Elotuzumab Injection

WHY is this medicine prescribed?

Elotuzumab injection is used along with lenalidomide (Revlimid) and dexamethasone or along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved with treatment or that had improved after treatment with other medications but later returned. Elotuzumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Elotuzumab comes as a powder to be mixed with sterile water and given intravenously (into a vein) by a doctor or nurse in a healthcare setting. When used in combination with lenalidomide and dexamethasone it is usually given once every week for the first 2 cycles (each cycle is a 28 day treatment period) and then once every 2 weeks. When used in combination with pomalidomide and dexamethasone it is usually given once a week for the first 2 cycles (each cycle is a 28 day treatment period) and then once every 4 weeks.

A doctor or nurse will watch you closely while you are receiving the infusion and after the infusion to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent reactions to elotuzumab. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during the infusion or for up to 24 hours after you receive the infusion: fever, chills, rash, dizziness, lightheadedness, slowed heart beat, chest pain, difficulty breathing, or shortness of breath.

Your doctor may decrease your dose of elotuzumab or permanently or temporarily stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with elotuzumab.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving elotuzumab injection,

• tell your doctor and pharmacist if you are allergic to elotuzumab, any other medications, or any of the ingredients in elotuzumab injection. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have an infection or if you have or have ever had liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving elotuzumab injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Elotuzumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• headache
• vomiting
• mood changes
• weight loss
• night sweats
• numbness or decreased sense of touch
• bone pain
• muscle spasms
• swelling of your arms or legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately:

• chills, sore throat, fever, or cough; shortness of breath; pain or burning upon urination; painful rash; or other signs of infection
• numbness, weakness, tingling, or burning pain in your arms or legs
• chest pain
• nausea, extreme tiredness and lack of energy, loss of appetite, yellowing of the skin or eyes, dark urine, pale stools, confusion, pain in the upper right part of the stomach
• vision changes

Elotuzumab injection may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication.

Elotuzumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to elotuzumab injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving elotuzumab injection.

Ask your pharmacist any questions you have about elotuzumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.