"Laboratoires Serono S.A."For "Serono International SA", Switzerland
Active substances of Lewis:
Form of release of Lewis:
Powder for solution for injection of 75 IU in bottles No. 1, No. 3, No. 10 complete with 1 ml solvent, No. 1, No.3, No. 10, in ampoules No. 1, No. 3, No. 10.
To whom is Luveris shown?
Luveris together with a follicle stimulating hormone( FSH) preparation is recommended to stimulate the development of follicles in women with severe LH and FSH deficiency( endogenous LH level in blood <1.2 IU / L).
How to use Luveris?
The use of Luveris should be started under the supervision of a specialist who is familiar with the problems of infertility treatment. Self-introduction by Lewis is possible only for well-motivated patients, trained properly and having the opportunity to consult with a specialist.
In women with a deficiency of LH and FSH secretion, the goal of Lewers in combination with FSH is the development of a single matur
To date, all clinical observations of the application of Luveris on such indications were obtained with the simultaneous administration of follitropin alfa.
Luveris is intended for subcutaneous administration. The powder should be dissolved in a solvent( supplied) immediately before use.
Treatment is carried out, taking into account the individual reaction of the patient, which is evaluated by ultrasound examination of the size of the follicle, the level of estradiol. It is recommended to start with 75 MO lutropin alfa( ie, one vial of Lewis) daily along with 75-150 MOFSH.
If an increase in the FSH dose is carried out properly, then a dose increase should be done better with 7 to 14-day intervals at 37.5 MO-75 MO.It is permissible to increase the duration of stimulation in any one treatment cycle up to 5 weeks.
When an optimal response is obtained, a single injection of 5000 IU - 10000 IU hCG in 24-48 hours is necessary. After the last injection of Lewis and FSH.The patient is recommended on the day of administration of the HCH and have sexual intercourse the next day.
Alternatively, intrauterine insemination may be performed.
It is necessary to take into account the probable need to support the luteal phase, since the absence of compounds with luteotropic activity( LH / HCH) after ovulation can lead to premature malnutrition of the yellow body.
If an excessive reaction is observed, treatment should be stopped and the administration of HCH is canceled. Treatment in the next cycle should start with a lower FSH dose than in the previous cycle.
Side effects of Lewis.
Luveris is used to stimulate the development of the follicle together with foliotropin alfa. Given this, it is difficult to attribute undesirable effects to any one of the drugs that have been applied.
A large post-marketing experience has been accumulated regarding the safety of the use of drugs containing human luteinizing hormone( CHL) isolated from urine. It is expected that the safety profile of Lewis is very similar to that of the HLH isolated from urine, with the exception of hypersensitivity reactions and disorders at the site of administration.
In clinical trials, minor and moderate local reactions( hematoma, pain, redness, pruritus, or swelling) were observed at the injection site, respectively, at 7.4% and 0.9% of the total number of injections. No significant reactions were reported at the injection site. To date, there are no reports of systemic allergic reactions to the introduction of Lewis.
Ovarian hyperstimulation syndrome was observed in less than 6% of patients who were injected with Luveris. There were no reports of severe cases of ovarian hyperstimulation syndrome.
In rare cases, with human menopausal gonadotropin therapy, thromboembolic events, ovarian distortions( a complication caused by ovarian enlargement) and hemoperitoneum may be associated. Although such side effects were not observed, it is impossible to exclude the possibility of their occurrence in the application of Luveris.
Ectopic pregnancy may also occur, especially in women who have tubing diseases in a previous medical history.
To estimate the frequency, such designations are used( cases / number of patients): very rare: & lt;1/10000, single: & gt;1/10000, & lt;1/1000, infrequent: & gt;1/1000, & lt;1/100, frequent: & gt;1/100, & lt;1/10, very frequent: & gt;1 / 10.
According to the estimated incidence after the introduction of Lewers, such side effects can occur.
- Impaired injection site: reactions at the injection site.
- Common disorders: headache, drowsiness.
- From the gastrointestinal tract: nausea, pain in the abdominal cavity, pain in the pelvic region.
- Reproductive disorders: ovarian hyperstimulation syndrome, ovarian cysts, chest pain.
The observed adverse events correspond to those that occur with the use of other drugs containing PGL, with the exception of local reactions that have a significantly lower frequency with the use of Lewers.
Before the start of treatment, the infertility of the couple should be evaluated, considering the suitability for treatment and the alleged contraindications to pregnancy. This medication can not be used if there is no way to get an effective reaction, i.e.with ovarian insufficiency, neoplasms of genital organs incompatible with pregnancy, or fibroid tumors of the uterus, incompatible with pregnancy. In addition, patients should be examined for hypothyroidism, adrenocortical insufficiency, hyperprolactinaemia and the presence of pituitary or hypothalamic tumors;they should be given the appropriate specific treatment.
Patients undergoing ovarian stimulation have an increased risk of hyperstimulation due to excessive estrogen secretion and the development of many follicles.
Ovarian hyperstimulation syndrome( GHSD) can become a serious medical complication, characterized by the presence of large ovarian cysts prone to rupture. Cyst rupture under the action of the drug can occur only in isolated cases, but this condition is provoked by the introduction of BCC to stimulate ovulation. Therefore, in such cases it is prudent to abolish the administration of HCH and suggest that the patient refrain from sexual intercourse or take precautions for at least 4 days.
For all patients, especially for patients with polycystic ovary syndrome, careful monitoring of the ovarian response is recommended before and during the stimulating therapy according to ultrasound data.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is higher compared to natural fertilization.
Ultrasound scanning and estradiol level determination are recommended to reduce the risk of GHSV and multiple pregnancies. With anovulation, the risk of developing CHDF increases with estradiol levels exceeding 900 pg / ml( 3300 p mol / l) and the presence of more than 3 follicles with a diameter of 14 mm or more.
Compliance with the recommended doses of Luveris and FSH, the mode of administration and careful monitoring of therapy will reduce the frequency of ovarian hyperstimulation and multiple pregnancies.
In clinical trials it was shown that the drug increases the sensitivity of the ovaries to follitropin alfa. If the FSH dose is increased appropriately, then a dose increase should be made better with 7 to 14-day intervals at 37.5 MO-75 MO.
In clinical trials, no reported increased sensitivity to lutropin alfa.
Direct comparison of Lewers with FSH and human menopausal gonadotropin( CHMG) was not performed. Comparison with the data obtained earlier suggests that the frequency of ovulation in the application of Luveris together with FSH is similar to that observed with the administration of HMG.
Who is contraindicated with Luveris?
Luveris is contraindicated in patients:
- with increased sensitivity to gonadotropins or any of the ingredients;
- with carcinoma of the ovary, uterus or mammary glands;
- with active, untreated tumors of the hypothalamus and pituitary gland;
- with ovarian enlargement or bones that are not due to polycystic ovary syndrome;
- with gynecological bleeding of unknown origin;
- during pregnancy and lactation.
Interaction of Lewis.
Lewis was not administered in a mixture with other drugs in a single injection, with the exception of folitropin alfa, for which it was shown that co-administration does not significantly affect the activity, stability, pharmacokinetic and pharmacodynamic properties of the active compounds.
Overdose of Lewis.
The effects of lutropin alpha overdose are unknown, but there is the possibility of developing the ovarian hyperstimulation syndrome.
Disposable doses of lutropin alfa to 40,000 IU, which were administered to healthy female volunteers, did not cause serious side effects and were well tolerated.