Generic name: isatuximab-irfc
Dosage form: injection, for intravenous use
Drug class: CD38 monoclonal antibodies

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 4, 2024.

What is Sarclisa?

Sarclisa (isatuximab-irfc) may be used to treat multiple myeloma in combination with:

• pomalidomide and dexamethasone, in adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
• carfilzomib and dexamethasone, in adults who have already received 1 to 3 lines of treatment and they did not work or are no longer working
• bortezomib, lenalidomide, and dexamethasone, in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

Sarclisa's mechanism of action involves binding to CD38, a protein expressed by blood and tumor cells, including multiple myeloma cells. This enhances programmed cell death (apoptosis) and the activation of other immune responses including natural killer cells. Sarclisa is not chemotherapy it is a targeted treatment.

Sarclisa first gained FDA approval on March 2, 2020. 

Sarclisa side effects

The most common side effects of Sarclisa are:

• lung infection (pneumonia) or upper respiratory tract infections
• decreased red blood cell counts (anemia) or platelet counts (thrombocytopenia)
• diarrhea

Additional side effects commonly reported when Sarclisa is used in combination with carfilzomib and dexamethasone are:

• tiredness and weakness
• high blood pressure
• trouble sleeping
• bronchitis
• cough
• back pain
• trouble breathing.

Additional common side effects when Sarclisa is used in combination with bortezomib, lenalidomide and
dexamethasone are:

• constipation
• swelling of the hands, legs, ankles and feet
• tiredness and weakness
• rash
• tingling or numbness of the arms or legs
• trouble sleeping
• COVID-19
• muscle or bone pain
• clouding of your eye or eyes (cataract).

Serious side effects and warnings

Sarclisa may cause the following serious side effects.

Infusion reactions. Infusion reactions are common with Sarclisa and can sometimes be severe or life-threatening. Your healthcare provider will prescribe medicines before each infusion of Sarclisa to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each dose. Your healthcare provider may slow down or stop your infusion, or completely stop treatment if you have an infusion reaction.

Get medical help right away if you develop any of the following symptoms of infusion reaction during or after an infusion of Sarclisa:

• shortness of breath, wheezing or trouble breathing
• swelling of the face, mouth, throat, or tongue
• throat tightness
• palpitations
• dizziness, lightheadedness, or fainting
• headache
• cough
• rash or itching
• nausea
• runny or stuffy nose
• chills.

Infections. Sarclisa can cause infections that are severe, life-threatening, or that may lead to death. Your
healthcare provider will monitor you for signs and symptoms of infection before and during treatment with
Sarclisa. Your healthcare provider may prescribe medicines for you to help prevent infections and treat you as
needed if you develop an infection during treatment with Sarclisa. Tell your healthcare provider right away if
you develop a fever or any signs or symptoms of infection during treatment with Sarclisa.

Decreased white blood cell counts. Decreased white blood cell counts are common with Sarclisa and certain white blood cells can be severely decreased. You may have an increased risk of getting certain infections, such as upper and lower respiratory tract infections and urinary tract infections. Your healthcare provider will check your blood cell counts during treatment. Your healthcare provider may prescribe an antibiotic or antiviral
medicine to help prevent infection, or a medicine to help increase your white blood cell counts during treatment.
Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment.

Risk of new cancers. New cancers have happened in people during treatment with Sarclisa. Your healthcare provider will monitor you for new cancers during treatment.

Change in blood tests. Sarclisa can affect the results of blood tests to match your blood type. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with Sarclisa before receiving blood transfusions.

Heart failure. Heart failure can happen during treatment with Sarclisa in combination with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop any of the following symptoms:

• trouble breathing
• cough
• swelling of your ankles, feet, and legs.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Before receiving Sarclisa

Do not receive Sarclisa if you have a history of a severe allergic reaction to isatuximab, Sarclisa, or any of the inactive ingredients in the Sarclisa injection. See the end of this page for a complete list of ingredients.

It is not known if Sarclisa is safe and effective in children. Sarclisa is only approved for adults.

Before receiving Sarclisa, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• have heart problems, if your healthcare provider prescribes Sarclisa in combination with carfilzomib and dexamethasone for you
• have had shingles (herpes zoster)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Sarclisa may harm your unborn baby. You should not receive this medicine during pregnancy. Females who are able to become pregnant should use an effective method of birth control during treatment and for 5 months after their last dose. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you think you are pregnant or become pregnant during treatment.

Breastfeeding

It is not known if Sarclisa passes into your breast milk. You should not breastfeed during treatment.

How will I receive Sarclisa?

Sarclisa will be given to you by your healthcare provider by intravenous (IV) infusion into your vein.

Sarclisa in combination with pomalidomide and dexamethasone, or Sarclisa in combination with
carfilzomib and dexamethasone is given in treatment cycles of 28 days (4 weeks).

• Cycle 1 (28-day cycle), Sarclisa is given weekly.
• Cycle 2 and beyond (28-day cycles), Sarclisa is given every 2 weeks.

Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone is given in treatment cycles of 42 days (6 weeks) from cycle 1 to 4 and in treatment cycles of 28 days (4 weeks) from cycle 5.

• Cycle 1 (42-day cycle), Sarclisa is given weekly (Days 1, 8, 15, 22, and 29).
• Cycles 2 to 4 (42-day cycles), Sarclisa is given every 2 weeks (Days 1, 15, and 29).
• Cycles 5 to 17 (28-day cycles), Sarclisa is given every 2 weeks (Days 1 and 15).
• Cycles 18 and beyond (28-day cycles), Sarclisa is given every 4 weeks.

Your healthcare provider will decide how many treatments you will receive. 

What happens if I miss a dose of Sarclisa?

If you miss any appointments for your Sarclisa infusion, call your healthcare provider as soon as possible to reschedule your appointment.

• Your healthcare provider will give you medicines before each dose of Sarclisa, to help reduce the risk of infusion reactions (make them less frequent and severe).

What other drugs will affect Sarclisa?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sarclisa may interfere with blood bank serologic tests with false positive reactions in indirect antiglobulin tests (indirect Coombs tests), antibody detection (screening) tests, antibody identification panels, and antihuman globulin crossmatches in patients treated with Sarclisa. 

Sarclisa ingredients

Active ingredient: isatuximab-irfc

Inactive ingredients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Who makes Sarclisa?

Sanofi-aventis U.S. LLC, makes Sarclisa.

Sarclisa Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Sarclisa.

Further information

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

Medical Disclaimer