Generic name: afamitresgene autoleucel
Brand name: Tecelra
Dosage form: intravenous suspension (-)
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com on Sep 17, 2024. Written by Cerner Multum.

What is afamitresgene autoleucel?

Afamitresgene autoleucel is an immunotherapy medicine used in adults to treat synovial sarcoma.

Afamitresgene autoleucel is usually given after other treatments have failed.

Your doctor will perform tests to make sure afamitresgene autoleucel is the right treatment for you.

Afamitresgene autoleucel may also be used for purposes not listed in this medication guide.

Afamitresgene autoleucel side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tell your caregivers or seek emergency medical attention if you have signs of life-threatening neurological problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Afamitresgene autoleucel may cause serious side effects. Call your doctor at once if you have:

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite;

• easy bruising or bleeding, unusual weakness; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of afamitresgene autoleucel may include:

• swelling in any part of your body;

• chest pain;

• fast heart rate;

• stomach or back pain;

• trouble breathing;

• low blood cell counts;

• nausea, vomiting, constipation, or diarrhea;

• loss of appetite;

• low blood pressure; or

• fever, chills, tiredness, or other signs of infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Tell your medical caregivers if you have symptoms of a serious side effect such as fever, chills, trouble breathing, vomiting, or severe tiredness.

Before taking this medicine

This treatment should not be used if you have a certain gene type. Ask your doctor if you have any questions

Tell your doctor if you have or have ever had:

• an active or recent infection;

• neurologic problems (such as stroke, seizures, memory loss);

• a previous infection or inflammatory condition such as cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection;

• heart problems;

• lung or breathing problems;

• low blood cell counts;

• if you use a blood thinner (such as warfarin) and you have routine "INR" or prothrombin time tests;

• low blood pressure; or

• liver or kidney disease.

Using afamitresgene autoleucel may increase your risk of developing other cancers. Ask your doctor about this risk.

You will need to take a pregnancy test before treatment with afamitresgene autoleucel.

Afamitresgene autoleucel is not recommended in pregnant women. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using afamitresgene autoleucel.

How is afamitresgene autoleucel given?

Your blood will be collected in a process called leukapheresis, and your own white blood cells will be used to make afamitresgene autoleucel.

You will not receive the medicine on the same day your blood cells are drawn. Your white blood cells are sent to a laboratory where they are made into afamitresgene autoleucel. The time to process your blood cells into afamitresgene autoleucel can take about 6 weeks.

A second blood collection attempt may be needed to make afamitresgene autoleucel and your treatment plan may be delayed or changed.

About 4 days before afamitresgene autoleucel is given, you will receive chemotherapy to help prepare your body for afamitresgene autoleucel.

You may be given other medications while you are waiting to receive afamitresgene autoleucel to help prevent serious side effects or allergic reaction.

When afamitresgene autoleucel is ready to be given, your dose is injected into a vein by a healthcare provider.

You will be watched closely after receiving afamitresgene autoleucel, and you will be followed up daily at the hospital or clinic for at least 7 days after the infusion to make sure you do not have an allergic reaction or serious side effects.

For at least 4 weeks, you should plan to stay near the hospital or clinic where you received afamitresgene autoleucel.

Your blood will need to be tested often and your doctor will need to check your progress on a regular basis.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using afamitresgene autoleucel.

Afamitresgene autoleucel dosing information

Usual Adult Dose for Soft Tissue Sarcoma:

2.68 x 10(9) to 10 x 10(9) melanoma-associated antigen A4 (MAGE-A4) T cell receptor positive T cells

Comments:
-This drug is provided as a single dose for infusion in one or more infusion bag(s). Verify the number of bags received for the indicated dose prior to preparation for infusion.
-Prior to infusion:
---Patient's identity should be verified
---A lymphodepleting regimen of cyclophosphamide and fludarabine should be administered
---Premedicate with acetaminophen and an H1-antihistamine

Use: For the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your afamitresgene autoleucel injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid after receiving afamitresgene autoleucel?

Avoid driving or hazardous activity for at least 4 weeks after you receive afamitresgene autoleucel.

Do not donate blood, organs, tissues, or cells for transplantation after receiving afamitresgene autoleucel.

What other drugs will affect afamitresgene autoleucel?

Other drugs may affect afamitresgene autoleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Afamitresgene autoleucel Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for afamitresgene autoleucel.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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