Posology : מינונים

  4.2    Posology and method of administration

Monotherapy
Adult females (including the elderly):
The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.

Combination Therapy with Palbociclib
When FASLODEX is used in combination with palbociclib, abemaciclib, or ribociclib, the recommended dose of FASLODEX is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29 and once monthly thereafter.

When FASLODEX is used in combination with Palbociclib, the recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Refer to the Full Prescribing Information of palbociclib.

When FASLODEX is used in combination with abemaciclib, the recommended dose of abemaciclib is 150 mg orally, twice daily. Abemaciclib may be taken with or without food. Refer to the Full Prescribing Information for abemaciclib.

When FASLODEX is used in combination with ribociclib, the recommended dose of ribociclib is 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Ribociclib can be taken with or without food. Refer to the Full Prescribing Information for ribociclib.

Pre/perimenopausal women treated with the combination of FASLODEX plus palbociclib, abemaciclib, or ribociclib, should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards [see Pharmacodynamic properties 5.1].


Special populations:
Renal impairment:
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance  30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min) and, therefore, caution is recommended in these patients (see section 4.4).


Hepatic impairment:
No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Paediatric population
The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.


Combination Therapy with Palbociclib, Abemaciclib, or Ribociclib
When FASLODEX is used in combination with palbociclib, abemaciclib, or ribociclib, refer to monotherapy instructions for FASLODEX.
Refer to the full prescribing information of co-administered palbociclib, abemaciclib, or ribociclib for dose modification, guidelines in the event of toxicities, for use with concomitant medications and other relevant safety information.


Method of administration
Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
For detailed instructions for administration see section 6.6.