INTERFERON ALFA-2B(Merck Sharp & Dohme )

Seventy-five percent of BESREMi patients experienced reduction in severe PV symptoms Medical chart review supports importance of symptomatic burden in real-world treatment of PV and clinical utility of cytoreductive therapies compared to phlebotomy alone BURLINGTON, Mass.--(BUSINESS WIRE)-- PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, announced today results from a real-world data review published in the Journal of Clinical Oncology supplement (abstract # e18530) for the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. The retrospective medical chart review demonstrates the potential for cytoreductive therapies (CTs) to impact the burden of illness of polycythemia vera (PV) in patients, with ropeginterferon alfa-2B (marketed as BESREMi®) showing the greatest percentage reduction (when compared to other CTs) in patients seen with severe PV symptoms. This review included patients receiving phlebotomy alone (n=103) and each of the following cytoreductive therapies with or without concomitant phlebotomy: hydroxyurea (n=165), ruxolitinib (n=115), peginterferon alfa-2a (n=44) and ropeginterferon alfa-2b (n=45). From their initial presentation to their most recent visit, healthcare providers observed a reduction in the number of patients with severe symptoms across all CTs, with the greatest reduction in severe symptoms seen in ropeginterferon alfa-2b patients, with a reduction from 12 to 3 patients reporting severe symptoms (75%). They observed a reduction for hydroxyurea from 7 to 4 patients (43%); in ruxolitinib from11 to 6 patients (45%), and in peginterferon alfa-2a from12 to 8 patients (33%). Among patients treated with phlebotomy alone, the top reasons physicians indicated they would initiate cytoreductive therapy would be worsening of symptoms (32%), increased frequency of phlebotomy (29%) or difficulty to control hematocrit (24%). “PV is a chronic and life-threatening myeloproliferative neoplasm associated with significant clinical, economic and patient burden,” said Adan Sosa, Pharm.D., Director of Health Economics and Outcomes Research at PharmaEssentia. “When phlebotomy fails, the top reason healthcare providers indicated they would initiate cytoreductive therapy for PV patients is worsening of symptoms – an insight that supports the importance of symptomatic burden in PV treatment, beyond hematologic response. As healthcare providers work towards best practice PV care, this review supports the importance of BESREMi as a therapeutic option that demonstrates clinical efficacy and may impact the symptomatic burden of illness for patients.” In 2023, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) were updated to include BESREMi as the only preferred therapeutic option for the treatment of adults with both high- and low-risk polycythemia vera, regardless of treatment history. In this review, 63% of patients were identified as high risk (>60 y/o with history of thrombosis). “Polycythemia vera is a chronic blood disorder which is now recognized as a type of cancer. Physicians have focused on the patient’s blood counts and molecular results to make treatment decisions, and these real-world data reinforce that, for patients, symptoms matter,” said Robert B. Geller, M.D., Head of Medical at PharmaEssentia USA. “We hope these results provide additional evidence regarding the meaningful clinical value of BESREMi for patients with this myeloproliferative neoplasm, as well as encourage treating physicians to consider early and optimal cytoreductive interventions for appropriate PV patients.” More About this Review This medical chart review took place from October to December 2023 and included a total of 420 unique charts of U.S. adult patients with a confirmed diagnosis of PV in the prior 12 months, from 125 healthcare providers representing academic, community and private practice settings. Data were collected at three points in time, initial presentation of PV, diagnosis and at the most recent HCP visit; additionally, healthcare professional rationale on treatment decision-making was captured. About Polycythemia Vera (PV) Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.1 About BESREMi® (ropeginterferon alfa-2b-njft) BESREMi is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has orphan drug designation for the treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and has recently received approval in Taiwan and South Korea. The drug candidate was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information, including Boxed Warning. Indication BESREMi is indicated for the treatment of adults with polycythemia vera. Important Safety Information WARNING: RISK OF SERIOUS DISORDERS Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy. CONTRAINDICATIONS Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment History or presence of active serious or untreated autoimmune disease Immunosuppressed transplant recipients WARNINGS AND PRECAUTIONS Depression and Suicide: Life-threatening or fatal neuropsychiatric reactions have occurred in patients receiving interferon alfa-2b products, including BESREMi. These reactions may occur in patients with and without previous psychiatric illness. Other central nervous system effects, including suicidal ideation, attempted suicide, aggression, bipolar disorder, mania and confusion have been observed with other interferon alfa products. Closely monitor patients for any symptoms of psychiatric disorders and consider psychiatric consultation and treatment if such symptoms emerge. If psychiatric symptoms worsen, it is recommended to discontinue BESREMi therapy. Endocrine Toxicity: These toxicities may