FASLODEXTM
(fulvestrant)

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

FASLODEX SAFETY

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 and pyrexia.3
  • The most common (~2%) Grade 8 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.4

Undesirable effects4

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.