Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
WARNING
VIRAL REACTIVATION
Tzield (teplizumab-mzwv) is a CD3-directed antibody. Teplizumab-mzwv is a humanized monoclonal antibody (IgG1 kappa) that binds to the CD3 antigen on T-lymphocytes. The teplizumab-mzwv molecule has a molecular weight of approximately 150 kDa. It is produced by a Chinese hamster ovary cell line.
Tzield (teplizumab-mzwv) injection is a sterile, clear, colorless, preservative-free solution for intravenous infusion. Each single-dose vial contains 2 mg of teplizumab-mzwv in 2 mL (1 mg/mL). Each mL also contains dibasic sodium phosphate (0.26 mg), monobasic sodium phosphate (0.71 mg), polysorbate 80 (0.05 mg), sodium chloride (8.77 mg), and Water for Injection, USP. The pH is 6.1.
TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see DOSAGE AND ADMINISTRATION].
Select adult and pediatric patients 1 year of age and older with Stage 2 T1D for Tzield treatment to delay the onset of Stage 3 T1D based on the confirmation of:
Ensure the patient’s diagnosis confirms an autoimmune origin and does not suggest type 2 diabetes or other forms of diabetes. These may include, but are not limited to, genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes in adults (LADA), or diabetes secondary to medications or surgery.
Prior to each of the first 5 days of Tzield infusion:
If needed, administer additional premedication doses.
Calculate the dosage using a body surface area (BSA) and administer Tzield once daily for 14 consecutive days as follows:
Administer Tzield by intravenous infusion over a minimum of:
If a planned Tzield infusion is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.
Do not administer two doses on the same day.
Using the dose calculated according to BSA, dilute Tzield prior to preparing the infusion according to the instructions below:
Tzield Dilution Preparation:
Tzield Infusion Solution Preparation:
Use of in-line filter is not recommended. If necessary, use a polyethylene sulfone (PES) filter. Do not use light protected (colored) infusion sets.
Injection: 2 mg per 2 mL (1 mg/mL) clear and colorless solution in a single-dose vial.
TZIELD (teplizumab-mzwv) injection is a clear and colorless solution (2 mg/2 mL (1 mg/mL)) supplied in a single-dose vial as follows:
| Carton Contents | NDC |
| 1 single dose vial | NDC 73650-316-01 |
| 10 single dose vials | NDC 73650-316-10 |
| 14 single dose vials | NDC 73650-316-14 |
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.
If not used immediately, store the diluted solution at room temperature [15°C to 30°C (59°F to 86°F)] and complete infusion within 4 hours of the start of preparation. Discard the diluted solution if not administered within 4 hours of preparation [see DOSAGE AND ADMINISTRATION].
Manufactured by: Provention Bio, Inc. 55 Broad Street, Red Bank, NJ 07701. Revised: Nov 2022
The following serious adverse reactions are described elsewhere in the Prescribing Information:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in Table 1 are derived from the placebo-controlled study (Study TN-10) in patients aged 8 years and older with Stage 2 type 1 diabetes (T1D) [see Clinical Studies]. These data reflect exposure of 44 patients of whom 93% completed the full 14-day treatment course.
Adverse reactions in TZIELD-treated patients were also evaluated in a larger pool of adult and pediatric patients who participated in five controlled clinical studies (including Study TN-10 described above):
In this pool:
In these studies, 436 patients received a 14-day dosing regimen of TZIELD with a total drug exposure that was comparable to the total drug exposure achieved with the recommended dosage [see DOSAGE AND ADMINISTRATION], 168 patients received a 14-day course of TZIELD with a lower total TZIELD drug exposure, and 169 patients received a 6-day course of TZIELD with a lower total TZIELD drug exposure. The mean age of TZIELD-treated patients was 17.6 years (median 15 years), 62% were <18 years old (40% age 12 to 17; 21% age 8 to 11), and 64% were male. The population was 72% White, 26% Asian, 1% Black or African American, 1% were multiple or unknown race, and <1% American Indian or Alaska Native; 5% were Hispanic or Latino ethnicity.
Table 1 presents common (≥ 5%) adverse reactions that occurred during treatment and through 28 days after the last study drug administration in Study TN-10. Adverse reactions observed in pediatric patients 8 years and older who received TZIELD were consistent with those reported in adult patients in this study.
Table 1: Common Adverse Reactions1 in Adult and Pediatric Patients Aged 8 Years and Older with Stage 2 Type 1 Diabetes (Study TN-10)2
| Adverse Reaction | Placebo N=32 |
TZIELD N=44 |
| Lymphopenia | 6% | 73% |
| Rash3 | 0% | 36% |
| Leukopenia | 0% | 21% |
| Headache | 6% | 11% |
| Neutropenia | 3% | 5% |
| Increased alanine aminotransferase | 3% | 5% |
| Nausea | 3% | 5% |
| Diarrhea | 0% | 5% |
| Nasopharyngitis | 0% | 5% |
| 1 That occurred during treatment and through 28 days after the last study drug administration 2 Adverse reactions that occurred in 2 or more TZIELD-treated patients 3 Composite of rash-related terms including rash erythematous, rash macular, rash papular, rash maculo-papular, rash pruritic |
||
In Study TN-10, CRS was reported in 2% of TZIELD-treated patients compared to 0% of placebo-treated patients.
Of the 39 TZIELD-treated patients that developed CRS (5% of all TZIELD-treated patients) in the pool of 5 clinical trials, 13% of the CRS cases were serious adverse reactions [see WARNINGS AND PRECAUTIONS]. Liver transaminase elevations were observed in 56% of TZIELD-treated patients who experienced CRS: 64% were up to 2.5 times ULN, 32% were more than 2.5 to 5 times ULN, and 4.5% were 5-10 times ULN.
In Study TN-10, serious infections (cellulitis, gastroenteritis, pneumonia, wound infection) were reported in 9% (4/44) of TZIELD-treated patients compared to 0% (0/32) of placebo-treated patients any time during or after the first dose of study treatment.
Hypersensitivity reactions were reported with TZIELD in Study TN-10. Serum sickness was observed in 2% (1/44) of TZIELD-treated patients compared to 0% (0/32) of placebo-treated patients. The patient who developed serum sickness had a prior history of positive anti-nuclear antibody and presented with arthralgias and elevated c-reactive protein and low C4 complement five days after completing their course of TZIELD; illness resolved in 2.5 months.
In the pool of 5 clinical trials of patients:
In Study TN-10, rash occurred in 39% of TZIELD-treated patients who developed anti-teplizumab-mzwv antibodies and in 33% of TZIELD-treated patients who did not develop anti-teplizumab-mzwv antibodies [see CLINICAL PHARMACOLOGY].
In Study TN-10, lymphopenia was reported in 73% of TZIELD-treated patients compared to 6% of placebo-treated patients. The average lymphocyte count nadir occurred at Day 5 of treatment, with recovery and return to baseline by Week 6 [see WARNINGS AND PRECAUTIONS].
In Study TN-10, neutropenia was observed in 7% of TZIELD-treated patients compared to 3% of placebo-treated patients.
In the pool of 5 clinical trials of patients, anemia was reported in 27% of TZIELD-treated patients compared to 21% of placebo-treated patients, and thrombocytopenia was reported in 13% of TZIELD-treated patients compared to 5% of placebo-treated patients during the 14-day treatment course; recovery occurred within 2 to 4 weeks of treatment. In clinical trials, 1.8% of TZIELD-treated patients discontinued treatment due to hemoglobin less than 8.5 g/dL (or a decrease of more than 2 g/dL to a value less than 10 g/dL), and 1% discontinued TZIELD due to platelet count less than 50,000 platelets/mcL.
Liver enzyme elevations were observed in TZIELD-treated patients, both in the context of CRS and in patients without CRS. In the pool of 5 clinical trials, elevated aminotransferases were reported in 25% of TZIELD-treated patients compared to 11% of placebo-treated patients during the 14-day treatment course. On laboratory analysis, 5.1% of TZIELD-treated patients experienced a peak ALT more than 3 times the ULN compared to 0.8% of control-treated patients. Most liver enzyme elevations were transient and resolved 1-2 weeks after treatment; 98% resolved by follow-up week 14.
