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 1-2 weeks before initiating treatment. Screening includes viral loads for CMV, EBV, hepatitis B/C, HIV serology, and TB testing.
- 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 all pediatric patients receive the first seven infusions in a clinical setting due to the potential for severe acute side effects. They can be transitioned to the home setting if they do well and have a mechanism for emergent evaluation if the need arises.
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
- Tzield® (teplizumab-mzwv). Prescribing information. Provention Bio, Inc; 2023. 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.
