Arimidex 1mg Astrazeneca treatment of breast cancer (2 blisters x 14 tablets)

ATC code: L02B G03 (Yeast inhibitor).

Arimidex is an aromatase inhibitor of non -steroide group, highly selective and strong effects. In postmenopausal women, Estradiol is produced mainly from the conversion of Androstenedione to Estrone thanks to the aromatase complex in peripheral tissues. Estrone then converted into Estradiol. The decrease in the amount of estradiol in the blood has been shown to bring beneficial effects on breast cancer patients. By using a high sensitivity test, Arimidex is found at a dose of 1 mg daily has reduced 80% of estradiol in postmenopausal patients.

Arimidex does not have the activity of progesterone, androgen or estrogen.

Treatment for early breast cancer support from the beginning

In a major study phase III on 9,366 postmenopausal women and breast cancer, surgery can be used for 5 years, Arimidex has proved better statistics compared to Tamoxifen in terms of survival time, Arimidex has been recorded for more benefits than Tamoxifen for non -disease survival. In a group of patients who have been determined before the study is a positive hormonal receptor.

Arimidex is much better than statistics compared to tamoxifen in time until the disease relapse. The difference in time comes more significant than the survival time in the group of 2 patients analyzed according to the intention of treatment (Intention to Treat-Ne ITT) and a group of patients with positive endocrine receptors.

Arimidex is superior to statistics compared to tamoxifen in time until the recurrence of metastases far away. The number of patients using Arimidex also extends the survival time without metastases than patients using Tamoxifen.

The full survival benefits of Tamoxifen are still maintained when using Arimidex. An additional analysis of the time after death after the recurrence shows that the number of patients using Arimidex extends the life time until the death is much higher than that of Tamoxifen.

In general, Arimidex tolerates well. The following unintended events have been reported whether it is related to cause and effect with the drug. The patient is using Arimidex less blushing, vaginal bleeding, vaginal discharge, endometrial cancer, venous thrombosis and ischemic event more than patients using Tamoxifen. Patients using Arimidex have an increase in joint disorders (including arthritis, osteoarthritis and joint pain) and more fractures than patients who are taking Tamoxifen. The rate of fractures in the Arimidex group is 22 over 1,000 patients/year, which has been recorded compared to 15 over 1,000 patients/year in the group using Tamoxifen with an average monitoring time of 68 months. The proportion of patients with fractures when taking Arimidex is within the scope of fracture that has been reported in the postmenopausal population group corresponding to the age.

When used in combination with Arimidex and Tamoxifen, the efficiency and safety are similar to the use of an individual tamoxifen regardless of the endocrine receptor status. The exact mechanism of this is still unclear, people do not think that this is due to the reduction of the ability to inhibit Estradiol of Arimidex.

Early stage support for breast cancer for patients who are being treated with Tamoxifen

A phase test III (ABCSG 8) performs over 2579 women after menopause with early -stage breast cancer with a positive estrogen receptor being supported with tamoxifen, showing that patients are switched to Arimidex with a long -lasting life that is superior to patients who continue to use Tamoxifen.

time comes until the disease relapses, the time comes until the relapse is locally relapse or the metastases far away and the recurrence of the distant metastases proves that Arimidex is better than statistically, in accordance with the results of the time of life without disease. The frequency of breast cancer is very low in both treatment branches, with favorable advantages in the number of patients using Arimidex. The whole survival rate is the same in two treatment groups.

Two other similar tests (GABG/ARNO 95 and ITA) with ARIMIDEX, as well as analysis of ABCSG 8 and GABG/ARNO 95, both support this result.

ARIMIDEX's safety in these three studies is suitable for safety of women after menopause with early stage breast cancer with known positive receptors.

Research in combination of anastrozole with bisphosphonate risesDronate (SABRE) mineral density of bone (BMD)

In Sabre Pha III/IV study, 234 postmenopausal women with early breast cancer have a positive estrogen receptor.

Arimidex 1mg/day is classified into low, medium and high -risk groups based on the risk of existing fractures. The main index to evaluate the effect is the lumbar spine density analyzed by a Dexa scanner. All patients are treated with vitamin D and calcium. Patients in the low -risk group are single -lawed with Arimidex (n = 42), patients in the average risk group are randomly treated with Arimidex in combination with Riseadronate 35 mg 1 time/week (n = 77) or Arimidex in combination with placebo (N = 77) and patients in the high -risk group are treated with Arimidex. Coordinate with Riseadronate 35 mg 1 time/week (n = 38). The main research criterion is the change in lumbar spine density at the time of the 12th treatment compared to the original value.

The main analysis for 12 months shows that patients in the group are at risk of medium -sized fractures from ARIMIDEX mg/day in combination with Riseadronate 35 mg 1 time/week without a decrease in bone density (assessed by lumbar spine density via Dexa scanner). Moreover, there is no statistical significance of BMD significance in a low -risk group that is monoed with Arimidex 1mg/day. The secondary license plate is a change in the density of all the hip bone in the 12th month compared to the original also the same result.

