Xofigo 1100 kBq/mL solution for injection

Minor wording update.

Minor wording update.

Minor wording update.

Minor wording update.

4.4    Special warnings and precautions for use

Contraception in males

 Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo (see section 4.6).

4.6    Fertility, pregnancy and lactation

Fertility

There are no human data on the effect of Xofigo on fertility.

Based on studies in animals, there is a potential risk that radiation from Xofigo may potentially have toxic effects on male gonads and spermatogenesis (see section 5.3). Male patients should seek advice on conservation of sperm prior to treatment.

3.      How Xofigo is used

Administration of Xofigo and conduct of the procedure

Saline solution replaced by sodium chloride.

6.      Contents of the pack and other information

"Diluted" added before hydrochloric acid.

Administration of Xofigo and conduct of the procedure

Saline solution replaced with sodium chloride

What Xofigo contains

"diluted" added before hydrochloric acid

4.4

Contraception in males

 Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo (see section 4.6).

4.6

Fertility

There are no human data on the effect of Xofigo on fertility.

Based on studies in animals, there is a potential risk that radiation from Xofigo may potentially have toxic effects on male gonads and spermatogenesis (see section 5.3). Male patients should seek advice on conservation of sperm prior to treatment.

(Reuploaded) BEC 17211, 20069, 15506

Note: Text in blue = added text

4.8      Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems listed below:

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

12/2021

BEC 17211, 20069, 15506

Note: Text in blue = added text

4.8       Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systems listed below:

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

12/2021

BEC 17211, 20069, 15506

Note: Text in blue = added text

4.            Possible side effects

Reporting of side effects

If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

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

6.            Contents of the pack and other information

[….]

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ireland

Bayer Limited

Tel: +353 1 216 3300

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

United Kingdom (Northern Ireland)

Bayer AG

Tel: +44-(0) 118 206 3000

This booklet was last revised in 12/2021.

HPRA ADR reporting wording update

HPRA ADR reporting wording update, new phone number for Bayer Ireland

Section 6.5: Update - Colourless Type I glass vial closed with a grey brompbutyl rubber stopper or a brompbutyl rubber stopper  either with or without foil-clad made of Ethylene tertrafluoroethylene (ETFE), both capped with alumnium seal, containing 6 ml of solution for injection.

Adding date of revision of the text to PDF file. No other changes.

Changes made to 4.2 Posology and method of administration -

Addition of 'Special Populations' heading.

Formatting Changes - " There is no relevant use of Xofigo in the paediatric population in the indication of prostate cancer."

Changes made to 4.4 Special warnings and precautions for use

Excipients with known effect  - Addition of WHO recommended intake - Depending on the volume administered, this medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, equivalent to 2.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Changes made to 4.7 Effects on ability to drive and use machines  - formatting changes - Xofigo has no or negligible influence on the ability to drive and use machines.

5.1 Pharmacodynamic properties - Formatting changes to Pharmacotherapeutic group:

5.1 Pharmacodynamic properties - Paediatric population  - "The European Medicines Agency has waived the obligation to submit the results of studies with Xofigo in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) and in the treatment of multiple myeloma (see section 4.2 for information on paediatric use)."

Update to Section 4.3, 4.4 and 5.1

Following revision of the primary standardisation for radium-223 by the National Institute of Standards and Technology (NIST) in 2015, the numerical value of the radioactivity concentration (in Bq/mL) contained in vials of Xofigo and hence the patient dose in Bq/kg body weight increased by approx. 10%. It is a change only in the numerical value of the radioactive content and patient dose of Xofigo and comes into effect once the product released according to the updated NIST 2015-traceable reference material becomes available from April 14th, 2016 onwards.

The main changes are:

o             an increase of the nominal value for the radioactivity from 1000 kBq/mL to 1100 kBq/mL at reference date and

o             an apparent increase in patient dose, from 50 kBq/kg body weight to 55 kBq/kg body weight.

This does not reflect a real change in the actual product radioactivity or in the amount of radioactivity given to the patient and therefore will not impact the safety and efficacy of Xofigo (radium-223 dichloride).

Colourless Type I glass vial closed with a grey chlorobutyl rubber stopper and aluminium seal, containing 6 mL of solution for injection.

Colourless Type I glass vial closed with a grey bromobutyl rubber stopper with foil-clad made of Ethylene tetrafluoroethylene (ETFE) and aluminium seal, containing 6 mL of solution for injection.