isatuximab

What is the most important information I should know about isatuximab?

Before using isatuximab tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding.

What is isatuximab?

Isatuximab is used treat multiple myeloma in adults. Isatuximab is usually given in combination with another cancer medicine (carfilzomib or pomalidomide) and a steroid (dexamethasone).

Isatuximab is given after other cancer treatments did not work or have stopped working.

Isatuximab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving isatuximab?

You may need to have a negative pregnancy test before starting this treatment.

If you use isatuximab while you are pregnant, make sure any doctor caring for your new baby knows that you used this medicine during pregnancy. Being exposed to isatuximab in the womb could affect your baby's vaccination schedule during the first few months of life.

You should not use isatuximab together with pomalidomide if you are pregnant or planning to become pregnant. Pomalidomide can cause severe, life-threatening birth defects with just one dose.

Both men and women using pomalidomide should use effective birth control to prevent pregnancy. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using isatuximab and pomalidomide.

Using isatuximab may increase your risk of developing other cancers. Ask your doctor about this risk.

How is isatuximab given?

Isatuximab is given as an infusion into a vein. A healthcare provider will give you this injection.

You will be watched closely for at least 30 minutes after your first 2 infusions to make sure you do not have an allergic reaction.

Isatuximab is given in a 28-day treatment cycle. You may need to use the medicine only during certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

Read all medication guides you receive for the other medicines used in combination with isatuximab.

Isatuximab can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using isatuximab.

If you receive a blood or plasma transfusion, tell the staff that you are being treated with isatuximab.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving isatuximab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of isatuximab?

Some side effects may occur during the injection. Tell your caregiver if you feel cold, itchy, nauseated, feel like you might pass out, or have a cough, headache, stuffy or runny nose, a tight feeling in your throat, pounding heartbeats, fluttering in your chest, or trouble breathing.

• easy bruising, unusual bleeding, purple or red spots under your skin;
• low white blood cell counts --fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
• low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• symptoms of pneumonia --cough with mucus, chest pain, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• low blood cell counts;
• pneumonia;
• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect isatuximab?

Other drugs may affect isatuximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about isatuximab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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