Isoniazid/Rifampin

The application is based on phase III results from the DINAMO trial showing Jardiance® (empagliflozin) tablets significantly reduced A1c (a marker of average blood sugar) versus placebo in participants aged 10-17 living with type 2 diabetes If approved, Jardiance would be the first SGLT2 inhibitor indicated for this vulnerable population RIDGEFIELD, Conn. and INDIANAPOLIS, March 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. "There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged 10-19 over the past two decades," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to working closely with the FDA during the review process and while we await a decision on our efforts to bring another potential treatment option to children 10 years and older with type 2 diabetes." The sNDA is based on the results from the DINAMO phase III trial, in which Jardiance was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c at 26 weeks compared with placebo in participants aged 10-17 years with type 2 diabetes. When added to other baseline treatments (diet, exercise, metformin and/or insulin), Jardiance 10 mg and 25 mg pooled doses reduced A1c by 0.84% compared with placebo at week 26 (95% CI −1.50 to −0.19; P=0.012). Reduction in A1c in participants treated with Tradjenta® (linagliptin) was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed. Results were presented during the International Diabetes Federation World Diabetes Congress 2022. Overall, the safety data in DINAMO was consistent with the previously known safety pro Jardiance. Initially approved in 2014, Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes; and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. Jardiance is not for patients with type 1 diabetes, or to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73 m2. Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, and in patients on dialysis. Please see additional Important Safety Information below. "Impacting an estimated 39,000 people under the age of 20, type 2 diabetes is a growing health issue for young people in the U.S.," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "If approved, Jardiance would be a new oral treatment option for type 2 diabetes in children 10 years and older in the U.S., making this application acceptance an important step forward as we add to the body of knowledge for this vulnerable patient population, for whom oral treatment options have been limited." About DINAMO: DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents DINAMO (NCT03429543) is a multicenter, randomized, double-blind, parallel group phase III trial that enrolled participants aged 10-17 years with type 2 diabetes (A1c 6.5% to 10.5%) previously treated with metformin or insulin. The primary endpoint was change from baseline in A1c at 26 weeks. Of the 262 participants screened, 158 were randomly assigned to treatment with Jardiance (10 mg) (n=52), Tradjenta (5 mg) (n=53) or placebo (n=53) once daily. Participants in the Jardiance group who did not have A1c below 7.0% by week 12 were re-randomized to either remain on 10 mg or increase to 25 mg. Participants in the placebo group were reassigned at week 26 to Tradjenta 5 mg or Jardiance 10 mg or 25 mg. All participants were treated with diet and exercise plus metformin and/or insulin (or no background if metformin intolerant). Safety was assessed until week 52. What is JARDIANCE? JARDIANCE is a prescription medicine used to: reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease lower blood sugar along with diet and exercise in adults with type 2 diabetes JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine). JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work. IMPORTANT SAFETY INFORMATION Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE. Do not take JARDIANCE if you are on dialysis. JARDIANCE can cause serious side effects, including: Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms, and if possible, check for ketones in your urine: nausea vomiting stomach-area (abdominal) pain tiredness trouble breathing Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE. You may be at a higher risk of dehydration if you: take medicines to lower your blood pressure, including water pills (diuretics) are on a low salt diet have kidney problems are 65 years of age or older Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long. Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting. Low blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include: headache drowsiness weakness dizziness confusion irritability hunger fast heartbeat sweating shaking or feeling jittery Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema). Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching. Yeast infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis. Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away. Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include: swelling of your face, lips, throat, and other areas of your skin difficulty with swallowing or breathing raised, red areas on your skin (hives) If you have any of these symptoms, stop taking JARDIANCE and contact your healthcare provider or go to the nearest emergency room right away. The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females. These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist. Before taking JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you: have kidney problems have liver problems have a history of infection of the vagina or penis have a history of urinary tract infections or problems with urination are going to have surgery. Your healthcare provider may stop JARDIANCE before you have surgery. Talk to your healthcare provider about when to stop taking JARDIANCE if you are having surgery and when to start it again are eating less or there is a change in your diet have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking) have type 1 diabetes. JARDIANCE should not be used to treat people with type 1 diabetes are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with JARDIANCE are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. For more information, please see Prescribing Information and Medication Guide. CL-JAR-100131 10.17.2022 What is TRADJENTA? TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. TRADJENTA is not for people with type 1 diabetes. If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TRADJENTA? TRADJENTA can cause serious side effects, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels. Stop taking TRADJENTA and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Who should not take TRADJENTA? Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA. Symptoms of a serious allergic reaction to TRADJENTA may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue, and throat that may cause difficulty breathing or swallowing. If you have any of these symptoms, stop taking TRADJENTA and call your healthcare provider right away or go to the nearest hospital emergency room. What should I tell my healthcare provider before taking TRADJENTA? Tell your healthcare provider about all your medical conditions, including if you have or have had inflammation of your pancreas (pancreatitis). Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works. Especially tell your healthcare provider if you take: insulin or other medicines that can lower your blood sugar rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis. Tell your healthcare provider if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed. What are the possible side effects of TRADJENTA? TRADJENTA may cause serious side effects, including Inflammation of the pancreas (pancreatitis). If you take TRADJENTA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, fast heartbeat, sweating, shaking or feeling jittery. Allergic (hypersensitivity) reactions have happened in people who are taking TRADJENTA. Symptoms may include swelling of your face, lips, tongue, throat, and other areas on your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives); skin rash, itching, flaking, or peeling. Joint pain. Some people who take medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors like TRADJENTA, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain. Skin Reaction. Some people who take medicines called DPP-4 inhibitors like TRADJENTA, may develop a skin reaction called bullous pemphigoid which can be serious and may need to be treated in a hospital. Tell your healthcare provider right away if you develop blisters. Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking TRADJENTA, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure. The most common side effects of TRADJENTA include stuffy or runny nose and sore throat, cough, and diarrhea. These are not all the possible side effects of TRADJENTA. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-TJ-100055 04.22.2022 Please see Prescribing Information and Medication Guide. Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an Alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the Alliance. The Alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. About Boehringer Ingelheim Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at . About Lilly Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram and LinkedIn. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance® as a treatment for adults with type 2 diabetes, to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, and as a potential treatment for children 10 years and older with type 2 diabetes, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date or that Jardiance® will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Jardiance® and Tradjenta® are registered trademarks of Boehringer Ingelheim. P-LLY MPR-US-102508 CONTACTS: Sheryl van der Hilst Boehringer Ingelheim Email: sheryl.van_der_hilst@boehringer-ingelheim.com Phone: (914) 772-7973 Kristiane Bello Eli Lilly and Company Email: bello_kristiane@lilly.com Phone: (317) 315-9052 Company Codes: NYSE:LLY

Aug. 24, 2022 10:00 UTC SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that four posters and one oral presentation will be presented at the European Society of Cardiology (ESC) Congress 2022, taking place August 26-29, 2022, and the European Respiratory Society (ERS) International Congress 2022, taking place September 4-6, 2022. Both congresses will be held in Barcelona, Spain. The presentation and posters describe completed and ongoing clinical studies of Tyvaso® (treprostinil) Inhalation Solution and Orenitram® (treprostinil) Extended-Release Tablets. “Along with the presentation of data on event-free survival in the open-label portion of the INCREASE clinical study of Tyvaso in pulmonary hypertension associated with interstitial lung disease, ERS 2022 provides us the opportunity to present additional details of the ongoing TETON studies of Tyvaso in idiopathic pulmonary fibrosis,” said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. “Additionally, at both ERS and ESC we’re delighted to present new clinical data describing the use of Orenitram in patients on dual background therapy for pulmonary arterial hypertension.” ESC posters include: Moderated e-poster session, Sunday, August 28, 11:15 AM - 12:00 PM CET: Station 7 – Efficacy and dose-response relationship of oral treprostinil in PAH patients on monotherapy or dual background therapy. Presented by Joan Albert Barberà, M.D., Ph.D., Hospital Clínic de Barcelona. Moderated e-poster session, Sunday, August 28, 11:15 AM -12:00 PM CET: Station 7 – Change in REVEAL Lite 2 and COMPERA 2.0 risk status in patients with pulmonary arterial hypertension initiating oral treprostinil on dual background therapy: a retrospective chart review. Presented by Margaret Sketch, Pharm.D., M.P.H, United Therapeutics Corporation. ERS INCREASE oral presentation details: Oral presentation, Monday, September 5, 11:55 AM - 12:00 PM CET: 8L/OA2279 – Inhaled treprostinil in patients with pulmonary hypertension due to interstitial lung disease: event-free survival in INCREASE study open-label extension. Presented by Steven D. Nathan, M.D., FCCP, Inova Fairfax Hospital. ERS posters include: Thematic poster session, Monday, September 5, 8:30 AM - 9:30 AM CET: TP-23/PA1934 – Study design and rationale for the TETON phase 3 clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis. Presented by Steven D. Nathan, M.D., FCCP, Inova Fairfax Hospital. Thematic poster session, Monday, September 5, 1:00 PM - 2:00 PM CET: TP-24/PA2682 – Efficacy of oral treprostinil as an add-on therapy for PAH. Presented by David Kiely, BSc (Hons), M.D., FRCP, University of Sheffield. About Tyvaso® (treprostinil) Inhalation Solution and Tyvaso DPI™ (treprostinil) Inhalation Powder TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prescription medicines used in adults to treat: Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the ability to exercise. Your ability to exercise decreases 4 hours after taking TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and effective in children under 18 years of age. Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3), which is high blood pressure in the lungs due to inflammation and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the ability to exercise. IMPORTANT SAFETY INFORMATION Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical conditions, including if you: Have low blood pressure Have or have had bleeding problems Have asthma or chronic obstructive pulmonary disease (COPD) Are pregnant or plan to become pregnant. It is not known if either product will harm your unborn baby. Are breastfeeding or plan to breastfeed. It is not known if either product passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Either product and other medicines may affect each other. Especially tell your healthcare provider if you take: Medicines used to treat high blood pressure or heart disease Medicines that decrease blood clotting (anticoagulants) Water pills (diuretics) Gemfibrozil (Lopid®) or rifampin (Rimactane®, Rifadin®, Rifamate®, Rifater®) What are the possible side effects of TYVASO or TYVASO DPI? Both products can cause serious side effects, including: Low blood pressure (symptomatic hypotension). If you have low blood pressure, either product may lower your blood pressure more. Bleeding problems. Either product may increase the risk of bleeding, especially in people who take blood thinners (anticoagulants). The most common side effects of both products are cough, headache, throat irritation and pain, nausea, reddening of the face and neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and shortness of breath. Like other inhaled prostaglandins, you may have trouble breathing after taking TYVASO or TYVASO DPI because it may cause the muscles around your airway to tighten (bronchospasm). These are not all the possible side effects. Call your doctor for medical advice about side effects or if you have trouble breathing. You may report side effects to the FDA at or call 1-800-FDA-1088. The risk information provided here is not comprehensive. To learn more about TYVASO or TYVASO DPI, talk with your healthcare provider. Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at or call 1-877-UNITHER (1‑877‑864‑8437). About Orenitram® (treprostinil) Extended-Release Tablets Orenitram is a prescription medicine used to treat pulmonary arterial hypertension (PAH) which is high blood pressure in the arteries of your lungs. Orenitram can help slow down the progression of your disease and improve your ability to exercise. It is not known if Orenitram is safe and effective in children. Important Safety Information for Orenitram Who should not take Orenitram? Do not take Orenitram if you have severe liver problems. What should I tell my healthcare provider before taking Orenitram? Tell your healthcare provider: If you have liver problems or diverticulosis. If you are pregnant, breastfeeding, and/or plan to become pregnant or breastfeed. It is not known if Orenitram will harm your unborn baby or if Orenitram passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Orenitram. About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orenitram and other medicines may affect each other causing side effects. Do not start any new medicine until you check with your healthcare provider. Especially tell your healthcare provider if you take another medicine that contains treprostinil, such as Remodulin® or Tyvaso®. How should I take Orenitram? Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a day (about every 12 hours). Your healthcare provider will tell you how often you should take Orenitram. If you have side effects, your healthcare provider may tell you to change your dose or when you take Orenitram. Take Orenitram with food. Swallow Orenitram tablets whole. Do not split, chew, crush, or break your Orenitram tablets. Do not take Orenitram tablets that are damaged or broken. If Orenitram tablets are not taken whole, they may release too much medicine at one time. This can lead to side effects. If you miss your dose of Orenitram, take the missed dose as soon as possible with food. If you miss 2 or more doses of Orenitram, call your healthcare provider to see if you need to change your dose. If you take too much Orenitram, call your healthcare provider or go to the nearest hospital emergency room right away. You may see the tablet shell in your stools (bowel movements). This is usually normal. The tablet shell is not digested. If you have diverticulosis, the tablet shell may get stuck in a blind pouch or diverticulum in your intestine. What are the possible side effects of Orenitram? Orenitram can cause serious side effects, including worsening of PAH symptoms. Stopping Orenitram suddenly may cause worsening of your PAH symptoms. Do not change your dose or suddenly stop taking Orenitram without first talking to your healthcare provider. The most common side effects of Orenitram include headache, diarrhea, nausea, vomiting, flushing, and pain in arms, legs, and jaw. These are not all of the possible side effects of Orenitram. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at or call 1-800-FDA-1088. The risk information provided here is not comprehensive. To learn more about Orenitram, talk with your healthcare provider. Please see Full Prescribing Information and Patient Information at or call Customer Service at 1-877-UNITHER (1‑877-864-8437). United Therapeutics: Enabling Inspiration At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization. You can learn more about what it means to be a PBC here: unither.com/PBC. Forward-looking Statements Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements relating to upcoming medical conference posters and presentations, our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs, providing superior financial performance for shareholders, and providing our communities with earth-sensitive energy utilization. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of August 24, 2022 and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. TYVASO and ORENITRAM are registered trademarks of United Therapeutics Corporation. TYVASO DPI is a trademark of United Therapeutics Corporation. View source version on businesswire.com: Contacts For Further Information: Dewey Steadman at (202) 919-4097 Email: ir@unither.com Source: United Therapeutics Corporation View this news release online at: