important information about TALVEY  

• TALVEY may cause side effects that are serious, life-threatening or lead to death, including Cytokine Release Syndrome (CRS) and neurologic problems.¹
• Due to the risk of these symptoms, TALVEY is only available through the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).¹
  • You will be given a Patient Wallet Card from your healthcare provider that lists signs and symptoms of CRS and neurologic problems. Carry the Patient Wallet Card with you at all times and show it to all of your healthcare providers. You should call your healthcare provider right away if you develop any of the signs or symptoms of CRS and neurologic problems listed below at any time during your treatment:  
    • Cytokine Release Syndrome (CRS): fever (100.4°F or higher), dizziness or lightheadedness, chills, difficulty breathing, feeling anxious, headache, fast heartbeat
    • Neurologic problems: headache, feeling confused, being less alert or aware, feeling disoriented, trouble speaking or writing, shaking (tremors), numbness and tingling (feeling like “pings and needles”), feeling sleepy, feeling very sleepy with low energy, slow or difficulty thinking, seizures, muscle weakness, memory loss, burning, throbbing, or stabbing pain
      

SUMMARY

Here is a passage from the TALVEY PRESCRIBING INFORMATION and MEDICATION GUIDE which may be helpful to address your question:

Please review the full TALVEY MEDICATION GUIDE for more information on “What is the most important information I should know about TALVEY” section.¹

What are the possible side effects of TALVEY?

TALVEY may cause serious side effects, including mouth problems and weight loss.

• Tell your healthcare provider or get medical help right away if you develop any of the following symptoms of mouth problems¹:
  • changes in sense of taste
  • dry mouth
  • trouble swallowing
  • mouth sores
• In clinical studies, most patients started to notice these mouth problems about 15 days after beginning TALVEY treatment, but they could happen at any time from 1 to 634 days after starting treatment. On average, it took about 43 days for the mouth problems to return to normal, with some patients needing between 1 and 530 days. For 65% of patients, the mouth problems did not return to normal.¹ 
• Your healthcare provider will monitor you for these symptoms and will monitor your weight during treatment with TALVEY. Tell your healthcare provider if you lose weight during treatment with TALVEY.¹ 

The most common side effects of TALVEY include:

• changes in your sense of taste¹   
• dry mouth¹ 
• very dry skin that may affect the mucous membranes (such as the mouth and eyes)¹ 
• difficulty swallowing¹ 
• weight loss¹ 

These are not all the possible side effects of TALVEY.¹

Call your doctor for medical advice about side effects. You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.¹

ADDITIONAL INFORMATION

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for TALVEY.¹