Pre-Treatment Considerations
Pre-Treatment Screenings
Prior to initiating treatment with teplizumab, it is advised that the following screenings be obtained:
- Vaccination status – No vaccines are to be administered during treatment1,2
- Live-attenuated vaccines – must be administered no less than 8 weeks prior to treatment or at least 52 weeks after treatment
- Inactivated or mRNA vaccines – must be administered no less than 2 weeks prior to treatment or least 6 weeks after treatment
- Recommend that patients are up to date on all vaccines to include influenza and COVID-19
- Active infections1,2 – Screening for active infections must occur before day 1 of therapy and is encouraged to be done 1 to 2 weeks before initiating treatment. Recommended screenings include EBV and CMV, as well as any other potential infections, such as hepatitis B/C, HIV, and TB. Treatment is not recommended in people with active serious infection or chronic active infection other than localized skin infections.
- Baseline laboratory evaluation and when appropriate to provide treatment1,2
- Lymphocyte count > 1000 lymphocytes/µL
- Hemoglobin >10 g/dL
- Platelet count >150,000 platelets/µL
- Absolute neutrophil count >1500 neutrophils/µL
- AST or ALT <2 times upper limit of normal
- Bilirubin <1.5 times upper limit of normal
- Negative pregnancy test
Determining Location of Treatment
Teplizumab can be administered in a variety of settings – patient home, infusion center, hospital-based outpatient clinic (ie, hematology/oncology), or in a healthcare providers office.
Considerations will include 14-day consecutive access to the location, duration of each treatment (which includes assessment of patient, preparation of the infusion, administration, and post-infusion observation) the comfort level of the clinician overseeing the care, and most importantly, the burden of inconvenience/cost of travel to the patient.
A hybrid combining two options is also a possibility, but this will need to be pre-arranged with the patient’s insurance prior to the initiation of therapy.
If the patient’s home is chosen, a registered nurse (RN) who is specialized in infusion therapy will be administering the treatment.
It is currently recommended that in-home infusions should be avoided in pediatric patients, for at least the first week or until the risk of significant adverse events decreases. However, since the location of infusion must be determined prior to starting treatment, changing locations based on needs may not be feasible. Ideally, home infusions should be limited to adult patients, and there must be a mechanism for prompt identification and evaluation in case adverse events occur, even after doctors’ office hours or on weekends.2
Intravenous Access
Teplizumab is administered intravenously. This can be done through a peripherally inserted catheter that remains in place for up to 3 days at a time or by using a more long-term access device, such as a peripherally inserted central catheter (PICC) or central venous catheter (CVC).
Please note that while laboratory studies can be drawn using a PICC or CVC, these catheters can only be accessed by an RN. If patients are having labs drawn at a commercial laboratory, the lab personnel are not authorized to access a central catheter, and a venipuncture will be performed.
In addition, labs will not be done in the patient home even if they have a central catheter due to the necessary immediacy of the results (ordered as STAT labs).
References
- Teplizumab (Tzield®) Prescribing information 2026. Sanofi. https://products.sanofi.us/tzield/tzield.pdf
- Mehta S, Ryebets-Lienhard A, Patel N, et al. Pediatric endocrine society statement on considerations for use of teplizumab (TzieldTM) in clinical practice. Horm Res Paediatr. 2024Apr 30:1-12.
