Sarclisa Side Effects

Generic name: isatuximab

Medically reviewed by Drugs.com. Last updated on Jul 8, 2024.

Note: This document provides detailed information about Sarclisa.

Applies to isatuximab: intravenous solution Side Effects associated with isatuximab. Some dosage forms listed on this page may not apply specifically to the brand name Sarclisa.

Applies to isatuximab: intravenous solution.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control while you are receiving this medicine and for at least 5 months after the last dose to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause serious infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, cough, dizziness, fast, irregular, pounding, or racing heartbeat or pulse, headache, nausea, runny or stuffy nose, trouble breathing, itching or skin rash, lightheadedness, or fainting after receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Isatuximab-irfc injection will lower 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 increase your risk of having secondary cancers, including bone marrow (myelodysplasia), breast, or skin cancer. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, a skin sore or reddish bump that does not heal, bloody or black, tarry stools, clear or bloody discharge from nipple, inverted nipple, dimpling of the breast, skin lump in the breast or under the arm, redness or swelling of the breast, sore on the skin of the breast that does not heal, or unusual bleeding, bruising, or weakness.

Make sure any doctor who treats you knows that you are receiving this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Sarclisa

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:

Other side effects of Sarclisa

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:

For healthcare professionals

Applies to isatuximab: intravenous solution.

General adverse events

The most common adverse reactions (20% or greater) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.^[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]

Hematologic

• Very common (10% or more): Anemia (99%), neutropenia (96%), lymphopenia (92%), Grade 3 to 4 neutropenia (85%), thrombocytopenia (84%), febrile neutropenia (12%)^[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]

See also:

Further information

Sarclisa 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