Elotuzumab

What is Elotuzumab?

• Elotuzumab (Empliciti) is a SLAMF7-directed immunostimulatory antibody used to treat people with multiple myeloma who have received one to three prior medications.

What are the uses of this medicine?

This medicine is used used to treat:

• multiple myeloma in combination with the medicines REVLIMID (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma.
• multiple myeloma in combination with the medicines POMALYST (pomalidomide) and dexamethasone in adults who have received at least two prior treatments including REVLIMID (lenalidomide) and a proteasome inhibitor.

How does this medicine work?

• Elotuzumab (el" oh tooz' ue mab) is humanized IgG1 monoclonal antibody to the cell surface receptor signaling lymphocyte activation molecule family member 7 (SLAMF7), which is a transmembrane glycoprotein that is frequently overexpressed on multiple myeloma cells and is found normally on natural killer (NK) cells.
• The monoclonal antibody binds to the cell surface receptor and triggers cell apoptosis of cancer cells and activation of NK cells which may increase its antineoplastic activity.
• In preregistration trials, the addition of elotuzumab to lenalidomide and dexamethasone led to an increase in overall response rates and prolongation of progression-free survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Empliciti can interfere with assays used to monitor M-protein.
• This interference can impact the determination of complete response.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen.

Recommended Dosage:

• With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity.
• With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity.

Administration

• Empliciti will be given to you by intravenous (IV) infusion into your vein.
• Your Empliciti treatment schedule is divided into cycles that are 28 days (4 weeks) long. A cycle includes the number of days you are on treatment and also the time you spend resting in between treatments.

Empliciti with REVLIMID and dexamethasone is usually given as follows:

• Cycles 1 and 2 (28 days per cycle), you will receive Empliciti one time every week.
• Cycles 3 and up (28 days per cycle), you will receive Empliciti one time every 2 weeks.

Empliciti with POMALYST and dexamethasone is usually given as follows:

• Cycle 1 and 2 (28 days per cycle), you will receive Empliciti one time every week.
• Cycle 3 and up (28 days per cycle), you will receive Empliciti one time every 4 weeks.
• Your healthcare provider will decide how many treatments you will receive.
• Before every Empliciti infusion, you will receive medicines to help reduce the risk of infusion reactions.
• If you miss any appointments call your healthcare provider as soon as possible.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Empliciti

What side effects can this medication cause?

The most common side effects of Empliciti when used with REVLIMID and dexamethasone include:

• fatigue
• diarrhea
• fever
• constipation
• cough
• numbness, weakness, tingling, or burning pain in your arms or legs
• sore throat or runny nose
• upper respiratory tract infection
• decreased appetite
• pneumonia

The most common side effects of Empliciti when used with POMALYST and dexamethasone include:

• constipation
• high blood sugar

Empliciti may cause serious side effects, including:

• Infusion reactions
• Infections
• Risk of new cancers (malignancies)
• Liver problems

What special precautions should I follow?

• Empliciti can cause infusion reactions. Premedication is required. Interrupt Empliciti for Grade 2 or higher and permanently discontinue for severe infusion reaction.
• Infections may occur. Monitor for fever and other signs of infection and treat promptly.
• Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving Empliciti.
• Hepatotoxicity were reported. Monitor liver function and stop Empliciti if hepatotoxicity is suspected.
• Empliciti can interfere with assays used to monitor M-protein. This interference can impact the determination of complete response.

What to do in case of emergency/overdose?

• The dose of Empliciti at which severe toxicity occurs is not known

Management of overdosage:

• Empliciti does not appear to be removed by dialysis as determined in a study of patients with renal impairment.
• In case of overdosage, monitor patients closely for signs or symptoms of adverse reactions and institute appropriate symptomatic treatment.

Can this medicine be used in pregnancy?

• There are no available data on Empliciti use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: elotuzumab
• Inactive ingredients: citric acid monohydrate, polysorbate 80, sodium citrate, sucrose

Who manufactures and distributes this medicine?

• Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ

What should I know about storage and disposal of this medication?

• Store Empliciti under refrigeration at 2°C to 8°C (36°F-46°F).
• Protect Empliciti from light by storing in the original package until time of use.
• Do not freeze or shake.

• Dailymed label info on Elotuzumab
• FDA Elotuzumab

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