Version May 2024
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.
(For additional information see "Teplizumab: Drug information")
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 (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): $8,476.20
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.
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.
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.
Refrigerate unopened 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.
If not used immediately, prepared infusion solution may be stored at room temperature of 15°C to 30°C (59°F to 86°F) and infusion completed within 4 hours of the start of preparation; discard prepared infusion solution if not administered within 4 hours of the start of preparation.
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
To delay the onset of symptomatic (stage 3) type 1 diabetes mellitus (T1DM) in patients with stage 2 T1DM (FDA approved in ages ≥8 years and adults).
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Teplizumab may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Teplizumab may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Teplizumab may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administration of inactivated vaccines is not recommended during the 2 weeks prior to teplizumab treatment, during therapy, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Teplizumab may diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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
COVID-19 Vaccine (Virus-like Particles): Teplizumab may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Management: Administration of inactivated vaccines is not recommended within the 2 weeks preceding teplizumab therapy, during therapy, or for 6 weeks following therapy. Risk D: Consider therapy modification
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Teplizumab may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Mumps- Rubella- or Varicella-Containing Live Vaccines: Teplizumab may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Pimecrolimus. Risk X: Avoid combination
Pneumococcal Vaccines: Teplizumab may diminish the therapeutic effect 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 enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Teplizumab may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Therapeutic Immunosuppressant Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect 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 combination
Typhoid Vaccine: Teplizumab may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Therapeutic Immunosuppressant Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Teplizumab may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or 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
Vaccines (Live): Teplizumab may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Teplizumab may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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).
Monitor CBC and liver chemistries (eg, AST, ALT, total bilirubin) prior to initiating therapy. Monitor liver enzymes, lymphocytes, and signs/symptoms of cytokine-release syndrome, infection, or hypersensitivity throughout therapy. In teplizumab approval trials, CBC and liver chemistries were obtained daily to identify toxicities that may require alterations in 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).
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