include worsening hypothyroidism and hyperthyroidism. Do not use BESREMi in patients with active serious or untreated endocrine disorders associated with autoimmune disease. Evaluate thyroid function in patients who develop symptoms suggestive of thyroid disease during BESREMi therapy. Discontinue BESREMi in patients who develop endocrine disorders that cannot be adequately managed during treatment with BESREMi. Cardiovascular Toxicity: Toxicities may include cardiomyopathy, myocardial infarction, atrial fibrillation and coronary artery ischemia. Patients with a history of cardiovascular disorders should be closely monitored for cardiovascular toxicity during BESREMi therapy. Avoid use of BESREMi in patients with severe or unstable cardiovascular disease, (e.g., uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction. Decreased Peripheral Blood Counts: These toxicities may include thrombocytopenia (increasing the risk of bleeding), anemia, and leukopenia (increasing the risk of infection). Monitor complete blood counts at baseline, during titration and every 3-6 months during the maintenance phase. Monitor patients for signs and symptoms of infection or bleeding. Hypersensitivity Reactions: Toxicities may include serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis). If such reactions occur, discontinue BESREMi and institute appropriate medical therapy immediately. Transient rashes may not necessitate interruption of treatment. Pancreatitis: Pancreatitis has occurred in 2.2% of patients receiving BESREMi. Symptoms may include nausea, vomiting, upper abdominal pain, bloating, and fever. Patients may experience elevated lipase, amylase, white blood cell count, or altered renal/hepatic function. Interrupt BESREMi treatment in patients with possible pancreatitis and evaluate promptly. Consider discontinuation of BESREMi in patients with confirmed pancreatitis. Colitis: Fatal and serious ulcerative or hemorrhagic/ischemic colitis have occurred in patients receiving interferon alfa products, some cases starting as early as 12 weeks after start of treatment. Symptoms may include abdominal pain, bloody diarrhea, and fever. Discontinue BESREMi in patients who develop these signs or symptoms. Colitis may resolve within 1 to 3 weeks of stopping treatment. Pulmonary Toxicity: Pulmonary toxicity may manifest as dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis. Some events have resulted in respiratory failure or death. Discontinue BESREMi in patients who develop pulmonary infiltrates or pulmonary function impairment. Ophthalmologic Toxicity: These toxicities may include severe eye disorders such as retinopathy, retinal hemorrhage, retinal exudates, retinal detachment and retinal artery or vein occlusion which may result in blindness. During BESREMi therapy, 23% of patients were identified with an eye disorder. Eyes disorders ≥5% included cataract (6%) and dry eye (5%). Advise patients to have eye examinations before and during BESREMi therapy, specifically in those patients with a retinopathy-associated disease such as diabetes mellitus or hypertension. Evaluate eye symptoms promptly. Discontinue BESREMi in patients who develop new or worsening eye disorders. Hyperlipidemia: Elevated triglycerides may result in pancreatitis. Monitor serum triglycerides before BESREMi treatment and intermittently during therapy and manage when elevated. Consider discontinuation of BESREMi in patients with persistently, markedly elevated triglycerides. Hepatotoxicity: These toxicities may include increases in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) and bilirubin. Liver enzyme elevations have also been reported in patients after long-term BESREMi therapy. Monitor liver enzymes and hepatic function at baseline and during BESREMi treatment. Discontinue BESREMi in patients who develop evidence of hepatic decompensation (characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome or variceal hemorrhage) during treatment. Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Avoid use of BESREMi in patients with eGFR <30 mL/min. Discontinue BESREMi if severe renal impairment develops during treatment. Dental and Periodontal Toxicity: These toxicities may include dental and periodontal disorders, which may lead to loss of teeth. In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with BESREMi. Patients should have good oral hygiene and regular dental examinations. Dermatologic Toxicity: These toxicities have included skin rash, pruritus, alopecia, erythema, psoriasis, xeroderma, dermatitis acneiform, hyperkeratosis, and hyperhidrosis. Consider discontinuation of BESREMi if clinically significant dermatologic toxicity occurs. Driving and Operating Machinery: BESREMi may impact the ability to drive and use machinery. Patients should not drive or use heavy machinery until they know how BESREMi affects their abilities. Patients who experience dizziness, somnolence or hallucination during BESREMi therapy should avoid driving or using machinery. Embryo-Fetal Toxicity: Based on the mechanism of action, BESREMi can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended in females of reproductive potential prior to treatment with BESREMi. Advise females of reproductive potential to use an effective method of contraception during treatment with BESREMi and for at least 8 weeks after the final dose. ADVERSE REACTIONS The most common adverse reactions reported in > 40% of patients in the PEGINVERA study (n=51) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. In the pooled safety population (n=178), the most common adverse reactions greater than 10%, were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%). DRUG