Version July 2025
Note: The FDA-approved dose does not reflect the dose used in the premarket clinical trial due to pharmacokinetic differences between the product used in the clinical trial and the product that was FDA approved; therefore, do not use the doses used in the clinical trial (Ref). Safety: Avoid use in patients with laboratory or clinical evidence of active serious infection (including acute Epstein-Barr virus or cytomegalovirus infection) or chronic infections other than localized skin infections.
Diabetes mellitus, type 1, delay onset of symptomatic disease (stage 3):
Note: For use in patients with stage 2 type 1 diabetes mellitus (ie, at least 2 positive pancreatic islet cell autoantibodies, dysglycemia without overt hyperglycemia following an oral glucose tolerance test, and clinical history not suggestive of type 2 diabetes mellitus).
Premedicate with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine, and/or an antiemetic for the first 5 days of teplizumab infusions to mitigate risk of cytokine release syndrome; administer additional doses of premedication, if needed.
IV: Administer once daily for 14 consecutive days using BSA as follows:
Day 1: 65 mcg/m2.
Day 2: 125 mcg/m2.
Day 3: 250 mcg/m2.
Day 4: 500 mcg/m2.
Days 5 through 14: 1,030 mcg/m2.
Missed doses: If a planned dose is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course. Do not administer 2 doses on the same day.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Avoid use in patients with ALT or AST >2 times ULN or bilirubin >1.5 times ULN; discontinue teplizumab for AST or ALT >5 times ULN or for bilirubin >3 times ULN.
Cytokine release syndrome: Treat symptoms of cytokine release syndrome (CRS) with antipyretics, antihistamines, and/or antiemetics; if severe CRS occurs, consider temporarily pausing dosing for 1 to 2 days or discontinuing treatment.
Lymphopenia: In most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within 2 weeks after treatment completion and without dose interruption; however, discontinue therapy if prolonged severe lymphopenia (ie, <500 cells/mcL lasting ≥1 week) occurs.
Refer to adult dosing; clinical studies did not include patients ≥65 years of age.
(For additional information see "Teplizumab: Pediatric drug information")
Diabetes mellitus, type 1, delay onset of symptomatic disease (stage 3):
Note: For use in patients with confirmed stage 2 type 1 diabetes mellitus (T1DM) (ie, at least 2 positive pancreatic islet cell autoantibodies and dysglycemia without overt hyperglycemia [using oral glucose tolerance test (OGTT) or alternative method if OGTT not available]). Patients should be current with all age-appropriate immunizations prior to initiation.
Premedication: Premedicate with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine, and/or an antiemetic prior to the first 5 infusions; for subsequent infusions, administer additional premedication doses as needed.
Children ≥8 years and Adolescents with stage 2 T1DM: IV: Administer once daily for 14 consecutive days as follows:
Day 1: IV: 65 mcg/m2 once.
Day 2: IV: 125 mcg/m2 once.
Day 3: IV: 250 mcg/m2 once.
Day 4: IV: 500 mcg/m2 once.
Days 5 through 14: IV: 1,030 mcg/m2 once daily.
Dosing adjustment for toxicity:
Children ≥8 years and Adolescents: IV:
Cytokine-release syndrome (CRS): Treat symptoms of CRS with antipyretics, antihistamines, and/or antiemetics; if severe CRS occurs, consider temporarily pausing dosing for 1 to 2 days or discontinuing treatment.
Lymphopenia: Lymphocyte <500 cells/mcL for ≥1 week duration: Discontinue therapy.
There are no dosage adjustments provided in the manufacturer's labeling.
Children ≥8 years and Adolescents: IV:
Hepatic impairment prior to treatment initiation:
There are no dosage adjustments provided in the manufacturer's labeling. Use not recommended in patients with ALT or AST >2 times ULN or bilirubin >1.5 times ULN.
Hepatotoxicity during therapy:
AST or ALT >5 times ULN or bilirubin >3 times ULN: Discontinue therapy.
