Teplizumab, the first immunomodulator to delay the onset of type 1 diabetes, requires standardized use and comprehensive management to ensure its efficacy.

Administration and Dosage of Teplizumab

1. Eligible Populations and Treatment Course

(1) This drug is indicated for adults and children aged 8 years and older diagnosed with Stage 2 type 1 diabetes.

(2) The treatment regimen consists of once-daily intravenous infusions for 14 consecutive days.

2. Dosage Calculation and Regimen

Dosing is precisely calculated based on body surface area (BSA) with a step-up titration schedule:

(1) Day 1: 65 micrograms per square meter (μg/m²)

(2) Day 2: 125 μg/m²

(3) Day 3: 250 μg/m²

(4) Day 4: 500 μg/m²

(5) Days 5–14: Maintain 1,030 μg/m²

(6) Each infusion must last a minimum of 30 minutes. No two doses may be administered on the same day.

3. Pre-Infusion Preparation

(1) Prior to each infusion, the drug must be diluted to the specified concentration with 0.9% sodium chloride injection.

(2) The reconstituted infusion solution must be administered within 4 hours; any unused portion should be discarded.

(3) To ensure medication safety, premedication is required before each infusion for the first 5 days of treatment, typically including an antipyretic-analgesic (e.g., ibuprofen or acetaminophen), an antihistamine, and an antiemetic.

Key Administration Considerations

1. Pre-Treatment Evaluation

(1) Confirm diagnosis: Verify the presence of at least two islet autoantibodies and dysglycemia confirmed by an oral glucose tolerance test (OGTT), and rule out type 2 diabetes.

(2) Comprehensive testing: Perform a complete blood count (CBC), liver function tests, and targeted infectious disease screening.

(3) Complete vaccinations: All age-appropriate vaccinations must be completed before treatment initiation.

2. Monitoring and Management During Treatment

(1) Cytokine release syndrome (CRS): Monitor for fever, headache, myalgia, nausea, and elevated liver enzymes within the first 5 days. Manage with premedication and symptomatic treatment; hold the drug for severe cases.

(2) Infection risk: The drug temporarily impairs immunity. Be alert for signs of infection (e.g., fever, cough, sore throat). Discontinue treatment for severe infections.

(3) Blood cell counts: Regularly monitor CBC, paying attention to lymphopenia. Consider treatment interruption for severe and persistent lymphopenia.

(4) Hypersensitivity reactions: Watch for rash, urticaria, facial or oropharyngeal edema, and other anaphylactic symptoms. Administer emergency management for severe reactions.

3. Missed Dose Management

(1) If a scheduled infusion is missed, resume treatment the next day and complete all remaining doses on consecutive days to finish the 14-day course.

(2) Do not administer two doses on the same day.

Healthy Lifestyle During Treatment

1. Balanced Nutrition and Blood Glucose Monitoring

(1) Healthy diet: Adhere to a balanced dietary pattern to ensure adequate nutrient intake and support immune function.

(2) Regular monitoring: Follow your physician’s advice to periodically monitor blood glucose (e.g., fasting and postprandial glucose) and glycated hemoglobin (HbA1c) to track changes in glycemic regulation.

2. Infection Prevention and Personal Hygiene

(1) Enhanced protection: Due to temporary immunosuppression, maintain strict personal hygiene (e.g., frequent handwashing), avoid crowded or poorly ventilated areas, and reduce exposure to infectious individuals during and for a period after treatment.

(2) Prompt reporting: Seek medical attention immediately if any suspected infection symptoms occur.