Dosing and Administration

TZIELD DOSAGE AND ADMINISTRATION

TZIELD is administered by intravenous infusion (over a minimum of 30 minutes), using a body surface area–based dosing, once daily for 14 consecutive days.¹

Once daily, consecutive 14-day course¹

If a planned infusion is missed, resume course by administering all remaining doses on consecutive days to complete the 14-day course.
Do not administer 2 doses on the same day.

≥30-minute administration¹

Administer TZIELD by IV infusion for a minimum of 30 minutes, using a body surface area–based dosing.

LABS PRIOR TO INITIATION

Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Use of TZIELD is not recommended in patients with certain laboratory abnormalities.¹

PREMEDICATION

Premedicate with: (1) a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, (2) an antihistamine, and/or (3) an antiemetic before each TZIELD dose for at least the first 5 days of the 14-day treatment course.¹

Please review the full Prescribing Information for more information and before prescribing TZIELD. Download the following for your practice:

What to Expect Guide, here
Dosing and Administration Guide, here

Learn more about our patient support program

Discover Provention Bio
COMPASS™

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.

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 in 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.

REFERENCE

1. TZIELD Prescribing Information. Provention Bio, Inc.