In the pool of 5 clinical trials, other laboratory abnormalities including decreased bicarbonate (15% in TZIELD-treated patients, compared to 7% in placebo-treated patients) and decreased blood calcium (19% in TZIELD-treated patients, compared to 13% in placebo-treated patients) were noted.
No Information provided
Included as part of the PRECAUTIONS section.
Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with Tzield. During and within 2 months of Tzield treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV- associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued Tzield despite persistent, severe lymphopenia [see PRECAUTIONS].
Prior to initiating treatment with Tzield, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). Tzield is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection [see DOSAGE AND ADMINISTRATION].
During treatment with Tzield, regularly monitor lymphocyte counts [see DOSAGE AND ADMINISTRATION, PRECAUTIONS] and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue Tzield and obtain viral load (e.g., PCR) promptly. Consider appropriate expert consultation for diagnostic testing recommendations as some diagnostic tests may give inaccurate results in immunosuppressed patients. If viral reactivation is confirmed, permanently discontinue Tzield [see DOSAGE AND ADMINISTRATION]. Consider appropriate expert consultation for the management of severe viral reactivation.
Cytokine release syndrome (CRS) has been observed in TZIELD-treated patients. In clinical trials, CRS was reported in 5% of TZIELD-treated patients compared to 0.8% of control-treated patients during the treatment period and through 28 days after the last study drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea, fatigue, headache, myalgia, arthralgia, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment [see ADVERSE REACTIONS].
To mitigate CRS:
Bacterial and viral infections have occurred in TZIELD-treated patients. In clinical trials, TZIELD-treated patients had a higher rate of serious infections (3.5%) than control-treated patients (2%), including gastroenteritis, cellulitis, pneumonia, abscess, sepsis [see ADVERSE REACTIONS]. Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD treatment. If serious infection develops, treat appropriately, and discontinue TZIELD.
In clinical trials, 78% of TZIELD-treated patients developed lymphopenia compared to 11% of control-treated patients. For most TZIELD-treated patients who experienced lymphopenia, lymphocyte levels began to recover after the fifth day of treatment and returned to pre-treatment values within two weeks after treatment completion and without dose interruption. Severe lymphopenia (<500 cells per mcL) lasting 1 week or longer occurred in 0.9% of TZIELD-treated patients, and 0.5% of TZIELD-treated patients permanently discontinued TZIELD because of lymphopenia [see ADVERSE REACTIONS].
Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) develops, discontinue TZIELD.
Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients [see ADVERSE REACTIONS]. If severe hypersensitivity reactions occur, discontinue use of TZIELD and treat promptly.
The safety of immunization with live-attenuated vaccines in TZIELD-treated patients has not been studied. Additionally, TZIELD may interfere with the immune response to vaccination and decrease vaccine efficacy.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients about the signs and symptoms of CRS [see WARNINGS AND PRECAUTIONS].
Inform patients that TZIELD may lower the ability of the immune system to fight infections. Instruct patients to contact their health care provider if they develop any symptoms of infection [see WARNINGS AND PRECAUTIONS].
Inform patients that although most TZIELD-treated patients had mild lymphopenia; a few had severe lymphopenia that required stopping TZIELD [see WARNINGS AND PRECAUTIONS].
Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking TZIELD and seek medical attention promptly if such symptoms occur [see WARNINGS AND PRECAUTIONS].
Advise patient to receive all age-appropriate vaccinations prior to starting TZIELD and avoid concurrent use of live, inactivated, and mRNA vaccines with TZIELD [see WARNINGS AND PRECAUTIONS].
Advise patients to inform their health care provider of a known or suspected pregnancy. Advise patients who are exposed to TZIELD during pregnancy to contact Provention Bio, Inc.’s Adverse Event reporting line at 1-844-778-2246 [see Use In Specific Populations].
