Femara (Letrozole)

Femara Review

Femara is used to treat postmenopausal women with breast cancer that is resistant to the more commonly-used anti-estrogen medications such as tamoxifen (Nolvadex). It also is approved for treating postmenopausal women after surgery who have hormone-sensitive early breast cancer.

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Femara Drug Class and Mechanism

Femara is an oral, anti-estrogen drug that is used for treating postmenopausal women with breast cancer. The growth of some breast cancers in postmenopausal women is promoted by estrogens that circulate in the blood, and the adrenal glands are the main source of these circulating estrogens. Femara inhibits the enzyme in the adrenal glands (aromatase) that produces the estrogens, estradiol and estrone.

Estrogens are produced by the conversion of androgens through the activity of the aromatase enzyme. Letrozole blocks production of estrogens in this way by competitive, reversible binding to the heme of its cytochrome P450 unit. The action is specific, and letrozole does not reduce production of mineralo- or corticosteroids. In contrast, the antiestrogenic action of tamoxifen, the major medical therapy prior to the arrival of aromatase inhibitors, is due to its interfering with the estrogen receptor, rather than inhibiting estrogen production.Take by mouth once daily with or without food or as directed. Do not stop taking this medication unless instructed to do so by your doctor or pharmacist. Continue to take your other medications unless instructed otherwise.

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Femara Side Effects

This drug is generally well tolerated. Fatigue, nausea, constipation, diarrhea, headache, drowsiness or dizziness may occur. If these persist or worsen, notify your doctor promptly. Unlikely, but report promptly: chest pain, stomach pain, trouble breathing, hot flushes, rash, itching. Very unlikely, but report promptly: swelling/redness/weakness/ pain in legs or arms, vision problems, unusual vaginal bleeding. If you notice other effects, not listed above, contact your doctor or pharmacist.

Femara Pregnancy

Femara® (letrozole tablets)may cause fetal harm when administered to pregnant women. Studies in rats at doses equal to or greater than 0.003 mg/kg (about 1/100 the daily maximum recommended human dose on a mg/m2 basis) administered during the period of organogenesis, have shown that letrozole is embryotoxic and fetotoxic, as indicated by intrauterine mortality, increased resorption, increased postimplantation loss, decreased numbers of live fetuses and fetal anomalies including absence and shortening of renal papilla, dilation of ureter, edema and incomplete ossification of frontal skull and metatarsals. Letrozole was teratogenic in rats. A 0.03 mg/kg dose (about 1/10 the daily maximum recommended human dose on a mg/m2 basis) caused fetal domed head and cervical/centrum vertebral fusion.

Femara Overdose

Isolated cases of Femara® (letrozole tablets) overdose have been reported. In these instances, the highest single dose ingested was 62.5 mg or 25 tablets. While no serious adverse events were reported in these cases, because of the limited data available, no firm recommendations for treatment can be made. However, emesis could be induced if the patient is alert. In general, supportive care and frequent monitoring of vital signs are also appropriate. In single- dose studies, the highest dose used was 30 mg, which was well tolerated; in multiple-dose trials, the largest dose of 10 mg was well tolerated.

Femara More Information

Since fatigue and dizziness have been observed with the use of Femara® (letrozole tablets) and somnolence was uncommonly reported, caution is advised when driving or using machinery.