Uses
What is Tecelra used for?
Tecelra (afamitresgene autoleucel) is commonly used to treat a certain type of synovial sarcoma. A synovial sarcoma is a type of cancer that occurs in soft tissue, such as a muscle or tendon. Tecelra is usually used after other treatments are tried.
Tecelra may also be used for other conditions as determined by your healthcare provider.
How does Tecelra work (mechanism of action)?
Tecelra is a type of medicine known as immunotherapy, which means the medicine makes your immune system fight cancer cells. Tecelra is made by using your own T cells, which are a type of white blood cell. Your healthcare provider will collect your blood and send it to a company that will make the Tecelra for you. The T cells in Tecelra find and attack cancer cells with specific markers on the cell surface, called HLA-A*02 and MAGE-A4. The T cells kill the cancer cells, helping to stop the cancer from growing or spreading.
How is Tecelra supplied (dosage forms)?
Tecelra is available in an injectable form that is given as an infusion over a period of time by a healthcare provider.
How should I store Tecelra?
Tecelra is given by a healthcare provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Tecelra?
The most common side effects of Tecelra are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Cytokine release syndrome (see below)
- Nausea and vomiting
- Tiredness
- Infection (see below)
- Fever
- Constipation
- Shortness of breath
- Stomach pain
- Chest pain
- Decreased appetite
- Fast heartbeat
- Back pain
- Low blood pressure
- Diarrhea
- Fluid retention
- Blood disorders (see below)
There may be other side effects of Tecelra that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Tecelra?
While less common, the most serious side effects of Tecelra are described below, along with what to do if they happen.
Severe Allergic Reactions. Tecelra may cause allergic reactions, which can be serious. Stop using Tecelra and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Cytokine Release Syndrome. Tecelra can cause a dangerous and sometimes life-threatening syndrome called cytokine release syndrome. This syndrome occurs when your immune system responds too aggressively. It can occur right away or be delayed for several days after people use Tecelra. Keep all appointments to have side effects checked with your healthcare provider. Get emergency help right away if you have any of the following symptoms of cytokine release syndrome after using Tecelra.
- Fever and chills
- Fast or racing heart
- Low blood pressure
- Nausea and vomiting
- Headache
- Shortness of breath
- Diarrhea
- Dizziness, lightheadedness, or feeling like you are about to pass out
Fluid Around the Lungs. Tecelra can cause fluid to build up around your lungs. This condition is called a pleural effusion. It can be a dangerous side effect, and a healthcare provider may need to drain the fluid. Contact your healthcare provider and get help right away if you have any of the following symptoms of a pleural effusion while using Tecelra.
- Cough
- Shortness of breath
- Fever
- Chest pain
Brain Problems. Tecelra can cause a condition called Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS). This condition can be delayed, but usually occurs within 2 days after people use Tecelra. Get help right away if you have any of the following symptoms.
- Confusion
- Losing or going in and out of awareness or consciousness
- Seizures
- Balance problems
- Trouble talking
- Weakness in your arms or legs
Blood Disorders. Tecelra can cause blood disorders, such as anemia, low platelet levels (thrombocytopenia), and low white blood cell levels (neutropenia). These can last for several weeks after using Tecelra. Keep all appointments to have your blood checked. Your healthcare provider needs to monitor your blood cell counts. Contact your healthcare provider and get help right away if you have any of the following symptoms of blood disorders.
- Fever
- Shortness of breath
- Pale or yellowish skin
- Easy bruising or bleeding
- Frequent infection
- Unusual weakness or tiredness
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Headache
- Fast or abnormal heartbeat
Infection. Tecelra can increase the risk of infections, including serious infections. Tecelra may also increase your risk of a previous infection becoming active again, causing an infection. Before you start treatment with Tecelra, tell your healthcare provider if you have ever had Epstein-Barr virus, cytomegalovirus, hepatitis B, hepatitis C, HIV, or any other infections. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
New Cancer. Tecelra can cause a new cancer to develop or cause a previously treated cancer to recur. Tell your healthcare provider about any new symptoms that you may get. Call the manufacturer at 855-246-9232 if you get another cancer.
Warnings & Precautions
Who should not use Tecelra?
Allergies to Ingredients. People who are allergic to any of the following should not use Tecelra.
- Amfamitresgene autoleucel
- Tecelra
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Tecelra.
Genetic Factors. Any person who is heterozygous or homozygous for a specific HLA antigen known as HLA-A*02:05P should not use Tecelra. This means that the medicine is not for anyone who carries at least one HLA-A*02:05P antigen on their genes.
What should I know about Tecelra before using it?
Tecelra is given by a healthcare provider in a hospital or clinic. You will likely be in a hospital before and after using Tecelra. After you leave the hospital, you will need to stay close to the hospital or clinic for at least 4 weeks. Your healthcare provider needs to check that Tecelra is working for you and treat any side effects that you may have.
Your healthcare provider will do blood tests while you are using Tecelra to make sure it is safe for you. It is important to keep all appointments with your healthcare provider, so they can monitor your blood tests. If you miss an appointment, contact them right away to reschedule it.
Tecelra can cause incorrect HIV test results. It can make HIV test results look positive when they are actually negative. Tell every healthcare provider that you are using Tecelra.
Tecelra can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination for at least 4 weeks after your Tecelra infusion.
After using Tecelra, you should not donate blood, organs, tissues, or cells for transplantation.
What should I tell my healthcare provider before using Tecelra?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Tecelra is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Seizures, stroke, confusion, or memory loss
- Heart problems
- Liver problems
- Kidney problems
- Low blood pressure
- Lung or breathing problems
- Past, recent, or current infections
- Blood cell count problems
- If you are taking a blood thinner
Pregnancy. It is not known if or how Tecelra could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant or have a partner who is able to become pregnant.
Breastfeeding. It is not known if Tecelra passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Tecelra while breastfeeding.
How can I get more information about Tecelra?
For more information about Tecelra, you can visit the manufacturer’s website at www.tecelra.com or call them at 855-246-9232.
Interactions
Does Tecelra interact with foods or drinks?
There are no known interactions between Tecelra and foods or drinks.
It is unknown if drinking alcohol will affect Tecelra.
Does Tecelra interact with other medicines (drug interactions)?
There are no known interactions between Tecelra and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Tecelra?
If you or someone else has used too much Tecelra, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Tecelra?
Teclera is given by a healthcare provider in a hospital. Your healthcare provider will make sure you are receiving Tecelra as scheduled. If you miss an appointment, call your healthcare provider right away to reschedule.
Are you currently using Tecelra (afamitresgene autoleucel)?
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