DOCSLIB.ORG

September 2017 ~ Resource #330909

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
September 2017 ~ Resource #330909 −This Clinical Resource gives subscribers additional insight related to the Recommendations published in− September 2017 ~ Resource #330909 Medications Stored in the Refrigerator (Information below comes from current U.S. and Canadian product labeling and is current as of date of publication) Proper medication storage is important to ensure medication shelf life until the manufacturer expiration date and to reduce waste. Many meds are recommended to be stored at controlled-room temperature. However, several meds require storage in the refrigerator or freezer to ensure stability. See our toolbox, Medication Storage: Maintaining the Cold Chain, for helpful storage tips and other resources. Though most meds requiring storage at temperatures colder than room temperature should be stored in the refrigerator, expect to see a few meds require storage in the freezer. Some examples of medications requiring frozen storage conditions include: anthrax immune globulin (Anthrasil [U.S. only]), carmustine wafer (Gliadel [U.S. only]), cholera (live) vaccine (Vaxchora), dinoprostone vaginal insert (Cervidil), dinoprostone vaginal suppository (Prostin E2 [U.S.]), varicella vaccine (Varivax [U.S.]; Varivax III [Canada] can be stored in the refrigerator or freezer), zoster vaccine (Zostavax [U.S.]; Zostavax II [Canada] can be stored in the refrigerator or freezer). Use the list below to help identify medications requiring refrigerator storage and become familiar with acceptable temperature excursions from recommended storage conditions. Abbreviations: RT = room temperature Abaloparatide (Tymlos [U.S.]) Aflibercept (Eylea) Amphotericin B (Abelcet, Fungizone) • Once open, may store at RT (68°F to 77°F • May store at RT (77°F [25°C]) for up to Anakinra (Kineret) [20°C to 25°C]) for up to 30 days. 24 hours (Canadian labeling). Anidulafungin (Eraxis) Abatacept (Orencia) Alglucosidase alfa (Lumizyme [U.S.]; • May store at RT (up to 77°F [25°C]) for up Abciximab (ReoPro) Myozyme [Canada]) to 96 hours. AbobotulinumtoxinA (Dysport) Alprostadil injection (Caverject 40 mcg, Antivenin, black widow (U.S.) Adalimumab (Humira) Prostin VR) Antivenin, coral snake (U.S.) • May store Humira pens or prefilled • May store Caverject 40 mcg at RT for up Anti-thymocyte globulin, rabbit syringes at RT (up to 77°F [25°C]) for up to 3 months (U.S. labeling). (Thymoglobulin) to 14 days. • U.S. Caverject strengths 5 mcg, 10 mcg, Aprepitant injection (Emend) Albiglutide (Tanzeum [U.S.], Eperzan and 20 mcg along with all Canadian Arformoterol (Brovana [U.S.]) [Canada]) strengths do not require refrigeration. • May store at RT (up to 77°F [25°C]) for up • May store at RT (up to 86°F [30°C]) for up • Caverject Impulse (U.S.) does not require to 6 weeks. to 4 weeks. refrigeration. Atezolizumab (Tecentriq) Alirocumab (Praluent) Alprostadil suppositories (Muse) Atracurium besylate • May store at RT (up to 77°F [25°C]) for up • May store at RT (up to 86°F [30°C]) for up Avelumab (Bavencio [U.S.]) to 30 days (U.S. labeling). to 14 days. Azithromycin ophthalmic (Azasite [U.S.]) Ado-trastuzumab emtansine (Kadcyla [U.S.]) Alteplase (Cathflo Activase [U.S.]; Cathflo • Once open, may store at RT (up to 77°F [Canada]) [25°C]) for up to 14 days. More. Copyright © 2017 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 PharmacistsLetter.com ~ PrescribersLetter.com ~ PharmacyTechniciansLetter.com ~ NursesLetter.com (Clinical Resource #330909: Page 2 of 6) Aztreonam (Cayston) Calcitonin nasal spray (generics [U.S.]) Diltiazem injection • After dispensing, may store at RT (up to • Once open, may store at RT (up to 77°F • May store at RT for up to 1 month. 