INTERACTIONS Patients on BESREMi who are receiving concomitant drugs which are CYP450 substrates with a narrow therapeutic index should be monitored to inform the need for dosage modification for these concomitant drugs. Avoid use with myelosuppressive agents and monitor patients receiving the combination for effects of excessive myelosuppression. Avoid use with narcotics, hypnotics or sedatives and monitor patients receiving the combination for effects of excessive CNS toxicity. USE IN SPECIFIC POPULATIONS Pregnancy: Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy. Advise pregnant women of the potential risk to a fetus. Lactation: There are no data on the presence of BESREMi in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children from BESREMi, advise women not to breastfeed during treatment and for 8 weeks after the final dose. Females of Reproductive Potential: BESREMi may cause embryo-fetal harm when administered to a pregnant woman. Pregnancy testing prior to BESREMi treatment is recommended for females of reproductive potential. Advise female patients of reproductive potential to use effective contraception during treatment with BESREMi and for at least 8 weeks after the final dose. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. About PharmaEssentia PharmaEssentia (TPEx: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website, LinkedIn or Twitter. Forward Looking Statement This press release may contain forward looking statements, including statements regarding the clinical benefits to be derived from ropeginterferon alfa-2b, the commercial opportunity and competitive positioning, new indications or labeling for ropeginterferon alfa-2b, and business prospects for ropeginterferon alfa-2b. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and similar legislation and regulations under Taiwanese law. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward looking statements as a result of various factors. These factors include whether BESREMi is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for BESREMi, and the ability to receive FDA and other regulatory approvals for additional indications for BESREMi. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. © 2024 PharmaEssentia Corporation. All rights reserved. PharmaEssentia, the PharmaEssentia logo, and BESREMi are trademarks or registered trademarks of PharmaEssentia Corporation. 1 Cerquozzi S, Tefferi A. Blast transformation and fibrotic progression in polycythemia vera and essential thrombocythemia: a literature review of incidence and risk factors. Blood Cancer J. 2015;5, e366; DOI:10.1038/bcj.2015.95

Final analysis shows ADSTILADRIN was well-tolerated with no new study drug-related adverse events — <4% of patients experienced Grade 3 AEs, there were no Grade 4 or 5 AEs — and no new safety signals reported In the overall study population at Month 60, the Kaplan-Meier (KM) estimated overall survival rate was 79.7% (95% CI 71.0-86.0), and the cystectomy-free survival rate was 48.8% (95% CI 40.0-57.1) Clinical muscle-invasive disease progression was rare over the 60-month treatment and follow-up period The Journal of Urology® publishes five-year analysis of the Phase 3 data, the longest-term follow-up efficacy and safety data ever reported for a novel agent for BCG-unresponsive NMIBC PARSIPPANY, N.J.--(BUSINESS WIRE)-- Ferring Pharmaceuticals today announced the final 60-month follow-up data from the Phase 3 study of ADSTILADRIN® (nadofaragene firadenovec-vncg) were presented at the American Urological Association (AUA) 2024 Annual Meeting. The study demonstrated an 80% overall survival rate and 49% cystectomy-free survival rate at Month 60 in adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1), and in patients with high-grade Ta/T1 without CIS. These data, which are the longest follow-up of efficacy and safety data reported for a novel agent for BCG-unresponsive NMIBC, were simultaneously published ahead of print and will be included in the July issue of The Journal of Urology®. ADSTILADRIN is the first and only intravesical non-replicating adenoviral vector-based gene therapy approved by the U.S. Food and Drug Administration (FDA) in patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors. The mechanism of action of ADSTILADRIN is designed to deliver the human interferon-alfa 2b gene (IFNα2b) directly into the bladder to enable secretion of interferon alfa-2b protein with a single treatment every three months. “ADSTILADRIN represents a novel treatment option for BCG-unresponsive NMIBC with a convenient quarterly dosing pattern for patients,” said Vikram M. Narayan, Assistant Professor at Emory University Department of Urology, Director of Urologic Oncology at Grady Memorial Hospital, who presented the five-year results at AUA. “Oftentimes, disease recurrence and progression can lead to bladder removal surgery, so it is important that ADSTILADRIN allowed bladder preservation in nearly half of the patients in the CIS cohort and two-thirds of those in the Ta/T1 cohort after five years.” About the Phase 3 ADSTILADRIN Data and Final Five-Year Analysis in BCG-Unresponsive NMIBC These new data are part of the final five-year follow-up analysis from the Phase 3 study which included two cohorts: patients with CIS ± Ta/T1 (CIS cohort) and patients with high-grade Ta/T1 without CIS (papillary disease [PD cohort]). Patients with NMIBC who fully met the criteria of being BCG-unresponsive, as defined by the 2018 FDA Guidance for Industry, were enrolled in the study. Patients with NMIBC CIS±Ta/T1 and high-grade Ta/T1 papillary disease (without CIS) received ADSTILADRIN 75 mL intravesical instillation (3x1011 