Elotuzumab, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by infusion to treat multiple myeloma, along with 2 other medicines.
• You may get infections more easily while taking this medicine. This medicine may cause a second type of cancer, liver problems, or other serious side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); chemotherapy; monoclonal antibody

Generic and brand names: elotuzumab, injection; Empliciti

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat multiple myeloma. It is given along with 2 other medicines, lenalidomide and dexamethasone. Before taking this medicine, you must be enrolled in a special program for lenalidomide.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine. Tell your healthcare provider if you currently have a fever or an infection of any kind.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if this medicine will harm an unborn baby. However, lenalidomide may cause death or severe birth defects. While taking this medicine along with lenalidomide, you must use 2 reliable methods of birth control such as birth control pills and condoms or a diaphragm. You will start using these birth control methods 1 month before you start treatment, during treatment, and for 1 month after you stop treatment. Do not breast-feed while receiving this treatment.

Males: Use condoms during sexual intercourse with females of childbearing age while you are receiving treatment with this medicine and lenalidomide, and for 1 month after you stop treatment, even if you have had a successful vasectomy. Do not donate sperm while receiving this medicine and for 1 month after you stop taking it.

How do I use it?

If you are also taking lenalidomide, read the Medication Guide that comes in the package when you start taking the medicine and each time you get a refill.

Your healthcare provider will give you these IV infusions. This medicine is usually given every week during your first 2 cycles, then every 2 weeks. Keep all your appointments for infusions. How long you will need this treatment will be determined by your healthcare provider.

Other medicines are given before each infusion of this medicine to help prevent infusion reactions. You will be watched closely during and after your infusion. Carefully follow your healthcare provider’s instructions for taking any other medicines.

What if I miss a dose?

If you miss an appointment for an infusion, contact your healthcare provider right away to reschedule.

What should I watch out for?

This medicine may cause serious or life-threatening infusion reactions while you are receiving this medicine or up to 24 hours after receiving this medicine. Tell your healthcare provider right away if you have any symptoms of an infusion reaction, such as fever, chills, trouble breathing, dizziness, lightheadedness, or skin rash.

This medicine can cause liver problems. Contact your healthcare provider right away if you have severe tiredness or weakness, severe nausea or vomiting, unexplained loss of appetite, stomach swelling, dark urine, or yellowing of your eyes and skin.

This medicine lowers the number of certain types of blood cells in your body. As a result, you may bleed or get infections more easily. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you have any signs of infection, or any unusual bruising or bleeding. Also, do not have any vaccines without getting your healthcare provider's approval first.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may increase your risk of developing a new cancer. Talk with your provider about this.

This medicine may cause drowsiness or dizziness. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reactions (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing)

Serious (Report these to your healthcare provider right away.): Numbness, tingling, or burning pain in your arms or legs; shortness of breath; severe dizziness; unexplained fever, sore throat, cough, or mouth sores; dark urine; light-colored bowel movements; unexplained loss of appetite; stomach swelling; yellowing of the skin or eyes; confusion; unusual tiredness or weakness; burning with urination; severe stomach pain, nausea, or vomiting; chest pain; fast or slow heartbeat; vision problems; unusual bruising or bleeding.

Other: Diarrhea; constipation; tiredness; runny nose.

What products might interact with this medicine?

No significant drug interactions have been reported for this medicine, however many drugs may interact with lenalidomide and dexamethasone. Talk with your healthcare provider about this.

Do not have any vaccines without getting your healthcare provider's approval first.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.