Pronunciation:

tep-LIZ-oo-mab - mzwv

Brand Names:

• Tzield

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

Teplizumab

Uses of This Medicine:

Teplizumab-mzwv injection is used to delay the onset of Stage 3 type 1 diabetes in patients who have Stage 2 type 1 diabetes and who have tested positive for 2 or more type 1 diabetes-related autoantibodies, have an abnormal blood sugar, and do not have type 2 diabetes.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of teplizumab-mzwv injection in children younger than 8 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of teplizumab-mzwv injection in the elderly. Stage 2 type 1 diabetes is a condition that usually occurs in children and younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Anthrax Vaccine Adsorbed
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Diphtheria Toxoid, Adsorbed
• Ebola Zaire Vaccine, Live
• Haemophilus B Vaccine
• Hepatitis A Vaccine, Inactivated
• Hepatitis B Vaccine
• Human Papillomavirus Vaccine
• Influenza Virus Vaccine
• Influenza Virus Vaccine, Live
• Japanese Encephalitis Virus Vaccine
• Measles Virus Vaccine, Live
• Meningococcal Polysaccharide Vaccine
• Meningococcal Vaccine
• Mumps Virus Vaccine, Live
• Pertussis Vaccine
• Pneumococcal Vaccine
• Pneumococcal Vaccine, Diphtheria Conjugate
• Pneumococcal Vaccine Polyvalent
• Poliovirus Vaccine, Inactivated
• Poliovirus Vaccine, Live
• Rabies Vaccine
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• SARS-COV-2 (COVID-19) Vaccine, Adenovirus 26 Vector (Janssen)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna)
• SARS-COV-2 (COVID-19) Vaccine, mRNA (Pfizer)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Novavax)
• SARS-COV-2 (COVID-19) Vaccine, Protein Subunit, Adjuvanted (Sanofi)
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tetanus Toxoid
• Tick-Borne Encephalitis Vaccine
• Typhoid Vaccine
• Typhoid Vaccine, Live
• Typhoid Vi Polysaccharide Vaccine
• Varicella Virus Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (eg, low white blood cells) or
• Infection, chronic or serious or
• Virus infection (eg, Epstein-Barr virus, cytomegalovirus)—Use is not recommended in patients with these conditions.

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. This medicine is given once a day for 14 days.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you other medicines (eg, an NSAID or acetaminophen, allergy medicine, and medicine to prevent nausea or vomiting) for the first 5 days of treatment to help reduce the side effects.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. You should not receive this medicine if you are pregnant and for at least 30 days before a planned pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS). Tell your doctor right away if you have fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

This medicine may cause serious infections. Check with your doctor right away if you have accumulation of pus, chest pain or tightness, confusion, cough, diarrhea, dizziness, fainting, fast heartbeat, fever or chills, itching, pain, redness, swelling, tenderness, or warmth on the skin, lightheadedness, loss of appetite, nausea, sneezing, stomach pain, swollen, red, tender area of infection, trouble breathing, or weakness.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reactions (eg, serum sickness, angioedema). Check with your doctor right away if you have chest tightness, cough, difficulty breathing, feeling of discomfort, fever, inflammation of joints, hives, itching, or skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, muscle aches, rash, swollen lymph glands, or vomiting.

While you are being treated with teplizumab-mzwv injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccines should not be given for at least 8 weeks before start of treatment, during treatment, or up to 52 weeks after treatment. Non-live vaccines should not be given for at least 2 weeks before start of treatment, during treatment, or 6 weeks after treatment.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

chest pain or tightness

cough or hoarseness

dizziness

fever or chills

headache

itching, pain, redness, swelling, tenderness, or warmth on the skin

loss of appetite

lower back or side pain

muscle aches or pain

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

rash

red, tender, or oozing skin at the incision

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

stuffy or runny nose

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Diarrhea

difficulty swallowing

faintness

fast heartbeat

general feeling of discomfort or illness

joint pain or swelling

muscle pain

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

vomiting

Rare

Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.