DOCSLIB.ORG

Iloprost 100 Micrograms/Ml Concentrate for Solution for Infusion

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Iloprost 100 Micrograms/Ml Concentrate for Solution for Infusion PHARMACODE Package leaflet: Information for the user POSITION GUIDE Iloprost 100 micrograms/ml GUIDE POSITION PHARMACODE Concentrate for solution for infusion Read all of this leaflet carefully before you Pregnancy, breast-feeding and fertility: start using this medicine because it Iloprost 100 micrograms/ml is not indicated contains important information for you. for pregnant or breast-feeding women. PHARMACODE ■ POSITION Keep this leaflet. You may need to read it GUIDE If you are pregnant or breast-feeding, think again. you may be pregnant or are planning to have ■ If you have any further questions, ask your a baby, ask your doctor for advice before GUIDE POSITION doctor, pharmacist or nurse. PHARMACODE using this medicine. Women of childbearing ■ This medicine has been prescribed for you potential have to use effective contraception only. Do not pass it on to others. It may during treatment. harm them, even if their signs of illness are the same as yours. Driving and using machines: ■ If you get any side effects, talk to your Iloprost 100 micrograms/ml lowers blood doctor, pharmacist or nurse. This includes pressure and may cause dizziness or any possible side effects not listed in this light-headedness in some people. Do not leaflet. ■ drive or operate any tools or machines if you The full name of this medicine is Iloprost feel these effects. 100 micrograms/ml Concentrate for solution for infusion but within the leaflet it will be referred to as Iloprost 100 3. How to use Iloprost micrograms/ml. 100 micrograms/ml What is in this leaflet Iloprost 100 micrograms/ml should be used 1. What Iloprost 100 micrograms/ml is and only under strict monitoring in hospitals or what it is used for out-patient clinics with adequate facilities. 2. What you need to know before you use Iloprost 100 micrograms/ml How Iloprost 100 micrograms/ml is 3. How to use Iloprost 100 micrograms/ml prepared for administration 4. Possible side effects Iloprost 100 micrograms/ml is a solution 5. How to store Iloprost 100 micrograms/ml contained in a glass ampoule. The content of 6. Contents of the pack and other information the ampoule is diluted with 0.9% physiological sodium chloride solution or a 5% glucose solution. The infusion solution should be 1. What Iloprost 100 micrograms/ prepared just before the infusion daily, to ml is and what it is used for ensure sterility. The content of the ampoule and the diluent must be mixed thoroughly. Iloprost 100 micrograms/ml contains the Iloprost 100 micrograms/ml must be used only active ingredient iloprost which imitates a after dilution. For further information for natural substance in the body called physicians or healthcare professionals on the prostacyclin. Iloprost 100 micrograms/ml and preparation of the dilution see section “The prostacyclin prevent unwanted blockages or following information is intended for medical narrowing of blood vessels and allow and healthcare professionals only” at the end improved blood flow in the arteries. of this leaflet. Iloprost 100 micrograms/ml promotes the healing of wounds caused by insufficient How Iloprost 100 micrograms/ml is given blood flow (ischemia) by providing better The solution is infused intravenously with a oxygenation, and relieving pain in severe, venous catheter directly into one of the veins chronic disorders of the blood circulation. in your arm or into a central intravenous catheter inserted into a vein near your neck. Iloprost 100 micrograms/ml is used in adults Iloprost 100 micrograms/ml is administered in the treatment of: as infusion over 6 hours daily. ■ Severe chronic ischaemia of lower limbs The dose is adjusted according to individual (decreased blood supply) in patients at tolerability within the range of 0.5 to 2.0 ng risk of amputation, in whom surgical iloprost/kg body weight/min. Your blood revascularisation or angioplasty (repair of pressure and heart rate will be measured at blood vessel) has failed or is not the start of the infusion and after every dose indicated, following the meeting of increase. physicians, surgeons and radiologists. ■ Severe Raynaud’s phenomena (reduced How much Iloprost 100 micrograms/ml blood flow to fingers and toes) in patients is given with progressive trophic disorders. During the first 2-3 days, the individually 2. What you need to know tolerated dose is established. before you use Iloprost For this purpose, your doctor will start the treatment at a low dose. Treatment should 100 micrograms/ml be started at an infusion rate of 0.5 ng/kg/ Do not use Iloprost 100 micrograms/ml if min for 30 minutes. The dose should then be you: increased at intervals of 30 minutes in steps ■ of 0.5 ng/kg/min up to 2.0 ng/kg/min. The have hypersensitivity (allergy) to iloprost exact infusion speed should be calculated on or any of the other ingredients of this the basis of body weight to reach an infusion medicine (listed in section 6 “Contents of within the range of 0.5 to 2.0 ng/kg/min (see the pack and other information”) ■ tables below for use with infusion pump or are at increased risk of bleeding – for syringe driver). example, if you have an active gastric (stomach) or duodenal ulcer, bleeding If adverse effects occur, such as headache from wounds or had bleeding inside the and nausea or an undesirable drop in blood skull pressure, tell your doctor immediately. The ■ have suspected fluid build-up in the infusion rate should be reduced until the lungs (pulmonary oedema) accompanied tolerable dose is found. If the adverse effects by difficulty in breathing are severe, the infusion should be ■ had a heart attack within the last six interrupted. For the remaining duration, the months treatment should be continued with the dose ■ have an irregular heart rate found to be tolerated in the first 2 to 3 days. ■ have poor blood flow to the heart muscle The doctor will determine whether Iloprost (severe coronary artery disease or 100 micrograms/ml will be infused unstable angina) intravenously by an infusion pump or with ■ are suffering withangina or chest pain syringe driver. If Iloprost 100 micrograms/ml ■ had an acute or chronic congestive heart is administered with an infusion pump, failure it will be diluted before infusion to a final ■ have congenital or acquired valvular concentration of 0.2 micrograms/ml. If defects with clinically relevant myocardial Iloprost 100 micrograms/ml is administered function disorders not related to with a syringe driver, it will be diluted before pulmonary hypertension infusion to a final concentration of 2 ■ had a stroke in the past 3 months micrograms /ml. ■ are pregnant or breast feeding If you have renal failure requiring dialysis Warnings and precautions or liver cirrhosis, iloprost elimination is reduced and a dose reduction (e.g. half the Talk to your doctor before using Iloprost 100 recommended dose) is necessary. Tell your micrograms/ml if you: doctor if you have problems with your liver ■ require urgent amputation. Surgery or kidneys. should not be delayed if you need urgent amputation (e.g. in case of infected How long Iloprost 100 micrograms/ml gangrene). is given: ■ are a smoker. You should stop smoking. The duration of treatment is up to 4 weeks. ■ have liver problems or severe kidney The safety and efficacy of Iloprost 100 problems, tell your doctor. You may be micrograms/ml have not been studied for prescribed a lower dose of Iloprost 100 treatment longer than 4 weeks or after micrograms/ml and your doctor will repetitive treatment cycles. monitor you closely. ■ have low blood pressure, care should be Continuous infusion over several days is not taken so as not to further reduce blood recommended, because it can lead to pressure (hypotension). reduced effect on platelets and increased ■ have severe heart disease, you will be platelet aggregation (platelet monitored closely. hyperaggregability) at the end of treatment. No clinical complications associated with After administration, when moving from a these phenomena have been reported. lying to upright position, your blood If you feel that the effect of Iloprost 100 pressure may fall. This can make you feel micrograms/ml is too strong or too weak, dizzy for a while until your blood pressure tell your doctor or pharmacist. returns to normal values (this is called “orthostatic hypotension”). Stand up slowly If you have any further questions about the when you get out of bed. This will help your use of this product, ask your doctor or body get used to this change in position and pharmacist. blood pressure. If you use more Iloprost 100 micrograms/ If undiluted Iloprost 100 micrograms/ml is ml than you should: infused in the veins this can lead to local Drop in blood pressure (hypotensive reaction) changes at the injection site due to can be expected, as well as headache, extravasation. redness of the face (flushing), nausea, If Iloprost 100 micrograms/ml comes into vomiting and diarrhoea. An increase in blood contact with your skin: pressure, reduced or increased heart rate and Iloprost 100 micrograms/ml solution should limb or back pain may also occur. not come into contact with your skin or eyes. No specific antidote is known. On contact with the skin, iloprost may cause In case of overdose, your doctor is advised to long-lasting but painless redness of the skin discontinue infusion of iloprost, to monitor (erythema). In the event of such contact, you and treat your symptoms. wash immediately the skin or the eyes with water or saline. If you stop using Iloprost 100 micrograms/ This medicinal product contains small ml: amounts of ethanol (alcohol), less than If the infusion therapy with Iloprost 100 100mg per dose.
