TEPLIZUMAB-MZWV INJ,SOLN

Clinical Criteria Summary

Type 1 or type 2 diabetes
Lymphocyte count less than 1,000 lymphocytes/mcL
Hemoglobin less than 10 g/dL
Platelet count less than 150,000 platelets/mcL
Absolute neutrophil count less than 1,500 neutrophils/mcL
Elevated ALT or AST greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN
Laboratory or clinical evidence of acute infection with Epstein-Barr virus or cytomegalovirus
Active serious infection or chronic active infection other than localized skin infections
Requires inactivated or mRNA vaccinations within the 2 weeks prior to teplizumab treatment, during treatment, or 6 weeks after completion of treatment
Requires live-attenuated vaccinations within the 8 weeks prior to teplizumab treatment, during treatment, or up to 52 weeks after treatment
Note: Safety of immunization with live-attenuated vaccines has not been studied; teplizumab may interfere with immune response and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting treatment. Administer live-attenuated vaccines at least 8 weeks prior. Administer inactivated or mRNA vaccines at least 2 weeks prior.

Provider is a VA or VA Community Care endocrinologist
Has relative with type 1 diabetes (age ≤45 years if parent, sibling, or offspring; age ≤20 years if second or third degree relative)
At least two positive pancreatic islet cell autoantibodies (Anti-GAD65, insulin autoantibody, anti-IA-2, islet cell autoantibody, anti-ZnT8)
Dysglycemia without overt hyperglycemia on TWO occasions during an oral glucose tolerance test (OGTT)
Dysglycemia defined as: fasting glucose level of 110 to 125 mg/dL, OR a 2-hour postprandial plasma glucose level of 140 mg/dL and less than 200 mg/dL, OR a postprandial glucose level at 30, 60, or 90 minutes ≥200 mg/dL

Pregnancy must be excluded prior to receiving teplizumab
Do not use during pregnancy and at least 30 days (6-half-lives) prior to planned pregnancy
Counseling provided on potential risks vs benefits of treatment
Use of effective contraception during therapy

Indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D
Adults up to age 45 years
Must have a relative with T1D
Must have ≥2 pancreatic islet cell autoantibodies
Must demonstrate dysglycemia on oral glucose tolerance test (OGTT)

Obtain complete blood count and liver enzyme tests prior to initiating therapy
Lymphocyte count must be ≥1,000 lymphocytes/mcL
Hemoglobin must be ≥10 g/dL
Platelet count must be ≥150,000 platelets/mcL
Absolute neutrophil count must be ≥1,500 neutrophils/mcL
ALT or AST must not exceed 2 times the upper limit of normal (ULN)
Bilirubin must not exceed 1.5 times ULN
No laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
Females of reproductive potential require a pregnancy test prior to treatment

Administer by intravenous infusion over a minimum of 30 minutes once daily for 14 days
Dosing schedule: 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
Premedicate prior to infusion for the first 5 days with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine, and/or an antiemetic

Monitor liver enzymes; discontinue if ALT or AST develops >5 times ULN
Monitor white blood cell counts during treatment; discontinue if prolonged severe lymphopenia (<500 cells/µL lasting 1 week or longer) develops
Treat cytokine release syndrome (CRS) symptoms with antipyretics, antihistamines, and/or antiemetics
If severe CRS develops, temporarily pause dosing for 1-2 days (administer remaining doses on consecutive days to complete the 14-day course) or discontinue treatment
Discontinue treatment if serious infections develop

Not recommended in patients with active serious infection or chronic active infection other than localized skin infections
Discontinue for severe hypersensitivity reactions
Only one course of therapy is approved; effect of repeated courses is unknown

Pregnancy: Do not receive during pregnancy and at least 30 days before a planned pregnancy
Breastfeeding: Pump and discard breast milk during treatment and for 20 days after receiving treatment
Vaccinations: Administer all age-appropriate vaccinations prior to starting; live-attenuated vaccines at least 8 weeks prior; inactivated or mRNA vaccines at least 2 weeks prior