Akeega 50 mg/500 mg film-coated tablets

Section 2 has been updated as follows:

....• blood clots in the lungs or legs, or have had them in the past.

....

If you develop low abnormal blood-cell counts for a long period of time while taking Akeega, this may be a sign of more serious problems with the bone marrow such as ‘myelodysplastic syndrome’ (MDS) or ‘acute myeloid leukaemia’ (AML). Your doctor may want to test your bone marrow to check for these problems.

Section 4

Multiple updates to 'Other side effects' sub section.

EMEA/H/C/005932/II/0003 - Magnitude Final Clinical Study Report

Section 4.2 - editorial change

Section 4.4 has been updated as follows:

....Marked increases in liver enzymes leading to treatment interruption or discontinuation occurred in clinical studies, although these were uncommon (see section 4.8). Serum aminotransferase and total bilirubin levels should be measured prior to starting treatment, every two weeks for the first three months of treatment, and monthly thereafter for the first year and then every other month for the duration of treatment.

....

In the MAGNITUDE study, Nno cases of MDS/AML have been observed in patients treated with 200 mg of niraparib and 1000 mg of abiraterone acetate plus prednisone or prednisolone.

Section 4.8

Multiple changes to this section - see SPC.

EMEA/H/C/005932/II/0003 - Magnitude Final Clinical Study Report