Isatuximab-irfc Injection

WHY is this medicine prescribed?

Isatuximab-irfc injection is used to treat certain types of multiple myeloma (a type of cancer of the bone marrow). 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Isatuximab-irfc injection comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse. Your doctor will tell you howoften you will receive isatuximab-irfc injection. The length of treatment depends on how your body responds to the medication and any side effects you experience.

Isatuximab-irfc injection may cause serious or life-threatening reactions while your receive the medication. A doctor or nurse will watch you closely while you are receiving the infusion. Your doctor may give you other medications to help prevent reactions to isatuximab-irfc injection. Tell your doctor or nurse immediately if you experience any of the following symptoms: nausea; shortness of breath; wheezing; difficulty breathing; swelling of the face, mouth, throat, or tongue; throat tightness; dizziness; lightheadedness; fainting; runny or stuffy nose; cough; rash or itching; fast, irregular, or pounding heart; headache; or chills.

Your doctor may stop or pause 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.

What SPECIAL PRECAUTIONS should I follow?

Before receiving isatuximab-irfc injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or anyother drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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 are receiving blood transfusions or if you have an infection. Also, tell your doctor if you have or have ever had shingles (a painful rash that occurs after infection with herpes zoster or chickenpox) or heart disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving isatuximab-irfc injection. You may need to have a pregnancy test before you start treatment. You should use birth control during your treatment 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 injection.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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
• constipation
• difficulty falling asleep or staying asleep
• numbness or tingling in the hands, feet, arms or legs
• muscle or bone pain

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:

• fever, chills, sore throat, 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 legs, ankles, or feet

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

Isatuximab-irfc can affect blood matching test results for up to 6 months after your final dose. Before having a blood transfusion, tell your doctor and the laboratory personnel that you are receiving or received isatuximab-irfc injection. Your doctor will do blood tests to match your blood type before you start treatment with isatuximab-irfc injection.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.