Empliciti (Elotuzumab)
Monoclonal Antibody for the Treatment of Multiple Myeloma
Empliciti (elotuzumab) is an immunostimulatory monoclonal antibody used in combination with other medicines to treat multiple myeloma in adults whose cancer has relapsed or not responded to prior therapy. It works by targeting the SLAMF7 protein on myeloma cells and natural killer cells, stimulating the immune system to attack cancer cells. This guide provides comprehensive, evidence-based information on its uses, dosage, side effects, and important precautions.
Quick Facts
Key Takeaways
- Empliciti (elotuzumab) is a targeted immunotherapy used in combination with lenalidomide or pomalidomide plus dexamethasone to treat relapsed or refractory multiple myeloma.
- It works by binding to SLAMF7 on myeloma and natural killer cells, directly activating the immune response against cancer cells through antibody-dependent cellular cytotoxicity.
- Infusion-related reactions are the most clinically significant risk, especially during the first dose; premedication with antihistamines, dexamethasone, and paracetamol is always required.
- Treatment is administered in 28-day cycles via intravenous infusion in a healthcare setting, with the dosing frequency reducing from weekly to biweekly or monthly from cycle 3 onward.
- Women of childbearing potential must use effective contraception during treatment and for 120 days after discontinuation; lenalidomide and pomalidomide are known teratogens.
What Is Empliciti and What Is It Used For?
Empliciti contains the active substance elotuzumab, a humanised IgG1 monoclonal antibody designed to recognise and bind to a specific target protein in the body called signalling lymphocytic activation molecule family member 7 (SLAMF7). This protein is found in high amounts on the surface of multiple myeloma cells as well as on certain immune cells known as natural killer (NK) cells.
When elotuzumab binds to SLAMF7 on myeloma cells or natural killer cells, it triggers a dual mechanism of action. First, it directly activates NK cells through SLAMF7 signalling, enhancing their cancer-killing activity. Second, it marks myeloma cells for destruction by the immune system through a process called antibody-dependent cellular cytotoxicity (ADCC). This dual mechanism makes elotuzumab unique among monoclonal antibodies used in myeloma treatment, as it both activates the immune system and targets cancer cells simultaneously.
Multiple myeloma is a type of blood cancer that develops in the bone marrow from a type of white blood cell called plasma cells. In myeloma, these plasma cells divide uncontrollably and accumulate in the bone marrow, producing abnormal proteins and causing damage to the skeleton, kidneys, and immune system. Myeloma remains largely incurable, and most patients will eventually relapse despite initial treatment, necessitating additional lines of therapy.
Empliciti is approved for use in adults with multiple myeloma who have received at least one prior therapy. It is not used as a standalone treatment but is always given in combination with other anti-myeloma medicines. The two approved combination regimens are elotuzumab plus lenalidomide and dexamethasone (known as Elo-Rd), or elotuzumab plus pomalidomide and dexamethasone (known as Elo-Pd). Clinical trials have demonstrated that adding elotuzumab to these backbone regimens significantly improves progression-free survival compared with the backbone regimens alone.
The ELOQUENT-2 phase III trial showed that the addition of elotuzumab to lenalidomide and dexamethasone reduced the risk of disease progression or death by 30% compared with lenalidomide and dexamethasone alone, with a median progression-free survival of 19.4 months versus 14.9 months. The ELOQUENT-3 trial demonstrated similar benefit when elotuzumab was combined with pomalidomide and dexamethasone in patients who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
What Should You Know Before Taking Empliciti?
Contraindications
You must not receive Empliciti if you have a known hypersensitivity (allergy) to elotuzumab or to any of the other ingredients in the medicine. These include sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80. If you are unsure whether you may be allergic to any of these components, discuss this with your doctor before treatment begins.
Since Empliciti is always used in combination with either lenalidomide or pomalidomide plus dexamethasone, the contraindications for all medicines in the combination regimen also apply. It is essential to read the patient information leaflets for all medicines being given alongside Empliciti before starting treatment.
