Thumbs Up 7 Blue 69K* Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Red 70K* Sexual enhancement Sildenafil, tadalafil and vardenafil Thumbs Up 7 White 11K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Yin‐Yang Essence Men Power Sexual enhancement Sildenafil and tadalafil Zing Plus Sexual enhancement Sildenafil *recalled FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 3 New Product Shortages Date Initially Posted Desmopressin Acetate (Stimate) Nasal Spray 3/12/21 Disopyramide phosphate capsules 3/19/21 Cortisone acetate tablets 3/26/21 Chlordiazepoxide hydrochloride USP capsules 3/30/21 Brand Name or Sole Source Product Discontinuations/Withdrawals Date Posted Neomycin sulfate, polymyxin b sulfate, bacitracin zinc, and hydrocortisone ointment (Cortisporin, Pfizer) 3/9/21 – alternative corticosteroid and antibiotic combinations remain available Neomycin sulfate, polymyxin b sulfate, and hydrocortisone cream (Cortisporin, Pfizer) ‐– alternative 3/9/21 corticosteroid and antibiotic combinations remain available Estradiol patch (Alora, Allergan) – alternative estradiol transdermal products remain available 3/24/21 Norethindrone acetate, ethinyl estradiol tablets (Femhrt, Allergan) – generics remain available 3/24/21 Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Tilia Fe, Allergan) – generics remain 3/24/21 available Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Estrostep Fe, Allergan) – generics remain 3/24/21 available New Drug Approvals: Description (See Attached Drug Summaries) Date Approved Serdexmethylphenidate and Central nervous system stimulant for the treatment of attention 3/2/21 dexmethylphenidate / Azstarys / deficit hyperactivity disorder in patients 6 years or older Corium, Inc Tivozanib / Fotivda / Aveo Kinase inhibitor for the treatment of relapsed or refractory 3/10/21 Pharmaceuticals, Inc advanced renal cell carcinoma in patients who have received two or more prior systemic therapies Ponesimod / Ponvory / Janssen Sphingosine 1‐phosphate receptor modulator for the treatment 3/18/21 Pharmaceuticals, Inc of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‐remitting disease, and active secondary progressive disease in adult patients. Dasiglucagon / Zegalogue / Zealand
Load more

Recommended publications
  • Emergency Use Authorization (EUA) for Sotrovimab 500 Mg Center for Drug Evaluation and Research (CDER) Review
    Emergency Use Authorization (EUA) for Sotrovimab 500 mg Center for Drug Evaluation and Research (CDER) Review Identifying Information Application Type EUA (EUA or Pre-EUA) If EUA, designate whether pre-event or intra-event EUA request. EUA Application EUA 000100 Number(s) Sponsor (entity EUA Sponsor requesting EUA or GlaxoSmithKline Research & Development Limited pre-EUA 980 Great West Road consideration), point Brentford Middlesex, TW8 9GS of contact, address, UK phone number, fax number, email GSK US Point of Contact address Debra H. Lake, M.S. Sr. Director Global Regulatory Affairs GlaxoSmithKline 5 Moore Drive PO Box 13398 Research Triangle Park, NC 27709-3398 (b) (6) Email: Phone Manufacturer, if GlaxoSmithKline, Parma. different from Sponsor Submission Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 Receipt Date(s) Part 1: March 24, 2021 Part 2: March 29, 2021 OND Division / Office Division of Antivirals /Office of Infectious Disease 1 Reference ID: 4802027 Product in the No Strategic National Stockpile (SNS) Distributor, if other (b) (4) than Sponsor I. EUA Determination/Declaration On February 4, 2020, the Secretary of Health and Human Services determined pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States (US) citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19.
