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Letrozole is weakly protein bound and has a large volume of distribution (approximately 1. Metabolism and Excretion: Metabolism to a pharmacologically-inactive carbinol metabolite (4,4’methanol-bisbenzonitrile) and renal excretion of the glucuronide conjugate of this metabolite is the major pathway of Letrozole clearance. Of the radiolabel recovered in urine, at least 75% was the glucuronide of the carbinol metabolite, about 9% was two unidentified metabolites, and 6% was unchanged Letrozole. In human microsomes with specific CYP isozyme activity, CYP3A4 metabolized Letrozole to the carbinol metabolite while CYP2A6 formed both this metabolite and its ketone analog. In human liver microsomes, Letrozole inhibited CYP2A6 and CYP2C19, the clinical significance of these findings is unknown. Specific Populations Pediatric, Geriatric and Race: In the study populations (adults ranging in age from 35 to greater than 80 years), no change in pharmacokinetic parameters was observed with increasing age. Differences in Letrozole pharmacokinetics between adult and pediatric populations have not been studied. Differences in Letrozole pharmacokinetics due to race have not been studied. Renal Impairment: In a study of volunteers with varying renal function (24-hour creatinine clearance: 9 to 116 mL/min), no effect of renal function on the pharmacokinetics of single doses of 2. In addition, in a study (AR/BC2) of 347 patients with advanced breast cancer, about half of whom received 2. Hepatic Impairment: In a study of subjects with mild to moderate non-metastatic hepatic dysfunction (e. In a pharmacokinetic study, subjects with liver cirrhosis and severe hepatic impairment (Child-Pugh classification C, which included bilirubins about 2-11 times ULN with minimal to severe ascites) had two-fold increase in exposure (AUC) and 47% reduction in systemic clearance. Breast cancer patients with severe hepatic impairment are thus expected to be exposed to higher levels of Letrozole than patients with normal liver function receiving similar doses of this drug. Carcinogenesis, Mutagenesis, Impairment of Fertility. A conventional carcinogenesis study in mice at doses of 0. The incidence of combined hepatocellular adenoma and carcinoma showed a significant trend in females when the high dose group was excluded due to low survival. In a separate study, plasma AUC 0-12hr levels in mice at 60 mg/kg/day were 55 times higher than the AUC 0-24hr level in breast cancer patients at the recommended dose. The carcinogenicity study in rats at oral doses of 0. Ovarian hyperplasia was observed in females at doses equal to or greater than 0. At 10 mg/kg/day, plasma AUC 0-24hr levels in rats were 80 times higher than the level in breast cancer patients at the recommended dose. The benign ovarian stromal tumors observed in mice and rats were considered to be related to the pharmacological inhibition of estrogen synthesis and may be due to increased luteinizing hormone resulting from the decrease in circulating estrogen. Letrozole tablets were not mutagenic in in vitro tests (Ames and E. Letrozole was not clastogenic in vivo (micronucleus test in rats), piston npp klx 150. In a fertility and early embryonic development toxicity study in female rats, oral administration of Letrozole starting 2 weeks before mating until pregnancy day 6 resulted in an increase in pre-implantation loss at doses ? 0. In repeat-dose toxicity studies, administration of Letrozole caused sexual inactivity in females and atrophy of the reproductive tract in males and females at doses of 0.
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For women with PCOS, the cancer drug letrozole (Femara) may be more successful at triggering ovulation than Clomid. Or, your doctor may suggest gonadotropins (injectable fertility drugs). A Word From Verywell. Remember that while you may be primarily familiar with Clomid and perhaps IVF treatment, there are, in fact, many more fertility treatment options for you to consider. Always talk to your doctor if you’re concerned about the next step or if Clomid isn’t working as you hoped it would. PCOS and Clomid Fertility Treatment and Pregnancy. PCOS and ovulation problems and Clomid treatment. Clomid (clomiphene citrate or Serophene) is an oral medication that is commonly used for the treatment of infertility. It is often given to try to induce ovulation in women that do not develop and release an egg (ovulate) on their own Women who do not ovulate (without drugs) are said to have a condition called anovulation The most common cause of anovulation is polycystic ovarian syndrome, PCOS This page is about Clomid treatment for women with polycystic ovarian syndrome, or with irregular menstrual cycles Clomid for women with regular periods is discussed elsewhere Ultrasound picture of a polycystic ovary Many small, immature follicles (black circles) are seen Normal ovary with a mature follicle (at cursors) 18mm diameter follicle is about ready for ovulation. PCOS and Clomid Treatment ‘ Ovulation and Pregnancy Success Rates. Can I conceive with PCOS? The chance for pregnancy with fertility treatments for PCOS is very good. The great majority of women with polycystic ovarian syndrome will be able to have a baby with treatment. 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