Teplizumab Dosage
Medically reviewed by Drugs.com. Last updated on Mar 18, 2025.
Applies to the following strengths: mzwv 2 mg/2 mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 1
Usual dose: Body surface area-based dosing by intravenous infusion once daily
Dosing:
- 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
Duration of therapy: 14 days
Comments:
- Confirm the presence of Stage 2 type 1 diabetes by documenting at least two positive pancreatic islet cell autoantibodies and state of dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT); an alternate test may be used if OGTT is not available.
- Patients should not have type 2 diabetes.
- Complete blood count and liver enzyme tests should be done before initiating the treatment.
- This drug is not recommended in patients with:
- Lymphocyte count less than 1,000 lymphocytes/mcL
- Hemoglobin less than 10 g/dL or Platelet count less than 150,000 platelets/mcL
- Absolute neutrophil count less than 1,500 neutrophils/mcL
- Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (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 (EBV) or cytomegalovirus (CMV)
- Active serious infection or chronic active infection other than localized skin infections
- All age-appropriate vaccination should be completed before initiating the treatment.
- Administer premedication before every dosing for the first 5 days with:
- A nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen
- An antihistamine and/or an antiemetic
- If a dose is missed, resume the administration of remaining doses based on 14-day dosing schedule.
- Do not administer this drug twice on the same day.
Use: To delay the onset of Stage 3 type 1 diabetes in patients of 8 years or older
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 8 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer this drug by intravenous route.
Storage requirements:
- Refrigerate at 2C to 8C (36F to 46F) in the original carton to protect from light.
- Store upright.
- Do not freeze or shake the vial.
- After reconstitution, store the solution at room temperature and use it within 4 hours.
Reconstitution/preparation techniques:
- Refer to manufacturer product information for detailed instruction.
Patient advice:
- Advise patient to read FDA-approved patient labeling.
- Patients should be informed of the signs and symptoms of CRS.
- Inform patients about the potential of this drug to weaken the immune response and to reach out to their health care provider if any symptoms of infection appear.
- Inform patients about the occurrence of lymphopenia and that in severe cases the treatment must be discontinued.
- Patients should be advised to stop the treatment and seek immediate medical attention if any signs and symptoms of hypersensitivity reaction develop.
- All appropriate vaccines should be taken prior to the start of the treatment and administration of live, inactivated, and mRNA vaccines should be avoided during treatment.
- Notify healthcare provider about known or suspected pregnancy.
- If pregnant women are exposed to this drug, contact Provention Bio, Inc.'s Adverse Event reporting line at 1-844-778-2246.
- Lactating women should stop breastfeeding and pump and discard breast milk during the treatment and for 20 days after the last dose of the drug to minimize drug exposure to a breastfed infant.
Frequently asked questions
More about teplizumab
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- Side effects
- During pregnancy
- Drug class: miscellaneous antidiabetic agents
- Breastfeeding
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.