TZIELD SAFETY PROFILE (TN-10)
Common adverse reactions* in the TN-10 trial1†
* Adverse reactions that occurred in 2 or more TZIELD-treated patients.1
† That occurred during treatment and through 28 days of the last TZIELD administration.1
‡ Composite of rash-related terms including rash erythematous, rash macular, rash papular, rash maculo-papular, rash pruritic.1
In the TN-10 trial, greater incidences of adverse reactions were observed in TZIELD-treated patients vs placebo-treated patients1:
- Cytokine release syndrome (2% vs 0%, respectively)
- Serious infections§ (9% vs 0%, respectively)
- Hypersensitivity reactions; serum sickness (2% vs 0%, respectively)
- Lymphopenia (73% vs 6%, respectively)
- Neutropenia (7% vs 3%, respectively)
§Serious infections included cellulitis, gastroenteritis, pneumonia, and wound infection.
Adverse reactions observed in TZIELD-treated pediatric patients (8 years and older) were consistent with those reported in TZIELD-treated adults.1
LYMPHOPENIA IN TN-10
CMV=cytomegalovirus; EBV=Epstein-Barr virus.
‖One TZIELD-treated patient in Study TN-10 reported symptoms consistent with reactivation of EBV.
Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) develops, discontinue TZIELD.1
Average absolute lymphocyte counts began to recover at Day 5 and returned to baseline by Week 6 in most patients1,2
‖Adapted from Herold KC, et al. Means and confidence intervals are shown.
ADDITIONAL Warnings and precautions
Cytokine release syndrome (CRS)
Premedicate, monitor liver enzymes, discontinue in those that develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal, and if severe CRS develops consider temporarily pausing dosing.1
Use of TZIELD is not recommended in patients with active serious infection or chronic infection. Monitor for signs and symptoms of infection during and after TZIELD treatment. If a serious infection develops, discontinue TZIELD.1
Administer all age-appropriate vaccinations prior to starting TZIELD. See recommendations regarding live-attenuated, inactivated, and mRNA vaccines.1
If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.1
See WARNINGS AND PRECAUTIONS (section 5.0) in the Prescribing Information for TZIELD to learn more.
The safety profile of TZIELD was also evaluated in a pooled analysis of >750 patients across 5 controlled, clinical studies.1
In the pooled analysis, adverse reactions were evaluated in 773 TZIELD-treated patients, and 245 patients received placebo or standard of care (1 study in patients with Stage 2 T1D [Study TN-10], 3 placebo-controlled studies in an unapproved population, and 1 open-label standard-of-care controlled study of TZIELD in an unapproved population).1