Load more

Recommended publications
  • VTE) Cindy Ward, DNP, RN-BC, CMSRN, ACNS-BC
    Chronic Complications of Venous Thromboembolism (VTE) Cindy Ward, DNP, RN-BC, CMSRN, ACNS-BC Roanoke, VA Disclosure • The speaker has no conflicts of interest to disclose. Carilion Roanoke Memorial Hospital • 3 time Magnet® designated • Flagship of Carilion Clinic, a 7 hospital system • Region’s only Level 1 Trauma Center • 703-bed academic medical center • System-wide, serves nearly 1 million patients across Virginia, West Virginia and North Carolina Objectives At the conclusion of this education activity, the learner will be able to: • recall VTE risk factors and prevention • describe post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension (CTEPH) • identify nursing implications of caring for patients with post-thrombotic syndrome and CTEPH What is VTE? Pulmonary Embolus Deep Vein (PE) Thrombosis (DVT) Signs/Symptoms of DVT • Swelling • Erythema • Pain • Warmth1 Signs/Symptoms of PE 1 • Sudden onset of dyspnea • Tachycardia • Irregular heartbeat • Chest pain, worse with deep breath • Hemoptysis • Low blood pressure, light-headedness or syncope • 350,000 – 900,000 people per year are affected by VTE1, 2 • VTE is the leading cause of preventable hospital death in the US2 • VTE can occur without symptoms (silent)3 Quick Facts • Patients with DVT who are untreated have a 37% incidence of PE that is fatal4 • Combined mortality from PE (initial and recurrence) is 73%4 Quick Facts • 1 in 20 hospitalized patients will suffer a fatal PE if they have not received adequate VTE prophylaxis5 • For 25% of patients with PE, the first
    [Show full text]
  • CDK4/6 Inhibitors in Breast Cancer Treatment: Potential Interactions with Drug, Gene and Pathophysiological Conditions
    Review CDK4/6 Inhibitors in Breast Cancer Treatment: Potential Interactions with Drug, Gene and Pathophysiological Conditions Rossana Roncato 1,*,†, Jacopo Angelini 2,†, Arianna Pani 2,3,†, Erika Cecchin 1, Andrea Sartore-Bianchi 2,4, Salvatore Siena 2,4, Elena De Mattia 1, Francesco Scaglione 2,3,‡ and Giuseppe Toffoli 1,‡ 1 1 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico (CRO), IRCCS, 33081 Aviano, Italy; [email protected] (E.C.); [email protected] (E.D.M.); [email protected] (G.T.) 2 Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, 20122 Milan, Italy; [email protected] (J.A.); [email protected] (A.P.); [email protected] (A.S-B.); [email protected] (S.S.); [email protected] (F.S.) 3 Clinical Pharmacology Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza dell'Ospedale Maggiore 3, 20162 Milan, Italy 4 Department of Hematology and Oncology, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, 20162 Milan, Italy * Correspondence: [email protected]; Tel.:+390434659130 † These authors contributed equally. ‡ These authors share senior authorship. Int. J. Mol. Sci. 2020, 21, x; doi: www.mdpi.com/journal/ijms Int. J. Mol. Sci. 2020, 21, x 2 of 8 Table S1. Co-administered agents categorized according to their potential risk for Drug-Drug interaction (DDI) in combination with CDK4/6 inhibitors (CDKis). Colors suggest the risk of DDI with CDKis: green, low risk DDI; orange, moderate risk DDI; red, high risk DDI. ADME, absorption, distribution, metabolism, and excretion; GI, Gastrointestinal; TdP, Torsades de Pointes; NTI, narrow therapeutic index. * Cardiological toxicity should be considered especially for ribociclib due to the QT prolongation.