77°F [25°C]) for up to 28 days. [25°C]) for up to 30 days (2 mL) or Dinoprostone vaginal gel (Prepidil, Prostin E2 Bacitracin powder for injection 35 days (3.7 mL). Vaginal Gel [Canada]) Basiliximab (Simulect) Canakinumab (Ilaris) Dinoprostone (Prostin E2 tablets [Canada]) Becaplermin (Regranex [U.S.]) Carboprost (Hemabate) Dinutuximab (Unituxin [U.S.]) Belatacept (Nulojix [U.S.]) Carfilzomib (Kyprolis) Dornase alfa (Pulmozyme) Bendamustine (Bendeka [U.S.]) Carmustine (BiCNU) Doxorubicin (Adriamycin) • Treanda (Canada) does not require Certolizumab pegol (Cimzia) Doxorubicin liposomal (Doxil [U.S.], Lipodox refrigeration. Cetuximab (Erbitux) [U.S.]; Caelyx [Canada]) Benzoyl peroxide/clindamycin gel (Duac Chlorambucil (Leukeran) Dronabinol capsules (Marinol [U.S.]) [U.S.], Neuac [U.S.]; Clindoxyl [Canada], Ciprofloxacin 6% otic (Otiprio [U.S.]) • May store between temperatures of 46°F Clindoxyl ADV [Canada]) Cisatracurium (Nimbex [U.S.]) and 59°F (8°C and 15°C), if not • After dispensing, store at RT (up to 77°F • Use within 21 days of removing from refrigerated. [25°C]) for up to 60 days. refrigerator, even if re-refrigerated. Dronabinol solution (Syndros [U.S.]) Benzylpenicilloyl polylysine injection Cladribine • Once open, may store at RT (up to 77°F (Pre-Pen) Conjugated estrogen injection (Premarin [25°C]) for up to 28 days. • May store at RT (up to 77°F [25°C]) for up Intravenous) Durvalumab (Imfinzi [U.S.]) to 24 hours. Corticorelin (Acthrel [U.S.]) Ecallantide (Kalbitor [U.S.]) Beractant (Survanta) Dacarbazine • May store at RT (up to 86°F [30°C]) for up Bevacizumab (Avastin) Daclizumab (Zinbryta [U.S.]) to 14 days. Bezlotoxumab (Zinplava [U.S.]) • May store at RT (up to 86°F [30°C]) for up Echothiophate iodide (U.S.) Bleomycin injection to 30 days. Elosulfase alfa (Vimizim) Brodalumab (Siliq [U.S.]) Daptomycin (Cubicin) Elotuzumab (Empliciti [U.S.]) • May store prefilled syringes at RT (up to Daratumumab (Darzalex) Emtricitabine oral solution (Emtriva [U.S.]) 77°F [25°C]) for up to 14 days. Darbepoetin alfa (Aranesp) • May store at RT (up to 77°F [25°C], with Bupivacaine liposomal (Exparel [U.S.]) Desmopressin (DDAVP Rhinal Tube [U.S.]; excursions up to 80°F [30°C]) for up to • May store at RT (up to 77°F [25°C]) for up DDAVP Rhinyle [Canada]) 3 months. to 30 days. • May store DDAVP Rhinal Tube at RT (up Enalapril oral solution (Epaned [U.S.]) Busulfan injection (Busulfex) to 77°F [25°C]) for up to 3 weeks. • May store at RT (up to 77°F [25°C]) for up Calcitonin injection (Miacalcin [U.S.]; Desmopressin injection (DDAVP [U.S.]; to 60 days. Calcimar [Canada]) Octostim [Canada]) Epirubicin (Ellence) • May store Calcimar at RT (up to 86°F Digoxin immune Fab (Digibind [U.S.]; Epoetin alfa (Epogen [U.S.], Procrit [U.S.]; [30°C]) for up to 2 weeks. DigiFab [Canada]) Eprex [Canada]) • May store Digibind at RT (up to 86°F [30°C]) for up to 30 days. More. Copyright © 2017 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 PharmacistsLetter.com ~ PrescribersLetter.com ~ PharmacyTechniciansLetter.com ~ NursesLetter.com (Clinical Resource #330909: Page 3 of 6) Eptifibatide (Integrilin) Evolocumab (Repatha) Hyaluronate/chondroitin (DuoVisc [U.S.]) • May store at RT (up to 77°F [25°C] with • May store at RT (up to 77°F [25°C] with Idarubicin (Idamycin PFS) excursions to 86°F [30°C]) for up to excursions up to 86° [30°C]) for up to Idarucizumab (Praxbind) 2 months. 