Isatuximab-irfc (eye-sa-TUX-i-mab - irfc)

Treats multiple myeloma.

Brand Name(s):

Sarclisa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the IV tube will need to stay in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You may receive other medicines (including allergy medicine, fever medicine, steroids) before starting treatment with this medicine to help prevent infusion-related reactions. You may also receive an antiviral medicine to help prevent shingles from coming back (herpes zoster reactivation).
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for at least 5 months after the last dose.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have any type of infection (including shingles).
• This medicine may cause the following problems:
  • Serious infusion-related reactions
  • Increased risk for other cancers (including bone marrow, breast, or skin cancer)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Chest tightness, headache, trouble breathing
• Clear or bloody discharge from nipple, inverted nipple, dimpling of the breast, skin lump in the breast or under the arm, redness or swelling of the breast, sore on the skin of the breast that does not heal
• Fever, chills, sore throat, cough, runny or stuffy nose, body aches
• Persistent non-healing sore, reddish patch or irritated area, white, yellow or waxy scar-like area
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088