    [Show full text]
  • GTH 2021 State of the Art—Cardiac Surgery: the Perioperative Management of Heparin-Induced Thrombocytopenia in Cardiac Surgery
    Review Article 59 GTH 2021 State of the Art—Cardiac Surgery: The Perioperative Management of Heparin-Induced Thrombocytopenia in Cardiac Surgery Laura Ranta1 Emmanuelle Scala1 1 Department of Anesthesiology, Cardiothoracic and Vascular Address for correspondence Emmanuelle Scala, MD, Centre Anesthesia, Lausanne University Hospital (CHUV), Lausanne, Hospitalier Universitaire Vaudois, Rue du Bugnon 46, BH 05/300, 1011 Switzerland Lausanne, Suisse, Switzerland (e-mail: [email protected]). Hämostaseologie 2021;41:59–62. Abstract Heparin-induced thrombocytopenia (HIT) is a severe, immune-mediated, adverse drug Keywords reaction that paradoxically induces a prothrombotic state. Particularly in the setting of ► Heparin-induced cardiac surgery, where full anticoagulation is required during cardiopulmonary bypass, thrombocytopenia the management of HIT can be highly challenging, and requires a multidisciplinary ► cardiac surgery approach. In this short review, the different perioperative strategies to run cardiopul- ► state of the art monary bypass will be summarized. Introduction genicity of the antibodies and is diagnostic for HIT. The administration of heparin to a patient with circulating Heparin-induced thrombocytopenia (HIT) is a severe, im- pathogenic HITabs puts the patient at immediate risk of mune-mediated, adverse drug reaction that paradoxically severe thrombotic complications. induces a prothrombotic state.1,2 Particularly in the setting The time course of HIT can be divided into four distinct of cardiac surgery, where full anticoagulation is required phases.6 Acute HIT is characterized by thrombocytopenia during cardiopulmonary bypass (CPB), the management of and/or thrombosis, the presence of HITabs, and confirma- HIT can be highly challenging, and requires a multidisciplin- tion of their platelet activating capacity by a functional ary approach.
    [Show full text]
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE
    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
    [Show full text]
  • Ventavis, INN-Iloprost
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ventavis 10 microgram/ml nebuliser solution 1 ml solution contains 10 microgram iloprost (as iloprost trometamol). Each ampoule with 1 ml solution contains 10 microgram iloprost. Each ampoule with 2 ml solution contains 20 microgram iloprost. Ventavis 20 microgram/ml nebuliser solution 1 ml solution contains 20 microgram iloprost (as iloprost trometamol). Each ampoule with 1 ml solution contains 20 microgram iloprost. Excipient with known effect • Ventavis 10 microgram/ml: Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol) • Ventavis 20 microgram/ml: Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nebuliser solution. Ventavis 10 microgram/ml nebuliser solution Clear, colourless solution. Ventavis 20 microgram/ml nebuliser solution Clear, colourless to slightly yellowish solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms. 4.2 Posology and method of administration Drug product Suitable inhalation device (nebuliser) to be used Ventavis 10 microgram/ml Breelib I-Neb AAD Venta-Neb Ventavis 20 microgram/ml Breelib I-Neb AAD Ventavis should only be initiated and monitored by a physician experienced in the treatment of pulmonary hypertension. 2 Posology Dose per inhalation session At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser.
