Elotuzumab

Generic name: elotuzumab
Brand name: Empliciti
Dosage form: intravenous powder for injection (300 mg; 400 mg)
Drug class: Miscellaneous antineoplastics

What is elotuzumab?

Elotuzumab is a prescription medicine that is used to treat multiple myeloma.

This medicine is used with a steroid drug (dexamethasone) and either lenalidomide or pomalidomide. Talk with the doctor about the risks and side effects that may happen with those drugs.

Description

Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody.

EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP .

Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg).

Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).

Mechanism of Action

Elotuzumab is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer (NK) cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Elotuzumab directly activates NK cells through the SLAMF7 pathway. Elotuzumab also targets SLAMF7 on myeloma cells and interacts with Fc receptors on effector cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). In nonclinical models, the combination of elotuzumab and lenalidomide resulted in enhanced activation of NK cells that was greater than the effects of either agent alone and increased anti-tumor activity in vitro and in vivo. Elotuzumab has also demonstrated increased anti-tumor activity when combined with pomalidomide in vivo.

Before taking elotuzumab, tell your doctor:

• If you are allergic to elotuzumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take elotuzumab.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take elotuzumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take elotuzumab?

• Tell all of your health care providers that you take elotuzumab. This includes your doctors, nurses, pharmacists, and dentists.
• Some people have unsafe allergic effects or bad side effects during the infusion or within 24 hours of the infusion. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take elotuzumab.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are pregnant or you get pregnant while taking elotuzumab, call your doctor right away.

How is elotuzumab best taken?

Use elotuzumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• Other drugs may be given to help with infusion side effects.

What do I do if I miss a dose?

• Call your doctor to find out what to do.
• If you miss a dose of the steroid drug (dexamethasone) or if it is stopped, talk with your doctor.

What are the side effects of elotuzumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Dizziness or passing out.
• Fast or slow heartbeat.
• Change in color or size of a mole.
• A skin lump or growth.
• Change in eyesight.
• Chest pain or pressure.
• Mood changes.
• Night sweats.
• Any unexplained bruising or bleeding.
• Shortness of breath.
• Swelling in the arms or legs.

What are some other side effects of elotuzumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Diarrhea.
• Constipation.
• A burning, numbness, or tingling feeling that is not normal.
• Nose or throat irritation.
• Signs of a common cold.
• Not hungry.
• Pain in arms or legs.
• Headache.
• Throwing up.
• Weight loss.
• Bone pain.
• Muscle spasm.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out elotuzumab?

• If you need to store elotuzumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

EMPLICITI 300 MG REPRESENTATIVE PACKAGING

EMPLICITI 400 MG REPRESENTATIVE PACKAGING

• NDC 0003-4522-11
  Rx only
  EmplicitiTM
  (elotuzumab)
  for Injection
  400 mg per vial
  For intravenous Infusion Only
  Reconstitute and Further Dilute Prior to Use
  Single-Dose Vial. Discard Unused Portion.Bristol-Myers Squibb

SRC: NLM .