FASLODEXTM is indicated as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- Not previously treated with endocrine therapy, or
- With disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy
Faslodex is also indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
- In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone agonist.
COMBINATION WITH PALBOCICLIB
SAFETY PROFILE OF FASLODEX IN COMBINATION WITH PALBOCICLIB
- In PALOMA-3 14 patients (4%) in the FASLODEX plus palbociclib arm vs. 3 patients (2%) in the FASLODEX plus placebo arm, discontinued treatment because of an AE.3
- The most frequently reported adverse reactions in PALOMA-3 were infections, neutropenia, leukopenia,
anaemia, thrombocytopenia, decreased appetite, nausea, stomatitis, diarrhoea, vomiting, alopecia, rash, fatigue andpyrexia.3
- The most common (~2%) Grade 8 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.4
FASLODEX combined with palbociclib: For further details, consult the FASLODEX SPC and palbociclib SPC.
|Very Common||Infections, neutropenia, leukopenia, anaemia, thrombocytopenia, decreased appetite, nausea, stomatitis, diarrhoea, vomiting, alopecia, rash, fatigue and pyrexia.
|Common||Dysgeusia, lacrimation increased, vision blurred, dry eye, epistaxis, dry skin, asthenia, AST increased and ALT increased.
|UnCommon||Febrile neutropenia. For further details of adverse reactions, particularly neutropenia, please consult FASLODEX SPC.