TZIELD teplizumab-mzwv 1 mg/mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the CD3-directed Antibody class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Tzield doesn't cure type 1 diabetes, and it's not an insulin replacement. What it does is slow down the immune system's attack on the insulin-producing cells in your pancreas. If y...
- What exactly does Tzield do — does it treat my diabetes or prevent it?
- Tzield is given as an IV infusion at a clinic or infusion center — you can't take it at home. If you have Stage 2 T1D, you'll have one infusion per day for 14 days in a row. If you...
- How is Tzield given, and how long does it take?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Teplizumab-mzwv — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.05 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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8.78 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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0.26 mg / 1 mL
UNII E1W4N241FO
A salt compound derived from phosphoric acid and sodium, used as a buffer to help maintain the medication's pH level and as a filler to give the tablet or capsule its proper form and size.
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1.13 mg / 1 mL
UNII 5QWK665956
A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9381 | $39.217 / J9381 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tzield 1 mg/mLthis 73650-0316-10 | Provention | 10 vials | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Nov 17, 2034 |
Is there a biosimilar for TZIELD 2 MG/2 ML VIAL?
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💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73650-0316-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | Active |
| 73650-0316-10 You're viewing this | 10 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-10) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | Active |
| 73650-0316-14 | 14 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-14) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | Active |
Pack size FAQ
What quantity is in NDC 73650-0316-10?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease.
The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Severe lymphopenia may be prolonged in adults. ( 5.1 , 5.4 ) Test patients for active EBV and CMV infection prior to starting treatment.
TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection). Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion.
If viral reactivation is suspected, discontinue TZIELD. ( 2.6 , 4 , 5.1 , 5.4 ) WARNING: Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk.
Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Severe lymphopenia may be prolonged in adults.
( 5.1 , 5.4 ) Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection). Adhere to lymphocyte count monitoring requirements and discontinuation recommendations.
Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD. ( 2.6 , 4 , 5.1 , 5.4 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TZIELD is indicated to [see Dosage and Administration (2.1) ]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline [see Clinical Studies (14.2) ] .
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D. TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions .
TZIELD is a CD3-directed antibody indicated to: ( 1 ) Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use : ( 1 ) There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D. TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Confirm Stage 2 T1D by documenting at least two positive pancreatic islet autoantibodies in those who have dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available ( 2.1 ). In patients who meet criteria for a diagnosis of Stage 2 T1D ensure the patient's diagnosis confirms an autoimmune origin and does not suggest insulin resistance due to obesity, type 2 diabetes (T2D) or dysglycemia due to other forms of diabetes.
Confirm Stage 3 T1D by documenting at least one positive pancreatic islet cell autoantibody and peak C-peptide ≥0.2 pmol/mL on a mixed-meal tolerance test (MMTT) or alternative method if appropriate and MMTT is not available ( 2.1 ). Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests and evaluate patients for active EBV and CMV infection, including assessment of viral load (e.g., polymerase chain reaction testing). Consider expert consultation for appropriate laboratory and clinical evaluation to assess for active EBV or CMV infection.
Use of TZIELD is not recommended in patients with certain laboratory abnormalities. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection) ( 2.2 ). Premedicate with: (1) a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, (2) an antihistamine, and (3) consider use of an antiemetic before each TZIELD dose for at least the first 5 days of the treatment course ( 2.3 ).
Administer TZIELD by intravenous infusion once daily for 14 days (Stage 2) or 12 days (Stage 3). See full prescribing information for the recommended dosage, dosing schedule, minimum infusion duration according to age, and recommendations regarding missed doses ( 2.4 , 2.5 ). See full prescribing information for recommendations on: monitoring lymphocyte counts, liver enzymes, bilirubin, and symptoms of viral reactivation; and discontinuing treatment ( 2.6 ).
Must dilute TZIELD in 0.9% Sodium Chloride Injection, USP. See full prescribing information for detailed preparation and administration instructions ( 2.7 ).
