Teplizumab

What is Teplizumab?

• Teplizumab (Tzield), is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that is expressed from a recombinant Chinese hamster ovary (CHO) cell line.

What are the uses of this medicine?

• Teplizumab (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.

How does this medicine work?

• Teplizumab-mzwv binds to CD3 (a cell surface antigen present on T lymphocytes).
• 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Teplizumab was approved for medical use in the United States in November 2022.
• The US Food and Drug Administration considers it to be a first-in-class medication.

How should this medicine be used?

• Select adult patients and pediatric patients 8 years of age and older for Tzield treatment who have a diagnosis of Stage 2 type 1 diabetes.
• Confirm Stage 2 T1D by documenting at least two positive pancreatic islet autoantibodies in those who have dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available.

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. 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.

Recommended dosage: Administer Tzield by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows:

• 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

Administration:

• Tzield is given by a healthcare provider through a needle placed in a vein (intravenous infusion) in your arm.
• You will receive a Tzield infusion one-time a day, every day, for 14 days.
• Each Tzield infusion will last about 30 minutes.
• For the first 5 days of treatment, your healthcare provider will give you medicines by mouth before starting your Tzield infusion.
• These medicines include ibuprofen, naproxen or other pain relievers such as acetaminophen, an antihistamine, and an anti-nausea medicine. These medicines may help reduce symptoms of CRS such as a fever, headache, muscle and joint pain, or nausea.
• If you miss a scheduled infusion, your healthcare provider will continue your treatment on the next scheduled day.
• You will not receive 2 infusions on the same day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2 mg per 2 mL (1 mg/mL) single-dose vial

This medicine is available in fallowing brand namesː

• Tzield

What side effects can this medication cause?

The most common side effects of this medicine include:

• rash
• leukopenia (decrease in white blood cell counts)
• headache

Less common, but serious side effects may include:

• Cytokine Release Syndrome
• Decrease in white blood cells

What special precautions should I follow?

• Cytokine release syndrome (CRS) has been observed in Tzield-treated patients. Inform patients about the signs and symptoms of CRS. Premedicate, monitor liver enzymes, discontinue in those that develop elevated ALT or AST more than 5 times the upper limit of normal, and if severe CRS develops consider temporarily pausing dosing.
• Bacterial and viral infections have occurred in Tzield-treated patients. Use of Tzield is not recommended in patients with active serious infection or chronic infection. Monitor for signs and symptoms of infection during and after Tzield treatment. If a serious infection develops, discontinue Tzield.
• Tzield-treated patients developed lymphopenia. 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.Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking Tzield and seek medical attention promptly if such symptoms occur.
• The safety of immunization with live-attenuated vaccines in Tzield-treated patients has not been studied. Advise patient to receive all age-appropriate vaccinations prior to starting Tzield and avoid concurrent use of live, inactivated, and mRNA vaccines with Tzield.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of overdose, general supportive measures should be instituted as necessary.
• Monitor the patient for adverse reactions.

Can this medicine be used in pregnancy?

• 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.
• Tzield may harm your unborn baby.
• Do not receive Tzield during pregnancy and at least 30 days before a planned pregnancy.
• If you become pregnant while taking Tzield, you are encouraged to report your pregnancy to the Provention Bio’s Adverse Event reporting line at 1-844-778-2246.

Can this medicine be used in children?

• It is not known if Tzield is safe and effective in children under 8 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: teplizumab-mzwv.
• Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 80, sodium chloride, and water for injection.

Who manufactures and distributes this medicine?

Manufactured by:

• Provention Bio, Inc.
• 55 Broad Street
• Red Bank, NJ

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Teplizumab
• FDA Teplizumab

Teplizumab Resources
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