Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (3)
- 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.
- ublituximab
ublituximab and teplizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
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
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
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.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
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
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