Advise a lactating woman that she may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after TZIELD administration to minimize drug exposure to a breastfed infant [see Use In Specific Populations].
No long-term studies have been performed to assess the carcinogenic potential of teplizumab-mzwv.
No studies have been performed to assess the mutagenic potential of teplizumab-mzwv. As an antibody, teplizumab-mzwv is not expected to interact directly with DNA.
Fertility and reproductive performance were unaffected in female and male mice that received a murine surrogate anti-mouse CD3 antibody administered by the subcutaneous route at doses up to 20 mg/kg.
Available case reports from clinical trials with TZIELD are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on teplizumab-mzwv, monoclonal antibodies can be actively transported across the placenta, and TZIELD may cause immunosuppression in the utero-exposed infant (see Clinical Considerations). To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days (6 half-lives) prior to planned pregnancy.
TZIELD is not active in rodents. In animal reproduction studies, mice were given a surrogate anti-mouse CD3 antibody subcutaneously during organogenesis through lactation. Pups born to dams administered the murine surrogate antibody during pregnancy showed a reduction in the adaptive immune response consistent with the expected pharmacology (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Report pregnancies to Provention Bio, Inc.’s Adverse Event reporting line at 1-844-778-2246.
Fetal/Neonatal Adverse Reactions
Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because teplizumab-mzwv may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to teplizumab-mzwv in utero. There are insufficient data regarding infant serum levels of teplizumab-mzwv at birth and the duration of persistence of teplizumab-mzwv in infant serum after birth to identify a specific timeframe to delay live virus immunizations in infants exposed in utero.
Animal Data
In an embryo-fetal developmental toxicity study, pregnant mice were administered a murine surrogate anti-mouse CD3 antibody by subcutaneous injection at dose levels of 0, 0.03, 0.3, or 20 mg/kg on Gestation Days 6, 10, and 14. Increase in post-implantation loss occurred in the 20 mg/kg group, in the presence of maternal toxicity.
In a pre- and postnatal development toxicity study in pregnant mice, in which the murine surrogate antibody was administered every 3 days from gestation day 6 through lactation day 19 at doses of 0, 0.3, 3, or 20 mg/kg, no maternal toxicity or increased incidence of post-implantation loss was observed. Reductions in T cell populations and increases in B cells, and a reduction in the adaptive immune response to keyhole limpet hemocyanin (KLH) were observed in the offspring on postnatal days 35 and 84 at 20 mg/kg. The surrogate antibody was present in the offspring serum at level less than 1.5% that of maternal serum at the high dose. A trend towards reduction in fertility was observed in the offspring of dams administered the murine surrogate antibody at 20 mg/kg. The human relevance of this finding is unknown.
There are no data on the presence of teplizumab-mzwv in either human or animal milk, the effects on the breastfed child, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred into human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to teplizumab-mzwv are unknown.
Although the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TZIELD and any potential adverse effects on the breastfed child from TZIELD or from the underlying maternal condition, a lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after TZIELD administration to minimize drug exposure to a breastfed child.
The safety and effectiveness of TZIELD to delay the onset of Stage 3 type 1 diabetes have been established in pediatric patients 8 years of age and older with Stage 2 type 1 diabetes. Use of TZIELD for this indication is supported by evidence from an adequate and well-controlled study (Study TN-10) in adults and pediatric patients 8 years of age and older (including 29 pediatric patients). Adverse reactions observed in pediatric patients 8 years of age and older who received TZIELD were consistent with those reported in adult patients [see ADVERSE REACTIONS].
The safety and effectiveness of TZIELD have not been established in pediatric patients younger than 8 years of age.
Stage 2 type 1 diabetes is largely a condition that occurs in pediatric and younger adult patients. Clinical studies of TZIELD to delay the onset of Stage 3 T1D did not include patients 65 years of age and older.
No Information provided
None.
Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes) and delays the onset of Stage 3 type 1 diabetes in adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood.
Clinical studies have shown that teplizumab-mzwv binds to CD3 molecules on the surface of both CD4+ and CD8+ T cells during treatment, with internalization of the teplizumab-mzwv/CD3 complex from the surface of T cells. Pharmacodynamic effects include lymphopenia in the absence of depletion of T cells with a nadir on the 5th day of dosing, during a 14-day course of TZIELD treatment [see WARNINGS AND PRECAUTIONS]. Teplizumab-mzwv exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of teplizumab-mzwv have not been fully characterized.
Steady state concentrations of teplizumab-mzwv are not expected to be achieved during the 14-day course of TZIELD.
The central volume of distribution (Vd) of teplizumab-mzwv was 2.27 L in a 60 kg subject.
Teplizumab-mzwv showed saturable binding and elimination. The mean (SD) terminal elimination half-life and clearance of teplizumab-mzwv are 4.5 (0.2) days and 2.7 (0.8) L/day in a 60 kg subject, respectively.
Teplizumab-mzwv is expected to be metabolized into small peptides by catabolic pathways.
No clinically significant differences in the pharmacokinetics of teplizumab-mzwv were observed based on age (8 to 35 years old), biologic sex, or racial groups (White, Asians).
BSA-based dosing normalizes the exposure to teplizumab-mzwv across body weight.
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of teplizumab-mzwv or of other teplizumab products.
In the placebo-controlled study in patients aged 8 years of age and older with Stage 2 type 1 diabetes (Study TN-10) [see Clinical Studies], approximately 57% of TZIELD-treated patients developed anti-teplizumab-mzwv antibodies, 46% of whom developed neutralizing antibodies. There is insufficient information to characterize the effects of ADA on pharmacokinetics, pharmacodynamics, or effectiveness of TZIELD. There was a higher incidence of rash in TZIELD-treated patients who developed anti-teplizumab-mzwv antibodies compared to those who did not develop anti-teplizumab-mzwv antibodies [see ADVERSE REACTIONS].
The effectiveness of TZIELD was investigated in a randomized, double-blind, event-driven, placebo-controlled study (Study TN-10; NCT01030861) in 76 patients, 8 to 49 years of age with Stage 2 type 1 diabetes. Stage 2 type 1 diabetes was defined as having both of the following:
1. Two or more of the following pancreatic islet autoantibodies: o Glutamic acid decarboxylase 65 (GAD) autoantibodies
2. Dysglycemia on oral glucose tolerance testing
In this study, patients were randomized to receive TZIELD or placebo once daily by intravenous infusion for 14 days. Patients in the TZIELD group had a total drug exposure that was comparable to the total drug exposure achieved with the recommended total TZIELD dosage [see DOSAGE AND ADMINISTRATION]. The primary efficacy endpoint in this study was the time from randomization to development of Stage 3 type 1 diabetes diagnosis.
In this study, 45% were female; 97% White, 1% Asian, and 1% reported multiracial background; 3% were Hispanic or Latino ethnicity; and 95% were from the United States. The median age was 14 years (72% were <18 years old) (Table 3).
Table 3: Baseline Age Characteristics of Adults and Pediatric Patients 8 Years of Age and Older with Stage 2 Type 1 Diabetes (Study TN-10)1
| TZIELD N=44 |
Placebo N=32 |
|
| Age Group | ||
| ≥ 18 Years | 34% | 19% |
| < 18 years | 66% | 81% |
| Pediatric Age Group Quartiles | ||
| 8 to <11 years | 21% | 25% |
| 11 to <14 years | 27% | 31% |
| 14 to <18 years | 18% | 25% |
| 1 Intent to treat (ITT) population | ||
Table 4 displays the baseline disease characteristics in Study TN-10.
