teplizumab

Contraindicated in:

Active or chronic infection (excluding localized skin infection);
Laboratory or clinical evidence of acute infection with Epstein-Barr virus or cytomegalovirus;
Lymphocyte count <1000 cells/mcL;
Hemoglobin <10 g/dL;
Platelet count <150,000 cells/mcL;
Absolute neutrophil count <1500 cells/mcL;
Elevated ALT or AST >2 times upper limit of normal (ULN) or bilirubin >1.5 times ULN;
OB: Pregnancy.

Use Cautiously in:

Lactation: Safety not established during breastfeeding;
Rep: Women of reproductive potential;
Pedi: Children <8 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

F and E: ↓bicarbonate, hypocalcemia

GI: ↑liver enzymes, diarrhea, nausea

Hemat: anemia, leukopenia, lymphopenia, thrombocytopenia, neutropenia

Neuro: headache

Misc: cytokine release syndrome (CRS), HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA), infection

Interactions ⬆ ⬇

Drug-drug:

May ↓ effectiveness of vaccines; do not administer inactivated or mRNA vaccines within 2 wk prior to treatment, during treatment, or for 6 wk after treatment completed; do not administered live-attenuated vaccines within 8 wk prior to treatment, during treatment, or up to 52 wk after treatment completed.

Availability ⬆ ⬇

Solution for injection: 1 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults and Children >8 yr): Day 1: 65 mcg/m² as single dose; Day 2: 125 mcg/m² as single dose; Day 3: 250 mcg/m² as single dose; Day 4: 500 mcg/m² as single dose; Day 5–14: 1030 mcg/m² once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to the CD3 on both CD4+ and CD8+ T cells, which may lead to partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes.

Therapeutic effects:

Delayed progression of stage 2 to stage 3 type 1 diabetes.

Classifications ⬆ ⬇

Therapeutic Classification: antidiabetics

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways; excretion pathway unknown.

Half-Life: 4.5 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Inform patient that vaccinations are not recommended during therapy.
Advise patient to notify health care professional for symptoms of CRS (fever, fatigue, nausea, headache, muscle and joint pain) or serious infection (cellulitis, gastroenteritis, pneumonia, wound infection).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. May interrupt breastfeeding and pump, discarding breast milk, during therapy and for 20 days after last dose. If exposed to teplizumab during pregnancy, encourage patient to contact Provention Bio, Inc.’s adverse event line at 1-844-778-2246.

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Indications ⬇

Contraind./Precautions ⬆ ⬇