Warnings and Precautions
The most important safety concern with Empliciti is infusion-related reactions. These reactions occur most frequently during or after the first dose and can include fever, chills, high blood pressure, nausea, chest tightness, throat tightness, cough, and flushing. In clinical trials, infusion-related reactions occurred in approximately 10% of patients treated with elotuzumab in combination with lenalidomide and dexamethasone.
To reduce the risk of infusion-related reactions, you will receive premedication before each infusion. This includes an antihistamine (such as diphenhydramine), dexamethasone (which serves as both premedication and part of the treatment regimen), and paracetamol (acetaminophen). You will be monitored during and after the infusion for signs of a reaction.
If an infusion-related reaction occurs, the infusion rate may be slowed or temporarily stopped. Once symptoms resolve, the infusion can usually be resumed at a slower rate. In cases of severe reactions, including anaphylaxis (a rare but potentially life-threatening allergic reaction), your doctor may decide to permanently discontinue Empliciti treatment.
Elotuzumab is a monoclonal antibody that can be detected on serum protein electrophoresis (SPEP) and immunofixation assays. Because these tests are used to monitor M-protein levels in myeloma patients, the presence of elotuzumab may interfere with accurate response assessment. Inform your laboratory and medical team that you are receiving Empliciti so they can account for this interference when interpreting test results.
Empliciti is not recommended for children and adolescents under 18 years of age, as the safety and efficacy of elotuzumab have not been established in this population. Clinical trials have been conducted exclusively in adult patients.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, you must inform your doctor before receiving Empliciti. The effects of elotuzumab on the developing foetus are not known, and therefore Empliciti should not be used during pregnancy unless your doctor determines that the potential benefit justifies the potential risk to the unborn child.
Women of childbearing potential must use effective contraception during treatment with Empliciti and for at least 120 days after the last dose. This requirement is critically important because Empliciti is given in combination with lenalidomide or pomalidomide, both of which are known teratogens (substances that can cause birth defects). When given with lenalidomide or pomalidomide, patients must strictly follow the pregnancy prevention programme associated with these medicines.
It is not known whether elotuzumab passes into breast milk. However, because Empliciti is always given with lenalidomide or pomalidomide, breastfeeding must be discontinued during treatment, as these companion medicines are contraindicated during breastfeeding. A decision must be made whether to discontinue breastfeeding or to discontinue Empliciti therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Men receiving Empliciti in combination with lenalidomide or pomalidomide must use condoms during treatment and for 180 days after the last dose to prevent exposing a pregnant partner to these medicines through seminal fluid.
Driving and Operating Machinery
Empliciti is not expected to directly affect your ability to drive or operate machinery. However, if you experience an infusion-related reaction with symptoms such as fever, chills, dizziness, or changes in blood pressure, you should not drive, cycle, or operate machinery until the reaction has fully resolved. Fatigue is also a common side effect that may impair your ability to perform tasks requiring concentration.
Empliciti contains 3.92 mg of sodium per 300 mg vial. This should be taken into consideration by patients on a controlled sodium (low-salt) diet. The sodium content is equivalent to approximately 0.2% of the WHO-recommended maximum daily intake of 2 g sodium for an adult.
How Does Empliciti Interact with Other Drugs?
Elotuzumab is a monoclonal antibody that is cleared through catabolism (natural protein breakdown) rather than through the liver enzyme systems (such as cytochrome P450 enzymes) that metabolise most small-molecule drugs. As a result, elotuzumab has a low likelihood of causing pharmacokinetic drug-drug interactions. No formal drug interaction studies have been conducted with elotuzumab.
However, because Empliciti is always administered as part of a combination regimen, it is essential to consider the drug interactions associated with lenalidomide, pomalidomide, and dexamethasone. Dexamethasone, in particular, is a known inducer of CYP3A4 and may reduce the effectiveness of medicines metabolised by this enzyme. Inform your doctor about all medicines you are taking, have recently taken, or plan to take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Key Combination Drug Considerations
| Interacting Medicine | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Dexamethasone (CYP3A4 substrates) | Enzyme induction | May reduce levels of CYP3A4 substrates | Review concomitant CYP3A4 substrates |
| Warfarin and anticoagulants | Via dexamethasone | Altered anticoagulant effect | Monitor INR closely |
| Erythropoiesis-stimulating agents | Additive risk (with lenalidomide) | Increased thrombotic risk | Use with caution; consider thromboprophylaxis |
| Digoxin | Via dexamethasone | Potential for reduced digoxin levels | Monitor digoxin levels |
| Hormonal contraceptives | Via dexamethasone (CYP3A4 induction) | Reduced contraceptive efficacy | Use additional or alternative contraception |
| Vaccines (live) | Immunosuppression | Risk of vaccine-related infection | Avoid live vaccines during treatment |
Laboratory Test Interference
One of the most clinically important considerations is that elotuzumab, being an IgG1 kappa monoclonal antibody, can be detected on serum protein electrophoresis (SPEP) and immunofixation assays. This can interfere with the accurate measurement of the monoclonal protein (M-protein) produced by myeloma cells, which is a key marker used to assess treatment response. Laboratories use specific assays to distinguish between therapeutic elotuzumab and disease-related M-protein, and your treating team should be aware of this potential interference when evaluating your disease status.
What Is the Correct Dosage of Empliciti?
The dose of Empliciti is calculated based on your body weight. It is administered by experienced healthcare professionals as an intravenous infusion (drip into a vein) over several hours. Treatment is organised in 28-day cycles and continues as long as the disease responds or remains stable and the side effects are tolerable.
With Lenalidomide and Dexamethasone (Elo-Rd)
Cycles 1 and 2: 10 mg/kg weekly
Empliciti 10 mg/kg is given on days 1, 8, 15, and 22 of each 28-day cycle.
Cycle 3 and beyond: 10 mg/kg biweekly
Empliciti 10 mg/kg is given on days 1 and 15 of each 28-day cycle.
With Pomalidomide and Dexamethasone (Elo-Pd)
Cycles 1 and 2: 10 mg/kg weekly
Empliciti 10 mg/kg is given on days 1, 8, 15, and 22 of each 28-day cycle.
Cycle 3 and beyond: 20 mg/kg monthly
Empliciti 20 mg/kg is given on day 1 of each 28-day cycle.
Infusion Rate Guidelines
Empliciti must be infused slowly, with the rate gradually increased over the course of each infusion if well tolerated. The infusion rate differs depending on the dose and cycle number.
| Time Interval | Cycle 1, Dose 1 | Cycle 1, Dose 2 | Cycle 1, Doses 3–4 & Subsequent |
|---|---|---|---|
| 0–30 minutes | 0.5 mL/min | 3 mL/min | 5 mL/min |
| 30–60 minutes | 1 mL/min | 4 mL/min (continue) | — |
| ≥60 minutes | 2 mL/min (continue) | — | — |
The maximum infusion rate must not exceed 5 mL/min for the 10 mg/kg dose. For the 20 mg/kg dose, the infusion starts at 3 mL/min and may be increased to a maximum of 5 mL/min after 30 minutes if well tolerated. When transitioning from 10 mg/kg to 20 mg/kg, the infusion rate must be reduced back to 3 mL/min for the first dose at the higher level.
Required Premedication
Before each infusion of Empliciti, you will receive the following premedications to help prevent infusion-related reactions:
- Antihistamine (e.g., diphenhydramine) – to reduce allergic-type reactions
- Dexamethasone – to reduce inflammation (this also serves as part of the anti-myeloma regimen)
- Paracetamol (acetaminophen) – to reduce pain and fever
Missed Dose
Since Empliciti is administered in a healthcare setting, missed doses are uncommon. If any of the medicines in the combination regimen are delayed, interrupted, or discontinued, your doctor will determine how your treatment should continue. Do not attempt to adjust your treatment schedule without consulting your healthcare team.
