Letrozole Sandoz Letrozole film-coated tablets Drug Medicine Information

The hazard ratio for survival in the letrozole arm compared to the tamoxifen arm was 0.87, with 95% CI (0.75, 1.02) (see Table 7). There were no significant differences in DFS, OS, SDFS, and Distant DFS from randomization in the Sequential Treatments Analyses. In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol. The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.

At the updated (final analysis), overall the side effects seen were consistent to those seen at a median treatment duration of 24 months. Femara (letrozole) is a non-steroidal aromatase inhibitor (lowers estrogen production) used to treat breast cancer in postmenopausal women. Femara is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years. Tamoxifen is another SERM commonly used as adjunctive therapy in breast cancer patients. Typically, histologically there is hyperplasia of the endometrial stroma without cellular atypia. Dilated endometrial glands, in association with endometrial atrophy, have been called cystic glandular atrophy.

4 Use in First and Second-Line Treatment of Advanced Breast Cancer

The following adverse reactions have been identified during postapproval use of letrozole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The recommended dose of letrozole tablet is one 2.5 mg tablet administered once a day, without regard to meals. Aromatase is an enzyme that works to help produce the hormone estrogen.

• Disease-free survival was measured as the time from randomization to the earliest event of loco-regional or distant recurrence of the primary disease or development of contralateral breast cancer or death.
• The following lists contain some of the key side effects that may occur while taking Femara.
• High-quality evidence shows no consistent advantage of any endometrial preparation has been established (62, 63).
• Typically, you’ll take letrozole 2.5, 5, or 7.5mg daily for five days.

This condition is called controlled ovarian hyperstimulation, or superovulation. Serious side effects from Femara aren’t common, but they can occur. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. In general, ovulatory problems frequently cause infertility, with as many as 25% of people experiencing infertility due to issues with the process of eggs releasing from their ovaries. Letrozole is useful for such ovulatory disorders because it can help promote ovulation. RxList does not provide medical advice, diagnosis or treatment.

Femara and alcohol

This is when your ovaries become overstimulated, leading to bloating, diarrhea, and even chest pain. If you’re ever concerned about any symptoms or side effects while taking letrozole, talk to your doctor. Letrozole inhibits the aromatase enzyme by competitively binding to the heme of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues. Treatment of women with letrozole significantly lowers serum estrone, estradiol and estrone sulfate and has not been shown to significantly affect adrenal corticosteroid synthesis, aldosterone synthesis, or synthesis of thyroid hormones. Adverse reactions that were reported in at least 5% of the patients treated with Femara 0.5 mg, Femara 2.5 mg, megestrol acetate, or aminoglutethimide in the two controlled trials AR/BC2 and AR/BC3 are shown in Table 5. Other less frequent (less than or equal to 2%) adverse reactions considered consequential for both treatment groups, included peripheral thromboembolic events, cardiovascular events, and cerebrovascular events.

Femara (letrozole) is indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. In humans, daily doses of 1–10mg of 81 suppressed estradiol levels. In a clinical trial on 17 postmenopausal women with advanced breast cancer, a dose of 10 mg kg−1 of ZD-1033 showed stabilization of the disease in four patients for 15–20 months (Plourde et al., 1994). Administration of 0.3 mg/kg/day resulted in AUC values that were similar to the AUC in adult patients receiving the recommended dose of 2.5 mg/day.

The incidence of osteoporosis was 5.1% for letrozole and 2.7% for tamoxifen [see ADVERSE REACTIONS]. In the extended adjuvant trial (MA-17), the incidence of bone fractures at any time after randomization was 13.3% for letrozole and 7.8% for placebo at a median follow-up of 62 months. The incidence of new osteoporosis was 14.5% for letrozole and 7.8% for placebo [see ADVERSE REACTIONS]. The extended adjuvant treatment trial (MA-17) was unblinded early [see ADVERSE REACTIONS].

How do I store and/or throw out this drug?

Do not start, stop, or change the dosage of any medicines without your doctor’s approval. The medians of overall survival Trenbolone acetate for both arms were not reached for the MAA. There was no statistically significant difference in overall survival.

Femara to Induce Ovulation When the enzyme aromatase is inhibited by the letrozole medication, estrogen levels are suppressed in young women. This results in the brain and pituitary gland increasing the output of FSH (follicle stimulating hormone). With the concomitant accumulation of androgens inside the ovary, promoting the follicular FSH receptor, IGF-1 and IGF-1 receptor expression, which in turn stimulates follicular growth. Normal central feedback mechanisms remain intact in letrozole ovarian induction protocol.

Why is this medication prescribed?

Call your doctor right away if you have a severe allergic reaction to Femara. As with most drugs, some people can have an allergic reaction after taking Femara. But it’s not known how often this occurs in people using Femara. There are also some things you can do to help minimize loss of bone strength while you’re taking Femara. If you have questions about how Femara may affect your bone density, talk with your doctor.