Cytokine release syndrome (CRS) has been reported in patients treated with teplizumab, including serious cases. Symptoms may include fever, nausea, fatigue, headache, myalgia, arthralgia, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, and increased total bilirubin. In clinical studies, the median duration of the CRS event was 3 days, and most cases were grade 1 and 2, although grade 3 events leading to treatment discontinuation were observed (Ref).
Mechanism: Dose-related; teplizumab-induced T-cell activation results in systemic inflammatory effects (Ref).
Onset: Rapid; most reactions occurred within 5 days of treatment initiation (range: 3 to 6 days) (Ref).
Lymphocytopenia has commonly been reported with teplizumab, including rare severe episodes (lymphocytes <500 cells/mcL). In most cases, lymphocyte levels began to recover after the fifth day of treatment and returned to baseline within 2 to 6 weeks without dose interruption (Ref). Additionally, leukopenia, neutropenia, anemia, and thrombocytopenia have been reported.
Mechanism: Lymphopenia: Dose-related; T-cell modulation results in transient reductions in lymphocytes from peripheral blood (Ref).
Hypersensitivity reactions, including anaphylaxis, angioedema, and serum sickness, have been reported with teplizumab use. Mild to moderate skin rash has been frequently reported; serious rash has been rarely reported.
Bacterial infection and viral infection, including serious infection, have occurred with teplizumab use. Reported infections include gastroenteritis, cellulitis, pneumonia, abscesses, sepsis, wound infection, Epstein-Barr infection, herpes simplex infection, cytomegalovirus disease, and varicella zoster infection (Ref).
Mechanism: Dose-related; due to suppression of T-cell immune function (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults. Note: The FDA-approved dose does not reflect the dose used in the premarket clinical trial due to pharmacokinetic differences between the product used in the clinical trial and the product that was FDA approved; therefore, adverse reactions and incidences reported in the product labeling may differ from the product that was FDA approved (FDA 2021; Herold 2019).
>10%:
Dermatologic: Skin rash
Hematologic & oncologic: Leukopenia, lymphocytopenia
Nervous system: Headache
1% to 10%:
Gastrointestinal: Diarrhea, nausea
Hematologic & oncologic: Neutropenia
Hepatic: Increased serum alanine aminotransferase
Hypersensitivity: Cytokine release syndrome, serum sickness
Infection: Serious infection (including abscess, cellulitis, gastroenteritis, pneumonia, sepsis, wound infection)
Respiratory: Nasopharyngitis
Frequency not defined: Infection: Bacterial infection, viral infection (including cytomegalovirus disease, Epstein-Barr infection, herpes simplex infection, and varicella zoster infection) (FDA 2021)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Immunogenicity: Development of anti-teplizumab antibodies, including neutralizing antibodies, may occur during therapy. Antibody-positive patients may have an increased incidence of adverse events (eg, rash).
Disease-related concerns:
• Liver function: Avoid use in patients with ALT or AST >2 times ULN or bilirubin >1.5 times ULN.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Other warnings/precautions:
• Immunizations: The safety of immunization with live-attenuated vaccines in patients treated with teplizumab has not been established; teplizumab may interfere with the immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate immunizations before initiating therapy, if possible. Administer live vaccines ≥8 weeks prior to initiation or >52 weeks after completing treatment; administer inactivated vaccines ≥2 weeks prior to initiation or >6 weeks after completing treatment.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Tzield: Teplizumab-mzwv 2 mg/2 mL (2 mL) [contains polysorbate 80]
No
Solution (Tzield Intravenous)
2 mg/2 mL (per mL): $8,646.57
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Dilute prior to administration; begin infusion within 2 hours of preparation. Administer over ≥30 minutes; complete infusion within 4 hours after the start of preparation. Premedicate with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine, and/or an antiemetic for the first 5 days of teplizumab infusions to mitigate risk of cytokine release syndrome.
Note: Premedicate with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine, and/or an antiemetic prior to each teplizumab infusion for the first 5 days to mitigate risk of cytokine-release syndrome.
