Description
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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
- Blurred vision
- body aches or pain
- chest pain
- chills
- clay-colored stools
- confusion
- cough
- dark urine
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- fever
- headache
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- loss of voice
- lower back or side pain
- nasal congestion
- nausea
- nervousness
- painful or difficult urination
- persistent sore that does not heal
- pink skin growth
- pounding in the ears
- reddish patch or irritated area
- redness of the skin
- runny nose
- shiny skin bump
- slow or fast heartbeat
- sneezing
- sore throat
- stomach pain or tenderness
- stuffy nose
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- troubled breathing or swallowing
- unusual tiredness or weakness
- vomiting
- white, yellow or waxy scar-like area on the skin
- yellow eyes or skin
Less common
- Agitation
- anxiety
- decreased awareness or responsiveness
- decreased urine output
- depression
- dizziness or lightheadedness
- fainting
- fast heartbeat
- hostility
- irritability
- loss of consciousness
- muscle twitching
- pale skin
- rapid weight gain
- seizures
- severe sleepiness
- troubled breathing with exertion
- unusual bleeding or bruising
- 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
- Blindness
- burning, numbness, tingling, or painful sensations
- decreased appetite
- decreased vision
- decreased weight
- diarrhea
- difficulty having a bowel movement
- muscle aches
- night sweats
- pain in the arms or legs
- unsteadiness or awkwardness
- 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.
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