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Drug Details

FASLODEX 250 mg/5 ml solution for injection

• Drug Class Description
  Anti-oestrogen
• Generic Name
  Fulvestrant
• Presentation
  Solution for injection. Clear, colourless to yellow, viscous liquid
• Description
  One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
• Indications
  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 antioestrogen therapy or disease progression on therapy with an antioestrogen.
• 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 evaluated 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
  Faslodex is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.
• Elderly Dosage
  See Adult 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 Drug 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:

  Body System/ Frequency	Very Common ( >1/10)	Common ( >1/100, <1/10)	Uncommon ( >1/1000, <1/100)
  Cardiovascular	• Hot flushes
  Gastrointestinal		• Gastrointestinal disturbance including nausea, vomiting, diarrhoea and anorexia.
  Hepatobiliary disorders		• Elevated liver enzymes, the vast majority <2xULN
  Reproductive and breast			• Vaginal haemorrhage • Vaginal moniliasis • Leukorrhea
  Skin		• Rash	• Hypersensitivity reactions, including angioedema and urticaria
  Urogenital		• Urinary tract infections
  Vascular		• Venous thromboembolism
  Whole body		• Injection site reactions including transient pain and inflammation in 7% of patients (1% of injections) when given as a single 5 ml injection. • Headache • Asthenia • Back pain