Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Adult females (including the elderly):

The recommended dose is 250 mg at intervals of 1 month.

Children and adolescents:

Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.

Patients with 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 eva luated in patients with severe renal impairment (creatinine clearance < 30 ml/min).

Patients with 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.

Method of administration:

Administer intramuscularly slowly into the buttock.

Child Dosage

Elderly Dosage

Contra Indications

Faslodex is contraindicated in:

• patients with known hypersensitivity to the active substance or to any of the excipients

• pregnancy and in breast-feeding

• severe hepatic impairment

Special Precautions

Use Faslodex with caution in patients with mild to moderate, hepatic impairment.

Use Faslodex with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).

Due to the route of administration, use Faslodex with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.

Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical trials. This should be taken into consideration when prescribing Faslodex to patients at risk.

There are no long-term data on the effect of fulvestrant on bone. Due to the mode of action of fulvestrant, there is a potential risk of osteoporosis.

Interactions

A clinical interaction study with midazolam 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. Dosage adjustment is therefore not necessary in patients who are co-prescribed fulvestrant and CYP 3A4 inhibitors or inducers.

Adverse Reactions

Approximately 47% of patients experienced adverse reactions in the clinical trial programme. However, only 0.9% of patients stopped therapy because of an adverse reaction. The most commonly reported adverse reactions are hot flushes, nausea, and injection site reactions.

The adverse reactions are summarised as follows:

Manufacturer

Drug Availability

Updated