Teplizumab: Overview of Efficacy, Safety, and Pre-infusion Considerations
Informed Consent
The process of obtaining your informed consent requires that the prescribing healthcare professional (HCP) will review and discuss the benefits of treatment, the side effects/adverse events known to occur with treatment, and that you and your caregivers can ask questions and discuss your concerns to ensure you fully understand and wish to/not to proceed with treatment.
You always can change your mind regardless of your initial response.
In addition to the information presented in this section, we have provided links to the FDA-approved medication guide1 and patient-centered website2 for more information about the infusion process and additional resources that are available. They can be found in the list of references.
What is teplizumab?3,4
Teplizumab is currently the only FDA-approved treatment to delay the need for those with Stage 2 type 1 diabetes from progressing to needing to take insulin (Stage 3 type 1 diabetes).
Type 1 diabetes (T1D) is an autoimmune disease where your own immune system believes the cells in your body that make insulin (beta cells) do not belong in your body. Your immune system will fight them off, like when you have an infection, to make you better. Unfortunately, this does not make you better and without the ability to make your own insulin, you will need to take insulin to keep the sugar in your bloodstream at normal levels.
Teplizumab helps to slow the destruction of your beta cells by helping the immune system to not attack them. This allows your beta cells to survive longer and to make your own insulin for a longer time – as long as close to 3 years, although the specific time can vary. For more information about teplizumab efficacy, please refer to other sections of the DETECT-T1D website on Delaying Type 1 Diabetes Progression.
How do I take teplizumab?1,5
Teplizumab is a liquid medication that is given to your body through one of the veins in your arm. This allows the medication to go directly into your blood stream and get to the area of your body that needs the help.
This will require a needle that will place a small and flexible tube (known as a catheter) in the vein of your arm. The needle does not remain in your arm once the catheter is in place.
Depending on the type used, the catheter can stay in place anywhere from 3 days to 14 days. If the 3-day catheter is used, it will need to be removed (by gently pulling it out) and another one placed. This will continue every 3 days until the end of the therapy.
Once the catheter is in place, it will be taped to help keep it in. Most people will feel discomfort when the needle is inserted into the skin, but typically do not notice anything once the catheter is in.
Teplizumab will then be added to a bag (or glass bottle) of fluid that will have a long flexible tube. This tube will be connected to the catheter in your arm and will then be slowly delivered to your bloodstream over a period of 30 minutes.
This will happen every time you receive the teplizumab.
How will I feel while I am receiving teplizumab?3,5
The most common side effects are a reduction of the white blood cells, rash, and headache.
Many patients report feeling sick – perhaps as if they are going to vomit/throw up, develop chills (a sign of a fever), or feel achy all over. Some also complain of feeling tired and others have developed an itchy rash.
Most of these symptoms are mild and can be taken care of by using other medications that will help you feel better. In fact, for the first 5 days of the treatment, you will take these medications to help reduce these symptoms even before they start and include pain reliever/fever reducers (acetaminophen, ibuprofen); antihistamines (diphenhydramine, loratadine); antinausea (ondansetron, prochlorperazine).
These symptoms may develop later in the day – after you have received the teplizumab – but you will be able to take these same medications as needed to help you to feel better.
The most important thing you can do to help prevent these symptoms is drink a lot of water during the day.
Very infrequently, someone might have a more serious reaction to the teplizumab (such as difficulty breathing, swelling to their lips/tongue, hives, vomiting). You will be treated with emergency medications and sent to the emergency room if these happen.
Your HCP can determine if you are at risk for experiencing a problem before you have symptoms. This is done by getting blood drawn several times during the 14-days of treatment. The frequency will be determined by your HCP and will be based on how you are feeling as well.
Included in the labs will be tests that evaluate your ability to fight infection and to make sure your liver is doing ok. Depending on the results, your treatment may be delayed a day or two or stopped all together. If it is delayed, you will still receive the full 14 treatments, but it will take longer than 14 days.
The cells in your body that fight infection are going to be less effective during treatment because of how the teplizumab works. You probably will not feel like going to school or work, but if you do, please consider wearing a mask to protect yourself from getting sick. Good handwashing after using the toilet and before eating; avoiding touching your eyes and nose; and staying away from others who are already sick are good ways to keep yourself from getting ill.
What about vaccines?1,5
It is very important to make sure you are up to date on all age-appropriate vaccines, as well as all Covid-19 boosters and annual flu vaccine. This will make sure you are the best prepared to fight an infection. All live vaccines must be received no less than 8 weeks before treatment and the inactive vaccines must be received no less than 2 weeks before treatment.
If you are missing a vaccine and have already started treatment, you will need to wait 1 year after treatment to receive live vaccines and 6 weeks after treatment for inactive vaccines.
What about pregnancy and or breastfeeding?1,5
It is not recommended to receive teplizumab while pregnant or for at least 30 days after treatment before conceiving. This is to reduce the risk of exposing the fetus to the medication. Therefore, all female patients of child-bearing potential will need to have a negative pregnancy test before day 1 of treatment and both men and women will be counseled on effective birth control/abstinence during this time.
It is also not recommended that a woman breastfeed during treatment and for at least 20 days after her last infusion. To maintain an adequate milk supply, she is encouraged to “pump and dump” the breastmilk during this time.
References
- Tzield® (teplizumab-mzwv). Prescribing information. Provention Bio, Inc; 2023. https://products.sanofi.us/tzield/tzield.pdf
- Herold KC, Gitelman SE, Gottlieb PA, Knecht LA, Raymond R, Ramos EL. Teplizumab: A disease-modifying therapy for type 1 diabetes that preserves β-cell function. Diabetes Care. 2023;46:1848-1856.
- Herold KC, Bundy BN, Long SA, et al. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381:603-613.
- Mehta S, Ryabets-Lienhard A, Patel N, et al. Pediatric Endocrine Society statement on considerations for use of teplizumab (TzieldTM) in clinical practice. Horm Res Paediatr. 2024;Apr 30:1-12.
- Rossen LM, Hamilton BE, Abma JC, et al. Updated methodology to estimate overall and unintended pregnancy rates in the United States. CDC Stacks. April 12,2023. https://dx.doi.org/10.15620/cdc:124395
