TZIELD: Anti-Diabetic Drug

Tzield:

Tzield (teplizumab-mzwv) is used to help slow down the progression from stage 2 to stage 3 type 1 diabetes. Type 1 diabetes is an autoimmune disorder where your own immune system attacks and destroys insulin-making cells (beta cells) in the pancreas. Tzield helps to prevent the immune system from attacking the beta cells, which may help slow down the progression of type 1 diabetes. Tzield can help patients stay at stage 2 for longer meaning that patients can spend more time symptom free without the complication of needing insulin injections, checking blood glucose levels regularly and the risk of diabetic ketoacidosis, which can be life threatening.

In type 1 diabetes, the body's immune system, which normally fights harmful bacteria, mistakenly attacks and destroys the insulin-producing cells (beta cells) in the pancreas. This leads to reduced insulin production and increased blood sugar levels. Stage 2 of type 1 diabetes occurs before any diabetic symptoms appear, but there is some damage to the beta cells, causing slightly elevated blood sugar levels. Tests also reveal the presence of at least two types of antibodies against the pancreatic cells. In stage 3 of type 1 diabetes, there is further damage to the beta cells, resulting in minimal insulin production. Stage 3 patients experience common diabetic symptoms such as increased thirst, frequent urination, weight loss, fatigue, and diabetic ketoacidosis. Tests also confirm the presence of antibodies against the pancreatic cells in stage 3 patients.

Tzield (teplizumab-mzwv) is an anti-CD3-directed antibody that binds to a protein (antigen) on the surface of T lymphocytes (white blood cell) which slows the immune system attacking the beta cells. Tzield is usually given as an infusion once a day for 14 days.

Who can use Tzield?

Tzield became FDA approved November 17, 2022 to be used 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. Patients should not fit the clinical history for type 2 diabetes. Patients must also be diagnosed as stage 2 type one diabetes by having:

• at least two positive pancreatic islet cell autoantibodies
• blood sugar levels that flucuate abnormally (dysglycemia) but without overt high blood sugar (hyperglycemia) , test using an oral glucose tolerance test (if an oral glucose tolerance test is not available, an alternative method for diagnosing dysglycemia without overt hyperglycemia may be appropriate).

Warning

Serious side effects can occur with Tzield

Cytokine Release Syndrome:

It is a serious side effect that may occur during the first 5 days of treatment. Tell your healthcare provider right away if, during treatment, you develop any of these signs and symptoms, feeling unusually tired, fever, headache, nausea, or muscle and joint pain.

Decrease in white blood cells:

This medicine may decrease the number of a type of white blood cells (lymphocytes) that can affect your body's ability to fight infections.

Liver and complete blood counts:

Your healthcare provider will do blood tests to check your liver and your complete blood counts before you start treatment and during treatment with this medicine.

During and after your treatment, 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 this medicine if you develop liver problems, have a serious infection, or if your blood counts stay too low.

Before taking this medicine:

Tell your doctor if you have:

• a serious infection or an infection that keeps returning or does not go away; or
• recently received or are scheduled to receive a vaccine. This medicine may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with this medicine before receiving a vaccine.

Pregnancy

Tzield may harm an unborn baby. Do not use if you are pregnant and for at least 30 days before a planned pregnancy. Tell your doctor if you become pregnant.

If you become pregnant while taking Tzield, you are encouraged to report your pregnancy to the Prevention Bio’s Adverse Event reporting line at 1-844-778-2246.

Breastfeeding

Do not breastfeed while using this medicine. If you are considering breastfeeding, use a breast pump and throw out any milk you collect during treatment with this drug and for at least 20 days after your last dose.

How will I receive Tzield?

Teplizumab is a solution injected into a vein (intravenous infusion) over approximately 30 minutes. You will receive this medicine once a day for 14 days.

Before starting this medicine you will have a complete blood count and liver enzyme tests.

You will be given other medications to help reduce side effects of fever, headache, muscle and joint pain, or nausea. Medicines may include ibuprofen, naproxen or other pain relievers such as acetaminophen, and an antihistamine, and an anti-nausea medicine.

You should receive all appropriate vaccines before you start using this medicine. Live-attenuated (live) vaccines should be given at least 8 weeks before Tzield treatment. Inactivated (killed) vaccines or mRNA vaccines should be given at least 2 weeks prior to treatment.

You will need regular blood tests before and during treatment with Tzield.

Your treatment may be temporarily or permanently discontinued if you have certain side effects.

Dosing information

Usual Adult and Pediatric Dose for Delay of Onset of Stage 3 Type 1 Diabetes:

Tzield is given 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: 1030 mcg/m2

Do not administer two doses on the same day.

Comments

• 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.
• In patients who meet criteria for a diagnosis of Stage 2 type 1 diabetes, ensure the clinical history of the patient does not suggest type 2 diabetes.
• Before starting treatment, obtain a complete blood count and liver enzyme tests.
• Use of this medicine is not recommended in patients with certain laboratory abnormalities.
• Must dilute Tzield in 0.9% Sodium Chloride Injection, USP. See full prescribing information for detailed preparation and administration instructions.
• Premedicate with a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, an antihistamine, and/or an antiemetic before each dose for at least the first 5 days of the 14-day treatment course.

What should I avoid while receiving Tzield?

Avoid receiving an inactivated, mRNA, and "live" vaccine. The vaccine may not work as well while you are using teplizumab.

Tzield side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Tzield may cause serious side effects. Call your doctor at once if you have:

• signs of infection-fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• liver problems-loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Tzield may include:

• rash;
• headache; or
• fever, mouth sores, skin sores, sore throat, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Tzield?

Other drugs may affect Tzield, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. To check for interactions with Tzield click on the link below.

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.

Storage

• 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.
• Diluted Tzield. 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.

Manufacturer

Provention Bio, Inc., 55 Broad Street, Red Bank, NJ 07701.

Reference:

Drugs.com