Teplizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Applies to teplizumab: intravenous solution.

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.

Serious side effects of teplizumab

Along with its needed effects, teplizumab 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 while taking teplizumab:

For healthcare professionals

Applies to teplizumab: intravenous solution.

Dermatologic adverse events

• Very common (10% or more): Rash (48%)
• Common (1% to 10%): Urticaria
• Uncommon (0.1% to 1%): Angioedema^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea^[Ref]

Hematologic

• Very common (10% or more): Anemia (27%), leukopenia (21%), lymphopenia (74%), thrombocytopenia (13%)
• Common (1% to 10%): Neutropenia^[Ref]

Hepatic

• Common (1% to 10%): Increased alanine aminotransferase^[Ref]

Hypersensitivity

• Common (1% to 10%): Cytokine Release Syndrome (CRS)^[Ref]

Immunologic

• Common (1% to 10%): Serum sickness^[Ref]

Metabolic

• Very common (10% or more): Liver transaminase elevations (56%)^[Ref]

In patients treated with this drug who experienced CRS, 56% of them reported increased liver transaminase levels: 64% were up to 2.5 times upper limit of normal (ULN), 32% were more than 2.5 to 5 times ULN, and 4.5% were 5-10 times ULN.^[Ref]

Other

• Very common (10% or more): Decreased bicarbonate (15%), decreased blood calcium (19%)
• Common (1% to 10%): Serious infection
• Uncommon (0.1% to 1%): Peripheral and generalized edema^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis^[Ref]

Nervous system

• Very common (10% or more): Headache (11%)^[Ref]

See also:

Frequently asked questions

• What is Tzeild?
• How does Tzield work?
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Further information

Teplizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer