Empliciti 300 mg and 400 mg powder for concentrate for solution for infusion

  • Name:

    Empliciti 300 mg and 400 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Elotuzumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/09/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 30/9/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Bristol-Myers Squibb Pharma EEIG

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 30 September 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

To update the SmPC section 5.1 with final overall survival data from study CA204-004. No changes to the PIL text but 'Date of Revision' updated to reflect overall product informationupdate

Updated on 30 September 2019 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To update the SmPC section 5.1 with final overall survival data from study CA204-004

Updated on 27 August 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to information for healthcare professionals

Updated on 27 August 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC update for the Empliciti extension of indication in relapsed and refractory multiple myeloma - the approved indication reads:

4.1     Therapeutic indications

​​“Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1).”

Updated on 7 March 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 6 March 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 10 DATE OF REVISION OF THE TEXT: Updated to 28 Feb to reflect overall product information update to the patient leaflet (addition of alternative batch release site)
 

Updated on 18 February 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 February 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 - New Marketing Authorisation Holder address

Updated on 20 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 July 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8     Undesirable effects

 

Table 3:           Adverse reactions in patients with multiple myeloma treated with Empliciti

Hypoaesthesia

 

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

5.2     Pharmacokinetic properties

 

The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma. Elotuzumab exhibits nonlinear PK with decrease in clearance with increase in dose from 0.5‑20 mg/kg.

 

Absorption

Elotuzumab is dosed via intravenous route and therefore is immediately and completely bioavailable.

 

Distribution

The geometric meanMean volume of distribution of elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state ranged from is 6.02 L (CV: 22.1%)36 mL/kg to 70 mL/kg (2.3‑4.6 L for a typical patient) and was independent from the dose in a dose range of 0.5 mg/kg to 20 mg/kg.

 

Biotransformation

The metabolic pathway of elotuzumab has not been characterized. As an IgG monoclonal antibody, elotuzumab is expected to be degraded into small peptides and amino acids via catabolic pathways.

 

Elimination

The geometric mean total clearance ofFollowing a single dose of 10 mg/kg, the elotuzumab at 10 mg/kg (in combination with lenalidomide and dexamethasone) at steady state is 0.194 L/day (CV: 62.9%)clearance was 13.2 mL/day/kg. Elotuzumab exhibits nonlinear pharmacokinetics with clearance of elotuzumab decreasing from 17.5 to 5.8 mL/day/kg with an increase in dose from 0.5 to 20 mg/kg, suggesting target‑mediated clearance, resulting in greater than proportional increases in Area under the Concentration time curve (AUC). Upon discontinuation of elotuzumab in combination with lenalidomide and dexamethasone, concentrations of elotuzumab will decrease to approximately 3% (approximately 97% washout as estimated by 5 half‑lives) of the population predicted steady‑state maximal serum concentration by 3 months

 

10.     DATE OF REVISION OF THE TEXT

 

14 July 2017

 

Updated on 26 May 2016 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 May 2016 PIL

Reasons for updating

  • New PIL for new product