Skip to Content

Isatuximab Side Effects

Medically reviewed by Drugs.com. Last updated on March 9, 2020.

For the Consumer

Applies to isatuximab: intravenous solution

Warning

Before using isatuximab tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel cold or nauseated, or have a cough or trouble breathing.

Call your doctor at once if you have:

  • easy bruising, unusual bleeding, purple or red spots under your skin;

  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

  • symptoms of pneumonia--cough with mucus, chest pain, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • low blood cell counts;

  • pneumonia;

  • diarrhea; or

  • cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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]

References

1. "Product Information. Sarclisa (isatuximab)." sanofi-aventis, Bridgewater, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.