Empliciti

Empliciti is a monoclonal antibody that blocks a certain protein in the body that can affect tumor cell growth. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Empliciti is used in combination chemotherapy to treat multiple myeloma (bone marrow cancer).

Empliciti is given together with either lenalidomide or pomalidomide, and a steroid medicine called dexamethasone.

Lenalidomide (Revlimid) and pomalidomide (Pomalyst) are available only under a special program. You must be registered in the program and understand the risks and benefits of taking these medicines.

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

Empliciti is given in combination with other drugs. You may also be given medicine to prevent certain side effects while you are receiving this medicine. 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.

Empliciti 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.

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

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

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

Tell your doctor if you have any type of infection.

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

Empliciti is used together 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 is able to get pregnant, even if you have had a vasectomy.
• Carefully follow all instructions about the use of birth control while using Empliciti 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 Empliciti 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 Empliciti with lenalidomide and dexamethasone, or with pomalidomide and dexamethasone.

Get emergency medical help if you have signs of an allergic reaction to Empliciti: 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.

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 Empliciti side effects 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.

Usual Adult Dose for Multiple Myeloma:

When used with lenalidomide and dexamethasone: 10 mg/kg IV every week for the first 2 cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity: -Cycles 1 and 2: 10 mg/kg IV once a week on days 1, 8, 15, and 22 of a 28-day cycle -Cycle 3 and beyond: 10 mg/kg IV once every 2 weeks on days 1 and 15 of a 28-day cycle When used with pomalidomide and dexamethasone: 10 mg/kg IV every week for the first 2 cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity: -Cycles 1 and 2: 10 mg/kg IV once a week on days 1, 8, 15, and 22 of a 28-day cycle -Cycle 3 and beyond: 20 mg/kg IV once every 4 weeks on day 1 of a 28-day cycle Manufacturer recommended infusion rate (at the recommended concentration of 25 mg/mL): CYCLE 1, DOSE 1: -Time interval 0 to 30 min; Rate 0.5 mL/min -Time interval 30 to 60 min; Rate 1 mL/min -Time interval 60 min or more; Rate 2 mL/min CYCLE 1, DOSE 2: -Time interval 0 to 30 min; Rate 3 mL/min -Time interval 30 min or more; Rate 4 mL/min CYCLE 1, DOSE 3 AND 4 AND ALL SUBSEQUENT CYCLES: -Rate 5 mL/min Comments: -The length of a cycle is 28 days. -This drug is given in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone; refer to their prescribing information for additional information. -Patients should be premedicated 45 to 90 minutes before administration of elotuzumab with dexamethasone, an antipyretic, an H1 blocker, and an H2 blocker. The manufacturer recommends: Dexamethasone 28 mg orally 3 to 24 hours before the elotuzumab infusion plus dexamethasone 8 mg IV 45 to 90 minutes prior to infusion; on days that elotuzumab is not administered but dexamethasone is due (e.g., days 8 and 22 of cycle 3 and beyond), administer the standard dexamethasone dose (40 mg orally) AND acetaminophen 650 to 1000 mg orally AND diphenhydramine 25 to 50 mg orally or IV (or equivalent H1 blocker) AND ranitidine 50 mg IV or 150 mg orally (or equivalent H2 blocker). Use: In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1 to 3 prior therapies, or in combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

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 Empliciti with lenalidomide or pomalidomide, and for 4 weeks after you stop taking it.

Other drugs may interact with 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?