elotuzumab (Rx)

Brand and Other Names:Empliciti
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 300mg/vial
  • 400mg/vial

Multiple Myeloma

Combination with lenalidomide and dexamethasone

  • Indicated in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received 1-3 prior therapies
  • Each 28-day period is 1 treatment cycle
  • Continue treatment until disease progression or unacceptable toxicity
  • Note: Premedicate before each dose (see Administration)
  • Cycles 1-2
    • Days 1, 8, 15, and 22: Elotuzumab 10 mg/kg IV
    • Days 1-21: Lenalidomide 25 mg PO
    • Days 1, 8, 15, and 22: Dexamethasone 28 mg PO given 3-24 hr before elotuzumab
  • Cycle 3 and thereafter
    • Days 1 and 15: Elotuzumab 10 mg/kg IV
    • Days 1-21: Lenalidomide 25 mg PO
    • Days 1 and 15 when elotuzumab is administered: Dexamethasone 28 mg PO given 3-24 hr before elotuzumab
    • Days 8 and 22 when elotuzumab is not administered: Dexamethasone 40 mg PO

Combination with pomalidomide and dexamethasone

  • Indicated in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor
  • Each 28-day period is 1 treatment cycle
  • Continue treatment until disease progression or unacceptable toxicity
  • Note: Premedicate before each dose (see Administration)
  • Cycles 1-2
    • Days 1, 8, 15, 22: Elotuzumab 10 mg/kg IV
    • Days 1-21: Pomalidomide 4 mg PO
    • Days 1, 8, 15, and 22 when elotuzumab is administered: Dexamethasone 28 mg (aged ≤75 yr) or 8 mg (aged >75 yr) PO given 3-24 hr before elotuzumab
  • Cycle 3 and thereafter
    • Day 1: Elotuzumab 20 mg/kg IV
    • Days 1-21: Pomalidomide 4 mg PO
    • Day 1 when elotuzumab is administered: Dexamethasone 28 mg (aged ≤75 yr) or 8 mg (aged >75 yr) PO given 3-24 hr before elotuzumab
    • Days 8, 15, and 22 when elotuzumab is not administered: Dexamethasone 40 mg (aged ≤75 yr) or 20 mg (age >75 yr) PO

Dosage Modifications

If 1 drug in the regimen is delayed, interrupted, or discontinued, continue treatment with the other drugs as scheduled

If dexamethasone is delayed or discontinued, base decision whether to administer elotuzumab on clinical judgment (ie, risk of hypersensitivity)

See prescribing information for dexamethasone, pomalidomide and lenalidomide for additional information

Infusion reactions

  • Grade ≥2
    • Interrupt infusion and institute appropriate medical and supportive measures
    • Resolves to Grade ≤1: Restart dose at 0.5 mL/min and gradually increase rate to 0.5 mL/min q30min as tolerated to the rate at which infusion reaction occurred; resume escalation if no recurrence of infusion reaction
    • If infusion reaction recurs, stop infusion and do not restart on that day
    • In patients who experience an infusion reaction, monitor vital signs q30min for 2 hr after completing infusion
    • Severe infusion reactions may require permanent discontinuation of therapy and emergency treatment

Renal impairment

  • Mild-to-severe (CrCl 15-89 mL/min) or ESRD (CrCl <15 mL/min) with or without hemodialysis: No dosage adjustment required

Hepatic impairment

  • Mild (total bilirubin ≤upper limit of normal (ULN) and AST >ULN OR total bilirubin 1-1.5x ULN and AST any value): No dosage adjustment required
  • Moderate or severe (total bilirubin >1.5-3x ULN and AST any value) to severe (total bilirubin >3x ULN and AST any value): Not studied

Safety and efficacy not established

Multiple Myeloma

Combination with lenalidomide and dexamethasone (Cycle 1-2)

  • Indicated in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received 1-3 prior therapies
  • Each 28-day period is 1 treatment cycle
  • Continue treatment until disease progression or unacceptable toxicity
  • Days 1, 8, 15, and 22: Elotuzumab 10 mg/kg IV
  • Days 1-21: Lenalidomide 25 mg PO
  • Days 1, 8, 15, and 22: Dexamethasone 28 mg PO given 3-24 hr before elotuzumab

Combination with lenalidomide and dexamethasone (Cycle 3 and thereafter)

