Anakinra (Amgen)

Adalimumab-aaty will be priced at an 85% discount to HUMIRA® (adalimumab) Branded and unbranded versions of Celltrion USA's adalimumab biosimilar help provide more affordable options for patients JERSEY CITY, N.J., May 9, 2024 /PRNewswire/ -- Celltrion USA announced today that adalimumab-aaty, the company's high-concentration (100 mg/mL) and citrate-free formulation biosimilar to HUMIRA ® (adalimumab), is now available at a low wholesale acquisition cost (WAC). Adalimumab-aaty will be priced as WAC list price at an 85% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is also available from Celltrion USA under the brand name YUFLYMA®, which launched in July 2023 and is available at a 5% discount to the current WAC list price of HUMIRA. Adalimumab-aaty is approved for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. "Access to medications in the U.S. has become increasingly complex, and there is so much value that biosimilars add with competition in the marketplace," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "The availability of branded and unbranded versions of adalimumab-aaty will improve the accessibility of adalimumab biosimilars in the U.S., providing economic benefits for patients and the overall healthcare system." Adalimumab-aaty is available as 40 mg/0.4mL, 80 mg/0.8mL and 20 mg/0.2mL. IMPORTANT SAFETY INFORMATION[1] This important safety information also applies to YUFLYMA® (adalimumab-aaty) SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic DMARDs (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS and HS, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa Please see full Prescribing Information including Boxed Warning for adalimumab-aaty About a dalimumab-aaty [1] Adalimumab-aaty is an unbranded version of YUFLYMA® (CT-P17, biosimilar adalimumab). YUFLYMA is a recombinant fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is FDA-approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis and Hidradenitis Suppurativa. Following the launch of 40mg/0.4mL in July 2023 and 80mg/0.8mL in December 2023, additional dosage form of 20mg/0.2mL was launched in the U.S. in March 2024. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a new biologic ZYMFENTRA™. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions with respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report. Although forward-looking statements contained in this presentation are based upon what management of Celltrion believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Trademarks HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References US-YUF-24-00007 04/24 Contacts Sarah Amundsen [email protected] +1 920-946-0918 SOURCE Celltrion USA

RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company's interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases. "With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases," said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. "Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings." The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo® and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023. "The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn's disease and ulcerative colitis, which affect nearly 1 in 100 Americans," said Michael Osso, President & CEO of the Crohn's & Colitis Foundation. "The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines." "This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis," said Steven Taylor, President & CEO of the Arthritis Foundation. "We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem." "Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis," said Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation. "We welcome the introduction of this additional formulation to expand the array of options available to our community." The FDA approval is based, in part, on data from clinical trial VOLTAIRE-HCLF, a Phase I clinical trial comparing the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm. About Cyltezo The FDA approved Cyltezo as an interchangeable biosimilar to Humira on October 15, 2021. The efficacy and safety of Cyltezo are supported by a large body of data, including the Phase III randomized VOLTAIRE-X comparative clinical trial, which studied the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira. To learn more about Cyltezo, please visit Cyltezo.com. Healthcare providers can learn more about Cyltezo at CylezoHCP.com. *For more information on interchangeability for Cyltezo, please refer to the Purple Book: . About Biosimilars A biosimilar is a biologic medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity. A biosimilar with an interchangeable designation, which is designated by the FDA, may be auto-substituted for the reference product by a pharmacist. Individual state laws control how and whether providers and patients must be notified. An interchangeable biosimilar first must meet the high FDA standards of a biosimilar. Then, to achieve the interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy compared with remaining on the reference product in any given patient. About Boehringer Ingelheim in Biologics and Biosimilars Through novel biologics and our interchangeable biosimilar, we strive to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide. Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, producing biologic medicines to support our diverse pipeline, as well as other companies' biopharmaceuticals on a contract basis. As a pioneer in biologics, to date, Boehringer Ingelheim's Biopharmaceutical Contract Manufacturing business has supported our customers to bring dozens of biologics to the market in therapeutic areas that include oncology, immunology and cardiovascular indications. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here: . For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use. What is CYLTEZO? This information also applies to Adalimumab-adbm injection for subcutaneous use. CYLTEZO is a medicine called a tumor necrosis factor (TNF) blocker. CYLTEZO is used: To reduce the signs and symptoms of: moderate to severe rheumatoid arthritis (RA) in adults. CYLTEZO can be used alone, with methotrexate, or with certain other medicines. moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. CYLTEZO can be used alone or with methotrexate. psoriatic arthritis (PsA) in adults. CYLTEZO can be used alone or with certain other medicines. ankylosing spondylitis (AS) in adults. moderate to severe hidradenitis suppurativa (HS) in adults. To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). To treat non-infectious intermediate, posterior, and panuveitis in adults. Important Safety Information for CYLTEZO® (adalimumab-adbm) injection, for subcutaneous use This important information also applies to Adalimumab-adbm injection for subcutaneous use. What is the most important information I should know about CYLTEZO? You should discuss the potential benefits and risks of CYLTEZO with your doctor. CYLTEZO is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking CYLTEZO if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting CYLTEZO and check you closely for signs and symptoms of TB during treatment with CYLTEZO, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB. Cancer. For children and adults taking TNF blockers, including CYLTEZO, the chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including CYLTEZO, your chances of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn't heal. What should I tell my doctor BEFORE starting CYLTEZO? Tell your doctor about all of your health conditions, including if you: Have an infection, are being treated for infection, or have symptoms of an infection. Get a lot of infections or have infections that keep coming back. Have diabetes. Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB. Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use CYLTEZO. Ask your doctor if you are unsure whether you have lived in an area where these infections are common. Have or have had hepatitis B. Are scheduled for major surgery. Have or have had cancer. Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome. Have or had heart failure. Have recently received or are scheduled to receive a vaccine. CYLTEZO patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting CYLTEZO. Are allergic to rubber or latex. Are allergic to any CYLTEZO ingredients. Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Have a baby and you were using CYLTEZO during your pregnancy. Tell your baby's doctor before your baby receives any vaccines. Also tell your doctor about all the medicines you take. You should not take CYLTEZO with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP). What should I watch for AFTER starting CYLTEZO? CYLTEZO can cause serious side effects, including: Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle. Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash. Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your face, eyes, lips, or mouth. Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain. Immune reactions, including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun. Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death. Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus. Call your doctor or get medical care right away if you develop any of the above symptoms. The most common side effects of CYLTEZO include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all the possible side effects with CYLTEZO. Tell your doctor if you have any side effect that bothers you or that does not go away. Remember to tell your doctor right away if you have an infection or symptoms of an infection, including: Fever, sweats, or chills Muscle aches Cough Shortness of breath Blood in phlegm Warm, red, or painful skin or sores on your body Diarrhea or stomach pain Burning when you urinate Urinating more often than normal Feeling very tired Weight loss These are not all the possible side effects of CYLTEZO. For more information, speak with your doctor or pharmacist . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CTZ-100017 SEPT 2023 For more information, please see full Prescribing Information, including Medication Guide and Instructions for Use. 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 three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at . Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Cyltezo® trademark under license. The other trademarks referenced above are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc. MPR-US-102954 4/24 Media Contact: Taylor Pepe Senior Associate Director, Human Pharma Communications [email protected] SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.