Alterpur, lyophilizate 75 me 1 ml 1pc.

The product contains highly purified follicle stimulating hormone (FSH) derived from the urine of postmenopausal women, with a small admixture of luteinizing hormone (LH).

The LH content in the final product is minimized by a chromatographic purification procedure. Stimulates the growth and maturation of follicles, causing an increase in estrogen concentration and endometrial proliferation.

FSH binds to receptors on the surface of granulosa cells of small follicles in the ovaries.

Indications

Active ingredient

Composition

1 vial of lyophilizate contains:

The active ingredient is urofoliotropin 75 IU, 150 IU .br>

Ancillary ingredients – lactose monohydrate 10.00 mg

Interaction

Alterpur can be given alone or in combination with gonadotropin-releasing hormone (GnRH) agonists or antagonists

Alterpur should not be mixed with other medications.

Alterpure and clomiphene have been suggested to increase follicle growth, although there is no clinical evidence for their combined use. If a GnRH agonist is used to decrease intrinsic pituitary activity, higher doses of the drug should be prescribed to achieve the desired follicular response.

Directions for use

The drug can be injected intramuscularly or subcutaneously. Subcutaneous method of administration is preferred because it provides the greatest absorption of the drug substance. The solution for injection is prepared immediately before injection.

The treatment with the drug should only be carried out under the supervision of a doctor with appropriate specialization and experience of infertility treatment. The dose of the drug, described below, is the same for both subcutaneous and intramuscular routes of administration. The dose must be adjusted individually depending on the ovarian response. This requires monitoring the response of the ovaries to ongoing therapy in the form of an ultrasound study combined with determination of plasma estradiol concentrations.

– Anovulation (including PCOS when clomiphene therapy has failed)

The recommended starting dose is 75-150 IU/day. Alterpure may be given daily. The drug should be started within the first 7 days of the menstrual cycle. If the ovaries do not respond sufficiently, the dose is gradually increased. The recommended interval for increasing the dose should be at least 7 days (preferably 14 days) to achieve an adequate rather than excessive ovarian response. The recommended booster dose is 37.5 IU, but no more than 75 IU. The maximum daily dose usually does not exceed 225 IU. Adequate ovarian development is usually seen after 7-14 days of therapy. If the therapeutic effect is not achieved within 4 weeks of treatment, Alterpur injections are stopped and then a new cycle is started with a higher dose of the drug.

If an adequate ovarian response is achieved 24-48 hours after the last Alterpur injection 5000-10000 IU of human chorionic gonadotropin (hCG) are injected once to induce ovulation. The patient is advised to have sexual intercourse on the day of hCG injection and the day after the injection. As an alternative method intrauterine insemination may be performed.
If the ovaries overreact (large number of follicles over 14 mm in diameter or an increase in estradiol concentration of more than twice a day for 2-3 consecutive days) the Alterpur injection should be stopped and the HCG injection should be stopped. The patient is advised to use barrier methods of contraception or abstain from sexual intercourse until the onset of menstruation.

The treatment should be resumed in the next cycle at a lower dose than in the previous cycle.

Controlled ovarian hyperstimulation to induce multiple follicle growth with BPT.

The commonly used protocol for hyperstimulation involves administering 150-225 IU of Alterpour daily starting on day 2 or 3 of the menstrual cycle and continuing until sufficient follicle size is achieved. The daily dose is adjusted according to the patient’s response to therapy. The daily dose should not exceed 450 IU of FSH daily.

24-48 hours after the last Alterpur injection one injection of hCG is given at a dose of 5000 IU-10000 IU to induce final follicle maturation.

In order to prevent the release of endogenous LH, gonadotropin-releasing hormone (aGnRH) agonists are now widely used. In this case Alterpur should be started about two weeks after starting treatment with a GnRH agonist. Thereafter both drugs are continued together until an adequate follicle development is achieved. The dose of Alterpur is adjusted according to the response of the patient’s ovaries.

Patients should be closely monitored for two weeks after HCG administration. If there is an excessive reaction to treatment with the drug, therapy should be discontinued, the HCG injection should be stopped and barrier contraception should be used until the next menstruation.

Special Instructions

Treatment should be under the care of a physician experienced in treating infertility.

An examination for hypothyroidism, adrenal insufficiency, hyperprolactinemia, pituitary or hypothalamic tumors; and appropriate specific treatment is recommended before starting Alterpur.

SGYA
SGYA is a syndrome distinct from uncomplicated ovarian enlargement, whose manifestations vary in severity. It includes a significant increase in the ovaries, a high concentration of estrogens in the blood serum, and an increase in vascular permeability, which may lead to the accumulation of fluid in the abdominal, pleural and, rarely, pericardial cavities (in severe SGNE). In moderate CGY, the following symptoms are observed: abdominal pain, abdominal bloating, significant ovarian enlargement, weight gain, shortness of breath, oliguria, and gastrointestinal symptoms, including nausea, vomiting, and diarrhea. In severe SUI, hypovolemia, hemoconcentration, electrolyte disturbances, ascites, hemoperitoneum, hydrothorax, acute respiratory distress syndrome, and thromboembolic complications develop.

The overreaction of the ovaries to gonadotropin administration rarely leads to the development of SVF unless hCG is administered to stimulate ovulation. Therefore, in cases of ovarian hyperstimulation, hCG should not be administered and the patient should be warned to refrain from intercourse or use barrier methods of contraception for at least 4 days. HCG can progress rapidly (within 24 hours to several days), becoming a serious medical complication, so patients should be monitored for at least 2 weeks after HCG injection. Adherence to the recommended doses of Alterpur, the administration regimen, and close monitoring of therapy can minimize cases of ovarian hyperstimulation and multiple pregnancies. With ART, aspiration of all follicle contents before ovulation can reduce the risk of IUF.

SGF can be more severe and prolonged in the development of pregnancy. Most commonly, SGY develops after discontinuation of gonadotropin treatment and peaks in severity within 7-10 days of the end of treatment. Typically, SGN passes spontaneously after the onset of menstruation.

In moderate to severe SGI, the patient is hospitalized and specific therapy is initiated.
SGI occurs with high frequency in patients with polycystic ovarian syndrome.

Multiple pregnancies

In multiple pregnancies, there is an increased risk of adverse maternal and perinatal outcomes. Multiple pregnancies are more common with the use of urofoliotropins than with natural conception. In the case of in vitro fertilization (IVF), the likelihood of a multiple pregnancy depends on the number of embryos injected, their quality and the age of the patient. The patient should be warned about the potential risk of multiple pregnancies before starting treatment.

Pregnancy complications

The rate of spontaneous abortions in pregnancies after treatment with Alterpur is higher than in healthy women.

Ectopic pregnancy

Women with a history of fallopian tube disease, whether from natural conception or fertility treatment, have a high risk of ectopic pregnancy. The prevalence of ectopic pregnancy after IVF is 2% to 5%, compared with 1% to 1.5% in the general population.

Reproductive system neoplasms

There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have been treated for infertility with multiple ART techniques. It has not yet been determined whether gonadotropin treatment increases the baseline risk of these tumors in women with infertility.

Congenital malformations

The prevalence of congenital fetal malformations with ART is slightly higher than with natural conception. This is thought to be due to individual characteristics of the parents (age of the mother, characteristics of the sperm) and multiple pregnancies.

Thromboembolic complications

Women with known risk factors for thromboembolic complications, such as individual or familial predisposition, obesity (body mass index > 30 kg/m2) or thrombophilia may have an increased risk of venous or arterial thromboembolic complications during or after gonadotropin treatment. In such cases, the benefits of their use should outweigh the risks. Note that pregnancy itself also increases the risk of thromboembolic complications.

Influence on driving and operating ability

Alterpure does not affect the ability to drive or operate machinery.

Features

After a single subcutaneous administration at a dose of 300 IU, the time to maximum plasma concentration of the drug (Tmax) is 21.33±9.18 hours, the maximum concentration (Cmax) is 5.74±0.95 IU/L. The area under the curve (AUC0-∞) is 541.22±113.83 IU/L x h.

The elimination half-life of the drug is approximately 50 hours.

The bioavailability after intramuscular administration is approximately 70%

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Contraindications

– Hypersensitivity to uropholitropin and other components of the drug.

– Tumors of the pituitary gland or hypothalamus.

– Decompensated diseases: hypothyroidism, insufficiency of the adrenal cortex, hyperprolactinemia.

– Age under 18 years old.

– Persistent ovarian enlargement, ovarian cysts (not caused by PCOS).

– Genital abnormalities incompatible with pregnancy.

– Uterine fibroid incompatible with pregnancy.

– Vaginal bleeding of unclear etiology.

– Estrogen-dependent tumors (ovarian cancer, uterine cancer or breast cancer).

– Primary ovarian insufficiency.

– Pregnancy and the period of breastfeeding.

With caution

The presence of risk factors for thromboembolic complications, such as individual or familial predisposition, severe obesity (body mass index >30 kg/m2) or thrombophilia, as there is an increased risk of venous or arterial thrombosis and thromboembolism during or after gonadotropin use. In this case, the benefits of gonadotropin treatment should outweigh the risks of gonadotropin use.

Side effects

Adverse adverse reactions were classified as follows:

very frequent – (> 1/10); frequent – (> 1/100 to < 1/10); infrequent – (> 1/1000 to < 1/100); rare – (> 1/10000 to < 1/1000); very rare – (< 1/10000).

. Organ system

Frequency

Adverse reaction

Endocrine system

infrequent

hyperthyroidism

Mental health

infrequent

mood lability, depression

Nervous system

often

infrequent

headache

lethargy, dizziness

Respiratory system

infrequent

shortness of breath, nasal bleeding

gastrointestinal tract

often

infrequently

constipation, abdominal bloating nausea, abdominal pain, dyspepsia

Skin and subcutaneous tissue

erythema, itching

Kidney and urinary tract

infrequently

cystitis

enlargement of the mammary glands, mammary gland soreness, hot flashes

General disorders and disorders at the injection site

often

infrequently

rarely

pain

fatigue

Hyperemia and hematoma at the injection site

Laboratory and instrumental findings

infrequent

increased bleeding duration

In rare cases, arterial thromboembolism associated with treatment with human urofoliotropin/CGC occurs.

The incidence of pregnancy termination with gonadotropin use is comparable to that in women with other fertility disorders. A small risk of ectopic pregnancy and multiple pregnancies has been reported.

Overdose

In case of overdose, the development of SHF and thromboembolic complications is possible.

The symptoms of SPY are enlarged ovaries, lower abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, shortness of breath.

The symptoms of mild to moderate SUI usually do not require additional treatment and go away on their own within 2-3 weeks.

Heavier CGY requires hospitalization in the intensive care units of specialized gynecological hospitals for comprehensive treatment.

Pregnancy use

The drug is contraindicated in pregnancy and during lactation.