  • Days 1, 15: Elotuzumab: 10 mg/kg IV q2Weeks
  • Days 1-21: Lenalidomide 25 mg PO
  • Days 1 and 15 when elotuzumab is administered: Dexamethasone 28 mg PO given 3-24 hr before elotuzumab
  • Days 8 and 22 when elotuzumab is not administered: Dexamethasone 40 mg PO

Combination with pomalidomide and dexamethasone (Cycles 1-2)

  • Indicated in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received ≥2 prior therapies (eg, lenalidomide and a proteasome inhibitor)
  • Each 28-day period is 1 treatment cycle
  • Continue treatment until disease progression or unacceptable toxicity
  • Days 1, 8, 15, 22: Elotuzumab 10 mg/kg IV
  • Days 1-21: Pomalidomide 4 mg PO Days 1, 8, 15, 22 (age ≤75 years): Dexamethasone 28 mg PO between 3-24 hr before elotuzumab
  • Days 1, 8, 15, 22 (age >75 years): Dexamethasone 8 mg PO between 3-24 hr before elotuzumab

Combination with pomalidomide and dexamethasone (Cycle 3 and thereafter)

  • Day 1: Elotuzumab 20 mg/kg IV
  • Days 1-21: Pomalidomide 4 mg PO
  • Day 1 when elotuzumab is administered: Dexamethasone 28 mg (aged ≤75 yr) or 8 mg (aged >75 yr) PO given 3-24 hr before elotuzumab
  • Days 8, 15, and 22 when elotuzumab is not administered: Dexamethasone 40 mg (aged ≤75 yr) or 20 mg (age >75 yr) PO
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Adverse Effects

All grades of severity are listed unless otherwise stated

>10% (Combination with lenalidomide and dexamethasone)

Heart rate <60 bpm (66%)

Fatigue (62%)

Heart rate ≥100 bpm (48%)

Diarrhea (47%)

Pyrexia (37%)

Constipation (36%)

Cough (34%)

Systolic blood pressure ≥160 mmHg (33%)

Systolic blood pressure <90 mmHg (29%)

Peripheral neuropathy (27%)

Nasopharyngitis (25%)

Upper respiratory tract infection (23%)

Decreased appetite (21%)

Pneumonia (20%)

Diastolic blood pressure ≥100 mmHg (17%)

Pain in extremities (16%)

Headache (15%)

Vomiting (14%)

Decreased weight (14%)

Lymphopenia (13%)

Cataracts (12%)

Grades 3 or 4

  • Pneumonia (14%)
  • Fatigue (13%)

>10% (Combination with pomalidomide and dexamethasone)

Heart rate <60 bpm (43%)

Heart rate ≥100 bpm (23%)

Constipation (22%)

Hyperglycemia (20%)

Pneumonia (18%)

Diarrhea (18%)

Systolic blood pressure ≥160 mmHg (18%)

Respiratory tract infection (17%)

Bone pain (15%)

Dyspnea (15%)

Muscle spasms (13%)

Peripheral edema (13%)

1-10% (Combination with lenalidomide and dexamethasone)

Oropharyngeal pain (10%)

Grades 3 or 4

  • Diarrhea (5%)
  • Peripheral neuropathy (3.8%)
  • Pyrexia (2.5%)
  • Decreased appetite (1.6%)
  • Decreased weight (1.3%)
  • Constipation (1.3%)

1-10% (Combination with pomalidomide and dexamethasone)

Lymphopenia (10%)

Diastolic blood pressure ≥100 mmHg (8%)

Systolic blood pressure <90 mmHg (7%)

Grades 3 or 4

  • Lymphopenia (8%)
  • Pneumonia (10%)
  • Hyperglycemia (8%)
  • Bone pain (3.3%)
  • Constipation (1.7%)

<1% (Grades 3 or 4)

Combination with lenalidomide and dexamethasone

  • Cough
  • Upper respiratory tract infection
  • Pain in extremities
  • Headache

Frequency Not Defined

Chest pain, night sweats

Hypersensitivity

Hypoesthesia

Altered mood

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Warnings

Contraindications

None

Cautions

Infusion reactions (eg, fever, chills, and hypertension) reported; bradycardia and hypotension also developed during infusions (see Dosage Modifications)

Infections reported, including opportunistic infections (eg, fungal infections, herpes zoster); monitor patients for development of infections and treat promptly

Second primary malignancies reported, including solid tumors and skin cancers; monitor patients for development of second primary malignancies

Elevations in liver enzymes (AST/ALT >3x ULN, total bilirubin >2x ULN, and alkaline phosphatase <2x ULN) consistent with hepatotoxicity reported; monitor liver enzymes periodically; stop elotuzumab for Grade ≥3 elevation of liver enzymes; consider resuming treatment after return to baseline values

Humanized IgG kappa monoclonal antibody can be detected on both serum protein electrophoresis (SPEP) and immunofixation (IFE) assays; may impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein

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Pregnancy & Lactation

Pregnancy

No available data on use in pregnant women to inform a drug associated risk of major birth defects and miscarriage

Therapy is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone, which can cause embryo-fetal 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 prior to initiating treatment in females of reproductive potential

Lactation

There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child 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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocytic activation molecule family member 7) protein

Elotuzumab directly activates natural killer cells through both the SLAMF7 pathway and Fc receptors; also targets SLAMF7 on myeloma cells and facilitates the interaction with natural killer cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC)

Absorption

Mean steady-state through concentration: 194 mcg/mL (with lenalidomide and dexamethasone); 124 mcg/mL (with pomalidomide and dexamethasone)

Elimination

Clearance (with lenalidomide and dexamethasone):17.5 mL/day/kg (0.5 mg/kg-dose) to 5.8 mL/day/kg (20 mg/kg-dose)

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Administration

IV Compatibility

0.9% NaCl

D5W

IV Incompatibility

Do not mix or administer with other medicinal products

IV Preparation

Reconstitution

  • Reconstitute with 13 mL (300-mg vial) or 17mL (400-mg vial) of sterile water for injection (SWI) for a concentration of 25 mg/mL
  • Hold vial upright and swirl solution by rotating vial to dissolve lyophilized cake; lyophilized powder should dissolve in <10 minutes
  • Invert vial a few times to dissolve any powder remaining on top of vial or stopper
  • Avoid vigorous agitation; DO NOT SHAKE
  • Once completely dissolved, allow reconstituted solution to stand for 5-10 minutes
  • Reconstituted preparation results in a colorless to slightly yellow, clear to slightly opalescent solution
  • Visually inspect for particulate matter and discoloration, whenever solution; discard solution if any particulate matter or discoloration is observed

Dilution

  • Withdraw calculated dose from each vial, up to 12 mL (300-mg vial) and 16 mL (400-mg vial)
  • Further dilute with either 0.9% NaCl or 5% D5W, into an infusion bag made of polyvinyl chloride or polyolefin to a final infusion concentration (1-6 mg/mL)
  • Volume can be adjusted; not to exceed 5 mL/kg of patient weight at any given dose of elotuzumab

Premedication

  • Complete administration of the following premedications 45-90 min before elotuzumab infusion
  • Dexamethasone 8 mg IV
  • Diphenhydramine 25-50 mg PO or IV (or equivalent H1 blocker)
  • Ranitidine 50 mg IV (or equivalent H2 blocker)
  • Acetaminophen 650-1000 mg PO

IV Administration

Administer with an infusion set and a sterile, nonpyrogenic, low protein-binding filter (with a pore size of 0.2-1.2 micrometer) using an automated infusion pump

IV infusion rate (10 mg/kg)

  • Initiate IV infusion at a rate of 0.5 mL/min; may increase infusion rate in a stepwise fashion described below; not to exceed 5 mL/min
  • Adjust rate if infusion reaction ≥Grade 2 occurs
  • Cycle 1, dose 1
    • 0-30 min: 0.5 mL/min
    • 30-60 min: 1 mL/min
    • ≥60 min: 2 mL/min
  • Cycle 1, dose 2
    • 0-30 min: 3 mL/min
    • ≥30 min: 4 mL/min
  • Cycle 1, dose 3 and 4 and all subsequent cycles: 5 mL/min

IV infusion rate (20 mg/kg)

  • Initiate IV infusion rate at 3 mL/min (20 mg/kg-dose) increase rate in a stepwise fashion described below; not to exceed 5 mL/min
  • Dose 1
    • 0-30 min: 3 mL/min
    • ≥60 min: 4 mL/min
  • Dose 2 and all subsequent doses: 5 mL/min

Storage

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF)
  • Protect from light by storing in the original package until time of use
  • Do not freeze or shake

Diluted infusion

  • Refrigerate at 2-8ºC (36-46ºF), protected from light, for up to 24 hr
  • Up to 8 hr of the total 24 hr can be at room temperature 20-25ºC (68-77ºF)
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.