    [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]
  • Mark Taylor; [email protected]; (317) 276-5795 (Media) Kevin Hern; Hern Kevin [email protected]; (317) 277-1838 (Investors)
    January 29, 2021 Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 U.S.A. +1.317.276.2000 www.lilly.com For Release: Immediately Refer to: Mark Taylor; [email protected]; (317) 276-5795 (Media) Kevin Hern; [email protected]; (317) 277-1838 (Investors) Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results • Revenue in the fourth quarter of 2020 increased 22 percent, driven by volume growth of 24 percent. Excluding bamlanivimab revenue of $871 million, fourth-quarter 2020 revenue grew 7 percent. • Full-year 2020 revenue increased 10 percent, driven by volume growth of 15 percent. Excluding bamlanivimab, full-year 2020 revenue grew 6 percent, driven by volume growth of 11 percent. • Key growth products launched since 2014, consisting of Trulicity, Verzenio, Taltz, Tyvyt, Olumiant, Jardiance, Emgality, Cyramza, Retevmo, Baqsimi and Basaglar contributed nearly 12 percentage points of revenue growth and represented approximately 48 percent of total revenue in the fourth quarter of 2020, or 55 percent of total revenue excluding bamlanivimab. • Fourth-quarter 2020 operating expenses increased 3 percent, driven by higher research and development investments, including expenses of $265 million to develop COVID-19 therapies. • Notable pipeline events included Emergency Use Authorizations from the FDA for both bamlanivimab and baricitinib for the treatment of COVID-19, as well as positive data readouts for donanemab for Alzheimer's disease, tirzepatide for type 2 diabetes and LOXO-305 for cancer. • Fourth-quarter 2020 earnings per share (EPS) increased to $2.32 on a reported basis and $2.75 on a non- GAAP basis. Full year 2020 EPS decreased to $6.79 on a reported basis and increased to $7.93 on a non- GAAP basis.
    [Show full text]
  • Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
    Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics
    [Show full text]
  • PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
    PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025.
    [Show full text]
  • Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And
    Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 24487 that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit.
    [Show full text]
  • Monoclonal Antibody Playbook
    Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide Outpatient administration guide for healthcare providers 2 SEPTEMBER 2021 1 Introduction to COVID-19 Monoclonal Antibody Therapy 2 Overview of Emergency Use Authorizations 3 Site and Patient Logistics Site preparation Patient pathways to monoclonal administration 4 Team Roles and Responsibilities Leadership Administrative Clinical Table of 5 Monoclonal Antibody Indications and Administration Indications Contents Preparation Administration Response to adverse events 6 Supplies and Resources Infrastructure Administrative Patient Intake Administration 7 Examples: Sites of Administration and Staffing Patterns 8 Additional Resources 1 1. Introduction to Monoclonal Therapy 2 As of 08/13/21 Summary of COVID-19 Therapeutics 1 • No Illness . Health, no infections • Exposed Asymptomatic Infected . Scope of this Implementation Guide . Not hospitalized, no limitations . Monoclonal Antibodies for post-exposure prophylaxis (Casirivimab + Imdevimab (RGN)) – EUA Issued. • Early Symptomatic . Scope of this Implementation Guide . Not hospitalized, with limitations . Monoclonal Antibodies for treatment (EUA issued): Bamlanivimab + Etesevimab1 (Lilly) Casirivimab + Imdevimab (RGN) Sotrovimab (GSK/Vir) • Hospital Adminission. Treated with Remdesivir (FDA Approved) or Tocilizumab (EUA Issued) . Hospitalized, no acute medical problems . Hospitalized, not on oxygen . Hospitlaized, on oxygen • ICU Admission . Hospitalized, high flow oxygen, non-invasive ventilation
    [Show full text]
  • Pharmacy Market Outlook Highlights Keeping You at the Forefront of Drug Price Projections and Market Developments
