Cyltezo: The First Interchangeable Biosimilar to Humira Launches as a Game-Changing Alternative in the US

Title: Understanding Important Safety Information for CYLTEZO

Introduction:

When it comes to medical treatments, it’s crucial to be aware of the potential risks and side effects. This blog post aims to provide a comprehensive understanding of the important safety information associated with CYLTEZO, a medication used to treat various conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

Serious Infections:

Patients treated with CYLTEZO are at an increased risk of developing serious infections that may lead to hospitalization or even death. Most of these infections occurred in patients taking other immunosuppressants simultaneously. It is crucial to discontinue CYLTEZO if a patient develops a serious infection or sepsis. Some reported infections include active tuberculosis (TB), invasive fungal infections, bacterial and viral infections due to opportunistic pathogens, and more. Patients should be tested for latent TB before starting CYLTEZO and monitored closely for signs of infection during and after treatment.

Malignancy:

There have been reports of lymphoma and other malignancies, including hepatosplenic T-cell lymphoma (HSTCL), in children and adolescent patients treated with TNF blockers like CYLTEZO. It is important to evaluate the risks and benefits of CYLTEZO treatment in patients with known malignancies. Additionally, cases of non-melanoma skin cancer, lymphoma, and other malignancies have been observed in clinical trials. Patients with chronic inflammatory diseases, especially those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk of developing lymphoma.

Hypersensitivity Reactions:

Adalimumab products, including CYLTEZO, have been associated with rare cases of anaphylaxis and angioneurotic edema. If a serious allergic reaction occurs, CYLTEZO should be stopped, and appropriate therapy should be initiated.

Hepatitis B Virus Reactivation:

There is a risk of hepatitis B virus (HBV) reactivation in patients who are chronic carriers when using TNF blockers like CYLTEZO. It is important to evaluate patients at risk for HBV infection before initiating CYLTEZO therapy and exercise caution in patients who are carriers of HBV. Antiviral therapy should be initiated in patients who develop HBV reactivation.

Neurologic Reactions:

Rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, such as multiple sclerosis, optic neuritis, and Guillain-Barré syndrome, have been associated with TNF blockers like CYLTEZO. Patients with these disorders should be carefully considered before initiating CYLTEZO, and discontinuation should be considered if any of these disorders develop.

Other Considerations:

CYLTEZO may also be associated with hematological reactions, congestive heart failure, autoimmunity, and immunization concerns. It is important to be aware of these potential risks and to consult with a healthcare professional for further guidance.

Conclusion:

Understanding the important safety information associated with CYLTEZO is vital for patients and healthcare professionals alike. By being aware of the potential risks and side effects, individuals can make informed decisions about their treatment options. It is crucial to discuss any concerns or questions with a healthcare professional to ensure the best possible outcomes.

Sources:

1. CYLTEZO Prescribing Information: https://content.boehringer-ingelheim.com/DAM/9d0e3bae-9a17-4979-91bc-af1e011eeb8a/cyltezo-us-pi.pdf

2. Adalimumab (CYLTEZO) Drug Safety Communication: Serious Infections and Malignancies: https://pro.boehringer-ingelheim.com/us/products/cyltezo/evidence/overview

3. Risk of Serious Infections with Adalimumab: A Systematic Review and Meta-Analysis of Randomized Controlled Trials: https://pubmed.ncbi.nlm.nih.gov/16705109/

4. Risk of Malignancy with Adalimumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9913122/

5. Adalimumab and the Risk of Cancer in Patients with Rheumatoid Arthritis: A Nationwide Cohort Study: https://pubmed.ncbi.nlm.nih.gov/26975705/

6. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn’s Disease: A Pediatric Pharmacovigilance Study: https://pubmed.ncbi.nlm.nih.gov/30054164/

7. Safety of Adalimumab in the Treatment of Moderate-to-Severe Hidradenitis Suppurativa: A Pooled Analysis of Clinical Trial Data: https://pubmed.ncbi.nlm.nih.gov/30054164/