Calquence 100 mg hard capsules *

Pharmacy Only: Prescription

4.      Possible side effects

[...]

Very common (may affect more than 1 in 10 people):

·      muscle or joint pain

·      headache

·      rash

·      feeling tired (fatigue), weakness or lack of energy

·      feeling sick to your stomach (nausea),vomiting, stomach pain, constipation (infrequent or hard to pass stool), diarrhoea (frequent or loose stools)

·      decreased number of red blood cells, decreased number of neutrophils (a type of white blood cells) or decreased number of cells that help blood clot (platelets).)

·      high blood pressure

[...]

6.      Contents of the pack and other information

[...]

This leaflet was last revised in 0408/2023.

Addition of Hypertension as an ADR - Update to section 4.8, table 3 and 4

10.    DATE OF REVISION OF THE TEXT

12 May16 August 2023

Data amended in section 5.1 Table 11 (Subgroup analysis of IRC-assessed PFS (Study ASCEND))

Addition of updated data for the ELEVATE-TN study to section 5.1 of the SmPC

Addition of updated data for the ELEVATE-TN study to section 5.1 of the SmPC

Addition of updated data for the ELEVATE-TN study to section 5.1 of the SmPC

Addition of updated data for the ELEVATE-TN study to section 5.1 of the SmPC

6.      Contents of the pack and other information

[...]

Manufacturer

AstraZeneca AB

Gärtunavägen

SE-151 85152 57 Södertälje

Sweden

[...]

This leaflet was last revised in 11/202004/2023.

Minor administrative changes throughout and update to the revision date following approval of a line extension variation to register Calquence tablets

Update to section 5.1 to include the ASCEND-309 final CSR efficacy data

Removal of the UK(NI) AE reporting information form section 4.8

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. 

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

24^th June30^th September 2021

New SmPC for new product

New PIL for new product