Elotuzumab

Elotuzumab is used along with other medicines to treat multiple myeloma (bone marrow cancer). Elotuzumab is given with lenalidomide or pomalidomide, and a steroid called dexamethasone.

Elotuzumab may also be used for other reasons not mentioned in this medication guide.

Do not use elotuzumab with lenalidomide or pomalidomide if you are pregnant, or if you are a man and your sexual partner is pregnant. You must use birth control to prevent pregnancy before, during, and shortly after treatment with these medicines.

You should not be treated with elotuzumab if you are allergic to it.

Tell your doctor if you have any type of infection.

Using elotuzumab may increase your risk of developing other types of cancer. Ask your doctor about your specific risk.

Elotuzumab is used with lenalidomide or pomalidomide, which must not be taken during pregnancy. Lenalidomide and pomalidomide are known to cause life-threatening birth defects or death of a baby if the mother or the father is taking the medicine at the time of conception or during pregnancy. Even one dose of lenalidomide or pomalidomide can cause major birth defects.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment, and again every month during treatment. You will be required to use two forms of birth control before, during, and shortly after chemotherapy treatment.
• If you are a man, do not use lenalidomide or pomalidomide if your sexual partner is pregnant or could become pregnant. These medicines may affect your sperm and cause birth defects in the baby. Always use latex condoms when having sex with a woman who can get pregnant, even if you have had a vasectomy.
• Carefully follow all instructions about the use of birth control while using elotuzumab with lenalidomide or pomalidomide, whether you are a man or a woman.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using elotuzumab with lenalidomide or pomalidomide.

Stop using these medicines and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

Lenalidomide and pomalidomide are available only from a certified pharmacy under a special program. You must be registered in the program and agree to use birth control measures as required.

You should not breast-feed while using elotuzumab with lenalidomide and dexamethasone.

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 right away if you feel dizzy, itchy, chilled, feverish, light-headed, or short of breath.

Elotuzumab may cause serious side effects. Call your doctor at once if you have:

• fever, cough, flu-like symptoms;
• pain or burning when you urinate;
• painful skin rash;
• liver problems--loss of appetite, stomach pain or swelling, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• signs of pneumonia--fever, chills, 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 of elotuzumab may include:

• fever, cough, tiredness;
• numbness, weakness, tingling, or burning pain in your arms or legs;
• loss of appetite;
• cold symptoms such as runny nose or sore throat;
• diarrhea, constipation; or
• increased thirst, increased urination.

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.

Elotuzumab is given as an infusion into a vein. A healthcare provider will give you this injection. elotuzumab must be injected slowly, and the infusion can take at least 30 minutes to complete.

Elotuzumab is given in combination with other drugs. You may also be given medicine to prevent certain side effects while you are receiving elotuzumab. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor's advice.

Elotuzumab is usually given every 1 to 4 weeks. You may need to take your other medications daily. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicines exactly as directed.

Your combination chemotherapy will be given in a 28-day treatment cycle. Your doctor will determine how long to treat you with elotuzumab.

Elotuzumab can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Call your doctor for instructions if you miss an appointment for your Empliciti injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not donate blood or sperm while you are using elotuzumab with lenalidomide or pomalidomide, and for 4 weeks after you stop taking it.

Other drugs may affect elotuzumab, 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.

• What is Empliciti (elotuzumab)? and how does Empliciti work?