Teplizumab-mzwv injection
Teplizumab-mzwv injection (Tzield) is a CD3-directed antibody used to delay the progression of type 1 diabetes in eligible patients with Stage 2 or recently diagnosed Stage 3 type 1 diabetes.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Tzield carries a serious boxed warning about viral reactivation. In some patients, dormant viruses — especially Epstein-Barr virus (EBV) and cytomegalovirus (CMV) — have reactivated during or after Tzield treatment, causing life-threatening illness. People with weakened immune systems are at the highest risk. Serious cases have also occurred in adults with larger body size or conditions like adrenal insufficiency or cardiovascular disease. Most serious cases happened in people who kept receiving Tzield even after their lymphocyte counts (infection-fighting white blood cells) dropped severely and stayed low for a prolonged period.
Before starting Tzield, you must be tested for active EBV and CMV infection. Tzield cannot be used if you are immunocompromised or have an active viral infection. Your lymphocyte counts will be monitored regularly during treatment, and you should be watched for signs of viral infection — such as fever, fatigue, or swollen glands — both during treatment and for at least 2 months after your last infusion. If viral reactivation is suspected, Tzield must be stopped immediately.
📖 Teplizumab-mzwv injection: Patient Information Guide
A plain-language walkthrough of Teplizumab-mzwv injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tzield (teplizumab-mzwv) is an intravenous CD3-directed antibody approved for specific stages of autoimmune type 1 diabetes:
- Tzield delays the onset of Stage 3 type 1 diabetes in adults and children aged 1 year and older who have Stage 2 T1D (abnormal blood sugar without overt diabetes symptoms, confirmed by at least two positive pancreatic autoantibodies)
- Tzield delays the decline in the body's own insulin production in children and teens aged 8 to 17 years who were recently diagnosed (within the last 8 weeks) with Stage 3 T1D — this use is approved under accelerated approval based on a surrogate measure of insulin production, and continued approval depends on confirmatory trial results
- Tzield has limited evidence of safety and effectiveness in patients aged 45 and older with Stage 2 T1D
- Tzield is not effective for blood sugar problems that are not caused by an autoimmune process (for example, type 2 diabetes, obesity-related insulin resistance, or genetic forms of diabetes)
⚙️How it works▾
Tzield is an antibody that attaches to a protein called CD3, which sits on the surface of T cells — the immune cells that drive the autoimmune attack destroying insulin-producing beta cells in the pancreas. By binding to CD3, Tzield appears to send a partial signal that quiets down the T cells that mistakenly attack the pancreas, while increasing the proportion of regulatory T cells (which help keep immune activity in check) and promoting a state of exhaustion in certain attacking T cells. The result is a slowing of the immune-driven destruction of beta cells, which buys more time before blood sugar control is lost.
💊How it's taken▾
Tzield is given as an intravenous (IV) infusion by a healthcare provider — it cannot be taken by mouth. The dosing schedule depends on the stage of type 1 diabetes being treated:
- Stage 2 T1D: Once daily for 14 consecutive days
- Stage 3 T1D (ages 8–17): Once daily for 12 consecutive days, then a second 12-day course given 6 months later (and no later than 12 months after the first course)
- The infusion takes at least 30 minutes for patients aged 8 and older, and at least 2 hours for children aged 1 to under 8 years
- If a dose is missed, take it as soon as possible and continue remaining doses on consecutive days — never double up on the same day
🤒Side effects — in detail▾
The most common side effects seen with Tzield include:
- Lymphopenia — a drop in infection-fighting white blood cells (very common; usually recovers within weeks after treatment)
- Rash
- Leukopenia — low overall white blood cell count
- Nausea and vomiting
- Headache
- Neutropenia — low levels of a specific type of white blood cell
- Elevated liver enzymes
- Diarrhea
- Fever
- Decreased hemoglobin (lower red blood cell count)
More serious reactions — including viral reactivation, cytokine release syndrome, severe infections, and serious allergic reactions — require immediate medical attention and are described in the warnings section.
⚠️Warnings & precautions▾
- Viral reactivation (boxed warning): Dormant viruses like EBV and CMV can reactivate during or after treatment, causing life-threatening illness — especially in immunocompromised patients or those with severely low lymphocyte counts. Monitoring continues for at least 2 months after the last infusion.
- Cytokine release syndrome (CRS): An immune overreaction causing fever, low blood pressure, chills, and liver enzyme elevations can occur, particularly early in the treatment course. Premedications are given to reduce this risk.
- Serious infections: Tzield is not recommended for people with active serious infections or chronic active infections. Watch for signs of infection during and after treatment.
- Lymphopenia: A significant drop in white blood cells is expected and is closely monitored. If counts stay severely low, treatment must be stopped to prevent serious viral complications.
- Hypersensitivity reactions: Serious allergic reactions including anaphylaxis, angioedema (facial/throat swelling), and serum sickness have been reported. Get emergency help for any signs of a severe allergic reaction.
- Vaccinations: All age-appropriate vaccines should be given before starting Tzield. Live vaccines must be given at least 8 weeks before treatment; inactivated or mRNA vaccines at least 2 weeks before.
🔀What it interacts with▾
The Tzield label highlights specific concerns around immunosuppression and vaccination timing rather than named drug-drug interactions:
- Live vaccines — must not be given within 8 weeks before starting Tzield, and timing of live vaccines in infants exposed to Tzield in the womb requires careful consideration due to possible immune effects
- Inactivated or mRNA vaccines — should be completed at least 2 weeks before starting Tzield to ensure adequate immune response
- Any immunosuppressive therapy — patients who are already immunocompromised cannot use Tzield, as the combined effect on the immune system greatly increases the risk of serious viral reactivation and infection
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- You must be tested for active EBV and CMV infection before starting Tzield — Tzield is contraindicated (cannot be used) if you have an active viral infection
- Tzield is contraindicated if you are immunocompromised (have a weakened immune system for any reason)
- Blood counts and liver enzyme tests must be checked before starting — Tzield is not recommended if counts or enzymes are significantly abnormal
- Pregnancy: Tzield may harm an unborn baby. Avoid Tzield during pregnancy and for at least 30 days before a planned pregnancy. Report any pregnancy to your healthcare provider
- Breastfeeding: It is unknown whether Tzield passes into breast milk. A breastfeeding woman may consider pumping and discarding breast milk during treatment and for 20 days after the last dose
- Children under 1 year: Safety and effectiveness have not been established for Stage 2 T1D in children under 1 year old
- Children under 8 years with Stage 3 T1D: Safety and effectiveness have not been established for this use in children under 8 years old
- Adults aged 45 and older with Stage 2 T1D: Evidence of safety and effectiveness is limited in this age group
- Older adults (65+): Clinical studies did not include patients aged 65 and older
- Tell your doctor if you have adrenal insufficiency or cardiovascular disease — serious viral reactivation cases have been reported more often in adults with these conditions
📡Pharmacodynamics — effects in the body▾
After Tzield binds to CD3 on T cells, the drug-CD3 complex is drawn inside the cell (internalized), removing it from the cell surface. One of the key measurable effects is lymphopenia — a temporary drop in circulating lymphocytes (white blood cells) that typically reaches its lowest point around Day 4–5 of the treatment course, then recovers within weeks. Importantly, this drop in lymphocyte count occurs without actual depletion (permanent destruction) of the T cells. The exposure-response relationship — meaning exactly how the drug's levels in the blood relate to its benefits and risks — has not been fully characterized.
🔬Pharmacokinetics — how your body processes it▾
Tzield is broken down by the body through normal protein-digesting pathways (catabolism) into small peptides, similar to other antibody-based medicines. It shows what is called saturable binding and elimination — meaning how quickly it is cleared depends on how much is present. The drug is distributed in a relatively small volume, suggesting it stays mostly in the bloodstream and nearby tissues. Dosing is based on body surface area (BSA), which helps ensure consistent exposure across different body sizes. No clinically meaningful differences in how the drug is processed were seen based on age (1 to 35 years), sex, or race. In children under 8 years, extending the infusion time to 2 hours achieves drug exposure levels similar to those in older patients.
📦How to store it▾
Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Store upright. Do not freeze or shake the vials.
📄 Written from Teplizumab-mzwv injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Teplizumab-mzwv injection
89 supplements and herbal products have documented interactions with Teplizumab-mzwv injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 85
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Teplizumab-mzwv injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Tzield do — is it a cure for type 1 diabetes? ▾
How is Tzield given, and will I need to come in every day? ▾
What side effects should I expect, and which ones mean I need to call my doctor right away? ▾
I heard there's a serious warning about viruses — what does that mean for me? ▾
Can I get vaccinations before or during Tzield treatment? ▾
Is Tzield safe during pregnancy or breastfeeding? ▾
Is Teplizumab-mzwv injection available over the counter? ▾
When was Teplizumab-mzwv injection first available? ▾
💬 Answers drafted from Teplizumab-mzwv injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Teplizumab-mzwv injection comes
Teplizumab-mzwv injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Tzield is used to delay the onset of Stage 3 type 1 diabetes in adults and children aged 1 year and older with Stage 2 T1D
- Tzield is used to delay the decline in the body's own insulin production in children aged 8 to 17 years recently diagnosed with Stage 3 T1D
- Tzield is not recommended for blood sugar problems that are not due to an autoimmune cause
- Tzield has limited evidence of safety and effectiveness in patients aged 45 and older with Stage 2 T1D
- Tzield is given by intravenous infusion once daily — 14 consecutive days for Stage 2 T1D, or two separate 12-day courses (6 months apart) for Stage 3 T1D in patients aged 8–17
- Tzield infusion takes a minimum of 30 minutes in patients aged 8 and older, and a minimum of 2 hours in children aged 1 to under 8 years
- Tzield must be diluted in 0.9% Sodium Chloride Injection before administration — preparation is done by healthcare staff
- Before each of the first 5 Tzield infusions, patients receive premedication with a pain reliever (NSAID or acetaminophen), an antihistamine, and possibly an anti-nausea medicine
📊 Teplizumab-mzwv injection across the U.S. market
How Teplizumab-mzwv injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Teplizumab-mzwv injection is used
A general measure of how commonly Teplizumab-mzwv injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Teplizumab-mzwv injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Teplizumab-mzwv injection prescribed? Of the 1,597 medications we measure, Teplizumab-mzwv injection ranks #1,522 by Medicaid prescriptions — more than 5% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Teplizumab-mzwv injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Teplizumab-mzwv injection NDCs with Medicaid activity.
🔍 Compare Teplizumab-mzwv injection products
A representative set of FDA-listed product records for Teplizumab-mzwv injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1 mg/mL | Intravenous | Provention Bio, Inc. × 5 listings | BLA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Teplizumab-mzwv injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Teplizumab-mzwv injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Teplizumab-mzwv injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Teplizumab-mzwv injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Teplizumab-mzwv injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Teplizumab-mzwv injection belongs to the CD3-directed Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Provention Bio, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.