Pronunciation:

el-oh-TOOZ-ue-mab

Brand Names:

• Empliciti

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.