Breast cancer:

Indications for FASLODEX:

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.

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.

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. Pregnancy: do testing within 7 days prior to initiation. Advise females of reproductive potential to use effective contraception during and for 1 year after last dose. Nursing mothers: not recommended (during and for 1 year after last dose).

Pharmacologic Class:

Estrogen receptor antagonist.

Interactions:

May interfere with estradiol measurement by immunoassay, resulting in falsely elevated estradiol levels.

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.

Metabolism:

Hepatic (CYP3A4); 99% protein bound.

Elimination:

Fecal (primarily), renal.

Generic Availability:

NO

How Supplied:

Prefilled syringe kit (2 x 5mL)—1

Pricing for FASLODEX

5ml of 50mg/ml syringe (Qty: 4)
Appx. price $1383
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