2.1Patient Selection Patients with Stage 2 T1D Select adult and pediatric patients 1 year of age and older with Stage 2 T1D for TZIELD treatment to delay the onset of Stage 3 T1D based on the confirmation of: At least two positive pancreatic islet cell autoantibodies, and Dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT): If an OGTT is not available, an alternative method for diagnosing dysglycemia without overt hyperglycemia may be appropriate. In adults aged 18 years or older , recommend following the definition of dysglycemia used in clinical trials to diagnose dysglycemia prior to use of TZIELD due to the lack of specificity of other measures [see Clinical Studies (14.1) ] .
Ensure the patient's diagnosis confirms an autoimmune origin and does not suggest insulin resistance due to obesity, type 2 diabetes (T2D) or dysglycemia due to other forms of diabetes. These may include, but are not limited to, genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery. Patients with Stage 3 T1D Select pediatric patients aged 8 to 17 years recently diagnosed (within the last 8 weeks) with Stage 3 T1D for TZIELD treatment to delay the decline in endogenous insulin production based on confirmation of both of the following: At least one positive pancreatic islet cell autoantibody Peak C-peptide ≥0.2 pmol/mL on a mixed-meal tolerance test (if a mixed meal tolerance test is not available, an alternative method for measuring peak C-peptide ≥0.2 pmol/mL may be appropriate).
2.2Laboratory and Infection Evaluation, and Vaccination Prior to Initiation Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Use of TZIELD is not recommended…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 2 mg/2 mL (1 mg/mL) clear and colorless solution in a single-dose vial. Injection: 2 mg/2 mL (1 mg/mL) single-dose vial ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection) [see Warnings and Precautions (5.1) ]. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection) ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): Premedicate, monitor liver enzymes and bilirubin during treatment, and discontinue in those that develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN. If severe CRS develops, consider temporarily pausing or discontinuing TZIELD. ( 5.2 ).
Serious Infections: 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 ( 5.3 ).
Lymphopenia: Monitor lymphocyte counts during the treatment period. If prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) develops, discontinue TZIELD ( 5.4 ). Hypersensitivity Reactions: If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly ( 5.5 ).
Vaccinations: Administer all age-appropriate vaccinations prior to starting TZIELD. See the full PI for recommendations regarding live-attenuated, inactivated, and mRNA vaccines ( 5.6 ).
5.1Viral Reactivation Serious, life-threatening cases of viral reactivation, including EBV and CMV infections, have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk.
TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection). The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. The duration of severe lymphopenia following TZIELD treatment may be prolonged in adults [see Warnings and Precautions (5.4) ].
Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm absence of active infection on assessment of viral load (e.g., PCR). TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection) [see Dosage and Administration (2.2) ].
During treatment with TZIELD, regularly monitor lymphocyte counts [see Dosage and Administration (2.6) , Warnings and Precautions (5.4) ] and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. Consider appropriate expert consultation for diagnostic testing recommendations as some diagnostic tests may give inaccurate results following treatment with TZIELD, including rapid heterophile antibody testing.
If viral reactivation is confirmed, permanently discontinue TZIELD [see Dosage and Administration (2.6) ]. Consider appropriate expert consultation for the management of severe viral reactivation.
5.2Cytokine Release Syndrome Cytokine release syndrome (CRS) has been observed in TZIELD-treated patients. In a pool of clinical trials, CRS was reported in 5% of TZIELD-treated patients compared to 0.8% of control-treated patients. In the PROTECT study, CRS was reported in 9% of TZIELD-treated patients compared to 1% of placebo-treated patients during the treatment period and through 28 days after the last study drug administration.
Manifestations of CRS in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment [see Adverse Reactions (6.1) ] . To m…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the Prescribing Information: Viral Reactivation [see Warnings and Precautions (5.1) ] Cytokine Release Syndrome [see Warnings and Precautions (5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Lymphopenia [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase and headache ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Provention Bio, Inc. at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Placebo-Controlled Study in Adult and Pediatric Patients Aged 8 Years and Older with Stage 2 T1D (TN-10) The data in Table 2 are derived from the placebo-controlled study (Study TN-10) in adult and pediatric patients aged 8 years and older with Stage 2 T1D [see Clinical Studies (14.1) ].
