Select a medication above to begin.
Tzield (teplizumab-mzwv)
teplizumab
Black Box Warnings .
Viral Reactivation
serious, life-threatening cases reported, including EBV and CMV reactivation; immunocompromised patients at incr. risk; most cases occurred in patients on tx despite persistent, severe lymphopenia; before tx start, evaluate for active EBV and CMV infection and confirm undetectable viral load; tx not recommended if lab or clinical evidence of active EBV or CMV infection; monitor lymphocytes as recommended and for signs/symptoms of viral reactivation during and >2mo after tx; D/C tx and obtain viral load if reactivation suspected
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = teplizumab-mzwv
diabetes mellitus prevention, type 1
- [65 mcg/m^2/dose IV x1 on day 1, then 125 mcg/m^2/dose IV x1 on day 2, then 250 mcg/m^2/dose IV x1 on day 3, then 500 mcg/m^2/dose IV x1 on day 4, then 1030 mcg/m^2/dose IV qd on days 5-14]
- Info: for patients with stage 2 type 1 diabetes mellitus to delay onset of stage 3 disease; premed with antipyretic, antihistamine before 1st 5 doses, then as needed; consider premed with antiemetic; D/C tx if lymphocytes <500 x1wk, ALT or AST >5x ULN, or bilirubin >3x ULN
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name clarification]
- Info: nonproprietary name = teplizumab-mzwv
diabetes mellitus prevention, type 1
- [1 yo and older]
- Dose: 65 mcg/m^2/dose IV x1 on day 1, then 125 mcg/m^2/dose IV x1 on day 2, then 250 mcg/m^2/dose IV x1 on day 3, then 500 mcg/m^2/dose IV x1 on day 4, then 1030 mcg/m^2/dose IV qd on days 5-14; Info: for patients with stage 2 type 1 diabetes mellitus to delay onset of stage 3 disease; premed with antipyretic, antihistamine before 1st 5 doses, then as needed; consider premed with antihistamine; D/C tx if lymphocytes <500 x1wk, ALT or AST >5x ULN, or bilirubin >3x ULN
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pregnancy
- baseline lymphocytes <1000
- baseline Hgb <10
- baseline Plt <150,000
- baseline ANC <1500
- baseline ALT or AST >2x ULN
- baseline bilirubin >1.5x ULN
- infection, active serious
- infection, chronic
- CMV infection, active
- EBV infection, active
- caution: patients of childbearing potential
- caution: immunocompromised patients
- caution: Down syndrome
Drug Interactions .
Overview
teplizumab
CD3 directed antibody
- immunomodulatory effects
- myelosuppressive effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- cytokine release syndrome
- infection, serious
- viral reactivation
- lymphopenia, including prolonged
- anemia
- thrombocytopenia
- DVT
- hypersensitivity reaction
- anaphylaxis
- angioedema
Common Reactions
- lymphopenia
- vomiting (peds patients)
- rash
- diarrhea
- anemia
- ALT or AST elevated
- leukopenia
- calcium decr.
- serum bicarbonate decr.
- thrombocytopenia
- headache
- infection, serious
- neutropenia
- cytokine release syndrome
- nausea
- nasopharyngitis
- serum sickness
Safety/Monitoring .
Monitoring Parameters
test for active CMV, EBV infection before tx start; CBC at baseline, then lymphocytes q2-3 days during tx and until recovery after tx; LFTs at baseline, then periodically; signs/symptoms of infection during and after tx; signs/symptoms of viral reactivation during and >2mo after tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available, though likely to cross placenta based on human data with other monoclonal antibodies; possible risk of neonatal immunosuppression based on drug's mechanism of action; for infants exposed to teplizumab in utero, weigh risk/benefit before administering live vaccines
Pregnancy Reporting
report any suspected fetal exposure to Provention Bio, Inc. at 1-800-633-1610 or https://ae.reporting.sanofi
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x30 days after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, consider holding breastfeeding during tx and x20 days after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for teplizumab: proteolytic degradation; CYP450: unknown
Excretion: for teplizumab: unknown; Half-life: unknown
Subclass: Diabetes: Anti-CD3 Antibodies
Mechanism of Action
for teplizumab: exact mechanism of action unknown; binds to CD3, may produce partial agonism and deactivation of pancreatic beta cell autoreactive T cells, increasing proportion of regulatory T cells and exhausted CD8+ T cells (monoclonal antibody)
Formulary .
No Formulary Selected
Join Now to View Patient Handouts!
Create a FREE epocrates Online account to access patient medication instructions. Your patients and caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Each handout addresses common concerns such as how to take the medication, and possible side effects.
Current Members: Sign In.
Pill Pictures
Join Now to View Pill Pictures!
Create a FREE epocrates Online account to access full-color images of medications within the drug monograph.
Current Members: Sign In.