Product image of Tzield (teplizumab-mzwv) (Teplizumab) 1 mg/mL INJECTION supplied by GNH India

Tzield (teplizumab-mzwv)

Active Ingredient:
Teplizumab
Form:
INJECTION
Brand:
Tzield
Origin:
USA

Tzield (teplizumab-mzwv) (Teplizumab INJECTION) 1 mg/mL

Tzield (teplizumab) is an FDA-approved monoclonal antibody therapeutic indicated for delaying the clinical onset of Stage 2 Type 1 Diabetes in at-risk patients. Approved in November 2022, it represents a breakthrough in diabetes prevention and is classified as an orphan drug for this rare indication. Tzield operates within the endocrinology and bone specialty therapeutic area.

Strength

1 mg/mL

Pack Size

1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Manufacturer / TM Owner

Sanofi

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

Indications & Clinical Uses

  • Tzield is used to delay the progression from Stage 2 to Stage 3 (clinical) Type 1 Diabetes in patients with confirmed autoimmunity and impaired glucose tolerance. The target patient population includes individuals with multiple diabetes-related autoantibodies who have not yet developed symptomatic diabetes. Teplizumab is a monoclonal antibody that binds to CD3 on T-lymphocytes, modulating the immune response and reducing the destruction of insulin-producing beta cells in the pancreas. By targeting the underlying autoimmune mechanism, Tzield provides a disease-modifying approach rather than symptomatic treatment. The drug is administered as an intravenous infusion over a 14-day treatment course. Clinical trials demonstrated that Tzield can delay the onset of clinical diabetes by a median of approximately 3 years in eligible patients, offering a significant window for disease management and lifestyle intervention.

Side Effects

  • Common adverse events include infusion reactions (fever, chills, nausea), lymphopenia, and transient increases in liver enzymes. Serious adverse events may include severe infections due to immune modulation, cytokine release syndrome, and anaphylaxis. Patients require baseline and periodic monitoring of complete blood counts, liver function tests, and immunological markers. Close clinical observation during and after infusion is essential. Lymphocyte counts typically recover within weeks post-treatment. Healthcare providers should monitor for signs of infection and educate patients on infection prevention strategies during the treatment period.

Precautions & Warnings

  • Tzield is contraindicated in patients with active infections or severe immunosuppression. Caution is advised in patients with hepatic or renal impairment, though dose adjustment is not required. Pregnancy category data is limited; use only if benefits outweigh risks. Pediatric use has been studied in clinical trials; safety and efficacy in children under 8 years are not established. Patients with a history of malignancy require careful risk-benefit assessment. Live vaccines should be avoided during treatment. Breastfeeding is not recommended due to potential immune effects on nursing infants. Patients with cardiac conditions or those taking concurrent immunosuppressive agents require enhanced monitoring.

Avoid Interactions

  • Tzield may interact with live vaccines and other immunosuppressive agents, potentially reducing vaccine efficacy or increasing infection risk. Concurrent use with other monoclonal antibodies or immunomodulatory drugs should be avoided or carefully managed. No significant food-drug interactions have been identified. Patients should inform healthcare providers of all medications, supplements, and recent vaccinations before treatment initiation. Timing of vaccinations relative to Tzield administration should be coordinated with the healthcare team to optimize immune response.

Frequently Asked Questions

Tzield is used to delay the clinical onset of Type 1 Diabetes in patients with Stage 2 disease who have confirmed autoimmunity and impaired glucose tolerance. It is the first FDA-approved therapy designed to modify the disease course by targeting the underlying autoimmune mechanism that destroys insulin-producing beta cells.

Tzield is administered as an intravenous infusion over a 14-day treatment course. Patients receive daily infusions in an outpatient or clinical setting with appropriate medical supervision and monitoring for infusion reactions.

Common side effects include infusion reactions such as fever, chills, and nausea, as well as temporary reductions in lymphocyte counts. Most adverse events are mild to moderate and resolve within days to weeks following treatment completion.

Tzield is manufactured by Sanofi, a global pharmaceutical company specializing in innovative therapeutics across multiple therapeutic areas including endocrinology.

Yes, Tzield received FDA orphan drug designation for Stage 2 Type 1 Diabetes due to the rarity of this specific disease stage and the unmet medical need. This designation provides regulatory incentives and market exclusivity to support development of this breakthrough therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Related Products

Other formulations containing Teplizumab

Tzield 2 mg

Tzield 2 mg

2 MG SOLUTION
Tzield

Tzield

1mg/ml Vials
Tzield

Tzield

1mg/ml Vials

Browse all products →

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Regulatory recognitions

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.

SGS GSDP Certification

GSDP Compliant from SGS

URS ISO 9001

URS ISO 9001 Certification

FDA Maharashtra

Licensed by FDA Maharashtra

IEC License DGFT

IEC License issued by DGFT