These data reflect exposure of 44 patients of whom 93% completed the full 14-day treatment course. Table 2 presents common (≥5%) adverse reactions that occurred during treatment and through 28 days after the last study drug administration in patients with Stage 2 T1D in Study TN-10. Adverse reactions observed in pediatric patients 8 years and older who received TZIELD were consistent with those reported in adult patients in this study.
Table 2. Common Adverse Reactions That occurred during treatment and through 28 days after the last study drug administration. in Adult and Pediatric Patients Aged 8 Years and Older with Stage 2 T1D (Study TN-10) Adverse reactions that occurred in 2 or more TZIELD-treated patients Adverse Reaction TZIELD N=44 Placebo N=32 Lymphopenia Grouped term includes other related terms 73% 6% Rash 36% 0% Leukopenia 21% 0% Headache 11% 6% Neutropenia 5% 3% Increased alanine aminotransferase 5% 3% Nausea 5% 3% Diarrhea 5% 0% Nasopharyngitis 5% 0% Placebo-Controlled Trial in Pediatric Patients Aged 8 to 17 Years with Stage 3 T1D In a 78-week placebo-controlled trial (PROTECT) in patients aged 8 to 17 years recently diagnosed with Stage 3 T1D, 328 patients were randomized to TZIELD or placebo daily by intravenous infusion for a 12-day course followed by another 12-day course 6 months later [see Clinical Studies (14.2) ].
Table 3 presents common adverse reactions (≥5%) that occurred during either of the two 12-day treatment courses and through 28 days after the last dose of study drug administration in the PROTECT trial. Table 3. Common Adverse Reactions Adverse reactions occurring in equal or more than 5% of participants in the TZIELD group, higher in TZIELD compared to placebo, in treatment course 1 through 28 days after the last dose. in Pediatric Patients Aged 8 to 17 Years with Stage 3 T1D (PROTECT Study) Adverse Reaction TZIELD n=217 Placebo n=111 Course 1 Lymphopenia Grouped term includes other related terms.
51% 3% Rash 51% 9% Leukopenia 34% 3% Nausea 34% 12% Headache 29% 16% Vomiting 26% 5% Neutropenia 23% 5% Abdominal pain 18% 11% Pyrexia 16% 3% Alanine aminotransferase increased 11% 0% Diarrhea 10% 6% Cytokine release syndrome 7% 1% Hypotension 7% 6% Aspartate aminotransferase increased 7% 1% Hemoglobin decreased 5% 4% Chills 5% 0% No new adverse reactions were observed with the second course of TZIELD treatment. Incidence rates were similar than those reported during the first treatment course. Pool of Five Controlled Clinical Studies in Stage 2 or Stage 3 T1D Adverse reactions in TZIELD-treated patients were also evaluated in a larger pool of adult and pediatric patients who participated in five controlled clinical studies (including Study TN-10…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy ( 8.1 ). Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration ( 8.2 ).
8.1Pregnancy Risk Summary Available case reports from clinical trials with TZIELD are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on teplizumab-mzwv in nonclinical studies, monoclonal antibodies can be actively transported across the placenta, and TZIELD may cause immunosuppression in the utero - exposed infant (see Clinical Considerations ). To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy.
TZIELD is not active in rodents. In animal reproduction studies, mice were given a surrogate anti-mouse CD3 antibody subcutaneously during organogenesis through lactation. Pups born to dams administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Report pregnancies to Provention Bio, Inc.'s Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.
Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because teplizumab-mzwv may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. There are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab-mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero.
Data Animal Data In an embryo-fetal developmental toxicity study, pregnant mice were administered a murine surrogate anti-mouse CD3 antibody by subcutaneous injection at dose levels of 0, 0.03, 0.3, or 20 mg/kg on Gestation Days 6, 10, and 14. Increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity. In a pre- and postnatal development toxicity study in pregnant mice, in which the murine surrogate antibody was administered every 3 days from gestation day 6 through lactation day 19 at doses of 0, 0.3, 3, or 20 mg/kg, no maternal toxicity or increased incidence of post-implantation loss was observed.
Reductions in T cell populations and increases in B cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (KLH) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. The surrogate antibody was present in the offspring serum at level less than 1.5% that of maternal serum at the high dose. A trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg.
