DARZALEX 1,800 mg solution for injection

  • Name:

    DARZALEX 1,800 mg solution for injection

  • Company:
    info
  • Active Ingredients:

    Daratumumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/06/20

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Summary of Product Characteristics last updated on medicines.ie: 23/7/2020
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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Janssen Sciences Ireland

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Medicine Name DARZALEX 1,800 mg solution for injection Active Ingredients Daratumumab
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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 23 July 2020 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic 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

5.1          Pharmacodynamic properties

Immunogenicity

In patients treated with subcutaneous daratumumab in clinical trials, less than 1% of patients developed treatment-emergent anti-daratumumab antibodies. The incidence of treatment‑emergent anti‑daratumumab antibodies for DARZALEX subcutaneous formulation treatment was low, with 1 out of 451 patients tested positive for anti‑drug antibodies. The 1 patient in monotherapy that was positive for anti‑daratumumab antibody also had transient neutralising antibodies. There were no treatment‑emergent anti‑daratumumab antibody positive patients in combination therapies study. The anti‑daratumumab antibodies and neutralising antibodies did not appear to impact daratumumab exposures.

 

However, the employed assay has limitations in detecting anti‑daratumumab antibodies in the presence of high concentrations of daratumumab. Therefore, the incidence of antibody development might not have been reliably determined.

Updated on 23 July 2020 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 10 July 2020 Ed-Both

Reasons for updating

  • Add New Doc

Updated on 10 July 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 10 July 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 11 June 2020 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 June 2020 SmPC

Reasons for updating

  • New SmPC 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

New SmPC for new Product June 2020