Pulmonary Edema

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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AU-007 demonstrates continued distinction in IL-2 class, with unique pro Treg reduction and correlated longer PFS outcomes, coupled with increases in tumor-killing Teffs Phase 2 clinical efficacy and safety data to be presented before end of year LARKSPUR, Calif.--(BUSINESS WIRE)--Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, today shared data and analyses used to determine dose selection for Phase 2 expansion cohorts in a Phase 1/2 clinical trial of its lead candidate, AU-007. The data and evaluations of pharmacodynamics, pharmacokinetics, safety and clinical efficacy were presented as a poster at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. The results continue to affirm AU-007’s unique pro interleukin-2 (IL-2) therapeutics, showing regulatory T cell (Treg) reduction, and demonstrating that deeper drops in peripheral Treg counts were associated with longer progression-free survival (PFS) outcomes in patients from the Phase 1 and Phase 2 portions of the AU-007 trial, across a range of dose levels, tumor types and lines of therapy. Additionally, increases in interferon-gamma and effector T cells (Teffs) were observed with escalating subcutaneously administered aldesleukin (recombinant human IL-2) dose levels. “These data point to a correlation between deeper reductions in Tregs and better clinical outcomes, which differentiates AU-007 from all other IL-2 therapeutics in development,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer . “We’re also excited about AU-007’s ability to increase Teffs and natural killer cells. These findings, combined with a mild and tolerable safety profile, further validate our belief in AU-007’s potential as a best-in-class IL-2 therapeutic for solid tumor cancers. We look forward to presenting new Phase 2 clinical efficacy and safety data, particularly in melanoma and renal cell carcinoma, later this year.” Created by Biolojic Design, AU-007 is the first human IgG1 monoclonal antibody designed by leveraging artificial intelligence to enter a human clinical trial. The antibody’s novel mechanism of action is to bind precisely to IL-2 instead of IL-2 receptors. By binding only to the portion of IL-2 that binds to CD25, AU-007 prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature and eosinophils, and redirects IL-2 to medium-affinity receptors on Teffs and natural killer (NK) cells. This allows Teffs and NK cells to expand and kill tumor cells. Safety data presented at the EORTC-NCI-AACR Symposium demonstrate manageable toxicity for AU-007 and low-dose, subcutaneous aldesleukin, with no vascular leak syndrome or pulmonary edema at all dose levels evaluated. Additionally, the AU-007 pharmacokinetic data show characteristics typical of an IgG1-LALA monoclonal antibody, with no evidence of neutralizing anti-drug antibody (ADA) activity and an approximate half-life of more than 15 days. No clear trends were observed in safety or efficacy data to determine if a single loading dose or multiple loading doses of aldesleukin would lead to better outcomes, and clinical investigation is ongoing in the Phase 2 dose expansion cohorts to determine the optimal dosing schedule. Based on these results, researchers will evaluate dosing regimens of 9 mg/kg for AU-007 every two weeks (Q2W) and 135K IU/kg subcutaneous aldesleukin administered either on a single loading dose schedule or a Q2W multiple dose schedule in the Phase 2 expansion cohorts. The Phase 2 expansion portion of the trial is currently ongoing in renal cell carcinoma (RCC), melanoma and non-small cell lung cancer (NSCLC) evaluating these two dosing regimens. The poster, “PB452: Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T effector cells,” (Abstract 464) is available to meeting registrants as an electronic poster on the EORTC-NCI-AACR Symposium’s online platform . It will be presented live in the poster session “New therapies in immuno oncology” on Friday, October 25, 2024, 9:00 a.m.-3:00 p.m. CEST in the Exhibition Hall. The poster presentation is also available on the Aulos Bioscience website in the Abstracts and Publications section. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ). For patients and providers in the U.S., please visit . For patients and health professionals in Australia, please visit . About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit , X ( @AulosBioscience ) and LinkedIn . Contacts Contact: info@aulosbio.com Media inquiries: Mike Beyer, Sam Brown Inc. / 312-961-2502 / mikebeyer@sambrown.com

