teplizumab (Rx)

Brand and Other Names:teplizumab-mzwv, Tzield
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/2mL (1mg/mL) single-dose vial

Type 1 Diabetes Mellitus

Indicated to delay the onset of stage 3 type 1 diabetes mellitus (T1DM) in adults and children aged ≥8 years who currently have stage 2 type 1 diabetes

Premedicate with NSAID or acetaminophen, an antihistamine, and/or an antiemetic, for the first 5 days of dosing

Administer by IV infusion over 30 min qDay x 14 consecutive days

Dosage regimen

  • Day 1: 65 mcg/m2
  • Day 2: 125 mcg/m2
  • Day 3: 250 mcg/m2
  • Day 4: 500 mcg/m2
  • Days 5-14: 1,030 mcg/m2

Dosage Modifications

Renal or hepatic impairment: No recommendations listed in prescribing information

Dosing Considerations

Patient selection

  • Ensure patient’s clinical history does not suggest type 2 diabetes
  • Confirm stage 2 type 1 diabetes by documenting
    • At least 2 positive pancreatic islet cell autoantibodies
    • Dysglycemia without overt hyperglycemia using an oral glucose tolerance test (use an alternative method of diagnosing if oral test unavailable)

Laboratory evaluation before initiating

  • Obtain complete blood count and liver enzyme tests
  • Use NOT recommended if
    • <1,000 lymphocytes/mcL
    • Hgb <10 g/dL
    • <150,000 platelets/mcL
    • ANC <1,500/mcL
    • Elevated ALT or AST >2x ULN or bilirubin >1.5x ULN
    • Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
    • Active serious infection or chronic active infection other than localized skin infections

Age-appropriate vaccinations before initiating

  • Administer live-attenuated (live) vaccines at least 8 weeks before treatment
  • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks before treatment

Dosage Forms & Strengths

injectable solution

  • 2mg/2mL (1mg/mL) single-dose vial

Type 1 Diabetes Mellitus

Indicated to delay the onset of stage 3 type 1 diabetes mellitus (T1DM) in adults and children aged ≥8 years who currently have stage 2 type 1 diabetes

Premedicate with NSAID or acetaminophen, an antihistamine, and/or an antiemetic, for the first 5 days of dosing

Administer by IV infusion over 30 min qDay x 14 consecutive days

Dosage regimen

  • Day 1: 65 mcg/m2
  • Day 2: 125 mcg/m2
  • Day 3: 250 mcg/m2
  • Day 4: 500 mcg/m2
  • Days 5-14: 1,030 mcg/m2

Dosage Modifications

Renal or hepatic impairment: No recommendations listed in prescribing information

Dosing Considerations

Patient selection

  • Ensure patient’s clinical history does not suggest type 2 diabetes
  • Confirm stage 2 type 1 diabetes by documenting
    • At least 2 positive pancreatic islet cell autoantibodies
    • Dysglycemia without overt hyperglycemia using an oral glucose tolerance test (use an alternative method of diagnosing if oral test unavailable)

Laboratory evaluation before initiating

  • Obtain complete blood count and liver enzyme tests
  • Use NOT recommended if
    • <1,000 lymphocytes/mcL
    • Hgb <10 g/dL
    • <150,000 platelets/mcL
    • ANC <1,500/mcL
    • Elevated ALT or AST >2x ULN or bilirubin >1.5x ULN
    • Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
    • Active serious infection or chronic active infection other than localized skin infections

Age-appropriate vaccinations before initiating

  • Administer live-attenuated (live) vaccines at least 8 weeks before treatment
  • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks before treatment
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Interactions

Interaction Checker

and teplizumab

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (70)

              • adenovirus types 4 and 7 live, oral

                teplizumab decreases effects of adenovirus types 4 and 7 live, oral by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • anthrax vaccine adsorbed

                teplizumab decreases effects of anthrax vaccine adsorbed by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • anthrax vaccine adsorbed, adjuvanted

                teplizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • axicabtagene ciloleucel

                teplizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • BCG vaccine live

                teplizumab decreases effects of BCG vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • brexucabtagene autoleucel

                teplizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • cholera vaccine

                teplizumab decreases effects of cholera vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • ciltacabtagene autoleucel

                teplizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • COVID-19 vaccine, adjuvanted-Novavax

                teplizumab decreases effects of COVID-19 vaccine, adjuvanted-Novavax by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • COVID-19 vaccine, mRNA-Moderna

                teplizumab decreases effects of COVID-19 vaccine, mRNA-Moderna by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • COVID-19 vaccine, mRNA-Pfizer

                teplizumab decreases effects of COVID-19 vaccine, mRNA-Pfizer by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • COVID-19 vaccine, viral vector-Janssen

                teplizumab decreases effects of COVID-19 vaccine, viral vector-Janssen by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • dengue vaccine

                teplizumab decreases effects of dengue vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • diphtheria & tetanus toxoids

                teplizumab decreases effects of diphtheria & tetanus toxoids by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • diphtheria & tetanus toxoids/ acellular pertussis vaccine

                teplizumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

                teplizumab decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • Ebola Zaire vaccine

                teplizumab decreases effects of Ebola Zaire vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • haemophilus influenzae type b vaccine

                teplizumab decreases effects of haemophilus influenzae type b vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • hepatitis A vaccine inactivated

                teplizumab decreases effects of hepatitis A vaccine inactivated by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • hepatitis a/b vaccine

                teplizumab decreases effects of hepatitis a/b vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • hepatitis b vaccine

                teplizumab decreases effects of hepatitis b vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • human papillomavirus vaccine, bivalent

                teplizumab decreases effects of human papillomavirus vaccine, bivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • human papillomavirus vaccine, nonavalent

                teplizumab decreases effects of human papillomavirus vaccine, nonavalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • human papillomavirus vaccine, quadrivalent

                teplizumab decreases effects of human papillomavirus vaccine, quadrivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • idecabtagene vicleucel

                teplizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • influenza A (H5N1) vaccine

                teplizumab decreases effects of influenza A (H5N1) vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine (H5N1), adjuvanted

                teplizumab decreases effects of influenza virus vaccine (H5N1), adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine quadrivalent

                teplizumab decreases effects of influenza virus vaccine quadrivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine quadrivalent, adjuvanted

                teplizumab decreases effects of influenza virus vaccine quadrivalent, adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine quadrivalent, cell-cultured

                teplizumab decreases effects of influenza virus vaccine quadrivalent, cell-cultured by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine quadrivalent, intranasal

                teplizumab decreases effects of influenza virus vaccine quadrivalent, intranasal by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • influenza virus vaccine quadrivalent, recombinant

                teplizumab decreases effects of influenza virus vaccine quadrivalent, recombinant by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine trivalent

                teplizumab decreases effects of influenza virus vaccine trivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine trivalent, adjuvanted

                teplizumab decreases effects of influenza virus vaccine trivalent, adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • influenza virus vaccine trivalent, recombinant

                teplizumab decreases effects of influenza virus vaccine trivalent, recombinant by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • Japanese encephalitis virus vaccine

                teplizumab decreases effects of Japanese encephalitis virus vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • lisocabtagene maraleucel

                teplizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • measles (rubeola) vaccine

                teplizumab decreases effects of measles (rubeola) vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • measles mumps and rubella vaccine, live

                teplizumab decreases effects of measles mumps and rubella vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • measles, mumps, rubella and varicella vaccine, live

                teplizumab decreases effects of measles, mumps, rubella and varicella vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine

                teplizumab decreases effects of meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • meningococcal A C Y and W-135 diphtheria conjugate vaccine

                teplizumab decreases effects of meningococcal A C Y and W-135 diphtheria conjugate vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • meningococcal A C Y and W-135 polysaccharide vaccine combined

                teplizumab decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • meningococcal C and Y/haemophilus influenza type B vaccine

                teplizumab decreases effects of meningococcal C and Y/haemophilus influenza type B vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • meningococcal group B vaccine

                teplizumab decreases effects of meningococcal group B vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • pneumococcal vaccine 13-valent

                teplizumab decreases effects of pneumococcal vaccine 13-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • pneumococcal vaccine 15-valent

                teplizumab decreases effects of pneumococcal vaccine 15-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • pneumococcal vaccine 20-valent

                teplizumab decreases effects of pneumococcal vaccine 20-valent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • pneumococcal vaccine heptavalent

                teplizumab decreases effects of pneumococcal vaccine heptavalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • pneumococcal vaccine polyvalent

                teplizumab decreases effects of pneumococcal vaccine polyvalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • poliovirus vaccine inactivated

                teplizumab decreases effects of poliovirus vaccine inactivated by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • poliovirus vaccine live oral trivalent

                teplizumab decreases effects of poliovirus vaccine live oral trivalent by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • rabies vaccine

                teplizumab decreases effects of rabies vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • rabies vaccine chick embryo cell derived

                teplizumab decreases effects of rabies vaccine chick embryo cell derived by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • rotavirus oral vaccine, live

                teplizumab decreases effects of rotavirus oral vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • rubella vaccine

                teplizumab decreases effects of rubella vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • SARS-CoV-2 vaccine, inactivated

                teplizumab decreases effects of SARS-CoV-2 vaccine, inactivated by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

                teplizumab decreases effects of smallpox (vaccinia) vaccine, attenuated by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • smallpox (vaccinia) vaccine, attenuated

                teplizumab decreases effects of smallpox (vaccinia) vaccine, attenuated by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • smallpox (vaccinia) vaccine, live

                teplizumab decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine

                teplizumab decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • tetanus toxoid adsorbed or fluid

                teplizumab decreases effects of tetanus toxoid adsorbed or fluid by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • tick-borne encephalitis vaccine

                teplizumab decreases effects of tick-borne encephalitis vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              • tisagenlecleucel

                teplizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • typhoid polysaccharide vaccine

                teplizumab decreases effects of typhoid polysaccharide vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • typhoid vaccine live

                teplizumab decreases effects of typhoid vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • varicella virus vaccine live

                teplizumab decreases effects of varicella virus vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • yellow fever vaccine

                teplizumab decreases effects of yellow fever vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • zoster vaccine live

                teplizumab decreases effects of zoster vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.

              • zoster vaccine recombinant

                teplizumab decreases effects of zoster vaccine recombinant by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.

              Monitor Closely (2)

              • efgartigimod alfa

                efgartigimod alfa will decrease the level or effect of teplizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.

              • isavuconazonium sulfate

                teplizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                >10%

                Lymphopenia (73%)

                Rash (36-48%)

                Anemia (27%)

                Leukopenia (21%)

                Headache (11%)

                1-10%

                Serious infections (9%)

                Increased ALT (5%)

                Nausea (5%)

                Diarrhea (5%)

                Nasopharyngitis (5%)

                Cytokine release syndrome (2%)

                Urticaria (1.9%)

                Peripheral and generalized edema (1.6%)

                <1%

                Hypersensitivity

                Angioedema

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                Warnings

                Contraindications

                None

                Cautions

                Bacterial and viral infections (eg, gastroenteritis, cellulitis, pneumonia, abscess, sepsis) reported; not recommended with active, serious infection or chronic infection other than localized skin infections; monitor for signs and symptoms during and after treatment; if serious infection develops, treat appropriately and discontinue drug

                Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting, and bronchospasm reported; if severe hypersensitivity reactions occur, discontinue use and treat promptly

                Cytokine release syndrome (CRS)

                • CRS observed in clinical trials during treatment through 28 days after the last dose
                • CRS manifestations included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT/AST, and increased total bilirubin
                • These manifestations typically occurred during the first 5 days of treatment
                • To mitigate CRS
                  • Premedicate with antipyretics, antihistamines, and/or antiemetics before treatment
                  • Monitor liver enzymes during treatment
                  • Discontinue treatment in patients who develop elevated ALT or AST >5x ULN or bilirubin >3x ULN
                  • Treat symptoms of CRS with antipyretics, antihistamines and/or antiemetics
                  • If severe CRS develops, consider temporarily pausing dosing for 1-2 days (and administering the remaining doses to complete the full 14-day course on consecutive days) or discontinuing treatment

                Lymphopenia

                • Lymphopenia commonly occurs during treatment
                • In most patients who experienced lymphopenia, lymphocyte levels began to recover after day 5 of treatment and returned to pretreatment values within 2 weeks after completion and without dose interruption
                • Monitor WBC counts during treatment period
                • Discontinue if prolonged severe lymphopenia (<500 cells/mcL lasting ≥1 week) develops

                Drug interaction overview

                • Vaccinations
                  • Administer all age-appropriate vaccinations prior to starting teplizumab
                  • Live-attenuated vaccines: Not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment
                  • Inactivated or mRNA vaccines: Not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment
                  • Safety of immunization with live-attenuated vaccines in treated patients has not been studied
                  • Additionally, teplizumab may interfere with immune response to vaccination and decrease vaccine efficacy
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                Pregnancy & Lactation

                Pregnancy

                Available case reports from clinical trials 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, monoclonal antibodies can be actively transported across the placenta, and teplizumab may cause immunosuppression in the utero-exposed infant

                Minimize fetal exposure by avoiding use during pregnancy and at least 30 days (6 half-lives) before planned pregnancy

                Report pregnancies to Provention Bio, Inc.’s Adverse Event reporting line at 1-844-778-2246

                Clinical considerations

                • Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester
                • Because teplizumab may interfere with immune response to infections, consider risks and benefits before administering live vaccines to infants exposed to in utero
                • Data are insufficient regarding infant serum levels of teplizumab at birth and the duration of persistence in infant serum after birth to identify a specific time frame to delay live virus immunizations in infants exposed in utero

                Animal studies

                • Mice were given a surrogate anti-mouse CD3 antibody SC during organogenesis through lactation
                • Pups born to dams who were administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology

                Lactation

                No data are available regarding presence of teplizumab in either human or animal milk, effects on breastfed children, or effects on milk production

                Endogenous maternal IgG and monoclonal antibodies are transferred into human milk

                A lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after administration to minimize drug exposure to a breastfed child

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Humanized monoclonal antibody (mAb) that targets the cluster of differentiation 3 (CD3) antigen, which is coexpressed with the T-cell receptor (TCR) on the surface of T lymphocytes

                The Fc region of the mAb has been engineered to have Fc receptor nonbinding (FNB) properties to avoid adverse effects (eg, cytokine release) associated with intact Fc

                Mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes, leading to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood

                Absorption

                Steady state concentrations are not expected to be achieved during the 14-day course

                Distribution

                Vd: 2.27 L (60-kg patient)

                Metabolism

                Expected to be metabolized into small peptides by catabolic pathways

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                Administration

                IV Compatibilities

                0.9% NaCl

                IV Preparation

                Inspect visually before use (supplied solution is clear and colorless); discard if particulate matter or coloration observed

                Preparation of diluted 10 mcg/mL solution

                • Prepare using aseptic technique; each vial is for single dose only
                • Prepare a sterile glass vial or PVC infusion bag with 18 mL of 0.9% NaCl, and slowly add 2 mg (2 mL) of teplizumab
                • Mix gently by slowly inverting vial or rocking infusion bag
                • Resulting 20 mL diluted solution contains 100 mcg/mL

                Preparation of infusion bag using diluted solution

                • Using an appropriately sized syringe (eg, 5 mL), withdraw volume of diluted teplizumab solution required for that day’s calculated dose from 100 mcg/mL solution
                • Slowly add contents of the syringe containing the dose to 25 mL 0.9% NaCl PVC infusion bag
                • Gently rock infusion bag to ensure the solution mixes sufficiently; do not shake
                • Discard unused portion of remaining diluted teplizumab solution in the sterile glass vial or PVC infusion bag
                • Start infusion within 2 hr of preparation
                • If not used immediately, store at room temperature (15-30ºC [59-86ºF]) and complete infusion within 4 hr of the start of preparation
                • Discard infusion solution if not administered within 4 hr of preparation

                IV Administration

                Infuse over 30 minutes

                Premedicate with NSAID or acetaminophen, an antihistamine, and/or an antiemetic for the first 5 days of dosing

                Missed dose

                • If a planned infusion 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

                Storage

                Unopened vials

                • Refrigerate at 2-8ºC (36-46ºF) in the original carton to protect from light
                • Store upright
                • Do not freeze or shake the vials

                Diluted solution

                • If not used immediately, store at room temperature (15-30ºC [59-86ºF]) and complete infusion within 4 hr of the start of preparation
                • Discard if not administered within 4 hr of preparation

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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                • View the formulary and any restrictions for each plan.
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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.