Teplizumab, as an innovative immunomodulator, can delay the onset of type 1 diabetes while potentially causing a range of manageable adverse effects.

Common and Serious Adverse Reactions of Teplizumab

1. Very Common Adverse Reactions

Based on clinical study data, adverse reactions with an incidence rate exceeding 10% primarily include:

(1) Lymphopenia: The most common reaction, occurring in approximately 73% of patients. It is an expected pharmacodynamic effect of the drug, typically reaching its trough around Day 5 and resolving spontaneously within weeks after treatment completion.

(2) Rash: Likely to occur in 36% to 48% of patients. Presentations vary, including erythema, maculopapular eruptions, and pruritic rashes; most cases are mild and self-limiting.

(3) Leukopenia: Incidence rate of approximately 21%. Associated with lymphopenia, it may compromise the body’s ability to fight infections.

(4) Headache: Incidence rate of approximately 11%.

2. Serious Adverse Reactions Requiring Vigilance

A small number of patients may experience serious reactions that require medical intervention:

(1) Cytokine Release Syndrome (CRS): Incidence rate of approximately 5%. Usually occurs within the first 5 days of treatment, with symptoms including fever, fatigue, nausea, headache, myalgia, arthralgia, and elevated liver enzymes. Treatment should be held for severe cases.

(2) Serious Infections: Incidence rate higher than that in the placebo group. Due to temporary immunosuppression induced by the drug, the risk of infections such as gastroenteritis, pneumonia, and cellulitis may increase.

(3) Severe Lymphopenia: Approximately 0.9% of patients may develop prolonged and severe lymphopenia (<500 cells/μL), necessitating permanent discontinuation of treatment.

(4) Hypersensitivity Reactions: Including serum sickness, angioedema, urticaria, bronchospasm, and in severe cases, anaphylaxis.

(5) Other Hematological Effects: Anemia, thrombocytopenia, neutropenia, and transient elevations in liver enzymes may occur.

Management and Mitigation Strategies for Adverse Reactions

1. Premedication

To reduce the incidence and severity of CRS, premedication is routinely administered prior to each infusion for the first 5 days of treatment, including:

(1) Antipyretic-Analgesics: Such as nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen) or acetaminophen.

(2) Antihistamines.

(3) Antiemetics.

(4) Continuation: May be continued in subsequent treatments based on the patient’s response.

2. Close Monitoring During Treatment

(1) Laboratory Monitoring: Complete blood counts and liver function tests must be regularly monitored before and during treatment. This facilitates early detection of severe lymphopenia, liver injury, or other hematological abnormalities.

(2) Clinical Symptom Monitoring: Healthcare providers and patients should closely monitor for fever, signs of infection (e.g., cough, sore throat, dysuria), severe rash, dyspnea, or edema. Immediate reporting is required if any of these occur.

3. Targeted Interventions

(1) For CRS: Symptomatic and supportive care is the mainstay, such as using antipyretic-analgesics to control fever and pain. If liver enzymes are markedly elevated (ALT/AST >5 times the upper limit of normal) or severe symptoms develop, consideration should be given to holding treatment for 1–2 days or permanently discontinuing the drug.

(2) For Infections: Teplizumab should be held and antimicrobial therapy initiated in the event of a serious active infection.

(3) For Persistent Severe Lymphopenia: Permanent discontinuation is recommended if severe lymphopenia persists for more than one week.

(4) For Hypersensitivity Reactions: In the event of a severe allergic reaction, treatment must be immediately discontinued and emergency medical intervention administered, such as the use of epinephrine, corticosteroids, etc.

Storage of Unopened Medicinal Product

Teplizumab injection (2mg/2mL) is supplied as single-dose vials and must be stored under strict conditions:

Temperature: Store at 2°C to 8°C (36°F to 46°F) (refrigerated).

Storage Method: Keep upright in the original packaging to protect from light.

Prohibitions: Do not freeze or shake the vials vigorously.