Sarclisa Escena

Sarclisa Escena (isatuximab-irfc subcutaneous) is used to treat multiple myeloma. It is a prescription medicine given by subcutaneous injection. Note that Sarclisa Escena has a different dosage and route of administration from intravenous isatuximab-irfc (Sarclisa) and is not interchangeable.

Multiple myeloma cells carry a marker called CD38 on their surface. Sarclisa Escena (isatuximab-irfc) is a targeted antibody that works by locking onto this marker and helps destroy the cancer cells in two ways: it signals the cells to die, and it calls in the body's own immune system to attack them. Studies also show that combining Sarclisa Escena with other myeloma medicines works better at killing cancer cells than either medicine used on its own. Sarclisa Escena belongs to the drug class called CD38-directed cytolytic antibodies.

Sarclisa Escena is used with two or three other medicines called pomalidomide, dexamethasone, carfilzomib, bortezomib, or lenalidomide. You should also read the Medication Guide that comes with these medicines.

Sarclisa Escena subcutaneous injection (isatuximab-irfc) received FDA approval on July 10, 2026. Sarclisa intravenous was FDA-approved on March 2, 2020.

Sarclisa Escena (isatuximab-irfc subcutaneous) is FDA-approved for multiple myeloma in combination with:

• pomalidomide and dexamethasone, to treat adults who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma.
• carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment, and they did not work or are no longer working.
• bortezomib, lenalidomide, and dexamethasone, to treat adults with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant).

It is not known if Sarclisa Escena is safe and effective in children.

Do not receive Sarclisa Escena if you have a severe allergic reaction to isatuximab-irfc or any of the ingredients in Sarclisa Escena. See the end of this guide for a complete list of ingredients in Sarclisa Escena.

Before you receive Sarclisa Escena, 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 Escena in combination with carfilzomib and dexamethasone for you
• have had shingles (herpes zoster).
• are pregnant or plan to become pregnant. Sarclisa Escena can harm your unborn baby
• are breastfeeding or plan to breastfeed.

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

Pregnancy

Sarclisa Escena can harm your unborn baby. Females who can become pregnant:

• Your healthcare provider will check for pregnancy before you start treatment with Sarclisa Escena
• Use an effective birth control (contraception) during treatment and for 7 months after your last dose of Sarclisa Escena. 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 with Sarclisa Escena

Females and Males: Before receiving Sarclisa Escena in combination with either pomalidomide or lenalidomide, females and males must agree to the instructions in the pomalidomide or lenalidomide REMS programs. The pomalidomide and lenalidomide REMS programs have specific requirements about birth control, pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about pomalidomide or lenalidomide.

Breastfeeding

It is not known if Sarclisa Escena passes into your breast milk. Do not breastfeed during treatment with Sarclisa Escena and for 7 months after your last dose.

Serious side effects

Sarclisa Escena can cause serious side effects, including:

• Allergic reactions. Sarclisa Escena can cause severe or life-threatening allergic reactions throughout the body (systemic administration reactions). Your healthcare provider may stop your injection and not complete it or completely stop treatment with Sarclisa Escena if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you develop any of the following signs and symptoms of an allergic reaction, including: shortness of breath, wheezing, or trouble breathing swelling of the face, mouth, throat, or tongue throat tightness heart beating faster than usual dizziness lightheadedness or fainting headache cough skin rash or itching nausea runny or stuffy nose chills
• Injection site reactions can happen at or near the Sarclisa Escena injection site. Symptoms of these local skin reactions include redness, swelling, and pain. Tell your healthcare provider if you develop injection site reactions during treatment with Sarclisa Escena.
• Decreased white blood cell counts. Decreased white blood cell counts are common and can be severe during treatment with Sarclisa Escena. If fever occurs, this may be a sign that you have an infection. Your healthcare provider will check your blood cell counts during treatment with Sarclisa Escena and may prescribe medicine to help increase your white blood cell counts. Tell your healthcare provider right away if you develop any fever or symptoms of infection during treatment with Sarclisa Escena.
• Infections. Sarclisa Escena can cause infections that are severe, life-threatening, or that can lead to death. Your healthcare provider will monitor you for signs and symptoms of infection before and during treatment with Sarclisa Escena. 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 Escena. Tell your healthcare provider right away if you develop a fever or any signs or symptoms of infection during treatment with Sarclisa Escena.
• Risk of new cancers. New cancers have happened in people during treatment with Sarclisa Escena. Your healthcare provider will monitor you for new cancers during treatment with Sarclisa Escena.
• Changes in blood tests. Sarclisa Escena may affect the results of blood tests to match your blood type for at least 6 months after your last injection of Sarclisa Escena. Your healthcare provider will do blood tests to match your blood type before you start treatment with Sarclisa Escena. Tell all of your healthcare providers that you are being treated with Sarclisa Escena before receiving blood transfusions.

Common side effects

The most common side effects of Sarclisa Escena in combination with pomalidomide and dexamethasone include:

• upper respiratory tract infection
• lung infection (pneumonia)
• tiredness
• muscle and joint pain
• diarrhea
• trouble sleeping
• COVID-19
• constipation
• swelling of the hands, legs, ankles, and feet

The most common side effects of Sarclisa Escena in combination with carfilzomib and dexamethasone include:

• upper respiratory tract infection
• muscle and joint pain
• lung infection (pneumonia)
• high blood pressure
• COVID-19
• trouble sleeping
• diarrhea
• fever

The most common side effects of Sarclisa Escena in combination with bortezomib, lenalidomide and dexamethasone include:

• tingling or numbness of the arms or legs
• constipation
• diarrhea
• tiredness
• muscle and joint pain
• upper respiratory tract infection
• reaction at the injection site
• trouble sleeping
• nausea and vomiting
• skin rash
• skin redness
• swelling throughout the body (edema)
• COVID-19
• back pain
• low blood pressure
• lung infection (pneumonia)
• bronchitis
• muscle spasm
• weight decreased
• flu
• urinary tract infection
• fever
• stomach (abdomen) pain

The most common abnormal blood test results during treatment with Sarclisa Escena combination therapies include:

• decreased white blood cell counts
• decreased red blood cell counts
• decreased platelet counts

Heart failure can happen during treatment with Sarclisa Escena 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 of the possible side effects of Sarclisa Escena. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Sarclisa Escena will be given to you by your healthcare provider as an injection under the skin (subcutaneously), in the abdomen (stomach).

Your healthcare provider will use either the CirCLIQ On-Body Injector or a syringe to administer Sarclisa Escena. The injection time is usually 20 minutes with CirCLIQ and over about 6 minutes with a syringe. Your healthcare provider will rotate the injection site for each injection, including for other medicines.

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

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

Sarclisa Escena in combination with bortezomib, lenalidomide, and dexamethasone is given in treatment cycles of 28 days (4 weeks).

• Cycle 1 (28-day cycle), Sarclisa Escena is given weekly.
• Cycle 2 to 12 (28-day cycles), Sarclisa Escena is given every 2 weeks.
• Cycle 13 and beyond, Sarclisa Escena is given every 4 weeks.

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

Your healthcare provider will give you medicines before each injection of Sarclisa Escena, to help reduce the risk and severity of allergic reactions for at least Cycle 1 of treatment.

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

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

Sarclisa Escena has no known interactions with other medicines, but it can affect certain laboratory tests. As an anti-CD38 antibody, it may cause false-positive results on blood bank serologic tests, including the indirect Coombs test. It can also be detected on serum protein electrophoresis and immunofixation assays used to monitor M-protein, potentially affecting response classification.

Active ingredient: isatuximab-irfc

Inactive ingredients: arginine hydrochloride, histidine, histidine hydrochloride monohydrate, poloxamer 188, sucrose, and water for injection.

Sarclisa Escena is manufactured by sanofi-aventis U.S. LLC, Morristown, NJ 07960, U.S. License No. 1752.