Fulvestrant parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of fulvestrant.
Drugs List
Therapeutic Indications
Uses
Hormone receptor +ve, HER2 -ve locally advanced or metastatic breast cancer
Hormone-dependent metastatic breast cancer in postmenopausal patients
Oestrogen receptor positive, locally advanced or metastatic breast cancer in post menopausal women not treated previously with endocrine treatment.
Oestrogen receptor positive, locally advanced or metastatic breast cancer in post menopausal women where disease has relapsed during or after anti-oestrogen treatment or disease progression while on anti-oestrogen treatment.
Adjunctive treatment with palbociclib in hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer in women who have received prior endocrine treatment.
When fulvestrant with palbociclib are given in combination in pre or peri-menopausal women, combine with luteinising hormone releasing hormone agonist.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
The recommended dose is 500mg fulvestrant at intervals of one month, with an additional 500mg dose given two weeks after the initial dose.
Administration
Two consecutive 5ml slow intramuscular injections (1-2 minutes/injection) one into each buttock.
Use caution if injecting at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Contraindications
Children under 18 years
Hypersensitivity to benzyl alcohol
Breastfeeding
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Haemorrhagic diathesis
Predisposition to thromboembolic disease
Epileptic disorder
Hepatic impairment
History of alcohol abuse
Renal impairment - creatinine clearance below 30 ml/minute
Thrombocytopenia
Advise ability to drive/operate machinery may be affected by side effects
Contains benzyl alcohol
Caution injecting at dorsogluteal site due to proximity of sciatic nerve
Potential risk of osteoporosis
Female: Ensure adequate contraception during treatment
Caution should be used when treating patients with bleeding diatheses, thrombocytopenia or those taking concurrent anti-coagulants because of the route of administration (deep intramuscular injection into the buttock).
The efficacy and safety of fulvestrant in patients with critical visceral disease (as either monotherapy or in combination with palbociclib) has not been studied.
Pregnancy and Lactation
Pregnancy
Fulvestrant is contraindicated during pregnancy.
The manufacturer recommends that fulvestrant is contraindicated during pregnancy. In animal studies, fulvestrant has been shown to cross the placenta and has shown reproductive toxicity, including an increased incidence of foetal abnormalities and death. If pregnancy occurs during treatment, the patient must be informed of the potential hazard to the foetus and the potential risk for loss of pregnancy.
Lactation
Fulvestrant is contraindicated during breastfeeding.
The manufacturer reccomends that breastfeeding must be discontinued during treatment with fulvestrant. It is not known whether fulvestrant is excreted in human breast milk but animal studies have shown that it is excreted into the milk of rats. Due to the potential for serious adverse reactions in a nursing infant, fulvestrant is contraindicated while breastfeeding.
Side Effects
Anaphylactic reaction
Anorexia
Asthenia
Back pain
Diarrhoea
Gamma glutamyl transferase (GGT) increased
Genital moniliasis
Haematoma (injection site)
Haemorrhage (injection site)
Headache
Hepatic failure
Hepatitis
Hot flushes
Hypersensitivity reactions
Increase in alkaline phosphatase
Increase in serum ALT/AST
Injection site reactions
Joint pain
Leukorrhoea
Musculoskeletal pain
Nausea
Neuralgia
Peripheral neuropathy
Rash
Reduced platelet count
Sciatica
Serum bilirubin increased
Urinary tract infections
Vaginal haemorrhage
Venous thrombosis
Vomiting
Effects on Laboratory Tests
Fulvestrant may cause falsely elevated estradiol results in assays. The similar chemical structure to estradiol means it may cross-react with the antibodies used in immunoassays.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2021
Reference Sources
Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 9 February 2021.
Summary of Product Characteristics: Faslodex 250 mg solution for injection. AstraZeneca UK Limited. Revised April 2020.
Summary of Product Characteristics: Fulvestrant Dr. Reddy's 250mg Solution for Injection in Pre-Filled Syringe. Dr. Reddy's Laboratories (UK) Ltd. Revised March 2020.
Summary of Product Characteristics: Fulvestrant Teva 250mg Solution for Injection in Pre-Filled Syringe. Teva UK Limited. Revised April 2018.
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