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Femara (Femara)
The international name
Letrozole (Letrozole)
Trade name
Femara (Femara)
The country-manufacturer
Switzerland
The firm-manufacturer
Novartis (Registered from: Novartis Pharma AG)
The number of the registration of the preparation
P-8-242 number 010 170
Form of issue
tablet coated films 2.5 mg
Pharmacological group
antitumor agent, estrogen synthesis inhibitor
Pharmacological group on ATC
L02BG04 Letrozole (Letrozole)
Pharmacological action
antileykopoeticheskoe
antiestrogennoe
protivoopujolevoe
zitosta
ticescoe
Date of registration, re-registration
04/20/1998
Codes TN VED CIS
3004 39 100 0
3004 39 900 0
ingredientstext from the main table
letrozole 2.5 mg
Dosage form
tablets, coated films
Section base
Medicines
pharmarticle from the main table
The NPD 42-8397-98
usetime from the main table
5 years
Indications according to ICD
A malignant neoplasm of the breast
The composition of the components of the
letrozole
Pharmacodynamics
Femara - antitumor agent, aromatase inhibitor non-steroidal structure. In those cases, when the growth of the tumor tissue depends on the presence of estrogen, the elimination of stimuli, indirect, estrogens, is a prerequisite for the suppression of tumor growth. For women in postmenopause estrogen is mainly formed with the participation of the aromatase enzyme, which converts androgens, synthesized in the adrenal glands (in the first place, androstenedione and testosterone), in estron and estradiol. Therefore, with the help of specific inhibition of the enzyme aromatase can be achieved suppression of the biosynthesis of estrogen and peripheral tissues and in the tumor tissue. Letrozole inhibits aromatase through competitive binding to ribosoma of this enzyme is the heme cytochrome P450, which ultimately reduces the estrogen biosynthesis in all tissues. In healthy postmenopausal women single dose of letrozole of 0.1, 0.5 and 2.5 mg reduces the levels of estrone in serum (compared with the initial level), respectively, 75-78% and 78%. The maximum reduction is achieved through 48-78 h. In postmenopausal women with advanced forms of breast cancer daily use of letrozole in the dose of 0.1 to 5 mg leads to lower levels of estradiol, estrone and estrone sulfate in blood plasma to 75-95% of the initial level, in all patients undergoing treatment. When using the drug in a dose of 0.5 mg or more, in many cases, the concentration of estrone and estrone sulfate are lower than the threshold sensitivity of the method used to determine hormone. This indicates that with the help of the data doses of the drug is achieved by a gradual suppression of the synthesis of estrogen. Suppression of estrogen is administered for treatment in all patients. Letrozole - highly specific inhibitor of aromatase activity. Violations of steroidogenesis in the adrenal glands were not found. In patients, which in the period of menopause treatment letrozole in a daily dose of 0.1-5 mg, clinically significant changes in the concentration in the blood plasma cortisol, aldosterone 11-deoksikortizola, 17-hydroxy-progesterone, ACTH, and the activity of the renin is not revealed. The test stimulation with ACTH after 6 and 12 weeks of treatment letrozole in a daily dose of 0.1, 0.25, 0.5, 1.0 and 5 mg not revealed any appreciable reduction of the production of aldosterone or cortisol. Thus, the necessity of the addendum of glucocorticoids and mineralocorticoids does not arise. In healthy postmenopausal women following application of letrozole in a single dose of 0.1, 0.5 and 2.5 mg, changes in the concentrations of androgens (androstenedione and testosterone) in the blood plasma is not revealed. In patients in postmenopausal, which tamoxifen letrozole in a daily dose of 0.1 to 5 mg, changes the level of androstenedione in the plasma is also not noted. All of this points to the fact that the blockade of estrogen biosynthesis does not lead to the accumulation of androgens, which are the precursors of estrogen. Letrozole does not affect the concentration of luteinizing and follicle stimulating hormones in the blood plasma, and does not affect the function of the thyroid gland, which is estimated on the level of thyroid-stimulating hormone, T4 and T3. According to the carefully controlled, double-blind clinical studies in patients who received Femara, the overall objective response (complete or partial) was observed in 23.6%, and in patients receiving megestrol acetate in 16.4%. The comparison of the results of treatment on the frequency of the answers showed a statistically reliable are the benefits of a letrozole used in the dose of 2.5 mg (P = 0.04).
The Pharmacokinetics Of
Letrozole rapidly and completely absorbed from the digestive TRACT (the average bioavailability is 99.9%). Food slightly reduces the rate of absorption of letrozole (average tmax, on an empty stomach is one hour, and in the case of taking the drug with food - two hours; the average Cmax on an empty stomach makes 129 + -20.3 nmol / l, and at the joint reception with food - 98.7 + -18.6 nmol / l), but the extent of absorption (judging by the size of the AUC) is not changed. Small changes in the rate of absorption is considered as having no clinical significance, therefore, letrozole can be taken irrespective of reception of food. Binding of letrozole with blood plasma proteins is approximately 60% and is carried out mainly to albumin (55%). The concentration of letrozole in erythrocytes is about 80% of its level in the blood plasma. After the introduction of 2.5 mg of 14C-labeled letrozole approximately 82% of the radioactivity in plasma of blood fell on the share of the unchanged active substance. Therefore, the impact of metabolites of letrozole small. Letrozole is rapidly and widely distributed into the tissues. The apparent volume of distribution at steady period is 1.87 + -0.47 l / kg. Letrozole to a large extent is metabolized with the formation of pharmacologically inactive karbinolovogo metabolite. The metabolic clearance of letrozole is 2.1 l / h, which is less than the value of hepatic blood flow (90 l / h). It was revealed that the transformation of letrozole in its metabolite is carried out under the action of isoenzymes 3A4 and 2A6 of cytochrome P450. As a result of metabolism of letrozole and other metabolites are formed, but their number is small and they have not yet been identified. A small number of letrozole return with urine and faeces in an unmodified form. Age has no effect on the pharmacokinetics of letrozole.
Indications
Treatment of advanced forms of breast cancer among women postmenopause (natural or induced artificially), received prior therapy antiestrogenami.
The dosage
In adults and patients of elderly age, the recommended dose of 2.5 mg and is taken once a day, every day. Drug treatment continued until then, until the progression of the disease. In the patients of elderly age change in dose Femara is not required. In children, the drug does not apply. In patients with impaired liver and / or kidney (with QC 10 ml / min and more) change in dose of the drug is not required.
Side effects of the
Adverse events that were noted in clinical trials, were generally mild or moderate. Heavy phenomenon, requiring cessation of treatment, were registered only in rare cases. Many of the undesirable phenomena could be caused by or major illness, or natural pharmacological effects of estrogen deficiency (for example, tides, thinning of the hair). Undesirable effects: headache, nausea, peripheral edema, fatigue, hot flashes, thinning of the hair, rash (including erythematous maculopapular rash and rash), vomiting, dyspepsia increased body mass, muscular-skeletal pain, including pain in the hands, back pain , pain in the legs, pain in the skeleton), anorexia, Leucorrhoea, constipation, dizziness, increased appetite, increased sweating, shortness of breath, throm (including thrombophlebitis of superficial and deep veins), vaginal bleeding, arterial hypertension, itching of the skin. Other undesirable phenomena, whose connection with the applicable means was evaluated as possible, and registered in at least three of the patients who took Femara, but at a frequency less than 2.0%, included weight loss, and generalized edema.
Contraindications
Hypersensitivity to the active substances or to any other ingredient of the preparation; endocrine status, characteristic for premenopauznogo period; pregnancy, lactation. Use during pregnancy and lactation. The research of influence of letrozole on the reproductive function of the animals is not yet completed. Femara is contraindicated during pregnancy and lactation. An Overdose. Information about overdose Femara to the present time are not available. Unknown and specific methods of treatment in case of overdosage; treatment should be symptomatic and supportive.
Interaction
The results of clinical studies of interaction with cimetidine and warfarin showed that the simultaneous appointment of Femara with these drugs does not lead to clinically significant interactions. Evidence of clinically significant interactions have not been observed also in a large clinical study Femara in patients receiving other often appointed by drugs (including, benzodiazepines, barbiturates; NSAIDS such as diclofenac sodium, ibuprofen, paracetamol; furosemide; omeprazole). Clinical experience on the application of Femara in combination with other protivoopujolevami means not currently available.
Special instructions
Femara not studied in patients with creatinine clearance < 10 ml / min. Given the low binding of letrozole with the plasma protein, it can be assumed that the product may be removed from the bloodstream by using dialysis. Before the appointment Femara such patients should be carefully evaluate the ratio between the expected effect and risk treatment. It is unlikely that the application of the Femara directly violate the ability of patients to drive a car or operate machinery.
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