pharmacopeia
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Boxed 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. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. ( 5.1 , 5.4 ) Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active 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 , 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. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. ( 5.1 , 5.4 ) Test patients for active EBV and CMV infection prior to starting treatment.

Mechanism of action

Sourced from openFDA

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. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes.

Indications

Sourced from openFDA
  • TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 type 1 diabetes [see Dosage and Administration (2.1) ] . TZIELD is a CD3-directed antibody indicated to 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 ( 1 ).ICD-10: E10.9

Contraindications

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  • None. None.contraindicated

Dosage & administration

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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 type 1 diabetes, ensure the patient's diagnosis confirms an autoimmune origin and does not suggest type 2 diabetes ( 2.1 ). Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., polymerase chain reaction testing). Use of TZIELD is not recommended in patients with certain laboratory abnormalities or patients with laboratory or clinical evidence of active infection with EBV or CMV ( 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 14-day treatment course ( 2.3 ). Administer TZIELD by intravenous infusion once daily for 14 days. See full prescribing information for the 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 for changes in 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.

Warnings & precautions

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Cytokine Release Syndrome (CRS): Premedicate, monitor liver enzymes, discontinue in those that develop elevated ALT or AST more than 5 times the upper limit of normal, and if severe CRS develops consider temporarily pausing dosing ( 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 white blood cell 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 recommendations regarding live-attenuated, inactivated, and mRNA vaccines ( 5.6 ). 5.1 Viral Reactivation Serious, life-threatening cases of viral reactivation, including EBV and CMV 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. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia [see Warnings and Precautions 5.4 ].

Adverse reactions

Sourced from openFDA

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 and headache ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Provention Bio at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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 The data in Table 1 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) ]. These data reflect exposure of 44 patients of whom 93% completed the full 14-day treatment course.

Use in specific populations

Sourced from openFDA

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 ). 8.1 Pregnancy 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.

Pharmacokinetics

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Metabolism
Distribution The central volume of distribution (Vd) of teplizumab-mzwv was 2.27 L in a 60 kg subject. Elimination Teplizumab-mzwv showed saturable binding and elimination.

Approval history

Sourced from openFDA
  • Nov 17, 2022BLABLA761183Provention Bio Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
493 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Rash11724%
  2. 2Nausea10722%
  3. 3Fatigue8617%
  4. 4Pyrexia8016%
  5. 5Headache6714%
  6. 6Vomiting6613%
  7. 7Lymphocyte Count Decreased387.7%
  8. 8Pain367.3%
  9. 9Chills346.9%
  10. 10Rash Pruritic326.5%
  11. 11Pruritus285.7%
  12. 12Diarrhoea244.9%
  13. 13White Blood Cell Count Decreased244.9%
  14. 14Alanine Aminotransferase Increased214.3%
  15. 15Aspartate Aminotransferase Increased193.9%

Clinical trials

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The 10 most recently updated of 27 ClinicalTrials.gov registrations naming Teplizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Teplizumab work?
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. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes.
What is Teplizumab used for?
According to FDA labeling, Teplizumab carries indications including: TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 type 1 diabetes [see Dosage and Administration (2.1) ] . TZIELD is a CD3-directed antibody indicated to 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 ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Teplizumab?
Teplizumab is classified as Other drugs used in diabetes, CD3-directed Antibody, Antibody-Surface Antigen Interactions, CD3-directed Antibody Interactions.
What are the brand names for Teplizumab?
Teplizumab is marketed under brand names including Tzield.
What are the contraindications for Teplizumab?
Teplizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for teplizumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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