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 (pomalidomide) and a steroid (dexamethasone).
Isatuximab is given after at least two 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 should not be treated with isatuximab if you are allergic to it.
You may need to have a negative pregnancy test before starting this treatment.
Isatuximab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your last dose.
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.
You should not breastfeed while using isatuximab.
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.
You may be given other medications to help prevent serious side effects or an allergic reaction. Keep using these medicines for as long as your doctor has prescribed.
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?
Call your doctor for instructions if you miss an appointment for your isatuximab injection.
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?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver if you feel cold or nauseated, or have a cough or trouble breathing.
Call your doctor at once if you have:
- 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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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