IV: Dilute prior to administration; begin infusion within 2 hours of preparation. Infuse teplizumab over ≥30 minutes; complete infusion within 4 hours after the start of preparation.
Missed doses : If a planned dose is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Tzield: https://proventionbio.com/s/tzield-medication-guide.pdf
Diabetes mellitus, type 1, delay onset of symptomatic disease (stage 3): To delay the onset of stage 3 type 1 diabetes mellitus in adults and pediatric patients ≥8 years of age with stage 2 type 1 diabetes mellitus.
Teplizumab may be confused with Tepezza, tepotinib, teprotumumab.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Teplizumab may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of BCG Products. Risk X: Avoid
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Chikungunya Vaccine (Live): Teplizumab may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Therapeutic Immunosuppressant Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing therapeutic immunosuppressants several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Teplizumab may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Management: Administration of the COVID-19 vaccine (inactivated virus) is not recommended during the 2 weeks prior to teplizumab, during treatment, or for 6 weeks following treatment. Risk D: Consider Therapy Modification
COVID-19 Vaccine (mRNA): Teplizumab may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: mRNA vaccines are not recommended during the 2 weeks before teplizumab, during treatment, or for 6 weeks afterward. The CDC recommends a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Teplizumab may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Management: Inactivated vaccines are not recommended during the 2 weeks prior to teplizumab, during therapy, or for 6 weeks afterward. Reduced efficacy of the vaccine may occur if administered to patients on immunosuppressant therapy. Risk D: Consider Therapy Modification
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Teplizumab may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Risk X: Avoid
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Denosumab. Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Teplizumab may decrease therapeutic effects of Influenza Virus Vaccines. Management: Influenza virus vaccines are not recommended in the 2 weeks prior to teplizumab treatment, during treatment, or for 6 weeks after treatment. Reduced efficacy of the vaccine may occur if administer to patients taking teplizumab. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Teplizumab may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Pimecrolimus. Risk X: Avoid
Pneumococcal Vaccines: Teplizumab may decrease therapeutic effects of Pneumococcal Vaccines. Management: Vaccination with inactivated vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during therapy, or for 6 weeks after completion of therapy. See full mono for recommendations for number, order, and timing of vaccines. Risk D: Consider Therapy Modification
Poliovirus Vaccine (Live/Trivalent/Oral): Teplizumab may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Teplizumab may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Use with non-biologic disease-modifying antirheumatic drugs (DMARDs) was permitted in psoriatic arthritis clinical trials. Risk X: Avoid
Typhoid Vaccine: Teplizumab may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Typhoid Vaccine. Risk X: Avoid
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Teplizumab may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Teplizumab may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Vaccination with non-live/inactivated/non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Teplizumab may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Therapeutic Immunosuppressant Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Administration of teplizumab should be avoided for at least 30 days prior to planning a pregnancy to minimize fetal exposure.
Teplizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
In utero exposure to teplizumab may cause immunosuppression in the newborn. Administration of teplizumab should be avoided during pregnancy.
Health care providers are encouraged report pregnancies exposed to teplizumab to the Provention Bio Inc adverse event reporting line (1-844-778-2246).
It is not known if teplizumab is present in breast milk
Teplizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Patients may express and discard milk during therapy and for 20 days after the last dose of teplizumab to decrease exposure to the breastfeeding child.
Monitor CBC and liver chemistries (eg, AST, ALT, total bilirubin) prior to initiating therapy. Monitor liver chemistries, lymphocytes, and signs/symptoms of cytokine release syndrome, infection, or hypersensitivity daily throughout therapy.
Teplizumab-mzwv binds to CD3 (a cell surface antigen) on both CD4+ and CD8+ T cells, which leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood. The mechanism behind the delay in progression from stage 2 to stage 3 type 1 diabetes mellitus may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes.
Distribution: Vd: 2.27 L (in a 60 kg subject).
Metabolism: Metabolized into small peptides via catabolic pathways.
Half-life elimination: Mean: 4.5 days (in a 60 kg subject).
Excretion: Clearance: Mean: 2.7 L/day (in a 60 kg subject).