30 days. • May store at RT (up to 77°F [25°C]) for no Estradiol/norethindrone acetate patch Exenatide (Byetta, Bydureon) more than 48 hours (protected from light) (CombiPatch [U.S.]; Estalis [Canada]) • Once open, may store Bydureon at RT (up or 6 hours (not protected from light). • After dispensing, may store at RT (up to to 77°F [25°C]) for up to 4 weeks. Idursulfase (Elaprase) 77°F [25°C]) for up to 6 months. • Once open, may store Byetta at RT (up to Immune Globulin (GamaSTAN S/D) Estradiol (Estradot [Canada] 77°F [25°C]) for up to 30 days. Infliximab (Inflectra, Remicade, Remsima • May store between 2°C and 30°C Famotidine injection [Canada]) (Canadian labeling). Filgrastim (Neupogen) • Remicade may store for no more than 6 Estramustine (Emcyt) • May store at RT for up to 24 hours (up to months at RT (up to 86°F [30°C]). • May store between 2°C and 25°C 86°F [30°C] for 14 days [Canadian Interferon alfa-2b (Intron A) (Canadian labeling). labeling]). • May store at RT (up to 77°F [25°C], per Etanercept (Enbrel, Brenzys [Canada]) Filgrastim (Grastofil [Canada]) Canadian labeling only) • May store at RT (up to 77°F [25°C]) for up Filgrastim-sndz (Zarxio [U.S.]) o Lyophilized powder: up to 4 weeks to 14 days (U.S. labeling) Formoterol (Perforomist [U.S.]) o Ready-to-use solution: up to 7 days • Per Canadian labeling • After dispensing, may store at 36°F to o Multi-dose pens: up to 48 hours over a o Enbrel single-dose prefilled syringes, 77°F (2°C to 25°C) for up to 3 months. four-week period prefilled SureClick, and multi-use vials Fosphenytoin (Cerebyx) Interferon beta-1a (Avonex) may be stored up to 27°C for up to • May store at RT for up to 48 hours. • May store lyophilized powder at RT (up to 60 days. Gabapentin oral solution (Neurontin [U.S.]) 77°F [25°C]) for a total of 30 days (U.S. o Brenzys may be stored up to 27°C for Galsulfase (Naglazyme) labeling). up to 60 days. Gemtuzumab ozogamicin (Mylotarg [U.S.]) • May store prefilled syringes and pens at o Multi-dose vial after reconstitution may Glatiramer acetate (Copaxone, Glatopa RT (up to 77°F [25°C] per U.S. labeling, be stored at RT (up to 77°F [25°C]) for [U.S.]) up to 86° [30°C] per Canadian labeling) up to 14 days. • May store at RT (59°F to 86°F [15°C to for up to 7 days. Etonogestrel/ethinyl estradiol vaginal ring 30°C]) for up to 1 month.
Load more

Recommended publications
  • Chapter 7: Monogenic Forms of Diabetes
    CHAPTER 7 MONOGENIC FORMS OF DIABETES Mark A. Sperling, MD, and Abhimanyu Garg, MD Dr. Mark A. Sperling is Emeritus Professor and Chair, University of Pittsburgh, Department of Pediatrics, Children’s Hospital of Pittsburgh of UPMC, Pittsburgh, PA. Dr. Abhimanyu Garg is Professor of Internal Medicine and Chief of the Division of Nutrition and Metabolic Diseases at University of Texas Southwestern Medical Center, Dallas, TX. SUMMARY Types 1 and 2 diabetes have multiple and complex genetic influences that interact with environmental triggers, such as viral infections or nutritional excesses, to result in their respective phenotypes: young, lean, and insulin-dependence for type 1 diabetes patients or older, overweight, and often manageable by lifestyle interventions and oral medications for type 2 diabetes patients. A small subset of patients, comprising ~2%–3% of all those diagnosed with diabetes, may have characteristics of either type 1 or type 2 diabetes but have single gene defects that interfere with insulin production, secretion, or action, resulting in clinical diabetes. These types of diabetes are known as MODY, originally defined as maturity-onset diabetes of youth, and severe early-onset forms, such as neonatal diabetes mellitus (NDM). Defects in genes involved in adipocyte development, differentiation, and death pathways cause lipodystrophy syndromes, which are also associated with insulin resistance and diabetes. Although these syndromes are considered rare, more awareness of these disorders and increased availability of genetic testing in clinical and research laboratories, as well as growing use of next generation, whole genome, or exome sequencing for clinically challenging phenotypes, are resulting in increased recognition. A correct diagnosis of MODY, NDM, or lipodystrophy syndromes has profound implications for treatment, genetic counseling, and prognosis.
