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Prescribing Information

The Summary of Product Characteristics (SmPC) document is available :

Please refer to your local approved licence and take that information into consideration when prescribing FASLODEX.

Abbreviated FASLODEX Prescribing Information

Name of the medicinal product1

Faslodex 250 mg solution for injection

Qualitative and quantitative composition1

One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.

Pharmaceutical form1

Solution for injection. Clear, colourless to yellow, viscous solution.

Therapeutic indications1

Faslodex is indicated for the treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-oestrogen therapy, or disease progression on therapy with an anti-oestrogen.

Please refer to your local approved licence and take that information into consideration when prescribing FASLODEX.

Posology and method of administration1

Posology

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.

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. No data are available.

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.

Contraindications1

  • Hypersensitivity to the active substance, or to any of the other excipients
  • Pregnancy and lactation
  • Severe hepatic impairment

Interaction with other medicinal products and other forms of interaction1

A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.

FASLODEX (fulvestrant) side effects1

The FASLODEX Summary of Product Characteristics (SmPC) details the side effects of FASLODEX.

The most frequently reported adverse reactions (with a frequency of ≥10%) are1:

  • Nausea
  • Increased hepatic enzymes (ALT, AST, ALP)*
  • Asthenia*
  • Injection site reactions**

Please refer to your local SmPC for full details of safety and tolerability.

*Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.

**The term injection site reactions does not include the terms injection site haemorrhage and injection site haematoma.

Reference

  1. FASLODEX Summary of Product Characteristics. Document available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000540/WC500021174.pdf.