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Tzield Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vials (2mL)—1, 10, 14
Manufacturer
Generic Availability
NO
Mechanism of Action
Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 type 1 diabetes. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood.
Tzield Indications
Indications
To delay onset of Stage 3 type 1 diabetes in patients ≥8yrs with Stage 2 type 1 diabetes.
Tzield Dosage and Administration
Adults and Children
<8yrs: not established. Confirm Stage 2 type 1 diabetes with ≥2 positive pancreatic islet cell autoantibodies, dysglycemia without overt hyperglycemia using an oral glucose tolerance test. Premedicate for the first 5 days of dosing with an NSAID or APAP, an antihistamine, and/or an antiemetic. Give as IV infusion once daily over ≥30mins. Dosing based on body surface area. ≥8yrs: Day 1: 65mcg/m2; Day 2: 125mcg/m2; Day 3: 250mcg/m2; Day 4: 500mcg/m2; Days 5–14: 1030mcg/m2.
Tzield Contraindications
Not Applicable
Tzield Boxed Warnings
Not Applicable
Tzield Warnings/Precautions
Warnings/Precautions
Risk of cytokine release syndrome (CRS). Obtain CBCs and liver tests prior to and during treatment. Discontinue if ALT/AST >5×ULN or bilirubin >3×ULN develops. If severe CRS develops, consider interrupting for 1–2 days or discontinuing treatment. Lymphocytes <1000 lymphocytes/mcL, hemoglobin <10g/dL, platelets <150,000 platelets/mcL, ANC <1500 neutrophils/mcL, ALT/AST >2×ULN, bilirubin >1.5×ULN, acute EBV or CMV infection, active serious or chronic active infection (other than localized skin infections): not recommended. Monitor for infection during and post-treatment; discontinue and treat if serious infection develops. Monitor WBCs; discontinue if severe lymphopenia (<500 cells/mcL lasting ≥1 week) develops. Discontinue if severe hypersentivity reactions occur. Complete all age-appropriate vaccinations prior to initiation. Pregnancy: not recommended (during and ≥30 days prior to planned pregnancy). Nursing mothers: discard breast milk during and for 20 days after treatment.
Tzield Pharmacokinetics
Elimination
Half-life: 4.5 days.
Tzield Interactions
Interactions
May interfere with response to vaccine or reduce efficacy. Avoid inactivated or mRNA vaccines within 2 weeks prior to, during, or 6 weeks post-treatment. Avoid live-attenuated vaccines within 8 weeks prior to, during, or up to 52 weeks post-treatment.
Tzield Adverse Reactions
Adverse Reactions
Lymphopenia, rash, leukopenia, headache; cytokine release syndrome, infections, hypersensitivity reactions.
Tzield Clinical Trials
See Literature
Tzield Note
Not Applicable
Tzield Patient Counseling
See Literature