The human relevance of this finding is unknown.
8.2Lactation Risk Summary There are no data on the presence of teplizumab-mzwv in either human or animal milk, the effects on the breastfed child, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to teplizumab-mzwv are unknown.
Although the developmental and health benefits of breastfeeding should be considered along with the mother's clinica…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available case reports from clinical trials with TZIELD are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on teplizumab-mzwv in nonclinical studies, monoclonal antibodies can be actively transported across the placenta, and TZIELD may cause immunosuppression in the utero - exposed infant (see Clinical Considerations ). To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy.
TZIELD is not active in rodents. In animal reproduction studies, mice were given a surrogate anti-mouse CD3 antibody subcutaneously during organogenesis through lactation. Pups born to dams administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. Report pregnancies to Provention Bio, Inc.'s Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.
Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because teplizumab-mzwv may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. There are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab-mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero.
Data Animal Data In an embryo-fetal developmental toxicity study, pregnant mice were administered a murine surrogate anti-mouse CD3 antibody by subcutaneous injection at dose levels of 0, 0.03, 0.3, or 20 mg/kg on Gestation Days 6, 10, and 14. Increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity. In a pre- and postnatal development toxicity study in pregnant mice, in which the murine surrogate antibody was administered every 3 days from gestation day 6 through lactation day 19 at doses of 0, 0.3, 3, or 20 mg/kg, no maternal toxicity or increased incidence of post-implantation loss was observed.
Reductions in T cell populations and increases in B cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (KLH) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. The surrogate antibody was present in the offspring serum at level less than 1.5% that of maternal serum at the high dose. A trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg.
The human relevance of this finding is unknown.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TZIELD have been established to: Delay the onset of Stage 3 T1D in pediatric patients 1 year of age and older with Stage 2 T1D. Use of TZIELD for this indication is supported by evidence from an adequate and well-controlled study (Study TN-10) in adult and pediatric patients 8 years of age and older (including 29 pediatric patients) with Stage 2 T1D and from additional pharmacokinetic and safety data in 23 pediatric patients aged 1 to less than 8 years of age with Stage 2 T1D (PETITE T1D) [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] .
Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. Use of TZIELD for this indication is supported by an adequate and well-controlled study (PROTECT Study) in pediatric patients recently diagnosed with Stage 3 T1D [see Clinical Studies (14.2) ] . Adverse reactions observed in pediatric patients 1 year of age and older who received TZIELD were consistent with those reported in adults [see Adverse Reactions (6.1) ] .
The safety and effectiveness of TZIELD have not been established to delay the onset of Stage 3 T1D in pediatric patients younger than 1 year of age with Stage 2 T1D. The safety and effectiveness of TZIELD have not been established to delay the decline in endogenous insulin production in pediatric patients less than 8 years of age years recently diagnosed with Stage 3 T1D.
🧓 Geriatric Use ▾
8.5Geriatric Use Stage 2 T1D is largely a condition that occurs in pediatric and younger adult patients. Clinical studies of TZIELD to delay the onset of Stage 3 T1D did not include patients 65 years of age and older.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 T1D in adult and pediatric patients aged 1 year and older with Stage 2 T1D and delays the decline in endogenous insulin production in patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood.
12.2Pharmacodynamics Clinical studies have shown that teplizumab-mzwv binds to CD3 molecules on the surface of both CD4+ and CD8+ T cells during TZIELD treatment, with internalization of the teplizumab-mzwv/CD3 complex from the surface of T cells. Pharmacodynamic effects include lymphopenia in the absence of depletion of T cells with a nadir approximately on the 5 th day of dosing, during a 14-day course (Stage 2) or 12-day course (Stage 3) of TZIELD treatment [see Warnings and Precautions (5.4) ]. Teplizumab-mzwv exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of teplizumab-mzwv have not been fully characterized.
12.3Pharmacokinetics Distribution The central volume of distribution (Vd) of teplizumab-mzwv was
2.27L in a 60 kg subject. Elimination Teplizumab-mzwv showed saturable binding and elimination. The clearance of teplizumab-mzwv is
2.66L/day in a 60 kg subject. Metabolism Teplizumab-mzwv is expected to be metabolized into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of teplizumab-mzwv were observed based on age (1 to 35 years old), sex, or racial groups (White, Asians).
