Drug Summary
What Is Tecelra?
Tecelra (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated 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 as determined by FDA-approved or cleared companion diagnostic devices.
What Are Side Effects of Tecelra?
Side effects of Tecelra include:
- systemic inflammatory response (cytokine release syndrome),
- nausea,
- vomiting,
- fatigue,
- infections,
- fever,
- constipation,
- shortness of breath,
- abdominal pain,
- non-cardiac chest pain,
- decreased appetite,
- fast heart rate,
- back pain,
- low blood pressure (hypotension),
- diarrhea,
- fluid retention (edema),
- decreased white cell blood count (including lymphocytes and neutrophils),
- decreased red blood cells,
- decreased platelet count, and
- pleural effusion.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Tecelra
- The recommended dose of Tecelra is between 2.68 x 109 to 10 x 109 MAGE-A4 T-cell receptor (TCR) positive T cells.
Tecelra In Children
The safety and effectiveness of Tecelra have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Tecelra?
Tecelra may interact with other medicines.
Tell your doctor all medications and supplements you use.
Tecelra During Pregnancy and Breastfeeding
Tecelra is not recommended for use during pregnancy, and pregnancy after Tecelra administration should be discussed with the treating physician. It is unknown if Tecelra has the potential to be transferred to the fetus and cause fetal toxicity. The pregnancy status of patients of reproductive potential should be verified prior to starting treatment with Tecelra. It is unknown if Tecelra passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Tecelra (afamitresgene autoleucel) Suspension, for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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