Calquence 100 mg hard capsules *
Pharmacy Only: Prescription

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 17 November 2021

File name

20211111 SPC IE MT Calquence Photoxicity ONC 21 0042_1637160626.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

The revisions are based on a response to a recommendation by the EMA, as highlighted in a CHMP Assessment Report, to update the SmPC including text referencing the ‘low-risk of phototoxicity’ associated with CALQUENCE in Sections 4.4 and 5.3, submitted as a Type II Variation. 

Updated on 07 October 2021

File name

20210930 SPC IE MT Calquence Variation AKA ACE-HV-114 ONC 21 0032_1633597892.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

4.5     Interaction with other medicinal products and other forms of interaction

[..]

Co-administration with moderate CYP3A inhibitors (400 mg fluconazole as single dose or 200 mg isavuconazole as repeated dose for 5 days) in healthy subjects increased acalabrutinib Cmax and AUC by 1.4-fold to 2-fold while the active metabolite ACP-5862 Cmax and AUC was decreased by 0.65-fold to 0.88-fold relative to when acalabrutinib was dosed alone. No dose adjustment is required in combination with moderate CYP3A inhibitors. Monitor patients closely for adverse reactions (see Section 4.2).

 

4.8     Undesirable effects

[..]

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom (Northern Ireland)

Yellow Card Scheme

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

 

 

10.     DATE OF REVISION OF THE TEXT

 

24th June30th September 2021

Updated on 30 September 2021

File name

20210624 SPC IE MT Calquence Variation Protein Binding ONC 21 0023_1632995889.pdf

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

New SmPC for new product

Updated on 30 September 2021

File name

20201105 Package Leaflet IE MT Calquence MAA ONC 20 0028_1632995792.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for new product