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What side effects could occur with TECELRA?

Possible serious side effects that may occur with TECELRA

Since TECELRA is a different kind of treatment, the side effects you may experience could be different from those you have previously experienced with other treatments. Prior to infusion, your doctor will discuss important risks associated with TECELRA. Be sure to speak with your doctor or care team about any side effects you may experience.

Important Warning

  • You will likely be in a hospital before and after getting TECELRA
  • TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash
  • Tell all your healthcare providers that you were treated with TECELRA
  • After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks
  • Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA

One serious side effect that is possible with TECELRA is called cytokine release syndrome

What is CRS?

TECELRA can cause cytokine release syndrome, or CRS, which can be severe or life-threatening. This is when immune cells create a large and rapid release of cytokines, proteins that affect the immune system, into the blood. CRS can happen after treatment with some cancer therapies, including TECELRA.

You should be monitored for CRS at a healthcare facility daily for at least 7 days after treatment with TECELRA and for CRS for at least 2 weeks following treatment with TECELRA.

What does having CRS feel like?

The most common symptoms of CRS include fever, fast or irregular heartbeat, low blood pressure, nausea/vomiting, and headache. Tell your doctor or care team right away if you develop fever or any of these other symptoms after receiving TECELRA.

How long did CRS last in the TECELRA study?

In the TECELRA clinical study, half of CRS cases occurred within 2 days of treatment (range: 1-7 days) and half improved within 3 days (range: 1-14 days).

The most common side effects of TECELRA include:

  • Nausea
  • Fatigue
  • Musculoskeletal pain
  • Infection
  • Fever (100.4°F/38°C or higher)
  • Constipation
  • Vomiting
  • Headache
  • Diarrhea
  • Cough
  • Fast heart rate
  • Swelling
  • Shortness of breath
  • Rash
  • Increased AST
  • Increased ALT
  • Decreased lymphocyte count
  • Decreased white blood cell count
  • Decreased neutrophil count
  • Decreased red blood cell count
  • Decreased platelet count
You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.
ALT=alanine aminotransferase; AST=aspartate aminotransferase.

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INDICATION and IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION
and INDICATION

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

INDICATION and IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY
INFORMATION and INDICATION

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

IMPORTANT SAFETY INFORMATION

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 2 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 2 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, fatigue, musculoskeletal pain, infection, fever (100.4°F/38°C or higher), constipation, vomiting, headache, diarrhea, cough, fast heart rate, swelling, shortness of breath, rash, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, decreased red blood cell count, and decreased platelet count.

You are encouraged to report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/medwatch or to US WorldMeds at 1-855-246-9232.

What is TECELRA?

TECELRA® is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you.

Please see Medication Guide, including Important Warning.

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