    SUMMER 2021 Pharmacy Market Outlook Highlights Keeping you at the forefront of drug price projections and market developments VIZIENT CENTER FOR PHARMACY PRACTICE EXCELLENCE 1 Pharmacy Market Outlook Summer 2021 Highlights © 2021 Vizient, Inc. All rights reserved. Table of contents Overview Executive summary ......................................................................................................3 Key findings by segment Acute care ......................................................................................................................6 Projections by therapeutic class Specialty pharmaceuticals ..........................................................................................7 Pediatrics .......................................................................................................................8 Oncology ........................................................................................................................9 Infectious disease .......................................................................................................10 Immunomodulators and disease-modifying therapies ........................................11 Plasma products: Intravenous immune globin and albumin ................................12 New: diabetes-related medications .........................................................................13 Management of high-cost therapies Biologics and biosimilars ...........................................................................................14 The evolution
    [Show full text]
  • Psychiatric Medication Update Objectives Abbreviations
    3/30/2021 Psychiatric Medication Update Kara Gagnon, PharmD, BCPS, BCPP Pharmacy & Behavioral Health Programs Manager Objectives Identify newly approved psychiatric medications Discuss medications currently in the pipeline Review pertinent FDA MedWatch Alerts Evaluate new treatment guidelines for schizophrenia Abbreviations ADHD: Attention Deficit Hyperactivity Disorder AP: Antipsychotic CNS: Central Nervous System FDA: Food and Drug Administration FGA: First Generation Antipsychotic SGA: Second Generation Antipsychotic VMAT2: Vesicular monoamine transporter 2 1 3/30/2021 FDA Drug Approval Process ✓ Drug developed ✓ Animals tested ✓ Investigational New Drug (IND) application ✓ Phase 1 → Phase 2 → Phase 3 trials ✓ Review meeting: FDA + drug sponsor ✓ New Drug Application ✓ FDA NDA Review ✓ Drug Labeling ✓ Manufacturer facility inspection ✓ Drug Approval ✓ Post-Marketing monitoring Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download FDA Drug Approval Process Faster Approval Options ➢ Accelerated Approval ➢ Fast Track Prescription Drug User Fee Act (1992) FDA MedWatch ➢ Voluntary system for physicians and consumers to report adverse events Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download AzstarysTM (serdexmethylphenidate/dexmethylphenidate) FDA Approval: March 2, 2021 CNS stimulant for treatment of ADHD in patients 6 years of age and older Norepinephrine dopamine reuptake inhibitor; Schedule II substance KemPharm, Inc. ➢ LAT® (Ligand Activated Therapy) technology Azstarys. Package Insert. KemPharm Inc. 2021. 2 3/30/2021 AzstarysTM (serdexmethylphenidate/dexmethylphenidate) Novel once-daily oral capsule ➢ First and only product with dexmethylphenidate prodrug Three strengths available ➢ 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg Warnings & Precautions ➢ Abuse/dependence, cardiovascular, psychiatric, growth suppression Azstarys.
    [Show full text]
  • (KPIC) PPO and Out-Of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier
    Kaiser Permanente Insurance Company (KPIC) PPO and Out-of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier This Drug Formulary was updated: September 1, 2021 NOTE: This drug formulary is updated often and is subject to change. Upon revision, all previous versions of the drug formulary are no longer in effect. This document contains information regarding the drugs that are covered when you participate in the California Nongrandfathered PPO and Out-of- Area Indemnity (OOA) Health Insurance Plans with specialty drug tier offered by Kaiser Permanente Insurance Company (KPIC) and fill your prescription at a MedImpact network pharmacy. Access to the most current version of the Formulary can be obtained by visiting kp.org/kpic-ca-rx-ppo-ngf. For help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit, please call 1-800-788-0710 or 711 (TTY) Monday through Friday, 7a.m. to 7p.m. For help with this Formulary, including the processes for submitting an exception request and requesting prior authorization and step therapy exceptions, please call MedImpact 24 hours a day, 7 days a week, at 1-800-788-2949 or 711 (TTY). For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit: kp.org/kpic-ca-rx-ppo-ngf. For help in your preferred language, please see the Kaiser Permanente Insurance Company Notice of Language Assistance in this document. KPIC PPO NGF Table of Contents Informational Section................................................................................................................................2
    [Show full text]
  • 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 .........................................................................
    [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]