Applies to isatuximab: intravenous solution.
Serious side effects of Isatuximab
Along with its needed effects, isatuximab 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 isatuximab:
More common
- Back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- body aches or pain
- chest pain or tightness
- chills
- cough
- difficulty in breathing
- dizziness
- ear congestion
- enlarged pupils
- feeling of warmth
- fever
- flushing
- headache
- hoarseness
- increased sensitivity of the eyes to light
- increased sweating, possibly with fever or cold, clammy skin
- loss of voice
- lower back or side pain
- nausea
- nervousness
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- redness of the face, neck, arms, and occasionally, upper chest
- runny or stuffy nose
- slow or fast heartbeat
- sneezing
- sore throat
- stiff or sore neck
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Other side effects of Isatuximab
Some side effects of isatuximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- trouble sleeping
For Healthcare Professionals
Applies to isatuximab: intravenous solution.
Hematologic
Very common (10% or more): Anemia (99%), neutropenia (96%), lymphopenia (92%), Grade 3 to 4 neutropenia (85%), thrombocytopenia (84%), febrile neutropenia (12%)[Ref]
Immunologic
Very common (10% or more): Infection (43%)
Frequency not reported: Immunogenicity[Ref]
Local
Very common (10% or more): Infusion-related reactions (39%)[Ref]
Oncologic
Frequency not reported: Second primary malignancies[Ref]
Respiratory
Very common (10% or more): Pneumonia (e.g., atypical pneumonia, bronchopulmonary aspergillosis, pneumonia, pneumonia haemophilus, pneumonia influenzal, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, candida pneumonia, pneumonia bacterial, haemophilus infection, lung infection, pneumonia fungal, pneumocystis jirovecii pneumonia) (31%), upper respiratory tract infection (e.g., bronchiolitis, bronchitis, bronchitis viral, chronic sinusitis, fungal pharyngitis, influenza-like illness, laryngitis, nasopharyngitis, parainfluenzae virus infection, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tracheitis, upper respiratory tract infection, upper respiratory tract infection bacterial) 57%), dyspnea (e.g., exertional or at rest) (17%), cough
Common (1% to 10%): Lower respiratory tract infection[Ref]
General
The most common adverse reactions (20% or greater) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.[Ref]
Nervous system
Very common (10% or more): Chills[Ref]
Cardiovascular
Very common (10% or more): Hypertension[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (26%), nausea (15%), vomiting (12%)[Ref]
