NOW APPROVED

THE FIRST AND ONLY TREATMENT INDICATED

TO DELAY THE ONSET OF STAGE 3 TYPE 1 DIABETES (T1D)

IN ADULT AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER WITH STAGE 2 T1D.1

Confirm Stage 2 T1D by documenting at least 2 positive pancreatic islet autoantibodies in those who have dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or alternative method if OGTT is not available. Ensure the clinical history of the patient does not suggest type 2 diabetes.1

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For more information about Provention Bio COMPASS, call 1-844-778-2246, Monday through Friday, 8 AM-8 PM ET.

A PERSONALIZED PATIENT ASSISTANCE & SUPPORT PROGRAM WITH HELPFUL RESOURCES.

Our team will provide information about financial assistance options, reimbursement, educational tools and resources, and additional support from the day of enrollment.

Provention Bio COMPASS is a patient support program that helps patients gain access to TZIELD and provides patients with education and resources related to TZIELD. Provention Bio COMPASS is not a healthcare service or an insurance provider and does not provide care coordination. Provention Bio COMPASS and the COMPASS Navigator will not provide medical or treatment advice. Provention Bio COMPASS services are available only to those who have been prescribed TZIELD and are intended for US residents only.

Your patients may be able to save on out-of-pocket costs for TZIELD


With the Provention Bio Copay Program,* commercially or privately insured individuals may pay as little as $0 for TZIELD. If your patient qualifies, their COMPASS Navigator can help enroll them into the copay program so they may be able to lower their out-of-pocket costs.

*Eligibility requirements and terms and conditions apply. Click here for more information.

This program is intended to help with the cost of TZIELD and its infusion administration only. It does not help with the cost of other medicines your patients take at the same time as TZIELD or with other facility fees.

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

 
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IMPORTANT SAFETY INFORMATION

Warnings and precautions
  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: 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 administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.
Adverse reactions

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

Use in Specific Populations
  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Before prescribing TZIELD, please see full Prescribing Information, including patient selection criteria, and Medication Guide.

1. TZIELD Prescribing Information. Provention Bio, Inc.