Faslodex

/ Astra Zeneca

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, the recommended dose 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. 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.
Please refer to the full prescribing information of palbociclib.
Pre/perimenopausal women treated with the combination FASLODEX plus palbociclib should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.
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.
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.
Paediatric population: The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established.
Combination Therapy with Palbociclib
When FASLODEX is used in combination with palbociclib, refer to monotherapy instructions for FASLODEX. Refer to the full prescribing information of palbociclib for its dose modification, management of toxicities, and for use with concomitant medication.
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.

Monotherapy
Faslodex is indicated for the treatment of estrogen 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 endocrine therapy; or
– disease progression on endocrine therapy
Combination Therapy with Palbociclib
FASLODEX is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy.

Known hypersensitivity to the active substance or any of the excipients. Pregnancy and lactation. Severe hepatic impairment.

See prescribing information for full details.

See prescribing information for full details.

A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP 3A4.
Clinical interaction studies with rifampicin (inducer of CYP 3A4) and ketoconazole (inhibitor of CYP 3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore not necessary in patients who are co-prescribed fulvestrant and CYP 3A4 inhibitors or inducers concomitantly. Fulvestrant has a similar chemical structure to estradiol. Due to the structural similarity of fulvestrant and oestradiol, fulvestrant may interfere with antibody based oestradiol assays and may result in falsely increased levels of oestradiol. The falsely elevated estradiol levels could lead the clinician to incorrect medical decisions and unnecessary procedures. If this situation has occurred, reassessing the status of the patient by other means or using an alternate method for estradiol measurement should be considered.
The results should always be assessed in correlation with the clinical evaluation.
The laboratory performing the Estradiol immunoassay should be informed that the patient is taking Faslodex.

Women of childbearing potential: Patients of child-bearing potential should be advised to use effective contraception while on treatment.
Pregnancy: Faslodex is contraindicated in pregnancy. If pregnancy occurs
while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Breast-feeding: Breast-feeding must be discontinued during treatment with Faslodex. Fulvestrant is excreted in milk in lactating rats. It is not known whether fulvestrant is excreted in human milk. Considering the potential
for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated.

There are isolated reports of overdose with Faslodex in humans. If overdose occurs, symptomatic supportive treatment is recommended. Animal studies suggest that no effects other than those related directly or indirectly to anti-oestrogenic activity were evident with higher doses of fulvestrant.