Furosemide

BRIDGEWATER, N.J., May 30, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, will host a commercial webinar on Tuesday, June 4, 2024, at 8:00 a.m. ET to discuss the market outlook for the Company's three most advanced programs, ARIKAYCE® (amikacin liposome inhalation suspension), brensocatib, and treprostinil palmitil inhalation powder (TPIP). Shareholders and other interested parties may participate in the conference call by dialing (800) 715-9871 (U.S.) and (646) 307-1963 (international) and referencing access code 7504027. The call will also be webcast live on the Company's website at . A replay of the conference call will be accessible approximately 1 hour after its completion through July 4, 2024, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7504027. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at . About ARIKAYCE ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in Europe as ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE® inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE® liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI). IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S. Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate. Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate. Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures. Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE. Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions. Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus. Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside. Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%). Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol. Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. U.S. INDICATION LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitation of Use : ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. Please see Full Prescribing Information . About Insmed Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed's first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is also advancing an early-stage research engine encompassing a wide range of technologies and modalities, including artificial intelligence-driven protein engineering, gene therapy, and protein manufacturing. Insmed is headquartered in Bridgewater, New Jersey, with additional offices and research locations throughout the United States, Europe, and Japan. Visit to learn more. Contact: Investors: Bryan Dunn Executive Director, Investor Relations Insmed (646) 812-4030 [email protected] Eleanor Barisser Associate Director, Investor Relations Insmed (718) 594-5332 [email protected] Media: Mandy Fahey Executive Director, Corporate Communications Insmed (732) 718-3621 [email protected] SOURCE Insmed Incorporated

MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)-- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced upcoming presentations by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 8 to 11, 2024, in Toronto, Canada. POSLUMA® (formerly referred to as 18F-rhPSMA-7.3) is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Axumin® is approved and indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. “We are pleased that our collaborators will be sharing important scientific information about POSLUMA, Axumin and investigational experience with 18F-flotufolastat with the imaging community at SNMMI,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “Two presentations relate to the use of POSLUMA and 18F-flotufolastat and the effects of urinary bladder activity on imaging quality. Results from a head-to-head study to be presented by Dr. Isabel Rauscher of the Technical University of Munich examine parameters of PET imaging between 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer, and a presentation by Dr. Ismaheel Lawal will discuss interim results from a study at Emory assessing PET imaging quality with and without the diuretic furosemide in patients with biochemical recurrence of prostate cancer (BCR). Dr. Nadine Mallak of Oregon Health and Science University will present interim results from an ongoing study of the use of Axumin in PSMA/PET-negative BCR patients, and Dr. Rauscher will also describe clinical experience with 18F-rhPSMA-7 and 18F-flotufolastat PET in salvage therapy planning for BCR.” Details of selected oral and poster presentations by Blue Earth Diagnostics collaborators are listed below. Presentations noted by “*” discuss results of experiences with an investigational agent for which the safety and efficacy have not been established by the FDA. POSLUMA (flotufolastat F 18), investigational 18F-flotufolastat and 18F-rhPSMA-7 DATE: Sunday, June 9, 2024 Title: Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial Presenter: Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga. Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241368 DATE: Sunday, June 9, 2024 Title: *Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat and 68Ga-PSMA-11-PET Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241424 DATE: Saturday, June 8, 2024 Title: *18F-rhPSMA-7 and 18F-flotufolastat PET-guided salvage radiotherapy in recurrent prostate cancer Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: Prostate Cancer: Focus on Imaging Session Type: Oral presentation Session Time: 3:30 – 4:45 PM ET Presentation: 3:35 – 3:45 PM ET Abstract ID.: 241112 Axumin (fluciclovine F 18) DATE: Sunday, June 9, 2024 Title: Role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT: interim results from a prospective trial Presenter: Nadine Mallak, MD, Associate Professor, Department of Diagnostic Radiology | Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Oregon Health and Science University, Portland, Ore. Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241835 Blue Earth Diagnostics invites participants at the 2024 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1639. The Company is hosting a Satellite Symposium, “Let’s Talk about POSLUMA®,” which will discuss the most recent innovations in PSMA-PET imaging for prostate cancer. It will feature invited speakers Sean Collins, MD, PhD, Professor, Georgetown University Hospital, and Elizabeth Hawk, MD, PhD, DABNM DABR, University of California San Diego, and be moderated by Todd Cohen, MD, VP of Medical Affairs, Blue Earth Diagnostics, Inc. The symposium will be held on Sunday, June 9, 2024, from 11:15 AM – 12:15 PM ET in the Toronto Convention Center, Room 701A, South Building – 700 Level. Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about the Company’s clinical research. For full session details and scientific presentation lists, please see the SNMMI online program here. Indication and Important Safety Information About Axumin INDICATION Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or . Full Axumin prescribing information is available at . Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . Axumin and POSLUMA are registered trademarks of Blue Earth Diagnostics Ltd. PP-rh-US-0492 This press release is for U.S. audiences only