Overdose
Because Empliciti is given by healthcare professionals in a controlled clinical setting, overdose is unlikely. In the unlikely event that too much Empliciti is administered, your medical team will monitor you closely for any adverse effects and provide supportive care as needed. There is no specific antidote for elotuzumab overdose.
What Are the Side Effects of Empliciti?
Like all medicines, Empliciti can cause side effects, although not everybody experiences them. Your doctor will discuss the benefits and risks of treatment with you and will monitor you for any adverse effects throughout your course of therapy. The following side effects have been reported in clinical trials with elotuzumab.
Infusion-Related Reactions
Infusion-related reactions are among the most clinically significant side effects of Empliciti. These reactions occur most frequently during or shortly after the first infusion and tend to decrease in frequency and severity with subsequent doses. Symptoms can include fever, chills, elevated blood pressure, flushing, nausea, and chest tightness. Tell your doctor or nurse immediately if you feel unwell during the infusion.
If an infusion-related reaction occurs, the infusion rate may be slowed or temporarily stopped. Your doctor may also give you additional medicines to manage the symptoms. In most cases, the infusion can be resumed at a slower rate once symptoms have improved. However, in cases of severe reactions, Empliciti treatment may need to be permanently discontinued.
Side Effects by Frequency
Very Common
May affect more than 1 in 10 people
- Fever (pyrexia)
- Sore throat (nasopharyngitis)
- Pneumonia (lung infection)
- Weight loss
- Low white blood cell count (lymphopenia, leukopenia)
- Cough
- Upper respiratory tract infection (common cold)
- Headache
- Diarrhoea
- Fatigue or feeling of weakness (asthenia)
Common
May affect up to 1 in 10 people
- Chest pain
- Blood clots in veins (deep vein thrombosis)
- Painful skin rash with blisters (herpes zoster / shingles)
- Night sweats
- Mood changes
- Decreased skin sensitivity (hypoaesthesia)
- Allergic reactions (hypersensitivity)
- Pain in the mouth or throat (oropharyngeal pain)
Uncommon
May affect up to 1 in 100 people
- Anaphylactic reaction (sudden, severe, life-threatening allergic reaction)
Contact your doctor or seek emergency medical care immediately if you experience signs of a severe allergic reaction (anaphylaxis) such as sudden difficulty breathing, swelling of the face, lips, tongue, or throat, rapid heartbeat, or severe drop in blood pressure. Also contact your doctor if you develop signs of a serious infection such as high fever, persistent cough with coloured sputum, or chest pain with difficulty breathing.
It is important to report any suspected side effects to your healthcare provider. Monitoring for side effects allows the continued assessment of the benefit-risk balance of the medicine. Your doctor may adjust your treatment or provide additional medicines to manage side effects as needed.
How Should You Store Empliciti?
Because Empliciti is administered in healthcare settings, you will not typically need to store this medicine yourself. However, the following storage information is provided for completeness and to help you understand how your treatment is handled by your healthcare team.
- Unopened vials: Store in a refrigerator at 2°C–8°C. Do not freeze. Keep the vials in the original packaging to protect from light.
- After reconstitution: The reconstituted solution should be transferred immediately from the vial to an infusion bag. Once diluted, the infusion must be completed within 24 hours from the time of reconstitution.
- If not used immediately: The reconstituted or diluted solution may be stored in a refrigerator at 2°C–8°C for up to 24 hours. Of this 24-hour period, the solution may be kept at room temperature (20°C–25°C) for a maximum of 8 hours, including the infusion time.
- Do not freeze the reconstituted or diluted solution at any stage.
Keep all medicines out of sight and reach of children. Do not use Empliciti after the expiry date stated on the vial label and carton. The expiry date refers to the last day of the stated month. Any unused medicine or waste material should be disposed of in accordance with local requirements.
What Does Empliciti Contain?
Empliciti is supplied as a white to off-white lyophilised (freeze-dried) powder in a glass vial. It must be reconstituted with water for injections and then diluted before administration. The reconstituted solution is colourless to slightly yellow and clear to slightly opalescent.
