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Pharmacologic class: Estrogen receptor antagonist

Therapeutic class: Antineoplastic

Pregnancy risk category D


Inhibits cell division by binding with and downgrading estrogen receptor protein in breast cancer cells


Prefilled syringes: 125 mg/2.5 ml, 250 mg/5 ml

Indications and dosages

Hormone receptor-positive advanced metastatic breast cancer in postmenopausal women with disease progression who have received antiestrogen therapy

Adults: 250 mg I.M. q month as a single 5-ml injection or two concomitant 2.5-ml injections


• Hypersensitivity to drug
• Pregnancy


Use cautiously in:
• bleeding disorders, hepatic dysfunction, thrombocytopenia
• breastfeeding patients.


• Expel air bubble from syringe before giving injection.
• Administer I.M. injection slowly.

Adverse reactions

CNS: depression, light-headedness, dizziness, headache, hallucinations, vertigo, insomnia, paresthesia, anxiety, weakness

CV: chest pain, vasodilation, peripheral edema

EENT: pharyngitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, anorexia

GU: urinary tract infection, pelvic pain

Hematologic: anemia

Musculoskeletal: back pain, bone pain, arthritis

Respiratory: dyspnea, increased cough

Skin: flushing, rash, diaphoresis

Other: food distaste, fever, hot flashes, injection site reactions, pain, flulike symptoms


Drug-drug.Anticoagulants: increased bleeding risk

Patient monitoring

• Monitor CBC.
• Assess liver function test results.

Patient teaching

• Advise patient to report signs and symptoms of infection, especially urinary tract infection.
• Caution patient to avoid driving and other hazardous activities until she knows how drug affects concentration and alertness.

Tell patient to notify prescriber immediately if she thinks she is pregnant.
• Teach patient comfort measures to minimize hot flashes and rash.
• Instruct patient to minimize GI upset and sore throat by eating frequent, small servings of healthy food and drinking adequate fluids.
• Tell patient that drug may cause headache, muscle aches, or bone pain. Encourage her to discuss activity recommendations and pain management with prescriber.
• Advise patient to establish effective bedtime routine to minimize sleep disorders.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.


(ful-vess-trant) ,


(trade name)


Therapeutic: antineoplastics
Pharmacologic: estrogen receptor antagonists
Pregnancy Category: D


Treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with progressive disease that has not responded to antiestrogen therapy.


Competitively binds to estrogen receptors. Binding results in down-regulation of estrogen receptor protein in cancerous breast tissue.

Therapeutic effects

Decreased progression of hormone receptor-positive breast cancer.


Absorption: Well absorbed following IM administration.
Distribution: Rapidly and extensively distributed.
Protein Binding: 99%.
Metabolism and Excretion: Mostly metabolized by the liver; negligible renal elimination.
Half-life: 40 days.

Time/action profile (effect on estrogen receptors)

IMrapid7 days30 days


Contraindicated in: Obstetric / Lactation: Pregnancy or lactation; Pediatric: Children; Hypersensitivity; Bleeding disorders, thrombocytopenia, concurrent anticoagulant therapy.
Use Cautiously in: Moderate to severe hepatic impairment.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • weakness (most frequent)
  • anxiety
  • depression
  • dizziness
  • insomnia

Ear, Eye, Nose, Throat

  • pharyngitis (most frequent)


  • cough (most frequent)
  • dyspnea (most frequent)


  • vasodilation (hot flushes) (most frequent)
  • chest pain
  • edema


  • abdominal pain (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • vomiting (most frequent)
  • anorexia


  • pelvic pain
  • urinary tract infection


  • rash
  • sweating


  • pain/inflammation at injection site (most frequent)


  • anemia


  • back pain (most frequent)
  • bone pain (most frequent)
  • arthritis


  • paresthesia


  • fever
  • flu syndrome


Drug-Drug interaction

None known.


Intramuscular (Adults) 500 mg on days 1, 15, and 29, and then once monthly (given as two injections of 250 mg (5 mL) each).

Hepatic Impairment

Intramuscular (Adults) Moderate hepatic impairment—250 mg on days 1, 15, and 29, and then once monthly (given as a single injection).


Solution for injection: 50 mg/mL in 5–ml prefilled syringes

Nursing implications

Nursing assessment

  • Assess patient for pain and other side effects periodically throughout therapy.

Potential Nursing Diagnoses

Acute pain (Adverse Reactions)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)


  • A negative pregnancy test should be determined prior to initiation of treatment.
  • Intramuscular: Follow proper technique for injection using the manufacturer's instructions for the use of the SAFETYGLIDE syringe and needle. Inject slowly over 1–2 min into the gluteus muscle as two 5–mL injections, one in each buttock.

Patient/Family Teaching

  • Inform patient that fulvestrant may cause mild pain and inflammation at injection site.
  • Advise patient to use contraception during treatment with fulvestrant. May cause teratogenic effects and fetal death.
  • Inform patient of potential for adverse reactions and advise her to notify health care professional.
  • Advise patient to report an increase in pain so treatment with analgesics can be initiated.

Evaluation/Desired Outcomes

  • Slowing of disease progression in women with advanced breast cancer.


an antineoplastic agent used to treat advanced breast carcinoma in estrogen-receptor-positive patients.
References in periodicals archive ?
The companies will also explore other combinations targeting tumour drivers and resistance mechanisms, including: Lilly s abemaciclib (CDK4 and 6 small molecule inhibitor) with Faslodex, AstraZeneca s marketed selective oestrogen receptor down regulator (SERD);Both CYRAMZAA (ramucirumab) and necitumumab, Lilly s anti-VEGFR and anti-EGFR monoclonal antibodies respectively, with AZD9291, AstraZeneca s investigational third generation EGFR inhibitor.
Lilly's abemaciclib (CDK4 and 6 small molecule inhibitor) with Faslodex, AstraZeneca's marketed selective estrogen receptor down regulator (SERD).
Hormonal agents like Tamoxifen, Faslodex (fulvestrant) and Aromatase Inhibitors are also discussed.
Raj Burmi, a PhD student at the centre who is doing the research, has identified 168 genes involved in Tamoxifen resistance and 141 associated with resistance to a similar drug called Faslodex.
The group has gained approval to launch its breast cancer drug Faslodex in the US and the news fuelled a healthy 20p gain to pounds 33.
The subject of the public contract is the supply of medicines Afinitor - L01XE10, Avastin - L01XC07, Faslodex 250 mg / 5 ml - L02BA03, Gilenya 0.
Other drugs, like Tamoxifen and Faslodex, inhibit cancer growth by competing with hormone receptors found on some types of cancer cells.
The current Study of Faslodex, Exemestane and Arimidex (SOFEA) trial will address this question.
Faslodex, a drug in the same family, is now used as a back-up for advanced cancer in those patients who have become resistant to tamoxifen.
Upon investigation, increasing levels of endogenous, prepubertal estrogens are plausible factors, as co-administration of the estrogen receptor antagonist Faslodex (Ashby 1999b) or the gonadotrophin-releasing hormone antagonist Antarelix (Odum et al.
Tenovus scientists are also currently evaluating two drugs - Zoladex and Faslodex - which aim to prevent breast and prostrate cancers spreading in the body.