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| Drug class description : | Anti-oestrogen |
| Generic Name : | Fulvestrant |
| Drug description : | Solution for injection. Clear, colourless to yellow, viscous liquid. |
| Presentation : | 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. 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) (See Special Precautions). Patients with hepatic impairment: Use Faslodex with caution in treating patients with mild to moderate hepatic impairment. Safety and efficacy have not been evaluated in patients with hepatic impairment (See Contraindications and Special Precautions). 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 (See Interactions) • severe hepatic impairment |
| Special Precautions : | Use Faslodex with caution in patients with mild to moderate, hepatic impairment (See Adult Dosage and Contraindications). 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 (See Adverse Reactions). 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. Pregnancy and lactation Faslodex is contraindicated in pregnancy (See Contraindications). Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit. Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths. 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. 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, breast-feeding is contraindicated (See Contraindications). |
| 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: Body System/Frequency Cardiovascular - Very Common (>1/10) • Hot flushes Gastrointestinal - Common (>1/100, <1/10) • Gastrointestinal disturbance including nausea,vomiting, diarrhoea and anorexia. Hepatobiliary disorders - Common (>1/100, <1/10) • Elevated liver enzymes, the vast majority <2xULN. Reproductive and breast - Uncommon >1/1000, <1/100 • Vaginal haemorrhage • Vaginal moniliasis • Leukorrhea Skin - Common (>1/100, <1/10) • Rash. Uncommon >1/1000, <1/100 • Hypersensitivity reactions, including angioedema and urticaria. Urogenital - Common (>1/100, <1/10) • Urinary tract infections. Vascular - Common (>1/100, <1/10) • Venous thromboembolism. Whole body - Common (>1/100, <1/10) • 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 |
| Manufacturer : | Astra Zeneca |
| Drug Availability : | (POM) |
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