– The INOmax EVOLVE DS is our next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device1 – – The INOmax EVOLVE DS is now available for contracting and distribution for use in U.S. hospitals – DUBLIN, Oct. 10, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the rollout of the U.S. Food and Drug Administration (FDA) cleared INOmax® EVOLVE™ DS delivery system for the delivery of INOmax® (nitric oxide) gas, for inhalation. This nationwide rollout follows the successful introduction of the INOmax EVOLVE DS Pilot program. The INOmax EVOLVE DS is our next-generation inhaled nitric oxide delivery system with a fully integrated design and includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 The INOmax EVOLVE DS is intended to help meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience.1 Please see Applications and Device Warnings below. INOmax is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.2 INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.2 Please see additional Important Safety Information for INOmax below. "We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care," said Lisa French, Executive Vice President & Chief Commercial Officer. "This innovation milestone reflects our long-standing commitment to providing delivery system options with comprehensive safety features.1 We will continue to work closely with our customers to support availability of the INOmax EVOLVE DS delivery system." A few of the many INOmax EVOLVE DS features include1: 1.4-lb mini-cylinders Automated pre-use checkout Pre-high-calibrated NO/NO2 gas sensor modules and automatic low calibration Automatic cylinder switching when empty Electronic blender with automatic activation when a minimum amount of oxygen flow has been detected Electronic medical record connectivity that transfers over 100 data parameters3 Touchscreen display with an easy-to-use interface The comprehensive INOmax EVOLVE DS Pilot program provided users the opportunity for an extensive review of our next-generation delivery system. We appreciate each hospital's feedback including one Respiratory Therapist's (RT) statement that, "After using the INOmax EVOLVE DS during the pilot introduction, and in current use, it is evident that Mallinckrodt took the input from bedside RTs into account. The smaller cylinders and streamlined design make it easier to move the device around the hospital and store supplies."1 INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.2,4 In 2023, the INOmax EVOLVE DS was awarded the Human Factors and Ergonomics Society Stanley Caplan User-Centered Product Design Award, presented to teams that have demonstrated outstanding innovation and design for products, software, and systems. Mallinckrodt accepted the award on February 15, 2024. If a customer is interested in learning more about the INOmax EVOLVE DS, they can reach out to their local representative or visit INOmax.com for the latest updates. APPLICATIONS The INOmax EVOLVE DS delivery system delivers INOmax (nitric oxide) gas, for inhalation. The EVOLVE DS must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and is indicated for use in term and near term (>34 weeks gestation) neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension. The EVOLVE DS is indicated for a maximum of 14 days of use. DEVICE WARNINGS Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert. Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. Do not use equipment that is not specified as part of the system or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the system to malfunction. If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. Use only INOmax, pharmaceutical grade NO. Rx Only For technical assistance or for information on the INOmax EVOLVE DS delivery system, call (877) 566-9466. IMPORTANT SAFETY INFORMATION (Cont'd) Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation. Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema. Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration. INOmax must be administered using a calibrated FDA-cleared Nitric Oxide delivery system. Please see Full Prescribing Information . ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to INOmax (nitric oxide) gas, the INOmax EVOLVE™ DS delivery system, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of the INOmax EVOLVE™ DS delivery system in U.S. hospitals in the future. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements, including the clinical guidelines and protocols, and hospital policies and practices; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with INOmax (nitric oxide) gas and the INOmax EVOLVE™ DS delivery system; and other risks identified and described in more detail in the "Risk Factors" section and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K , Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400582 10/24 References 1 INOmax EVOLVETM DS Operation Manual. Mallinckrodt Pharmaceuticals. 2 INOmax. Package insert. INO Therapeutics LLC; 2023. 3 EVOLVE DS. Serial Data Protocol for versions 01.04.09 and later. Technical Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023. 4 Data on File – Ref-01753. Mallinckrodt Pharmaceuticals. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED