Tzield

About Tzield 

• Tzield diabetes drug has received approval from the US FDA administration on November 17, 2022.
• Tzield is a monoclonal antibodies, which belongs to the class called miscellaneous antidiabetic agents. 
• Tzield (teplizumab) is used to slow the progression from stage 2 to stage 3 type 1 diabetes, an autoimmune disorder where the immune system targets and destroys insulin-producing beta cells in the pancreas. 
• Tzield helps by protecting the insulin-making cells in the pancreas from the body’s own immune system, giving more time before type 1 diabetes advances. 
• This means people can go longer without symptoms, reducing the need for insulin shots, regular blood sugar checks, and the risk of a serious condition called diabetic ketoacidosis.
• Tzield insulin injection is suitable for individuals diagnosed with stage 2 type 1 diabetes, excluding those with a clinical history of type 2 diabetes. 
• Diagnosis for stage 2 type 1 diabetes involves having at least two positive pancreatic islet cell autoantibodies and experiencing abnormal fluctuations in blood sugar levels (dysglycemia) without clear high blood sugar (hyperglycemia). 
• Diagnosis is confirmed through an oral glucose tolerance test, or if unavailable, an alternative method may be used to identify dysglycemia without overt hyperglycemia.

Strength

Injection: 2 mg/2 mL (1 mg/mL) solution in a single-dose vial

Recommended Dosage

Administering IV injections involves trained healthcare professionals using aseptic techniques, including handwashing, gloves, and site cleaning. Continuous monitoring for adverse reactions is crucial, and proper disposal of used materials according to medical waste guidelines is essential.

• Tzield should be administered intravenously over at least 30 minutes using body surface area-based dosing. 
• This occurs once daily for 14 consecutive days, with escalating doses as follows, 65 mcg/m2 on Day 1, 125 mcg/m2 on Day 2, 250 mcg/m2 on Day 3, 500 mcg/m2 on Day 4, and 1,030 mcg/m2 on Days 5 through 14. 
• It is crucial not to administer two doses on the same day.

Important

To confirm Stage 2 Type 1 Diabetes (T1D), assess patients for at least two positive pancreatic islet autoantibodies in the presence of dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or an alternative method if OGTT is not available. Ensure the clinical history aligns with a diagnosis of Stage 2 T1D, excluding characteristics suggestive of Type 2 diabetes. Before initiating TZIELD, conduct a complete blood count and liver enzyme tests, avoiding use in patients with specific laboratory abnormalities. 

Dilute TZIELD in 0.9% Sodium Chloride Injection and follow detailed preparation and administration instructions. Premedicate with a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, an antihistamine, and/or an antiemetic for the initial 5 days of the 14-day treatment course. Administer TZIELD intravenously over a minimum of 30 minutes once daily for 14 days, adhering to the prescribed dosing schedule as outlined in the full prescribing information.

Warnings & Precautions

• When considering Tzield treatment, be cautious of potential risks and take necessary precautions. 
• Premedication is advised to manage Cytokine Release Syndrome (CRS), with ongoing monitoring of liver enzymes. 
• If elevated ALT or AST levels surpass five times the upper normal limit, discontinuation is recommended. 
• In severe CRS cases, temporarily pausing dosing may be considered. Tzield is not recommended for those with active serious or chronic infections, and vigilant monitoring for infection signs during and after treatment is crucial. 
• In the event of a serious infection, discontinuing Tzield is advised. 
• Regular monitoring of white blood cell counts is essential, and if prolonged and severe lymphopenia occurs, discontinuation is warranted. 
• Severe hypersensitivity reactions call for immediate Tzield discontinuation and prompt treatment. 
• Ensure all age-appropriate vaccinations are administered before starting Tzield, following recommendations for different vaccine types.

Common Tzield Side Effects:

• Lymphopenia
• Rash
• Leukopenia
• Headache
• Fever
• Mouth sores
• Skin sores
• Sore throat
• Cough

Use in Specific Population

• Tzield may pose a risk of fetal harm, and it is crucial to inform your doctor if you are pregnant, think you might be pregnant, or are planning to conceive. 
• For lactating women, considering pumping and discarding breast milk during and for 20 days after Tzield administration is advised. Prior to starting the treatment, discuss breastfeeding plans with your doctor. 
• The safety and effectiveness of Tzield have not been established in pediatric patients below 8 years of age. 
• Stage 2 type 1 diabetes is predominantly observed in pediatric and younger adult patients. Clinical studies focusing on Tzield’s impact on delaying the onset of Stage 3 T1D did not include individuals aged 65 and older. 

Storage and Handling

• Store Tzield at room temperature of 2°C to 8°C (36°F to 46°F).
• If the diluted solution is not used immediately, store it at room temperature (15°C to 30°C or 59°F to 86°F). 
• Ensure the complete infusion is done within 4 hours of preparation. Discard the diluted solution if not administered within this 4-hour timeframe. 
• Do not freeze or shake the injection.
• Protect Tzield from light and moisture.
• Keep Tzield out of the reach of children and pets.