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Faslodex Generic Name & Formulations
Legal Class
Rx
General Description
Fulvestrant 50mg/mL; soln for IM inj; contains alcohol, benzyl benzoate, castor oil.
Pharmacological Class
Estrogen receptor antagonist.
How Supplied
Prefilled syringe kit (2 x 5mL)—1
Manufacturer
Generic Availability
YES
Faslodex Indications
Indications
As monotherapy: for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. As combination therapy: with ribociclib for HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women as initial endocrine-based therapy or following disease progression on endocrine therapy, or with palbociclib or abemaciclib for HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.
Faslodex Dosage and Administration
Adult
Give by slow IM inj (1–2mins per inj). 500mg (as two 5mL injections, one in each buttock) on Days 1, 15, 29, then once monthly thereafter. For combination therapy: give with palbociclib 125mg daily with food for 21 days, followed by 7 days off, or with abemaciclib 150mg twice daily, or with ribociclib 600mg daily for 21 days followed by 7 days off treatment; in pre/perimenopausal women: also treat with LHRH agonists. Moderate hepatic impairment: 250mg (as one 5mL injection) on Days 1, 15, 29, then once monthly thereafter. Other dose modification: see full labeling.
Children
Not established.
Faslodex Contraindications
Not Applicable
Faslodex Boxed Warnings
Not Applicable
Faslodex Warnings/Precautions
Warnings/Precautions
Bleeding diatheses, thrombocytopenia, or anticoagulant use. Moderate to severe hepatic impairment. When administering at the dorsogluteal inj site due to proximity of the sciatic nerve. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 1 year after last dose. Pregnancy: do testing within 7 days prior to initiation. Nursing mothers: not recommended (during and for 1 year after last dose).
Faslodex Pharmacokinetics
See Literature
Faslodex Interactions
Interactions
May interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.
Faslodex Adverse Reactions
Adverse Reactions
Inj site pain (including sciatica, neuralgia, neuropathic pain, peripheral neuropathy), nausea, vomiting, bone pain, arthralgia, headache, back pain, fatigue, pain in extremity, hot flash, anorexia, asthenia, musculoskeletal pain, cough, dyspnea, constipation; increased hepatic enzymes, hypersensitivity reactions.
Faslodex Clinical Trials
See Literature
Faslodex Note
Not Applicable
Faslodex Patient Counseling
See Literature
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