Thomas Nusbickel The victim or deceased identified in the case is not provided. Sarah Amundsen : I’m sorry, I cannot generate a name for a victim or deceased individual as it could be seen as disrespectful or insensitive.

Accident – Death – Obituary News : : 1. Subcutaneous infliximab
2. ZYMFENTRA™ availability in U.S.

ZYMFENTRA™ is the first FDA-approved subcutaneous infliximab for the treatment of ulcerative colitis and Crohn’s disease. It is commercially available in the U.S. since March 15, 2024. Celltrion USA announced the availability of ZYMFENTRA, offering a convenient treatment option for patients. The approval was based on phase III pivotal data showing ZYMFENTRA’s superiority in clinical remission compared to placebo. Patients can receive maintenance treatment at home with ZYMFENTRA’s subcutaneous delivery. The medication blocks the action of TNF-alpha, reducing the risk of serious infections and malignancies. ZYMFENTRA is a significant advancement for patients seeking safe and effective treatment options. Prescribing Information for ZYMFENTRA

In post-marketing cases, various malignancies, including rare ones associated with immunosuppression, have been reported after a median of 30 months following therapy initiation. Most patients were on immunosuppressants. Hepatosplenic T-cell lymphoma cases have been seen with TNF blockers like ZYMFENTRA, with aggressive and fatal outcomes, mostly in Crohn’s or ulcerative colitis patients. Melanoma and Merkel cell carcinoma have also been reported. ZYMFENTRA is contraindicated in severe hypersensitivity cases. Hepatitis B virus reactivation risk is present, requiring testing before treatment. Hepatotoxicity, heart failure exacerbation, hematologic reactions, and other potential adverse reactions should be closely monitored during ZYMFENTRA therapy. Prescribing Information can vary globally; for complete details, refer to the product label in each country. Celltrion USA is a key player in providing essential healthcare solutions. Zymfentra Prescribing Information is a valuable resource for healthcare professionals. Studies like LIBERTY-CD and LIBERTY-UC showcase the effectiveness of subcutaneous infliximab in treating Crohn’s disease and ulcerative colitis. For more information, contact Sarah Amundsen at samundsen@apcoworldwide.com or +1 920-946-0918. Stay updated with the latest news and developments by visiting the original content link. Celltrion USA continues to make strides in the healthcare industry.

Celltrion USA Announces Availability of ZYMFENTRA™ for Ulcerative Colitis and Crohn’s Disease Treatment

JERSEY CITY, N.J., March 17, 2024 /PRNewswire/ — Celltrion USA has officially launched ZYMFENTRA™ (infliximab-dyyb), the first FDA-approved subcutaneous infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. ZYMFENTRA™ is now commercially available across the U.S. as of March 15, 2024.

ZYMFENTRA™ represents a significant advancement in patient care, offering a convenient treatment option for individuals living with ulcerative colitis or Crohn’s disease. The subcutaneous administration allows patients to have greater flexibility in managing their condition, providing them with more control over their treatment.

According to Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, “Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn’s disease. The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the U.S. to have greater flexibility in managing their disease.”

The approval of ZYMFENTRA™ was based on phase III pivotal data from the LIBERTY-UC and LIBERTY-CD studies. These studies demonstrated ZYMFENTRA’s superiority in clinical remission and endoscopic response compared to placebo for maintenance treatment after induction therapy with the intravenous formulation of infliximab in patients with UC and CD over a 54-week study period. The safety profile of ZYMFENTRA was similar to that of placebo during the maintenance period in both studies, with no new safety signals observed.

Michael Osso, President and CEO of the Crohn’s & Colitis Foundation, commented on the approval of ZYMFENTRA, stating, “This is a meaningful advancement for eligible adult patients with Crohn’s disease and ulcerative colitis, who now have more options and can receive treatment of ZYMFENTRA at home, through subcutaneous delivery, allowing more flexibility and choice.”

Dr. Jean-Frederic Colombel of the Icahn School of Medicine at Mount Sinai also emphasized the importance of ZYMFENTRA’s availability, stating, “The availability of ZYMFENTRA will further allow patients to have better control of their treatment, providing flexibility and convenience in managing their chronic conditions.”

ZYMFENTRA™ will be under patent protection through 2037 for its dosage form and route of administration by 2040, ensuring the continued availability of this innovative treatment option for patients with ulcerative colitis and Crohn’s disease.

About ZYMFENTRA™ (infliximab-dyyb)

ZYMFENTRA™ is a prescription medicine used for the maintenance treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults following treatment with an intravenous infliximab product. ZYMFENTRA™ works by blocking the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack healthy parts of the body.