    [Show full text]
  • Statistical Analysis Plan – Part 1
    NCT03251482 Janssen Research & Development Statistical Analysis Plan – Part 1 A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery Protocol 64179375THR2001; Phase 2 JNJ-64179375 Status: Approved Date: 18 October 2017 Prepared by: Janssen Research & Development, LLC Document No.: EDMS-ERI-148215770 Compliance: The study described in this report was performed according to the principles of Good Clinical Practice (GCP). Confidentiality Statement The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. 1 Approved, Date: 18 October 2017 JNJ-64179375 NCT03251482 Statistical Analysis Plan - Part 1 64179375THR2001 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF IN-TEXT TABLES AND FIGURES ...............................................................................................
    [Show full text]
  • Antiplatelet Effects of Prostacyclin Analogues: Which One to Choose in Case of Thrombosis Or Bleeding? Sylwester P
    INTERVENTIONAL CARDIOLOGY Cardiology Journal 20XX, Vol. XX, No. X, XXX–XXX DOI: 10.5603/CJ.a2020.0164 Copyright © 20XX Via Medica REVIEW ARTICLE ISSN 1897–5593 eISSN 1898–018X Antiplatelet effects of prostacyclin analogues: Which one to choose in case of thrombosis or bleeding? Sylwester P. Rogula1*, Hubert M. Mutwil1*, Aleksandra Gąsecka1, Marcin Kurzyna2, Krzysztof J. Filipiak1 11st Chair and Department of Cardiology, Medical University of Warsaw, Poland 2Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Center of Postgraduate Education Medical, European Health Center Otwock, Poland Abstract Prostacyclin and analogues are successfully used in the treatment of pulmonary arterial hypertension (PAH) due to their vasodilatory effect on pulmonary arteries. Besides vasodilatory effect, prostacyclin analogues inhibit platelets, but their antiplatelet effect is not thoroughly established. The antiplatelet effect of prostacyclin analogues may be beneficial in case of increased risk of thromboembolic events, or undesirable in case of increased risk of bleeding. Since prostacyclin and analogues differ regarding their potency and form of administration, they might also inhibit platelets to a different extent. This review summarizes the recent evidence on the antiplatelet effects of prostacyclin and analogue in the treatment of PAH, this is important to consider when choosing the optimal treatment regimen in tailoring to an individual patients’ needs. (Cardiol J 20XX; XX, X: xx–xx) Key words: prostacyclin analogues, pulmonary arterial hypertension, platelets, antiplatelet effect, thrombosis, bleeding Introduction tiproliferative effects [4]. The main indication for PGI2 and analogues is advanced pulmonary arterial Since 1935 when prostaglandin was isolated hypertension (PAH) and peripheral vascular disor- for the first time [1], many scientists have focused ders [5].
    [Show full text]
  • Digital Ischemic Events Related to Gemcitabine: Report of Two Cases and a Systematic Review
    257 case report Digital ischemic events related to gemcitabine: Report of two cases and a systematic review Cvetka Grasic Kuhar, Tanja Mesti, Branko Zakotnik Department of Medical Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia Received 1 February 2010 Accepted 1 March 2010 Correspondence to: Cvetka Grasič Kuhar, MD. PhD, Department of Medical Oncology, Institute of Oncology Ljubljana, Zaloška c. 2, SI-1000 Ljubljana, Slovenia; Phone: +386 1 5879282; Fax: +386 1 5879305; E-mail: [email protected] Disclosure: No potential conflicts of interest were disclosed. Background. Gemcitabine is a potent cytotoxic agent used in the treatment of many solid tumours, sarcomas and lymphomas. Vascular toxicity and thrombotic events related to gemcitabine seem to be underreported. Case report. We report two cases of gemcitabine related digital ischemic events. Case 1. A 65-year-old man was given the first-line treatment with gemcitabine for the advanced adenocarcinoma of pancreas. After four weekly doses of gemcitabine (total dose 4000 mg/m2) he presented with Raynaud’s like phenom- enon and ischemic fingertips necrosis in five digits of both hands. Symptoms resolved in all but one digit after stopping chemotherapy and treatment with iloprost trometamol infusion. Case 2. A 77-year-old man, ex-smoker, was administered a combination of gemcitabine and cisplatin as the first-line treatment for the locally advanced bladder cancer. After 4 cycles of the treatment (total dose of gemcitabine 4000 mg/m2) the patient suffered digital ischemia and necrosis on two digits of a right leg. Arteriography revealed preex- isting peripheral arterial occlusive disease (PAOD) of both legs with very good peripheral collateral circulation and absent microcirculation of affected two digits.
