Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Empliciti

Descriptions


Elotuzumab injection is used together with lenalidomide and dexamethasone to treat multiple myeloma (a blood cell cancer) in patients who have received one to three previous cancer treatments. It is also used together with pomalidomide and dexamethasone to treat multiple myeloma in patients who have received at least two previous cancer treatments (eg, lenalidomide, proteasome inhibitor). Elotuzumab interferes with the growth of cancer cells, which are then destroyed by the body. It is an antineoplastic agent (cancer medicine).

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of elotuzumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elotuzumab injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tofacitinib

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Infection—May decrease your body's ability to fight infections.
  • Liver disease—Use with caution. May make this condition worse.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all of the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

Your doctor will give you this medicine every week for 2 cycles (28 days each cycle) together with lenalidomide and dexamethasone or pomalidomide and dexamethasone. For cycles 3 and up, you will receive this medicine every 2 weeks together with lenalidomide and dexamethasone or every 4 weeks together with pomalidomide and dexamethasone.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine, stomach medicine, or steroid) 45 to 90 minutes before infusion to prevent unwanted effects (eg, infusion reactions).

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Precautions

It is very important that your doctor check you at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine together with lenalidomide and dexamethasone or pomalidomide and dexamethasone while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control to prevent pregnancy during treatment with this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Infusion reactions may occur with this medicine. Tell your doctor right away if you have a skin rash, dizziness, fever or chills, headache, nausea or vomiting, slow or fast heartbeat, lightheadedness or fainting, sweating, or unusual tiredness or weakness.

Call your doctor right away if you have a cough that would not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, or blurred vision. These may be symptoms of an infection.

Using this medicine may increase your risk of getting other types of cancer (including skin cancer). Talk to your doctor if you have concerns about this risk.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by this medicine.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Blurred vision
  2. body aches or pain
  3. chest pain
  4. chills
  5. clay-colored stools
  6. confusion
  7. cough
  8. dark urine
  9. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  10. ear congestion
  11. fever
  12. headache
  13. hives, itching, skin rash
  14. hoarseness
  15. irritation
  16. joint pain, stiffness, or swelling
  17. loss of appetite
  18. loss of voice
  19. lower back or side pain
  20. nasal congestion
  21. nausea
  22. nervousness
  23. painful or difficult urination
  24. persistent sore that does not heal
  25. pink skin growth
  26. pounding in the ears
  27. reddish patch or irritated area
  28. redness of the skin
  29. runny nose
  30. shiny skin bump
  31. slow or fast heartbeat
  32. sneezing
  33. sore throat
  34. stomach pain or tenderness
  35. stuffy nose
  36. sweating
  37. swelling of the eyelids, face, lips, hands, or feet
  38. tightness in the chest
  39. troubled breathing or swallowing
  40. unusual tiredness or weakness
  41. vomiting
  42. white, yellow or waxy scar-like area on the skin
  43. yellow eyes or skin

Less common

  1. Agitation
  2. anxiety
  3. decreased awareness or responsiveness
  4. decreased urine output
  5. depression
  6. dizziness or lightheadedness
  7. fainting
  8. fast heartbeat
  9. hostility
  10. irritability
  11. loss of consciousness
  12. muscle twitching
  13. pale skin
  14. rapid weight gain
  15. seizures
  16. severe sleepiness
  17. troubled breathing with exertion
  18. unusual bleeding or bruising
  19. unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Blindness
  2. burning, numbness, tingling, or painful sensations
  3. decreased appetite
  4. decreased vision
  5. decreased weight
  6. diarrhea
  7. difficulty having a bowel movement
  8. muscle aches
  9. night sweats
  10. pain in the arms or legs
  11. unsteadiness or awkwardness
  12. weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.