viral particles) once every three months for up to 12 months (quarterly dosing), or until unacceptable toxicity or recurrent high-grade (HG) NMIBC. Retreatment in patients who did not achieve a complete response at three months after a single dose was not allowed, per the protocol. Three clinical trials in the existing multi-year ADSTILADRIN studies program that were previously announced include retreatment. At 12 months after initial treatment, patients had a biopsy of five sites (dome, trigone, right and left lateral wall, and posterior wall) in the bladder. Patients with no evidence of high-grade recurrence continued receiving ADSTILADRIN once every three months at the discretion of their treating physician, entering an additional four-year treatment and monitoring phase. Data Show ADSTILADRIN is a Well-Tolerated and Novel Treatment Option for BCG-unresponsive NMIBC Median follow-up was 50.8 months (IQR 39.1-60.0), with 26.8% receiving five instillations and 7.6% receiving treatment for 57 months. Among patients who were high-grade recurrence free (HGRF) at Month 3, 13 patients were followed and remained HGRF at month 57. The Kaplan-Meier (KM)-estimated probability of remaining HGRF for at least 57 months was 13.2% and 32.7% in the CIS and PD cohorts, respectively. The overall survival at 60 months was 76.3% in the CIS cohort and 85.9% in the PD cohort. The cystectomy-free survival rate at Month 60 was 43.2.% and 58.7% in the CIS and PD cohorts, respectively. Clinical progression to muscle invasion was rare in the trial population and seen in only 3.3% of all patients (four with CIS and one with Ta/T1) over the five-year follow-up period. Most treatment emergent adverse events (TEAEs) experienced by patients were transient Grade 1 or 2 (66% of all patients studied), and <4% of patients experienced Grade 3 TEAEs with the most common being discharge around the catheter during instillation, fatigue, bladder spasm, urgency to urinate, chills, dysuria, pyrexia, and urinary incontinence. There were no Grade 4 or 5 TEAEs, no treatment-related deaths, and no new safety signals reported with long-term follow-up. “These positive five-year follow-up data from our Phase 3 trial continue to demonstrate the efficacy and safety of ADSTILADRIN for NMIBC patients who no longer respond to BCG therapy,” said Pierre-Yves Berclaz, M.D., Ph.D., Executive Vice President and Chief Science and Medical Officer, Ferring Pharmaceuticals. “This first-of-its-kind study adds to the body of evidence from our 24-month and 36-month data results and makes ADSTILADRIN the only novel agent with five-year data. With ADSTILADRIN, Ferring has pioneered gene therapy for NMIBC, representing a critical advancement that offers patients renewed hope for more time without disease progression and radical treatment. We look forward to enlarging the body of evidence for ADSTILADRIN with our expanded clinical trial program, which we announced earlier this year.” If you are a healthcare provider interested in the ADSTILADRIN clinical trial program, please visit . About ADSTILADRIN ADSTILADRIN® (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally-occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer. ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).1 About Non-Muscle Invasive Bladder Cancer (NMIBC) NMIBC is a form of bladder cancer that is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.2 In the United States, bladder cancer is the seventh most common cancer, fourth among men,3-4 and it is estimated that there will be approximately 83,190 new cases of bladder cancer in the U.S. in 2024.5 Historically, 75% of bladder cancer presents as NMIBC.6 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.5 Current treatment options for BCG-unresponsive patients are very limited, and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).7 INDICATION ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product. WARNINGS AND PRECAUTIONS: Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy. Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals. DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use, or oral administration. USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose. ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination). You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING. Please click to see the full Prescribing Information. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit , call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X (Twitter). References: ADSTILADRIN in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. . Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol 2021; 22: 107–17. Bladder Cancer Advocacy Network. Bladder Cancer Advocacy Network Responds to American Cancer Society’s 2024 Projections. Bladder Cancer Advocacy Network Responds to American Cancer Society's 2024 Projections – Bladder Cancer Advocacy Network (bcan.org), page last accessed: March 2024. American Cancer Society. Cancer Facts & Figures 2024 Report. Cancer Facts & Figures 2024, page last accessed: March 2024 American Cancer Society. Cancer Facts & Figures 2024. Atlanta: American Cancer Society; 2024. . Accessed April, 2024. Babjuk M, Burger M, Capoun O, European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94. National Comprehensive Cancer Network. Bladder Cancer (Version 1.2024). . Accessed March 7, 2024. More information is available at the following: Healthcare Providers: If you are interested in ordering ADSTILADRIN, please sign up for information and updates at . Patients and Consumers: For more information about ADSTILADRIN, please call 1-888-FERRING (888-337-7464), and select option number one.