What Are the Possible Side Effects of TECVAYLI?  

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, including:

• Liver problems: TECVAYLI can cause liver problems that may lead to death. Increases in liver enzymes can happen with or without cytokine release syndrome (CRS). Tell your healthcare provider right away if you develop any symptoms of a liver problem including¹:
  • 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: TECVAYLI can cause bacterial and viral infections that are severe, life-threatening, or that may cause death.¹ 
  • Your healthcare provider may prescribe medicines to help prevent infections and treat you as needed if you develop an infection during treatment with TECVAYLI.
  • Tell your healthcare provider right away if you get a fever, chills or any signs or symptoms of an infection.  
• Decreased white blood cell counts: Fever sometimes also happens with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.¹ 
• Allergic reactions and injection site reactions¹: 
  • Allergic reactions: can include fever, rash, swollen tongue, or trouble breathing. Get medical help right away if you develop any symptoms of an allergic reaction during treatment with TECVAYLI.
  • Injection site reactions: 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.
• Your healthcare provider will check your liver enzymes and white blood cell counts before you start and during treatment with TECVAYLI.¹ 
• Your healthcare provider will monitor you for signs and symptoms of these serious side effects during treatment and may temporarily or permanently stop TECVAYLI if you develop severe side effects.¹ 

The most common side effects of TECVAYLI when used alone include:

• Fever¹
• CRS¹
• Muscle, joint, and bone pain¹
• Injection site rejection¹
• Tiredness¹
• Upper respiratory tract infection¹
• Nausea¹
• Headache¹
• Pneumonia¹
• Diarrhea¹

The most common side effects of TECVAYLI when used with daratumumab and hyaluronidase-fihj include:

• Low blood levels of antibodies called immunoglobins¹
• Upper respiratory tract infection¹
• CRS¹
• Cough¹
• Diarrhea¹
• Muscle, joint, and bone pain¹
• COVID-19¹
• Pneumonia¹
• Injection site reaction¹
• Tiredness¹
• Fever¹
• Headache¹
• Nausea¹
• Stomach area pain or cramps¹
• Decreased weight¹

The most common severe abnormal blood test results with TECVAYLI include:

• Decreased white blood cells, red blood cells, and platelets.¹ 

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