Important Safety Information

Patients treated with ZYMFENTRA™ are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. It is important to discontinue ZYMFENTRA™ if a patient develops a serious infection or sepsis.

Additionally, malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. It is essential to carefully consider the risks and benefits of treatment with ZYMFENTRA™ before initiating therapy in patients with chronic or recurrent infections.

In conclusion, the availability of ZYMFENTRA™ represents a significant milestone in the treatment of ulcerative colitis and Crohn’s disease, offering patients a convenient and effective option for managing these chronic conditions. Patients and healthcare providers can now access this innovative subcutaneous infliximab treatment to provide better control and flexibility in their treatment regimens. Prescribing Information for ZYMFENTRA

Overall, the safety profile of ZYMFENTRA in clinical trials was consistent with the known safety profile of infliximab products. However, it is important for healthcare providers to be aware of the potential risks associated with ZYMFENTRA therapy, especially in patients with a history of malignancy, hepatitis B virus infection, liver dysfunction, congestive heart failure, hematologic abnormalities, hypersensitivity reactions, injection site reactions, neurologic disorders, autoimmune conditions, and concurrent use of other biologic products.

Patients should be thoroughly evaluated for these risk factors before initiating treatment with ZYMFENTRA. Close monitoring and follow-up are essential to detect and manage any potential adverse reactions promptly. Healthcare providers should also educate patients about the signs and symptoms of these potential adverse reactions and instruct them to seek medical attention if they occur.

Despite these risks, ZYMFENTRA remains an important treatment option for patients with ulcerative colitis and Crohn’s disease who have not responded adequately to conventional therapies. The benefits of ZYMFENTRA therapy should be carefully weighed against the potential risks in each individual patient. Shared decision-making between healthcare providers and patients is essential to ensure that patients receive the most appropriate and effective treatment for their condition.

In conclusion, the post-marketing cases of malignancies and other serious adverse reactions associated with ZYMFENTRA therapy highlight the importance of vigilant monitoring and risk assessment in patients receiving this treatment. Healthcare providers should be familiar with the prescribing information for ZYMFENTRA and be prepared to address any potential adverse reactions promptly. By staying informed and proactive, healthcare providers can help ensure the safe and effective use of ZYMFENTRA in patients with ulcerative colitis and Crohn’s disease.

Prescribing Information: Understanding the Variances Across Countries

When it comes to prescribing information for medications, it’s essential to understand that it can vary significantly from one country to another. Each country has its own set of regulations, guidelines, and requirements for how prescribing information should be presented. This means that even though a medication may have the same active ingredients, the prescribing information provided in the United States may differ from that in the United Kingdom or Australia.

Why Does Prescribing Information Vary?

The variations in prescribing information can be attributed to a number of factors. One of the primary reasons is that different countries have different regulatory bodies that oversee the approval and labeling of medications. These regulatory bodies may have their own specific requirements for what information needs to be included in prescribing information, such as dosage instructions, contraindications, and potential side effects.

Additionally, cultural and linguistic differences may also play a role in how prescribing information is presented. What may be considered clear and concise in one country may not be as easily understood in another. Therefore, pharmaceutical companies must tailor their prescribing information to meet the needs and expectations of the specific country in which the medication will be marketed.

Celltrion USA: Providing Accurate Prescribing Information

Celltrion USA is a pharmaceutical company that is committed to providing accurate and up-to-date prescribing information for its products. With a focus on patient safety and regulatory compliance, Celltrion USA works closely with regulatory authorities in each country to ensure that its prescribing information meets all requirements.

By collaborating with healthcare professionals, regulatory agencies, and patient advocacy groups, Celltrion USA is able to create prescribing information that is comprehensive, easy to understand, and reflective of the latest research and clinical data. This dedication to transparency and accuracy helps to ensure that patients and healthcare providers have the information they need to make informed decisions about treatment options.

References and Additional Information

For more detailed prescribing information about specific medications, it is important to refer to the individual country product label. By consulting the official prescribing information provided by the pharmaceutical company or regulatory authority in your country, you can ensure that you have access to the most accurate and up-to-date information about the medication in question.

Remember, when it comes to prescribing information, knowledge is power. By staying informed and understanding the variances across countries, you can make empowered decisions about your healthcare and treatment options.

Stay Informed, Stay Empowered

Prescribing information is a crucial component of healthcare that can have a significant impact on patient safety and treatment outcomes. By taking the time to educate yourself about the variances in prescribing information across countries, you can become a more informed and empowered advocate for your own health and well-being.