Pediatric Patients 1 to Less Than 8 Years Old No clinically significant difference in the AUC of teplizumab-mzwv was observed in pediatric patients aged 1 to less than 8 years compared to that in adult and pediatric patients aged 8 years and older. By extending the infusion duration from 30 minutes to 2 hours in pediatric patients aged 1 to less than 8 years, the C max of teplizumab-mzwv was comparable to that in adult and pediatric patients aged 8 years and older. Body weight BSA-based dosing normalizes the exposure to teplizumab-mzwv across body weight.
12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of teplizumab-mzwv or of other teplizumab products. In the placebo-controlled study in patients aged 8 years of age and older with Stage 2 T1D (Study TN-10) [see Clinical Studies (14.1) ] , approximately 57% (24/42) of TZIELD-treated patients developed anti-teplizumab-mzwv antibodies after one 14-day course of TZIELD treatment, 46% (11/24) of whom developed neutralizing antibodies.
There was a higher incidence of rash in TZIELD-treated patients who developed anti-teplizumab-mzwv antibodies (39%) compared to those who did not develop anti-teplizumab-mzwv antibodies (33%) [see Adverse Reactions (6.1) ] . Results from the analysis up to Week 52 from the PETITE-T1D study in patients 1 to less than 8 years of age with Stage 2 T1D, approximately 87% (20/23) of TZIELD-treated patients developed anti-teplizumab-mzwv antibodies, 70% (14/20) of whom developed neutralizing antibodies [see Adverse Reactions (6.1) ] .
There was a higher incidence of skin and subcutaneous tissue disorders (most of which were mild or moderate) in TZIELD-treated patients who developed anti-teplizumab-mzwv antibodies (70%) compared to those who did not develop anti-teplizumab-mzwv antibodies (33%) [see Adverse Reactions (6.1) ] . There is insufficient inf…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 T1D in adult and pediatric patients aged 1 year and older with Stage 2 T1D and delays the decline in endogenous insulin production in patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING TZIELD (teplizumab-mzwv) injection is a clear and colorless solution (2 mg/2 mL (1 mg/mL)) supplied in a single-dose vial as follows: Carton Contents NDC 1 single dose vial NDC 73650-316-01 Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Store upright. Do not freeze or shake the vials.
Once diluted, it is recommended that the product should be used immediately [see Dosage and Administration (2.7) ] .
📦 Storage and Handling ▾
Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Store upright. Do not freeze or shake the vials. Once diluted, it is recommended that the product should be used immediately [see Dosage and Administration (2.7) ] .
📋 Description ▾
11 DESCRIPTION Teplizumab-mzwv is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that has a molecular weight of approximately 150 kilodalton (kDa) and is expressed from a recombinant Chinese hamster ovary (CHO) cell line. TZIELD (teplizumab-mzwv) injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. Each mL contains 1 mg of teplizumab-mzwv, dibasic sodium phosphate (0.26 mg), monobasic sodium phosphate (0.98 mg), polysorbate 80 (0.05 mg), sodium chloride (8.78 mg), and water for injection.
The pH is 6.1.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Viral Reactivation Inform patients that TZIELD may cause serious, life-threatening viral reactivation, including EBV and CMV infections. Instruct patients to contact their healthcare provider immediately if they develop any symptoms of viral reactivation (such as fever, malaise, or swollen glands) during or at least 2 months after TZIELD treatment [see Warnings and Precautions (5.1) ].
Cytokine Release Syndrome Advise patients that TZIELD may cause cytokine release syndrome (CRS), which most commonly occurs during the first 5 days of treatment. Inform the patient that signs and symptoms of CRS may include fever, nausea, vomiting, fatigue, headache, muscle or joint pain, and increased transaminases or bilirubin. Instruct patients to contact their healthcare provider promptly if any of these symptoms occur.
