Elotuzumab (Empliciti™)

How to Take Elotuzumab

Elotuzumab is administered intravenously (IV, directly into a vein). The dose is based on your height and weight. How often you receive the medication is based on which cycle you are in. The medication is given until the disease progresses or intolerance of side effects.

Patients are given pre-medications including dexamethasone (steroid), diphenhydramine (Benadryl), ranitidine, and acetaminophen (Tylenol) to help prevent or lessen the side effects of an infusion reaction. It is important to follow the directions on how to take the pre-medications. You may be required to take dexamethasone up to 24 hours prior to your dose of elotuzumab.

Possible Side Effects

There are a number of things you can do to manage the side effects of elotuzumab. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Infection Risk and Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. This medication can suppress your immune system, putting you at higher risk of getting an infection whether or not your WBC count is low.

You should let your doctor or nurse know right away if you have a fever (temperature greater than 38°C or 100.4°F), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal. Infections are a common side effect of treatment with elotuzumab. Some of the most common infections include upper respiratory tract infection, nasopharyngitis (common cold), cough, and pneumonia.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bathe daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your doctor or nurse before scheduling dental appointments or procedures.
• Ask your doctor or nurse before you, or someone you live with has any vaccinations.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib) etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding use of these agents and all over the counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

High Blood Sugar

This medication can cause elevated blood sugar levels in patients with and without diabetes. Your oncology care team will monitor your blood sugar. If you develop increased thirst, urination or hunger, blurry vision, headaches or your breath smells like fruit, notify your healthcare team. Diabetics should monitor their blood sugar closely and report elevations to the healthcare team.

Diarrhea

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads, cereals, and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Constipation

There are several things you can do to prevent or relieve constipation. Include fiber in your diet (fruits and vegetables), drink 8-10 glasses of non-alcoholic fluids a day, and keep active. A stool softener once or twice a day may prevent constipation. If you do not have a bowel movement for 2-3 days, you should contact your healthcare team for suggestions to relieve the constipation.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Peripheral Neuropathy (Numbness or Tingling in the Hands and/or Feet)

Peripheral neuropathy is a toxicity that affects the nerves. It causes numbness or a tingling feeling in the hands and/or feet, often in the pattern of a stocking or glove. This can get progressively worse with additional doses of the medication. In some people, the symptoms slowly resolve after the medication is stopped, but for some it never goes away completely. You should let oncology care team know if you experience numbness or tingling in the hands and/or feet, as they may need to adjust the doses of your medication.

Decrease in Appetite

Nutrition is an important part of your care. Cancer treatment can affect your appetite and, in some cases, the side effects of treatment can make eating difficult. Ask your oncology care team about nutritional counseling services at your treatment center to help with food choices.

• Try to eat five or six small meals or snacks throughout the day, instead of 3 larger meals.
• If you are not eating enough, nutritional supplements may help.
• You may experience a metallic taste or find that food has no taste at all. You may dislike foods or beverages that you liked before receiving cancer treatment. These symptoms can last for several months or longer after treatment ends.
• Avoid any food that you think smells or tastes bad. If red meat is a problem, eat chicken, turkey, eggs, dairy products and fish without a strong smell. Sometimes cold food has less of an odor.
• Add extra flavor to meat or fish by marinating it in sweet juices, sweet and sour sauce or dressings. Use seasonings like basil, oregano or rosemary to add flavor. Bacon, ham and onion can add flavor to vegetables.

Less common, but important side effects can include:

• Infusion Reaction: In some cases, patients can have an allergic reaction to this medication. This most often occurs during the first dose. To help prevent an infusion reaction you will receive medications prior to your treatment including: dexamethasone (steroid), diphenhydramine (Benadryl), ranitidine (Zantac), and acetaminophen (Tylenol). Signs of a reaction can include: fever, chills, rash, trouble breathing, dizziness, light-headedness, bradycardia (a slower than normal heart rate), hypotension (low blood pressure) and hypertension (high blood pressure). If you notice any changes in how you feel during the infusion, let your nurse know immediately. The infusion will be slowed or stopped if this occurs.
• Secondary Cancers: Patients being treated with elotuzumab, lenalidomide and dexamethasone have a higher risk of developing new cancers, which can occur during or after treatment. A secondary cancer is one that develops as a result of cancer treatment for another cancer. This is quite rare, but you should be aware of the risk. In most cases, a secondary cancer related to chemotherapy is a blood cancer (leukemia, lymphoma). This can occur years after treatment. This is most often associated with repeated treatments or high doses. Your provider will monitor your labs closely. Consider having a complete blood count with differential checked annually by your healthcare provider if you received high risk therapies.

Reproductive Concerns

Although there are no specific recommendations regarding pregnancy while taking elotuzumab, it is required that patients follow the REMS program if they are receiving lenalidomide or pomalidomide in combination with elotuzumab. Lenalidomide and pomalidomide can cause life-threatening birth defects. You should not become pregnant or father a child while taking either of these medications. For more information please see the medication sheets for lenalidomide and pomalidomide.