Usual Adult Dose for Diabetes Type 1

Usual dose: Body surface area-based dosing by intravenous infusion once daily
Dosing:

• Day 1: 65 mcg/m2
• Day 2: 125 mcg/m2
• Day 3: 250 mcg/m2
• Day 4: 500 mcg/m2
• Days 5 through 14: 1,030 mcg/m2

• Confirm the presence of Stage 2 type 1 diabetes by documenting at least two positive pancreatic islet cell autoantibodies and state of dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT); an alternate test may be used if OGTT is not available.
• Patients should not have type 2 diabetes.
• Complete blood count and liver enzyme tests should be done before initiating the treatment.
• This drug is not recommended in patients with:
• Lymphocyte count less than 1,000 lymphocytes/mcL
• Hemoglobin less than 10 g/dL or Platelet count less than 150,000 platelets/mcL
• Absolute neutrophil count less than 1,500 neutrophils/mcL
• Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN
• Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
• Active serious infection or chronic active infection other than localized skin infections
• All age-appropriate vaccination should be completed before initiating the treatment.
• Administer premedication before every dosing for the first 5 days with:
• A nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen
• An antihistamine and/or an antiemetic
• If a dose is missed, resume the administration of remaining doses based on 14-day dosing schedule.
• Do not administer this drug twice on the same day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 8 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug by intravenous route.

• Refrigerate at 2C to 8C (36F to 46F) in the original carton to protect from light.
• Store upright.
• Do not freeze or shake the vial.
• After reconstitution, store the solution at room temperature and use it within 4 hours.

• Refer to manufacturer product information for detailed instruction.

• Advise patient to read FDA-approved patient labeling.
• Patients should be informed of the signs and symptoms of CRS.
• Inform patients about the potential of this drug to weaken the immune response and to reach out to their health care provider if any symptoms of infection appear.
• Inform patients about the occurrence of lymphopenia and that in severe cases the treatment must be discontinued.
• Patients should be advised to stop the treatment and seek immediate medical attention if any signs and symptoms of hypersensitivity reaction develop.
• All appropriate vaccines should be taken prior to the start of the treatment and administration of live, inactivated, and mRNA vaccines should be avoided during treatment.
• Notify healthcare provider about known or suspected pregnancy.
• If pregnant women are exposed to this drug, contact Provention Bio, Inc.'s Adverse Event reporting line at 1-844-778-2246.
• Lactating women should stop breastfeeding and pump and discard breast milk during the treatment and for 20 days after the last dose of the drug to minimize drug exposure to a breastfed infant.

Frequently asked questions

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