important information about tecvayli  

• TECVAYLI 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, TECVAYLI 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), difficulty breathing, chills, dizziness or lightheadedness, fast heartbeat, feeling anxious, confusion or restlessness, headache, increased liver enzymes in your blood
    • Neurologic problems: headache, jerking movements, rigid muscles, feeling restless, numbness and tingling (feeling like “pins and needles”), confusion, trouble speaking, muscle spasms, tremor, double vision, changes in your handwriting, problems walking, muscle weakness in your body or face, hearing loss, burning, throbbing, or stabbing pain

SUMMARY

See below for information from the TECVAYLI MEDICATION GUIDE, which may be helpful to address your question.

Please review the full TECVAYLI MEDICATION GUIDE for more information on “Important information I should know about TECVAYLI” section.¹

TECVAYLI may cause serious side effects, including¹:

• Liver problems: TECVAYLI can cause liver problems that may lead to death. Increased bilirubin and liver enzymes in your blood are common with TECVAYLI and can also sometimes be severe. These increases in liver enzymes can happen with or without you also having CRS. Your healthcare provider will monitor you for these problems before you start and during treatment with TECVAYLI.  Tell your healthcare provider if you develop any symptoms of a liver problem including:
  • Tiredness
  • Loss of appetite
  • Pain in your right upper stomach-area (abdomen)
  • Dark urine
  • Yellowing of your skin or white part of your eyes
• Infections: Upper respiratory tract infections and pneumonia are common with TECVAYLI. TECVAYLI can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
  • Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with TECVAYLI.  
  • Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as needed if you develop an infection during treatment with TECVAYLI.
  • Tell your healthcare provider if you get a fever, chills or any signs or symptoms of an infection.
• Decreased white blood cell counts: Decreased white blood cell counts are common with TECVAYLI and can also be severe. Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will check your blood cell counts before you start and during treatment with TECVAYLI, and treat you as needed.
• Allergic reactions and injection site reactions: TECVAYLI can cause allergic reactions that can affect your whole body (systemic), and also cause injection site reactions.
  • Some people taking TECVAYLI can develop symptoms of an allergic reaction that can affect your whole body and may include fever or a swollen tongue. Get medical help right away if you develop symptoms of an allergic reaction during treatment with TECVAYLI.
  • Injection site reactions are common with TECVAYLI and can include: redness, heat, swelling, bruising, bacterial skin infection (cellulitis), discomfort, blood collection under the skin at the injection site (hematoma), and rash.
  • Tell your healthcare provider if you develop any severe injection site reactions.
• The most common side effects of TECVAYLI include¹:
  • Fever
  • Pain in your joints and muscles, back and chest muscles, and in your arms and legs
  • Tiredness and weakness
  • Upper respiratory tract infections and pneumonia (See “Infections” above)
  • Nausea
  • Headache
  • Diarrhea
  • The most common severe abnormal lab test results with TECVAYLI include: decreased white blood cells, red blood cells and platelets.

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