Elotuzumab

Elotuzumab is a prescription medication used in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adults who have received 1 to 3 prior therapies. It is also used in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

• Elotuzumab is available under the following different brand names: Empliciti

Common side effects of Elotuzumab include:

• fatigue
• diarrhea
• fever
• constipation
• cough
• tingling or numbness in the hands and feet
• sore throat
• runny or stuffy nose
• upper respiratory tract infection
• decreased appetite
• pneumonia
• pain in the extremities
• headache
• vomiting
• weight loss
• low white blood cell count (lymphocytopenia)
• cataracts

Serious side effects of Elotuzumab include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• anemia
• blood clot in the lungs (pulmonary embolism)
• acute kidney failure
• chills

Rare side effects of Elotuzumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 300 mg/vial
• 400 mg/vial

Multiple myeloma

Adult and geriatric dosage

• Combination with lenalidomide and dexamethasone
• Each 28-day period constitutes 1 treatment cycle
• Continue treatment until disease progression or unacceptable toxicity
• Note: Premedicate before each dose 
• Cycles 1-2
  • Days 1, 8, 15, and 22: elotuzumab 10 mg/kg IV
  • Days 1-21: lenalidomide 25 mg orally.
  • Days 1, 8, 15, and 22: dexamethasone 28 mg orally given 3-24 hours before elotuzumab.
• Cycle 3 and thereafter
  • Days 1 and 15: Elotuzumab 10 mg/kg IV
  • Days 1-21: lenalidomide 25 mg orally
  • Days 1 and 15 when elotuzumab is administered: dexamethasone 28 mg orally given 3-24 hours before elotuzumab.
  • Days 8 and 22 when elotuzumab is not administered: dexamethasone 40 mg orally.

Geriatric dosage

• Cycle 3 and thereafter
  • Days 1 and 15: elotuzumab 10 mg/kg IV every 2 weeks
  • Days 1-21: lenalidomide 25 mg orally.
  • Days 1 and 15 when elotuzumab is administered: dexamethasone 28 mg orally given 3-24 hours before elotuzumab.
  • Days 8 and 22 when elotuzumab is not administered: dexamethasone 40 mg orally.
  • Combination with pomalidomide and dexamethasone
  • Each 28-day period constitutes 1 treatment cycle
  • Continue treatment until disease progression or unacceptable toxicity
  • Note: Premedicate before each dose 
• Cycles 1-2
  • Days 1, 8, 15, 22: elotuzumab 10 mg/kg IV.
  • Days 1-21: pomalidomide 4 mg orally.
  • Days 1, 8, 15, and 22 when elotuzumab is administered: dexamethasone 28 mg (aged 75 years and below) or 8 mg (aged above 75 years) orally given 3-24 hours before elotuzumab.
• Cycle 3 and thereafter
  • Day 1: elotuzumab 20 mg/kg IV.
  • Days 1-21: pomalidomide 4 mg orally.
  • Day 1 when elotuzumab is administered: dexamethasone 28 mg (aged 75 years and below) or 8 mg (aged above 75 years) orally given 3-24 hours before elotuzumab.
  • Days 8, 15, and 22 when elotuzumab is not administered: dexamethasone 40 mg (aged 75 years and below) or 20 mg (aged above 75 years) orally.

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Elotuzumab has no noted severe interactions with any other drugs.
• Elotuzumab has no noted serious interactions with any other drugs.
• Elotuzumab has no noted moderate interactions with any other drugs.
• Elotuzumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Elotuzumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Elotuzumab?”

Cautions

• Infusion reactions (eg, fever, chills, and hypertension) were reported; bradycardia and hypotension also developed during infusions
• Infections reported, including opportunistic infections (eg, fungal infections, herpes zoster); monitor patients for the development of infections and treat them promptly
• Second primary malignancies reported, including solid tumors and skin cancers; monitor patients for the development of second primary malignancies
• Elevations in liver enzymes (AST/ALT above 3× ULN, total bilirubin above 2×ULN, and alkaline phosphatase below 2 × ULN) consistent with hepatotoxicity reported; monitor liver enzymes periodically; stop elotuzumab for Grade 3 and more elevations of liver enzymes; consider resuming treatment after return to baseline values
• Elotuzumab is a humanized IgG kappa monoclonal antibody, which can be detected on both serum protein electrophoresis (SPEP) and immunofixation (IFE) assays; this may impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein

Pregnancy and Lactation

• No data available on the drug’s use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage
• Therapy is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone, which can cause embryofetal harm and are contraindicated for use in pregnancy; refer to lenalidomide, pomalidomide, and dexamethasone prescribing information for additional information; lenalidomide and pomalidomide are only available through REMS program
• Contraception
  • Refer to lenalidomide and pomalidomide labeling for contraception requirements before initiating treatment in women of reproductive potential
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on breastfed children, or milk production; because of the potential for serious adverse reactions in breastfed children from elotuzumab
  • Administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone, advise lactating women not to breastfeed during treatment; refer to lenalidomide, pomalidomide, and dexamethasone