Dosing & Uses
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
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
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
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.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)
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
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