Empliciti (elotuzumab)

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Empliciti (elotuzumab)

How to buy Empliciti (elotuzumab): You can order Empliciti (elotuzumab) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Multiple Myeloma
Marketing Authorisation Holder Bristol-Myers Squibb
Mode of Action SLAMF7-directed immunostimulatory antibody (immunotherapy)
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Package 1 vial of powder - Vials

What is Empliciti (elotuzumab) for?

Elotuzumab is a cancer medicine used in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma who have received one to three prior therapies2,3,4.

How does Empliciti (elotuzumab) work?

The active substance in Empliciti, elotuzumab, is a monoclonal antibody that activates the body’s immune cells to attack the multiple myeloma cancer cells. It does this by attaching to a protein on the surface of the immune cells called SLAMF7, causing them to act against the cancer cells and thereby slowing down the disease. Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells1.

Is Empliciti (elotuzumab) approved?

Elotuzumab was approved for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone as second or fourth line treatment by:

  • FDA (USA) on November 30, 20155

  • EMA (EU) on May 11, 20161

  • TGA (AUS) on September 22, 20164

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Empliciti (elotuzumab) taken?

The standard dosage is for Empliciti (elotuzumab) is:

  • 10 mg/kg administered intravenously every week for the first two cycles (1 cycle = 4 weeks) and every 2 weeks thereafter until disease progression or unacceptable toxicity

  • Administer with lenalidomide and dexamethasone

Complete information about elotuzumab dosage and administration can be found in the resources section2,3,4.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Empliciti (elotuzumab)?

Common adverse reactions

The most common adverse reactions (20% or higher) a listed in the prescribing information include: 

  • fatigue
  • diarrhea
  • pyrexia
  • constipation
  • cough
  • peripheral neuropathy
  • nasopharyngitis
  • upper respiratory tract
  • infection
  • decreased appetite
  • pneumonia

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

  • infusion reactions
  • infections
  • Second Primary Malignancies (SPM)
  • hepatotoxicity.

Use in specific populations

Empliciti (elotuzumab) is administered in combination with lenalidomide and dexamethasone. Lenalidomide can cause embryo-fetal harm and is contraindicated for use in pregnancy. Because of the potential for serious adverse reactions in breast-fed infants from elotuzumab administered with lenalidomide and dexamethasone, breastfeeding is not recommended.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information listed in our resources section2,3,7.

More Information
Working ingredient elotuzumab
Shipping method Cold chain (temperature controlled)
Package 1 vial of powder -
Therapeutic Area Oncology
Oncology Multiple Myeloma
Indication Multiple myeloma
Administration Intravenous
Mode of Action SLAMF7-directed immunostimulatory antibody (immunotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Bristol-Myers Squibb

The approvals were based on a study (ELOQUENT-2) involving 646 multiple myeloma patients2,3,4. The study compared the effects of taking elotuzumab plus lenalidomide and dexamethasone (N = 321) with the effects of taking only lenalidomide and dexamethasone (N = 325)2,3,4.

Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. The evaluation was based on two parameters: the progression free survival (PFS) and the overall response rate (ORR). The PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease where it does not get worse6. The ORR is the portion of patients with a tumour size reduction of a predefined amount for a minimum time period7.

  • The median PFS in patients that took elotuzumab in addition to lenalidomide and dexamethasone was 4.2 months longer than in patients who took lenalidomide and dexamethasone only (18.5 months (95% CI 16.5, 21.4) vs 14.3 months (95% CI 12.0, 16.0).

  • The 1-year PFS rate — the portion of patients that after 1 year of treatment had no progression of their disease yet — was 68% of the patients on the elotuzumab addition compared with 56% of the patients on the other two drugs only.

  • The 2-year PFS rate and the 3-year response rate were 39% and 23% for patients with elotuzumab and 26% and 15% for patients without.

  • The median ORR was 78.5% (95% CI 73.6, 82.9) with elotuzumab and 65.5% (95% CI 60.1, 70.7) without, with a complete response of 4.4% vs. 7.4%.

  • The median overall survival (OS) was 43.7 months with elotuzumab and 39.6 months without2,3,4.

1. Human Medicines: Empliciti (elotuzumab)
    EMA, cited on March 2017

2. Summary of Product Characteristics: Empliciti (elotuzumab) [PDF]
    Bristol-Myers Squibb, FDA, May 2017

3. Summary of Product Characteristics: Empliciti (elotuzumab) [PDF]
    Bristol-Myers Squibb, EMA, Dec 2016

4. Summary of Product Characteristics: Empliciti (elotuzumab)
    Bristol-Myers Squibb Australia, TGA, Sep 2016

5. Empliciti (elotuzumab)
    Drugs.com, cited March 2017

6. NCI Dictionary of Cancer Terms: progression-free survival
    NIH National Cancer Institute, cited March 2017

7. Endpoints for Assessing Drug Activity in Clinical Trials [PDF]
    Pazdur R., The Oncologist,  April 2013

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.