Teplizumab
Teplizumab is a monoclonal antibody therapy that delays the onset of Stage 3 Type 1 Diabetes in at-risk individuals by targeting CD3 on T lymphocytes.
An immunotherapy that delays Type 1 Diabetes progression by modulating T-cell mediated destruction of insulin-producing beta cells.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- A10XX01
- RxNorm
- 2621880
- Generic
- Teplizumab
- Class
- atc-a10
- Brands
- Tzield
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 16mg once daily
- Maximum
- consult physician
- Frequency
- daily for 12 days (14-day treatment course)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 16mg once daily
- Maximum
- consult physician
- Frequency
- daily for 12 days (14-day treatment course)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 16mg once daily
- Maximum
- consult physician
- Frequency
- daily for 12 days (14-day treatment course)
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
use only if potential benefits outweigh potential risks to the fetus
regular fetal monitoring and ultrasound assessments
Use with caution and monitor for adverse effects.
pregnancy
second third trimesteravoid if possible
use only if potential benefits outweigh potential risks; monocolonal antibodies may cross placenta
regular fetal monitoring
Use with caution and monitor for adverse effects.
lactation
breastfeedingnot established
breastfeeding not recommended during treatment and for at least 6 months after last dose
monitor infant for signs of immunosuppression
pediatric_age
age 2 to 7 yearsnot recommended
safety and efficacy not established in patients under 8 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
age 8 to 17 yearsno adjustment required
approved for delay of Stage 3 type 1 diabetes in patients 8 years and older
monitor for signs of cytokine release syndrome and immune reactions
geriatric
age 65 and olderuse with caution
limited clinical experience in patients 65 years and older; use with caution due to potential increased susceptibility to infections
close monitoring for infections and adverse reactions
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderatenot established
not studied specifically in renal impairment; use with caution
monitor renal function
hepatic_impairment
anynot established
not studied in hepatic impairment; use with caution
monitor liver function tests
Statistics and clinical data
FDA approval year
FDA approval for Teplizumab (Tzield) for delaying onset of type 1 diabetes
Drug class
Immunomodulatory monoclonal antibody
Primary indication
Indicated to delay onset of type 1 diabetes in at-risk individuals
Route of administration
Administered as 14-day course of daily infusions
Delays onset of Stage 3 Type 1 Diabetes in adults and pediatric patients aged 1 year and older with Stage 2 T1D, and delays decline in endogenous insulin production in patients aged 8-17 years.
Binds to CD3, a cell surface antigen present on T lymphocytes, modulating the immune response that attacks insulin-producing pancreatic beta cells.
Administered as a single 14-day course via IV infusion. May cause cytokine release syndrome, lymphopenia, and other immune-related adverse effects. Requires pre-screening and monitoring. The first disease-modifying therapy approved to delay T1D progression.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy