Generic Name and Formulations:
Fulvestrant 50mg/mL; soln for IM inj.
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. In combination therapy with palbociclib: HR-positive, HER2-negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.
Give by IM inj slowly (1–2 mins/injection). 500mg (as two 5mL injections, one in each buttock) on Days 1, 15, 29, then once per month thereafter. For combination therapy: give with palbociclib 125mg daily with food for 21 days, followed by 7 days off; in pre/perimenopausal women: also treat with LHRH agonists. Moderate hepatic impairment: 250mg (as one 5mL injection) on Days 1, 15, 29, then once per month thereafter. Other dose modification: see full labeling.
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. Pregnancy: do testing within 7 days prior to initiating; use effective contraception during therapy and for 1 year after last dose. Nursing mothers: not recommended (during therapy and for 1 year after last dose).
May interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.
Estrogen receptor antagonist.
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.
Hepatic (CYP3A4); 99% protein bound.
Fecal (primarily), renal.
Prefilled syringe kit (2 x 5mL)—1
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