Inform patients that premedication will be given before each of the first 5 days of TZIELD infusion to help reduce the risk of CRS [see Warnings and Precautions (5.2) ] . Serious Infections Advise patients that TZIELD may lower the immune system's ability to fight infections. Instruct patients to contact their healthcare provider immediately if they develop signs or symptoms of infection during or after TZIELD treatment [see Warnings and Precautions (5.3) ] .
Lymphopenia Advise patients that a decrease in white blood cell counts (lymphopenia) is common with TZIELD treatment and in some instances it may be severe and may require discontinuation. Instruct patients to inform their healthcare provider immediately of fatigue, malaise, swollen glands, or signs of infection, as these may indicate lymphopenia [see Warnings and Precautions (5.4) ]. Hypersensitivity Reactions Advise patients that TZIELD may cause serious allergic reactions, including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm.
Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking TZIELD and seek medical attention promptly if such symptoms occur [see Warnings and Precautions (5.5) ]. Vaccinations Advise patient to receive all age-appropriate vaccinations prior to starting TZIELD. Instruct patients to contact their healthcare provider before receiving any vaccination prior to any TZIELD treatment course, during treatment, or after a treatment course [see Warnings and Precautions (5.6) ].
Advise patient to contact their healthcare provider if planning any vaccination between treatment courses [see Warnings and Precautions (5.6) ] . Pregnancy Advise patients to inform their healthcare provider of a known or suspected pregnancy. Inform patients that TZIELD may cause fetal harm and that use of TZIELD during pregnancy and at least 30 days prior to a planned pregnancy should be avoided.
Advise patients who are exposed to TZIELD during pregnancy to contact Provention Bio, Inc.'s Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi [see Use in Specific Populations (8.1) ] . Lactation Advise a lactating woman that she may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after TZIELD administration to minimize drug exposure to a breastfed child [see Use in Specific Populations (8.2) ].
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2026 MEDICATION GUIDE TZIELD ® (TEE-zeeld) (teplizumab-mzwv) injection, for intravenous use What is the most important information I should know about TZIELD?
TZIELD may cause serious side effects, including: Viral Reactivation . Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in your body after an initial infection. TZIELD may cause these viruses to become active again which, especially in people with a weakened immune system, can become serious and potentially life-threatening.
These infections can happen during treatment with TZIELD and for up to 2 months after your last dose. Your healthcare provider will test you for active EBV and CMV infections before treatment with TZIELD. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD (such as fever, swollen glands, or fatigue).
Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include: fever nausea with or without vomiting feeling tired (fatigue) headache muscle and joint pain increased liver enzymes in your blood These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.
Serious Infections : Treatment with TZIELD may lower your immune system's ability to fight infections, which may increase your risk of getting a serious infection. TZIELD is not recommended if you currently have a serious infection, or an infection that keeps coming back or does not go away (chronic infection), other than a minor skin infection. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD such as. fever or chills redness, warmth, or swelling of the skin feeling tired cough or shortness of breath severe stomach pain or diarrhea Decrease in white blood cells.
TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body's ability to fight infections. A decrease in white blood cell counts can happen after your first dose of any treatment course.
Your white blood cell counts will start to go back to normal after your fifth dose of TZIELD. Some people may develop longer and more severe decreases in lymphocytes. Your healthcare provider will do blood tests to check for active infections, verify your liver function and your complete blood counts before you start treatment and during treatment with TZIELD.
During and after your treatment with TZIELD, your healthcare provider will check for side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection or viral reactivation, or if your blood counts stay too low. See " What are the possible side effects of TZIELD? " for more information about side effects.
What is TZIELD? TZIELD is a prescription medicine used to: delay the onset of Stage 3 type 1 diabetes (T1D) in adults and children 1 year of age and older who have Stage 2 T1D delay the decline in insulin produced by the body (endogenous) in children 8 to 17 years of age who were recently diagnosed with Stage 3 T1D It is not known if TZIELD is safe and effective in children under 1 year of age who have Stage 2 T1D. It is not known if TZIELD is safe and effective in children under 8 years of age who have Stage 3 T1D.
There is limited evidence of TZIELD being safe and effective in people 45 years of age and older with Stage 2 T1D. TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions . These are conditions when your blood sugar goes too high and is not caused by your immune system.
Do not take TZIELD if you have a w…