This research provides evidence that it is advisable to consider using bisphosphonate to control the loss of bone mineral losses that may occur in postmenopausal women with early -stage breast cancer that is treated with arimidex.

lipid

In the Sabre study, patients treated with Arimidex in combination with riseadronate are neutral with plasma lipids.

Pediatrics

3 Clinical trials are conducted in children (2 tests on male patients at puberty with emulsifying women and 1 test on women with McCurne-Alright syndrome).

Studies on female emulsifiers

Testing 0006 is a random, double, multicolored study over 82 male patients at puberty (from 11 to 18 years old) with Asian female emulsified for more than 12 months treated with Arimidex 1 mg/day or placebo for 6 months. There is no significant difference in the number of patients with a total volume of total breasts decreased by 50% or more after 6 months of treatment between the group treated with Arimidex 1 mg and the placebo group.

Test 0001 is an open -labeled pharmacokinetic study, multi -dose of Arimidex 1 mg/day on 36 patients in the year at puberty with female Nhu Nhu Hoa more than 12 months. The secondary goal is to evaluate the patient rate. There is a decrease in the volume on both breasts at least 50% compared to the initial value between the first day and after 6 months of treatment and safety as well as the patient's tolerance. A pharmacological group of pharmacies includes: 25 male patients selected from research to survey the potential benefits of Anastrozole. Records of total breast volume reduced = 50% after 6 months over 55.6% of children (measured by ultrasound) and 77.8% of children (measured by measurement compa) (these are the results recorded from data, do not perform statistical analysis).

McCune-Alright syndrome research

Test 0046 is an international exploration test, multi-center, open label of Arimidex on 28 women's children (from 2 to 10 years old) suffered from McCune-Albright syndrome (MAS). The main goal is to evaluate the safety and effectiveness of Arimidex 1mg/day on patients with mas.

The effectiveness of treatment in research is based on the proportion of patients fully responding to the set standards related to vaginal bleeding, bone density according to age and growth rate.

No statistical changes are not recorded for vaginal bleeding days in treatment. There is no significant change over 9 clinicals for the level of classification by tanner, the average volume of the ovaries or the average volume of the uterus. Do not record changes that are statistically significant about increased bone density according to age in treatment compared to before treatment. Development rate (cm/year) decreases significant (p

Overview of unintended events in children under 18 years of age shows no concerns about safety and tolerance.

pharmacokinetics

anastrozole is quickly absorbed and usually reaches a maximum plasma concentration within 2 hours after drinking (when hungry). Anastrozole is slowly eliminated with the excreted time of 40-50 hours. Food can reduce the absorption rate, not reduce the absorption level of the drug. The minor change of the absorption rate does not cause any significant impact on clinically on the drug concentration in a stable phase in plasma when using the only ‘arimidex’ dose of the day. About 90-95% of the concentration of Anastrozole in a stable phase in plasma is achieved after 7 days with a single dose of the day. There is no evidence that the parameters of pharmacokinetics of Anastrozole depend on the dose or use time.

Anastrozole only connects 40% to plasma proteins.

In male patients with emulsifying women in puberty, Anastrozole is absorbed quickly, widely distributed and slowly eliminated with a semi -waste time of approximately 2 days. In women's patients, the clearance of Anastrozole is lower than the year but the concentration and contact time are higher.

In women's patients, Anastrozole is widely distributed and slowly eliminated with the sale time of approximately 0.8 days.

Be cautious when using

should not use 'arimidex' for children because they have not determined the safety and effectiveness in this patient group.

There is no data on the safety of 'Arimidex' patients with average or severe total liver injury, or in patients with severe kidney function damage (Creatinine clearance

Women with osteoporosis or at risk of osteoporosis should be officially assessed with bone density with bone density meter, such as a dexa scanner, before starting arimidex treatment and later. The treatment or preventing osteoporosis should be started when appropriate and carefully monitored.

There is no data on the use of Anastrozole with a substance that has the same structure as LHRH, this combination should not be done except for use in clinical trials.

Because Arimidex ”reduces blood estrogen levels, it can reduce the mineral density of bone with the result that can increase the risk of fractures. Using bisphosphonate can stop the loss of minerals of the bone caused by Anastrozole in postmenopausal women and can consider applying.

This product contains lactose. This drug should not be used for patients with rare genetic problems such as galactose intolerance, lapp lactase defects or glucose-galactose.

Drug interactions

Clinically clinical interactive studies with antipipyrine and cimetidine show that the common use of ‘arimidex’ with other drugs does not cause drug interactions, cytochrome p450 intermediaries, significantly clinically.

Database of safety in clinical studies does not show any evidence of clinical significant drug interactions in patients treated with ‘arimidex’, which have been used for other prescription drugs. There is no significant interaction clinically with bisphosphonate.

No simultaneous treatment of tamoxifen or therapies containing estrogen with arimidex because they can lose the pharmacological effect of the drug.