Isatuximab

Isatuximab is used to treat multiple myeloma in adults. Isatuximab is usually given along 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 reasons not mentioned in this medication guide.

Isatuximab is given through an infusion into a vein. A healthcare provider will administer this injection.

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

Isatuximab is given in a 28-day treatment cycle. You may only need to use the medicine on specific days of each cycle. Your doctor will decide how long you should be treated with this medicine.

You may receive other medications to help prevent serious side effects or an allergic reaction. Continue taking these medicines for as long as your doctor has prescribed.

Read all medication guides you get for the other medicines used alongside isatuximab.

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

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

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

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

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 isatuximab and for at least 5 months after your last dose.

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.

You should not breastfeed while using isatuximab.

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

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 happen 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.

Isatuximab may cause serious side effects. Call your doctor right away 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 stopped permanently if you have certain side effects.

Common side effects of isatuximab 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.

Usual Adult Dose for Multiple Myeloma:

IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE:-Cycle 1: 10 mg/kg IV on Days 1, 8, 15, and 22 (weekly)-Cycle 2 and beyond: 10 mg/kg IV on Days 1 and 15 (every 2 weeks)-Each treatment cycle consists of a 28-day period. -Therapy is repeated until disease progression or unacceptable toxicity.Recommended Premedications (administer 15 to 60 minutes prior to the infusion):-Dexamethasone 40 mg orally or IV (or 20 mg orally or IV for patients 75 years or older).-Acetaminophen 650 mg to 1000 mg orally (or equivalent).-H2 antagonists.-Diphenhydramine 25 to 50 mg orally or IV (or equivalent). The IV route is preferred for at least the first 4 infusions.Use: In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor

Usual Geriatric Dose for Multiple Myeloma:

IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE:-Cycle 1: 10 mg/kg IV on Days 1, 8, 15, and 22 (weekly)-Cycle 2 and beyond: 10 mg/kg IV on Days 1 and 15 (every 2 weeks)-Each treatment cycle consists of a 28-day period. -Therapy is repeated until disease progression or unacceptable toxicity.Recommended Premedications (administer 15 to 60 minutes prior to the infusion):-Dexamethasone 40 mg orally or IV (or 20 mg orally or IV for patients 75 years or older).-Acetaminophen 650 mg to 1000 mg orally (or equivalent).-H2 antagonists.-Diphenhydramine 25 to 50 mg orally or IV (or equivalent). The IV route is preferred for at least the first 4 infusions.Use: In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor

Call your doctor for guidance if you miss an appointment for your isatuximab injection.

Since isatuximab is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

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.