Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, 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
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
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
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
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.
CON-XXXXXXXX