Active Substance
Each vial contains 300 mg of elotuzumab. After reconstitution with 13.0 mL of water for injections, the resulting solution contains 25 mg/mL of elotuzumab with a total extractable volume of approximately 13.6 mL.
Inactive Ingredients (Excipients)
- Sucrose – a stabiliser that helps maintain the structure of the antibody during freeze-drying and storage
- Sodium citrate – a buffering agent that maintains the correct pH of the solution
- Citric acid monohydrate – a buffering agent used in conjunction with sodium citrate
- Polysorbate 80 (E433) – a surfactant that prevents the protein from aggregating during reconstitution and administration
The final infusion solution is prepared by diluting the reconstituted concentrate with either sodium chloride 9 mg/mL (0.9%) solution or glucose 5% solution. The final concentration of the infusion should be between 1 mg/mL and 6 mg/mL, and the total volume should not exceed 5 mL per kilogram of body weight at any given dose.
Frequently Asked Questions About Empliciti
Empliciti (elotuzumab) is used to treat multiple myeloma, a cancer of the bone marrow, in adults. It is given in combination with lenalidomide and dexamethasone, or with pomalidomide and dexamethasone, for patients whose cancer has not responded to or has returned after prior therapies. It is not used as a standalone treatment.
Empliciti is given as an intravenous (IV) infusion in a hospital or clinic setting. The infusion is given over several hours and the rate is gradually increased if well tolerated. In the first two cycles, it is given weekly; from cycle 3 onward, the frequency is reduced to biweekly or monthly depending on the combination regimen. You will always receive premedication before each infusion to reduce the risk of reactions.
The most common side effects include infusion-related reactions (fever, chills, high blood pressure), upper respiratory tract infections, pneumonia, weight loss, low white blood cell counts, cough, headache, diarrhoea, and fatigue. These side effects are generally manageable with appropriate medical care and monitoring.
Empliciti should not be used during pregnancy unless specifically recommended by your doctor, as the effects on the unborn baby are unknown. Critically, Empliciti is always given with lenalidomide or pomalidomide, which are known to cause birth defects. Women must use effective contraception during treatment and for 120 days after the last dose. Breastfeeding must be stopped during treatment. Men must use condoms during treatment and for 180 days after the last dose.
Empliciti works through a unique dual mechanism. It targets a protein called SLAMF7 that is found on both myeloma cells and natural killer (NK) immune cells. When elotuzumab binds to SLAMF7 on NK cells, it directly activates them to kill cancer cells. When it binds to SLAMF7 on myeloma cells, it marks them for destruction by the immune system through antibody-dependent cellular cytotoxicity (ADCC). This makes Empliciti a true immunostimulatory antibody that both activates the immune system and tags cancer cells.
Before each infusion, you will receive three types of premedication: an antihistamine (such as diphenhydramine) to reduce allergic reactions, dexamethasone (a corticosteroid that also serves as part of the treatment regimen) to reduce inflammation, and paracetamol (acetaminophen) to prevent fever and pain. These medicines are given to reduce the risk of infusion-related reactions, which are most common during the first infusion.
References
- European Medicines Agency (EMA). Empliciti (elotuzumab) – Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu
- Lonial S, Dimopoulos MA, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma (ELOQUENT-2). N Engl J Med. 2015;373(7):621–631. doi:10.1056/NEJMoa1505654
- Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma (ELOQUENT-3). N Engl J Med. 2018;379(19):1811–1822. doi:10.1056/NEJMoa1805762
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 2.2025. Available at: nccn.org
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd edition, 2023. Available at: who.int
- Zonder JA, Mohrbacher AF, Jber S, et al. A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma. Blood. 2012;120(3):552–559. doi:10.1182/blood-2011-06-360552
- Collins SM, Bakan CE, Swartzel GD, et al. Elotuzumab directly enhances NK cell cytotoxicity against myeloma via CS1 ligation. Cancer Immunol Immunother. 2013;62(12):1841–1849. doi:10.1007/s00262-013-1493-8
- British National Formulary (BNF). Elotuzumab. Available at: bnf.nice.org.uk
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