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Generic Name: elotuzumab (EL oh TOOZ ue mab)
Brand Names: Empliciti

What is Empliciti?

Empliciti (elotuzumab) 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 lenalidomide and a steroid medicine called dexamethasone.

Lenalidomide (Revlimid) is available only under a special program. You must be registered in the program and understand the risks and benefits of taking this medicine.

Important information

Do not use Empliciti with lenalidomide 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.

Before taking this medicine

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

Empliciti is used together with lenalidomide and dexamethasone. Lenalidomide is known to cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects. Do not take lenalidomide if you are pregnant.

  • If you are a woman, you may need to have a negative pregnancy test before your chemotherapy treatment starts, and again every month while using Empliciti with lenalidomide. 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 Empliciti and lenalidomide if your sexual partner is pregnant or could become pregnant. Lenalidomide 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, 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.

Stop using lenalidomide 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 is available only from a certified pharmacy under a special program called Revlimid REMS. You must be registered in the program and sign documents stating that you understand the dangers of this medicine and that you agree to use birth control measures as required by the program. You will be limited to a 28-day supply of lenalidomide each time your prescription is refilled.

To make sure Empliciti is safe for you, 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.

It is not known whether elotuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Empliciti with lenalidomide and dexamethasone.

How is Empliciti given?

Empliciti is given in combination with other drugs. You may 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 injected into a vein through an IV. A healthcare provider will give you this injection. This medicine must be injected slowly, and the IV infusion can take at least 30 minutes to complete.

Your combination chemotherapy will be given in a 28-day treatment cycle. Empliciti is usually given once per week. Your doctor will determine how long to treat you with this medicine.

You may need to take your other medications daily. Follow all directions on your prescription label. Do not take your medicines in larger or smaller amounts or for longer than recommended.

Empliciti can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using elotuzumab.

Empliciti dosing information

Usual Adult Dose of Empliciti for Multiple Myeloma:

10 mg/kg IV every week for the first 2 cycles and every 2 weeks thereafter

Manufacturer recommended infusion rate for elotuzumab:
-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
-Time interval 0 to 30 min; Rate 1 mL/min
-Time interval 30 min or more; Rate 2 mL/min
-Rate 2 mL/min

-The length of a cycle is 28 days.
-This drug is given in combination with lenalidomide and dexamethasone.
-Patients should be premedicated 45 to 90 minutes before administration of this drug with dexamethasone, diphenhydramine (or equivalent H1 blocker), ranitidine (or equivalent H2 blocker), and acetaminophen. Consult manufacturer product information or local protocol for instructions concerning premedication.
-Do not mix elotuzumab with, or administer an infusion with, other medicinal products.

Use: In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1 to 3 prior therapies

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Empliciti injection.

If you miss a dose of the other medications you take as part of your combination treatment, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since Empliciti is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Empliciti?

Do not donate blood or sperm while you are using Empliciti with lenalidomide, and for 4 weeks after you stop taking it.

Empliciti side effects

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, flu-like symptoms;

  • pale skin, feeling light-headed or short of breath;

  • easy bruising or bleeding (nosebleeds, bleeding gums);

  • pain or burning when you urinate;

  • cough with yellow or green mucus, stabbing chest pain, wheezing; or

  • upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

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, tingling, or burning pain in your arms or legs;

  • loss of appetite;

  • diarrhea, constipation; or

  • cold symptoms such as runny nose or sore throat.

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.

See also: Side effects (in more detail)

What other drugs will affect Empliciti?

Other drugs may interact with elotuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Empliciti.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Empliciti only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2016-01-14, 2:27:25 PM.