Sarclisa

Sarclisa (isatuximab-irfc) is used to treat multiple myeloma, a cancer of the plasma cells in the bone marrow. It is always given in combination with other myeloma medicines, in adults:

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

Sarclisa is a targeted treatment, not chemotherapy. It belongs to a group of medicines called CD38 monoclonal antibodies.

Sarclisa is given as an intravenous (IV) infusion. It has a different dose and route of administration from Sarclisa Escena, which is given as an injection under the skin, and the two are not interchangeable.

Sarclisa received FDA approval on March 2, 2020. The subcutaneous formulation, Sarclisa Escena, received FDA approval on July 10, 2026. There is currently no generic or biosimilar Sarclisa or Sarclisa Escena.

Sarclisa works by attaching to CD38, a protein found in large amounts on the surface of multiple myeloma cells. Once Sarclisa binds to CD38, it signals the cancer cells to die and calls in the body's own immune system to help attack them. Using Sarclisa together with other myeloma medicines works better at killing cancer cells than those medicines used on their own.

Sarclisa was studied in three main phase 3 clinical trials, each adding Sarclisa to standard myeloma medicines. In each trial, the main measure was progression-free survival, which is the length of time during and after treatment that a person lives without their myeloma getting worse.

• ICARIA-MM (with pomalidomide and dexamethasone, after at least 2 prior therapies): adding Sarclisa extended median progression-free survival to 11.5 months, compared with 6.5 months without it. More people also responded to treatment (60% compared with 35%).
• IKEMA (with carfilzomib and dexamethasone, after 1 to 3 prior therapies): adding Sarclisa extended median progression-free survival to about 41.7 months, compared with 20.8 months without it.
• IMROZ (with bortezomib, lenalidomide, and dexamethasone, in newly diagnosed adults not eligible for a transplant): adding Sarclisa lowered the risk of the myeloma progressing or death by about 40%.

Do not receive Sarclisa if you have had a severe allergic reaction to isatuximab or to any of the inactive ingredients in Sarclisa. A full list of ingredients is at the end of this page.

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

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

• have an infection
• have heart problems, if Sarclisa is prescribed with carfilzomib and dexamethasone
• 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, so it should not be used during pregnancy. People who can become pregnant should use effective birth control during treatment and for 5 months after the last dose of Sarclisa, or 7 months after the last dose of Sarclisa Escena. Tell your healthcare provider right away if you think you are or become pregnant during treatment. Before receiving Sarclisa with pomalidomide or lenalidomide, you must also follow the instructions in the pomalidomide or lenalidomide REMS programs.

Breastfeeding

It is not known if Sarclisa passes into breast milk. You should not breastfeed during treatment, and for 7 months after the last dose of Sarclisa Escena.

Serious side effects

Sarclisa may cause serious side effects, including:

• Infusion and allergic reactions. These are common and can sometimes be severe or life-threatening. Your healthcare provider will give you medicines before each dose to lower this risk, and will monitor you during treatment. The infusion or injection may be slowed or stopped if a reaction occurs. Get medical help right away if you develop shortness of breath, wheezing or trouble breathing, swelling of the face, mouth, throat, or tongue, throat tightness, palpitations or fast heartbeat, dizziness or fainting, headache, cough, rash or itching, nausea, a runny or stuffy nose, or chills.
• Injection site reactions. With Sarclisa Escena, reactions such as redness, swelling, and pain can happen at or near the injection site. Tell your healthcare provider if these occur.
• Infections. Sarclisa can cause infections that are severe or life-threatening. Your healthcare provider will monitor you before and during treatment and may prescribe medicines to help prevent infection. Tell your provider right away if you develop a fever or any signs of infection.
• Decreased white blood cell counts. Low white blood cell counts are common and can be severe, which raises the risk of infection. Your provider will check your blood counts during treatment and may prescribe a medicine to help raise them.
• Risk of new cancers. New cancers have occurred in people during and after treatment with Sarclisa. Your provider will monitor you for this.
• Changes in blood tests. Sarclisa can affect blood tests used to match your blood type for about 6 months after your last dose. Tell all of your healthcare providers that you are receiving Sarclisa before you have any blood transfusion.

Heart failure can happen when Sarclisa is used with carfilzomib and dexamethasone. Tell your healthcare provider right away if you develop trouble breathing, a cough, or swelling of your ankles, feet, and legs.

Common side effects

The most common side effects depend on which medicines Sarclisa is combined with.

With pomalidomide and dexamethasone:

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

With carfilzomib and dexamethasone:

• upper respiratory tract infection
• tiredness and weakness
• high blood pressure
• diarrhea
• lung infection (pneumonia)
• trouble breathing
• trouble sleeping
• bronchitis
• cough
• back pain
• decreased red blood cell count (anemia)
• decreased platelet count (thrombocytopenia)

With bortezomib, lenalidomide, and dexamethasone:

• upper respiratory tract infection
• diarrhea
• tiredness and weakness
• tingling or numbness of the arms or legs
• lung infection (pneumonia)
• muscle or bone pain
• clouding of the eye (cataract)
• constipation
• swelling of the hands, legs, ankles, and feet
• rash
• trouble sleeping
• COVID-19
• decreased red blood cell count (anemia)
• decreased platelet count (thrombocytopenia)

These are not all the possible side effects of Sarclisa. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Sarclisa is given by a healthcare provider as an intravenous (IV) infusion into a vein. Sarclisa Escena is given as an injection under the skin (subcutaneous injection) into the stomach area (abdomen). Before each dose, you will be given premedications to lower the risk and severity of reactions.

When given with pomalidomide and dexamethasone, or with carfilzomib and dexamethasone, Sarclisa is given in 28-day (4-week) treatment cycles:

• Cycle 1: once a week (Days 1, 8, 15, and 22)
• Cycle 2 and beyond: every 2 weeks (Days 1 and 15)

When given with bortezomib, lenalidomide, and dexamethasone, Sarclisa (IV) is given in 42-day (6-week) cycles for cycles 1 to 4, then 28-day (4-week) cycles from cycle 5:

• Cycle 1: once a week (Days 1, 8, 15, 22, and 29)
• Cycles 2 to 4: every 2 weeks (Days 1, 15, and 29)
• Cycles 5 to 17: every 2 weeks (Days 1 and 15)
• Cycles 18 and beyond: every 4 weeks (Day 1)

Treatment continues until the myeloma gets worse or side effects become unacceptable. Your healthcare provider will decide how many treatments you receive.

If you miss an appointment for your Sarclisa infusion, call your healthcare provider as soon as possible to reschedule. Your provider will adjust your treatment schedule and will give you premedications before each dose to reduce the risk of infusion reactions.

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

Sarclisa has no known interactions with other medicines, but it can affect certain laboratory tests. As a CD38 antibody, it may cause false-positive results on blood bank cross-matching tests, including the indirect Coombs test. It can also show up on serum protein electrophoresis and immunofixation tests used to monitor M-protein (a marker of myeloma), which may affect how your response to treatment is measured.

Sarclisa and Sarclisa Escena are stored by your healthcare provider or pharmacy. Vials are kept in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect them from light. Do not freeze and do not shake.

Active ingredient: isatuximab-irfc

Inactive ingredients:

• Sarclisa: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injection
• Sarclisa Escena: arginine hydrochloride, histidine, histidine hydrochloride monohydrate, poloxamer 188, sucrose, and water for injection