    [Show full text]
  • Old and New Challenges in Uveitis Associated with Behçet's Disease
    Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage.
    [Show full text]
  • Myalept® (Metreleptin)
    UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 2032-11 Program Prior Authorization/Medical Necessity Medication Myalept® (metreleptin) P&T Approval Date 5/2014, 7/2014, 8/2014, 7/2015, 6/2016, 5/2017, 5/2018, 5/2019, 5/2020, 5/2021 Effective Date 8/1/2021; Oxford only: 8/1/2021 1. Background: Myalept (metreleptin) is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.1 Myalept is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS), called the Myalept REMS program, because of the risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and the risk of lymphoma. 2. Coverage Criteria: A. Initial Authorization 1. Myalept will be approved based on all of the following criteria: a. Diagnosis of congenital or acquired generalized lipodystrophy associated with leptin deficiency -AND- b. Myalept is being used as an adjunct to diet modification -AND- c. Prescribed by an endocrinologist -AND- d. Documentation demonstrates that patient has at least one of the following: (1) Diabetes mellitus or insulin resistance with persistent hyperglycemia (HgbA1C > 7.0) despite both of the following: (a) Dietary intervention (b) Optimized insulin therapy at maximum tolerated doses © 2021 UnitedHealthcare Services, Inc. 1 -OR- (2) Persistent hypertriglyceridemia (TG > 250) despite both of the following: (a) Dietary intervention (b) Optimized therapy with at least two triglyceride-lowering agents from different classes (e.g., fibrates, statins) at maximum tolerated doses Authorization will be issued for 12 months B.
    [Show full text]
  • The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands
    The Activation of the Glucagon-Like Peptide-1 (GLP-1) Receptor by Peptide and Non-Peptide Ligands Clare Louise Wishart Submitted in accordance with the requirements for the degree of Doctor of Philosophy of Science University of Leeds School of Biomedical Sciences Faculty of Biological Sciences September 2013 I Intellectual Property and Publication Statements The candidate confirms that the work submitted is her own and that appropriate credit has been given where reference has been made to the work of others. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of Clare Louise Wishart to be identified as Author of this work has been asserted by her in accordance with the Copyright, Designs and Patents Act 1988. © 2013 The University of Leeds and Clare Louise Wishart. II Acknowledgments Firstly I would like to offer my sincerest thanks and gratitude to my supervisor, Dr. Dan Donnelly, who has been nothing but encouraging and engaging from day one. I have thoroughly enjoyed every moment of working alongside him and learning from his guidance and wisdom. My thanks go to my academic assessor Professor Paul Milner whom I have known for several years, and during my time at the University of Leeds he has offered me invaluable advice and inspiration. Additionally I would like to thank my academic project advisor Dr. Michael Harrison for his friendship, help and advice. I would like to thank Dr. Rosalind Mann and Dr. Elsayed Nasr for welcoming me into the lab as a new PhD student and sharing their experimental techniques with me, these techniques have helped me no end in my time as a research student.
    [Show full text]
  • Idarucizumab Reverses Dabigatran Anticoagulant Activity in Healthy Chinese Volunteers: a Pharmacokinetics, Pharmacodynamics, and Safety Study
    Adv Ther (2020) 37:3916–3928 https://doi.org/10.1007/s12325-020-01439-2 ORIGINAL RESEARCH Idarucizumab Reverses Dabigatran Anticoagulant Activity in Healthy Chinese Volunteers: A Pharmacokinetics, Pharmacodynamics, and Safety Study Zining Wang . Xia Zhao . Pengkang He . Shuqing Chen . Jie Jiang . Akiko Harada . Steven Brooks . Yimin Cui Received: May 25, 2020 / Published online: July 20, 2020 Ó The Author(s) 2020 ABSTRACT b.i.d., oral). After a washout period, the 12 subjects again received dabigatran etexilate Introduction: Idarucizumab is a humanized (220 mg b.i.d., oral) and idarucizumab monoclonal antibody fragment that specifically (2.5 ? 2.5 g, intravenous) 2 h after the last binds to dabigatran with high affinity and administration of dabigatran etexilate. reverses its anticoagulant effect. This study Results: The geometric mean (gMean) values of investigated the pharmacokinetics (PK) and area under the plasma concentration–time pharmacodynamics (PD) of idarucizumab in curve (AUC0–?) and maximum concentration healthy Chinese subjects at steady state of (Cmax) were 44,200 nmol h/L and 30,900 nmol/ dabigatran and explored the effect of idaru- L, respectively. An amount of 35.3 lmol of cizumab on PK and PD of dabigatran. idarucizumab, corresponding to 33.8% of the Methods: Twelve subjects received dabigatran total dose, was excreted by urine over 72 h. The etexilate treatment alone (220 mg twice daily, area under the effect (AUECabove,2–12) in the presence and absence of idarucizumab was close to zero for all coagulation parameters, diluted Zining Wang and Xia Zhao contributed equally to this work. thrombin time (dTT), ecarin clotting time (ECT), activated partial thromboplastin time Digital Features To view digital features for this article (aPTT), and thrombin time (TT), which indi- go to https://doi.org/10.6084/m9.figshare.12613334.
    [Show full text]
  • WO 2017/048702 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date W O 2017/048702 A l 2 3 March 2017 (23.03.2017) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 487/04 (2006.01) A61P 35/00 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/519 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, (21) International Application Number: DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/US20 16/05 1490 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (22) International Filing Date: KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 13 September 2016 (13.09.201 6) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (25) Filing Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (26) Publication Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 62/218,493 14 September 2015 (14.09.2015) US (84) Designated States (unless otherwise indicated, for every 62/218,486 14 September 2015 (14.09.2015) US kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (71) Applicant: INFINITY PHARMACEUTICALS, INC.
    [Show full text]
  • Project Protocol
    CADTH Health Technology Assessment June 2016 (Update Drugs for the management of rheumatoid May 2017) arthritis: clinical evaluation – project protocol PROSPERO Registration Number: CRD42016041498 1 Cite as: Drugs for the management of rheumatoid arthritis: clinical evaluation – project protocol. Ottawa: CADTH; 2016 Jun; updated 2017 April. This report is prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH) in collaboration with the Canadian Institutes of Health Research (CIHR) Drug Safety and Effectiveness Network (DSEN). This report contains a comprehensive review of existing public literature, studies, materials, and other information and documentation (collectively the “source documentation”) available to CADTH at the time it was prepared, and its creation was guided by expert input and advice throughout its preparation. The information in this report is intended to help health care decision-makers, patients, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment in respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this report to ensure that its contents are accurate, complete, and up-to-date, CADTH does not make any guarantee to that effect. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or as a result of the use (or misuse) of any information contained in or implied by the information in this report.
    [Show full text]
  • Reversal of Oral Anticoagulation in Patients with Acute Intracerebral Hemorrhage Joji B
    Kuramatsu et al. Critical Care (2019) 23:206 https://doi.org/10.1186/s13054-019-2492-8 REVIEW Open Access Reversal of oral anticoagulation in patients with acute intracerebral hemorrhage Joji B. Kuramatsu* , Jochen A. Sembill and Hagen B. Huttner Abstract In light of an aging population with increased cardiovascular comorbidity, the use of oral anticoagulation (OAC) is steadily expanding. A variety of pharmacological alternatives to vitamin K antagonists (VKA) have emerged over recent years (direct oral anticoagulants, DOAC, i.e., dabigatran, rivaroxaban, apixaban, and edoxaban) which show a reduced risk for the occurrence of intracerebral hemorrhage (ICH). Yet, in the event of ICH under OAC (OAC-ICH), hematoma characteristics are similarly severe and clinical outcomes likewise substantially limited in both patients with VKA- and DOAC-ICH, which is why optimal acute hemostatic treatment in all OAC-ICH needs to be guaranteed. Currently, International Guidelines for the hemostatic management of patients with OAC-ICH are updated as several relevant large-sized observational studies and recent trials have established treatment approaches for both VKA- and DOAC-ICH. While the management of VKA-ICH is mainly based on the immediate reversal of elevated levels of international normalized ratio using prothrombin complex concentrates, hemostatic management of DOAC-associated ICH is challenging requiring specific antidotes, notably idarucizumab and andexanet alfa. This review will provide an overview of the latest studies and trials on hemostatic reversal agents and timing and summarizes the effects on hemorrhage progression and clinical outcomes in patients with OAC-ICH. Keywords: Intracerebral hemorrhage, Anticoagulation reversal, Tranexamic acid, Ciraparantag, Desmopressin Introduction importantly have a greater frequency of hematoma ex- Of all stroke sub-types, intracerebral hemorrhage (ICH) pansion (HE), all of which are significant outcome pre- constitutes roughly 15% and is associated with the worst dictors determining an even poorer prognosis [11–13].