Table 4: Baseline Disease Characteristics of Adults and Pediatric Patients 8 Years of Age and Older with Stage 2 Type 1 Diabetes (Study TN-10)1
| TZIELD N=44 |
Placebo N=32 |
|
| Glucose, mg/dL2 | ||
| median (min, max) | 165 (115,207) | 154 (103,200) |
| HbA1c, % | ||
| median (min, max) | 5.2 (4.6, 6.1) | 5.3 (4.3, 5.6) |
| HLA-DR4 | ||
| Missing | 5% | 0 |
| Absent | 34% | 34% |
| Present | 61% | 66% |
| HLA-DR3 | ||
| Missing | 5% | 0 |
| Absent | 48% | 53% |
| Present | 48% | 47% |
| HLA-DR3/DR4 | ||
| Both DR3 and DR4 | 25% | 22% |
| DR3 only | 23% | 25% |
| DR4 only | 36% | 44% |
| Missing | 5% | 0 |
| Neither DR3 nor DR4 | 11% | 9% |
| Autoantibodies Positive (N) | ||
| 1 | 2% | 0 |
| 2 | 27% | 22% |
| 3 | 25% | 16% |
| 4 | 27% | 44% |
| 5 | 18% | 19% |
| Autoantibody Type Positive | ||
| GAD65 | 91% | 88% |
| IAA | 43% | 34% |
| IA-2A | 59% | 75% |
| ICA | 66% | 88% |
| ZnT8 | 73% | 75% |
| 1 Intent to treat (ITT) population 2 The glucose data are area under the time-concentration curve (AUC) values from the oral glucose tolerance test |
||
Abbreviations: HbA1c=hemoglobin A1c, SD=standard deviation, HLA = human leukocyte antigen, GAD65=Glutamic acid decarboxylase 65 (GAD) autoantibodies, IAA=Insulin autoantibody, IA-2A=Insulinoma-associated antigen 2 autoantibody, ZnT8A=Zinc transporter 8 autoantibody, ICA=Islet cell autoantibody
In Study TN-10, Stage 3 type 1 diabetes was diagnosed in 20 (45%) of the TZIELD-treated patients and in 23 (72%) of the placebo-treated patients. A Cox proportional hazards model, stratified by age and oral glucose tolerance test status at randomization, demonstrated that the median time from randomization to Stage 3 type 1 diabetes diagnosis was 50 months in the TZIELD group and 25 months in the placebo group, for a difference of 25 months. With a median follow-up time of 51 months, therapy with TZIELD resulted in a statistically significant delay in the development of Stage 3 type 1 diabetes, hazard ratio 0.41 (95% CI: 0.22 to 0.78; p=0.0066) (Figure 1).
Study TN-10 was not designed to assess whether there were differences in the effectiveness between subgroups based on demographic characteristics or baseline disease characteristics.
Figure 1: Kaplan-Meier Curve of Time to Diagnosis of Stage 3 Type 1 Diabetes in Adult and Pediatric Patients Aged 8 Years and Older with Stage 2 Type 1 Diabetes by Treatment Group (Study TN-10)1
 |
TZIELD™
(TEE-zeeld)
(teplizumab-mzwv) injection, for intravenous use
What is the most important information I should know about TZIELD?
TZIELD may cause serious side effects, including:
These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.
Decrease in white blood cells. TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body's ability to fight infections. A decrease in white blood cell counts can happen after your first dose. Your white blood cell counts will start to go back to normal after your fifth dose of TZIELD. Some people may develop longer and more severe decreases in lymphocytes.
Your healthcare provider will do blood tests to check your liver and your complete blood counts before you start treatment and during treatment with TZIELD. During and after your treatment with TZIELD, your healthcare provider will check for serious side effects, as well as other side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection, or if your blood counts stay too low.
See “What are the possible side effects of TZIELD?” for more information about side effects.
What is TZIELD?
TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years of age and older who have Stage 2 type 1 diabetes. This means that they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels and do not have type 2 diabetes.
It is not known if TZIELD is safe and effective in children under 8 years of age.
Before or after receiving TZIELD, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive TZIELD?
Tell your healthcare provider if you think something will stop you from completing treatment with TZIELD.
What are the possible side effects of TZIELD?
TZIELD may cause serious side effects including:
The most common side effects of TZIELD include:
These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800- FDA-1088. You may also report side effects to Provention Bio at 1-844-778-2246.
General information about the safe and effective use of TZIELD.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about TZIELD that is written for health professionals.
What are the ingredients in TZIELD?
Active ingredient: teplizumab-mzwv.
Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 80, sodium chloride, and water for injection.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
