FASLODEX - hormonal treatment for hormone receptor-positive metastatic breast cancer

FASLODEX is a hormonal treatment for hormone receptor-positive metastatic breast cancer in postmenopausal women whose disease has returned or progressed following antiestrogen therapy.

FASLODEX was evaluated in two international clinical trials involving a total of 851 postmenopausal women with advanced breast cancer whose disease had returned or progressed following previous antiestrogen therapy. The women in the study were randomly assigned to receive either FASLODEX or anastrozole, another hormonal breast cancer treatment. These trials established the safety and effectiveness of FASLODEX in this setting.

FASLODEX is given once a month as an intramuscular (IM) injection administered by your health care professional. With a monthly injection, you won’t have to worry about missing a daily pill or traveling to a pharmacy to refill your medication. The monthly injection also ensures you are consistently receiving the same dosage. The regular monthly visit to your doctor gives you the opportunity to update your physician or nurse about your health. (See Questions for Your Doctor).

Your nurse or doctor will decide whether you should receive your monthly dose of FASLODEX in a single 5 mL injection or two 2.5 mL injections into the buttock. As with any injection, you may briefly feel mild discomfort around the injection site.

Important Safety Information

Only postmenopausal women should take FASLODEX. Do not take FASLODEX if you are pregnant and do not become pregnant while taking FASLODEX, because it may harm your unborn child. (See WARNINGS and CONTRAINDICATIONS sections of Full Prescribing Information).

Because FASLODEX is administered intramuscularly, it should not be used in patients with certain blood disorders or in patients receiving anticoagulants (sometimes called blood thinners, for example, warfarin).

In clinical studies, the most commonly reported side effects were nausea, vomiting, constipation, diarrhea, abdominal pain headache, back pain, hot flashes, sore throat and injection site reactions with mild, transient pain and inflammation.

Generic name: Fulvestrant injection
Manufacturer: AstraZeneca
Drug Class: Estrogen receptor antagonist
Indications: For treatment of hormone receptor positive metastatic breast cancer in post-menopausal women with disease progression following antiestrogen therapy.
Dosage: 250 mg administered intramuscularly into the buttock at intervals of 1 month as either a single 5mL injection or two concurrent 2.5 mL injections; administer injection slowly.
Of Note:

Rapidly cleared by the hepatobiliary route with excretion primarily in the feces; renal elimination negligible.

No known drug-drug interactions.

Rule out pregnancy before starting treatment.