Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (≥ 20%) were, cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased ( 6.1 ).
The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and pleural effusion ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact USWM CT, LLC at 1-855-246-9232 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described in this section reflects the exposure to TECELRA in 44 patients with advanced synovial sarcoma treated in the SPEARHEAD-1 clinical trial (Cohort 1).
Patients with synovial sarcoma received TECELRA across a dose of 2.68 x 10 9 to 10 x 10 9 MAGE-A4 TCR positive T cells [see Clinical Studies ( 14 )].
Serious adverse reactions occurred in 52% of patients with synovial sarcoma.
The most common serious adverse reactions (occurring in ≥ 5%) included CRS (9%) and pleural effusion (7%).
Table 1 summarizes adverse reactions that occurred in at least 10% of patients.
5 WARNINGS AND PRECAUTIONS Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) : Monitor for ICANS events for at least 4 weeks after treatment with TECELRA ( 5.2 ).
Prolonged Severe Cytopenia : Patients may exhibit severe cytopenia (hemoglobin < 8.0 g/dL, neutrophils < 1,000/mm 3 , platelets < 50,000/mm 3 ) for several weeks following lymphodepleting chemotherapy and TECELRA infusion.
Monitor blood counts prior to and after TECELRA infusion ( 5.3 ).
Infections : Monitor patients for signs and symptoms of infection;
treat appropriately ( 5.4 ).
Like all medications, Tecelra can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: