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Sarclisa Side Effects

Generic name: isatuximab

Medically reviewed by Drugs.com. Last updated on Nov 16, 2020.

Note: This document contains side effect information about isatuximab. Some of the dosage forms listed on this page may not apply to the brand name Sarclisa.

For the Consumer

Applies to isatuximab: intravenous solution

Side effects requiring immediate medical attention

Along with its needed effects, isatuximab (the active ingredient contained in Sarclisa) 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

Side effects not requiring immediate medical attention

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

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.