Applies to teplizumab: intravenous solution.
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:
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
For Healthcare Professionals
Applies to teplizumab: intravenous solution.
Dermatologic
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
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]
Very common (10% or more): Liver transaminase elevations (56%)[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]