    [Show full text]
  • Prostacyclin Therapies for the Treatment of Pulmonary Arterial Hypertension
    Eur Respir J 2008; 31: 891–901 DOI: 10.1183/09031936.00097107 CopyrightßERS Journals Ltd 2008 SERIES ‘‘PULMONARY HYPERTENSION: BASIC CONCEPTS FOR PRACTICAL MANAGEMENT’’ Edited by M.M. Hoeper and A.T. Dinh-Xuan Number 2 in this Series Prostacyclin therapies for the treatment of pulmonary arterial hypertension M. Gomberg-Maitland* and H. Olschewski# ABSTRACT: Prostacyclin and its analogues (prostanoids) are potent vasodilators and possess AFFILIATIONS antithrombotic, antiproliferative and anti-inflammatory properties. Pulmonary hypertension (PH) *Dept of Cardiology, University of Chicago Hospitals, Chicago, IL, USA. is associated with vasoconstriction, thrombosis and proliferation, and the lack of endogenous #Dept of Pulmonology, Medical prostacyclin may considerably contribute to this condition. This supports a strong rationale for University Graz, Graz, Austria. prostanoid use as therapy for this disease. The first experiences of prostanoid therapy in PH patients were published in 1980. CORRESPONDENCE H. Olschewski Epoprostenol, a synthetic analogue of prostacyclin, and the chemically stable analogues Dept of Pulmonology iloprost, beraprost and treprostinil were tested in randomised controlled trials. The biological Medical University Graz actions are mainly mediated by activation of specific receptors of the target cells; however, new Auenbruggerplatz 20 data suggest effects on additional intracellular pathways. In the USA and some European Graz 8010 Austria countries, intravenous infusion of epoprostenol and treprostinil, as well as subcutaneous infusion Fax: 43 3163853578 of treprostinil and inhalation of iloprost, have been approved for therapy of pulmonary arterial E-mail: horst.olschewski@ hypertension. Iloprost infusion and beraprost tablets have been approved in few other countries. meduni-graz.at Ongoing clinical studies investigate oral treprostinil, inhaled treprostinil and the combination of Received: inhaled iloprost and sildenafil in pulmonary arterial hypertension.
    [Show full text]
  • Study Protocol
    Protocol 3-001 Confidential 28APRIL2017 Version 4.1 Asahi Kasei Pharma America Corporation Synopsis Title of Study: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects with Severe Sepsis and Coagulopathy Name of Sponsor/Company: Asahi Kasei Pharma America Corporation Name of Investigational Product: ART-123 Name of Active Ingredient: thrombomodulin alpha Objectives Primary: x To evaluate whether ART-123, when administered to subjects with bacterial infection complicated by at least one organ dysfunction and coagulopathy, can reduce mortality. x To evaluate the safety of ART-123 in this population. Secondary: x Assessment of the efficacy of ART-123 in resolution of organ dysfunction in this population. x Assessment of anti-drug antibody development in subjects with coagulopathy due to bacterial infection treated with ART-123. Study Center(s): Phase of Development: Global study, up to 350 study centers Phase 3 Study Period: Estimated time of first subject enrollment: 3Q 2012 Estimated time of last subject enrollment: 3Q 2018 Number of Subjects (planned): Approximately 800 randomized subjects. Page 2 of 116 Protocol 3-001 Confidential 28APRIL2017 Version 4.1 Asahi Kasei Pharma America Corporation Diagnosis and Main Criteria for Inclusion of Study Subjects: This study targets critically ill subjects with severe sepsis requiring the level of care that is normally associated with treatment in an intensive care unit (ICU) setting. The inclusion criteria for organ dysfunction and coagulopathy must be met within a 24 hour period. 1. Subjects must be receiving treatment in an ICU or in an acute care setting (e.g., Emergency Room, Recovery Room).