    [Show full text]
  • Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
    antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution.
    [Show full text]
  • List of Approved Ndas for Biological Products That Were Deemed to Be Blas on March 23, 2020
    List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020 On March 23, 2020, an approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) was deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (see section 7002(e)(4)(A) of the Biologics Price Competition and Innovation Act of 2009). To enhance transparency and facilitate planning for the March 23, 2020, transition date, FDA compiled a preliminary list of approved applications for biological products under the FD&C Act that were listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and that would be affected by this transition provision. FDA posted this list on the FDA website in December 2018, and periodically updated this list before the March 23, 2020, transition date. The September 2019 update to this preliminary list added certain administratively closed applications related to approved applications for biological products that were on the December 2018 version of this list. The January 2020 update to the preliminary list reflected a change to the definition of “biological product” made by the Further Consolidated Appropriations Act, 2020, which was enacted on December 20, 2019. Section 605 of this Act further amended the definition of a “biological product” in section 351(i) of the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein.” FDA has provided below a list of each approved application for a biological product under the FD&C Act that was deemed to be a license (i.e., an approved biologics license application (BLA)) for the biological product on March 23, 2020.
    [Show full text]
  • Assessment of Overall Survival, Quality of Life, And
    Supplementary Online Content Salas-Vega S, Iliopoulos O, Mossialos E. Assesment of overall survival, quality of life, and safety benefits associated with new cancer medicines [published online December 29, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.4166 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 eTable 2. Regulatory evidence in support of classification of drug clinical benefits eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits eTable 3. Interagency agreement–Krippendorff’s alpha coefficients eMethods This supplementary material has been provided by the authors to give readers additional information about their work. Online-Only Supplement © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Contents eExhibits ......................................................................................................................................................... 3 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 (Summary of eTable 2) ................................................................................................................... 3 eTable 2. Regulatory evidence in support of classification of drug clinical benefits ....................... 6 eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits
    [Show full text]
  • Corticorelin Acetate, a Synthetic Corticotropin-Releasing Factor with Preclinical Antitumor Activity, Alone and with Bevacizumab, Against Human Brain Tumor Models
    ANTICANCER RESEARCH 30: 5037-5042 (2010) Corticorelin Acetate, a Synthetic Corticotropin-releasing Factor with Preclinical Antitumor Activity, alone and with Bevacizumab, against Human Brain Tumor Models IDOIA GAMEZ1, ROBERT P. RYAN1 and STEPHEN T. KEIR2 1Celtic Pharmaceutical Development Services America, Inc., New York, NY 10022, U.S.A.; 2The Preston Robert Tisch Brain Tumor Center, Duke University, Durham, NC 27710, U.S.A. Abstract. Background: Corticorelin acetate (CrA) is a brain tumors. The cause of PBE is believed to result in part synthetic form of corticotropin-releasing factor that is from the leakage of edematous brain tumor fluid from currently undergoing clinical trials in the treatment of abnormal tumor vasculature into the surrounding tissue (1, peritumoral brain edema (PBE). This study preclinically 2). The mechanism(s) of action by which CrA exerts its investigated its potential as an antitumor agent against beneficial effect in the therapy of PBE has not been human brain tumor xenografts. Materials and Methods: The elucidated, but two factors appear to be relevant: decreased in vivo efficacy of CrA as a single agent and in combination vascular leakage and preserved integrity of the endothelial with the antiangiogenic agent, bevacizumab, was examined cells, which ultimately helps to maintain the blood-brain in three different patient-derived human brain tumor barrier (3, 4). xenografts implanted orthotopically (intracranially) or CrA appears to mediate its activity through two subtypes subcutaneously in athymic mice. Results: CrA significantly of G-protein coupled receptors: CRF receptor-1 (CRFR1) increased the lifespan of mice implanted orthotopically with and CRF receptor-2 (CRFR2) (5). These CRFRs are widely two different pediatric brain tumor xenograft models.
    [Show full text]