Isatuximab-irfc injection is used along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) in adults who have received at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used along with carfilzomib (Kyprolis) and dexamethasone to treat multiple myeloma in adults whose cancer has returned or is unresponsive to at least one other treatment. Isatuximab-irfc injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Isatuximab-irfc injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse. Initially, it is usually given on days 1, 8, 15, and 22 of the first 28-day cycle. After the first cycle, it is usually given on days 1 and 15 of 28-day cycle. This cycle may be repeated as long as the medication continues to work and does not cause severe side effects.

A doctor or nurse will watch you closely while you are receiving the infusion and after the infusion to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent reactions to isatuximab-irfc. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion or for up to 24 hours after you receive the infusion: nausea; shortness of breath; wheezing; difficulty breathing; swelling of the face, mouth, throat, or tongue; throat tightness; dizziness; lightheadedness; fainting; runny or stuffy nose; nasal congestion; cough; or chills.

Your doctor may permanently or temporarily stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with isatuximab-irfc.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before receiving isatuximab-irfc injection,

• tell your doctor and pharmacist if you are allergic to isatuximab-irfc, any other medications, or any of the ingredients in isatuximab-irfc injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an infection or heart disease.
• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with isatuximab-irfc injection. You should use birth control to prevent pregnancy during your treatment with isatuximab-irfc injection and for 5 months after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving isatuximab-irfc injection, call your doctor. Isatuximab-irfc injection may harm the fetus.
• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment with isatuximab-irfc.

If you miss an appointment to receive isatuximab-irfc, call your doctor as soon as possible.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Unless your doctor tells you otherwise, continue your normal diet.

Isatuximab-irfc injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• chills, sore throat, fever, or cough; pain or burning upon urination; or other signs of infection
• unusual bleeding, easy bruising, or red blood in stools
• shortness of breath, dizziness or weakness, or pale skin
• difficulty breathing, cough, or swelling of the leg(s)

Isatuximab-irfc may increase your risk of developing other cancers. Talk to your doctor about the risks of receiving this medication.

Isatuximab-irfc may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to isatuximab-irfc injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving isatuximab-irfc injection.

Ask your pharmacist any questions you have about isatuximab-irfc injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Sarclisa®