    [Show full text]
  • Nippon Shinyaku (4516)
    01 September 2016 Asia Pacific/Japan Equity Research Specialty Pharmaceuticals (Pharmaceuticals (Japan)) / MARKET WEIGHT Nippon Shinyaku (4516 / 4516 JP) Rating OUTPERFORM* Price (31 Aug 16, ¥) 4,795 INITIATION Target price (¥) 6,300¹ Chg to TP (%) 31.4 Early entry into niche indications paying off Market cap. (¥ bn) 323.65 (US$ 3.13) Enterprise value (¥ bn) 302.35 ■ Initiating coverage at OUTPERFORM with target price of ¥6,300 Number of shares (mn) 67.50 Free float (%) 55.0 (potential return 31%): We expect Nippon Shinyaku to be the next 52-week price range 5,960 - 3,760 Japanese pharmaceutical company to benefit from the global launch of *Stock ratings are relative to the coverage universe in each Uptravi (selexipag), an internally-discovered drug of blockbuster calibre; and analyst's or each team's respective sector. a strong partnership. The company shifted focus to niche indications almost ¹Target price is for 12 months. a decade ago, and this strategy is on its way to paying off, in our view. Research Analysts ■ Uptravi (selexipag) the biggest driver: Selexipag was originally Yen Ting Chen, PhD 81 3 4550 9936 discovered by Nippon Shinyaku and ex-Japan rights licensed to Actelion. In [email protected] January 2016, selexipag was launched in the US market for pulmonary Fumiyoshi Sakai arterial hypertension (PAH) followed by Germany in June. We forecast peak 81 3 4550 9737 sales of $1.65bn globally, with ¥17.5bn in Japan for the PAH market. With [email protected] additional revenue from royalties and manufacturing, we expect total revenue from selexipag to reach ¥39bn for Nippon Shinyaku in FY3/21.
    [Show full text]
  • Binding and Activity of the Prostacyclin Receptor (IP) Agonists, Treprostinil
    Biochemical Pharmacology 84 (2012) 68–75 Contents lists available at SciVerse ScienceDirect Biochemical Pharmacology jo urnal homepage: www.elsevier.com/locate/biochempharm Binding and activity of the prostacyclin receptor (IP) agonists, treprostinil and iloprost, at human prostanoid receptors: Treprostinil is a potent DP1 and EP2 agonist a b b c, Brendan J. Whittle , Adam M. Silverstein , David M. Mottola , Lucie H. Clapp * a William Harvey Research Institute, Barts and the London School of Medicine, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK b United Therapeutics Corporation, 55 T.W. Alexander Drive, Research Triangle Park, NC 27709, USA c Centre for Clinical Pharmacology, Division of Medicine, University College London, Rayne Building, London WC1E 6JF, UK A R T I C L E I N F O A B S T R A C T Article history: The prostacyclin analogues, iloprost and treprostinil are extensively used in treating pulmonary Received 24 January 2012 hypertension. Their binding profile and corresponding biochemical cellular responses on human prostanoid Accepted 19 March 2012 receptors expressed in cell lines, have now been compared. Iloprost had high binding affinity for EP1 and IP Available online 27 March 2012 receptors (Ki 1.1 and 3.9 nM, respectively), low affinity for FP, EP3 or EP4 receptors, and very low affinity for EP2, DP1 or TP receptors. By contrast, treprostinil had high affinity for the DP1, EP2 and IP receptors (Ki 4.4, 3.6 Keywords: and 32 nM, respectively), low affinity for EP1 and EP4 receptors and even lower affinity for EP3, FP and TP Prostacyclin analogues receptors.
    [Show full text]