Adult Dosing

Hormone receptor positive metastatic breast cancer in postmenopausal women

• Recommended dose: 500 mg IM, injected into the buttocks slowly (1-2 minutes per injection)
• Administer two 5-mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Moderate hepatic impairment (Child-Pugh class B): 250 mg IM, injected slowly into the buttock (1-2 minutes per injection) on days 1, 15, and 29 and once monthly thereafter
• Severe hepatic impairment (Child-Pugh class C): Dose adjustments not defined

See Supplemental Patient Information

• Use cautiously in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use
• Dosage should be reduced to 50% in patients with moderate hepatic impairment
• Fulvestrant may cause fetal harm when administered to a pregnant woman

Cautions: Use cautiously in

• Hepatic impairment

Supplemental Patient Information

• Advise women of childbearing potential not to become pregnant while receiving fulvestrant; and if the patient becomes pregnant during therapy, apprise them about the potential hazard to the fetus

Pregnancy Category:D

Breastfeeding: It is unknown whether fulvestrant is excreted in human milk. According to the manufacturer's data, because there is a possibility for serious adverse reactions in breastfed infants from the drug, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CV: Vasodilatation, peripheral edema
• CNS: Headache, dizziness, insomnia
• NEURO: Asthenia, paresthesia
• GI: Nausea, vomiting, anorexia, constipation, diarrhea, abdominal pain
• GU: Urinary tract infection
• HEMA: Anemia, leukopenia, thromboembolism
• DERM: Hot flash, rash, sweating
• RESP: Cough, pharyngitis, dyspnea
• MUSC: Bone pain, back pain, arthralgia, pelvic pain, musculoskeletal pain
• LOCAL: Injection site pain
• LABTESTS: Elevated LFTs
• MISC: Extremity pain, flu syndrome, fatigue, hypersensitivity reactions

• Estrogen antagonist; competitively binds to estrogen receptors present in cancer cells and produces antiestrogenic effects by downregulating the estrogen receptor protein in human breast cancer cells or by degrading the estrogen receptors to which it is bound
• Metabolized in the liver; CYP450: 3A4 substrate
• Excreted in feces (90%) and urine (<1%)
• Half-life: 40 days

US Trade Name(s)

• Faslodex

US Availability

Faslodex

• INJ: 50 mg/mL (5 mL prefilled syringes)

Canadian Trade Name(s)

• Faslodex

Canadian Availability

Faslodex

• INJ: 50 mg/mL (5 mL prefilled syringes)

UK Trade Name(s)

• Faslodex

UK Availability

Faslodex

• INJ: 250 mg/5 mL (prefilled syringes)

Australian Trade Name(s)

• Faslodex

Australian Availability

Faslodex

• INJ: 50 mg/mL (5 mL prefilled syringes)

[Outline]

Hematology/Oncology

Antineoplastics

Estrogen Receptor Antagonists