Urofollytropyn | Alterpur lyoph. d / prg. r-ra d / p and in / m vv. 75 IU 1ml bottle with rast-m (ampoule) 1 pc.

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SKU
BID587701
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Latin name

Alterpur
Latin name

Alterpur

Packaging

1 vial

Pharmacological action

The composition of the drug includes highly purified follicle-stimulating hormone (FSH), obtained from the urine of postmenopausal women, with a slight admixture of luteinizing hormone (LH). The content of LH 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

Anovulation (including polycystic ovary syndrome (PCOS) with clomiphene therapy ineffectiveness)

Controlled ovarian hyperstimulation to induce the growth of multiple follicles during assisted reproductive technology (ART).

Contraindications

В· Hypersensitivity to urofollitropin and other components of the drug.

В· Pituitary or hypothalamic tumors.

В· Decompensated diseases: hypothyroidism, adrenal insufficiency, hyperprolactinemia.

В· Age to 18 years.

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

В· Anomalies of the development of the genitals that are incompatible with pregnancy.

В· Uterine fibroids incompatible with pregnancy.

В· Vaginal bleeding of unknown etiology.

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

В· Primary ovarian failure.

В· Pregnancy and lactation.

Caution

Presence of risk factors for thromboembolic complications, such as an individual or family predisposition, severe obesity (body mass index> 30 kg / m2), or thrombophilia, since in this case there is an increased risk of venous or arterial thrombosis and thromboembolism during or after the use of gonadotropins. In this case, the benefits of treatment with gonadotropins should exceed the risk of their use.

Recommendations for use

The drug can be administered intramuscularly or subcutaneously. A subcutaneous route of administration is preferable since it provides the greatest absorption of the drug substance. A solution for injection is prepared immediately before administration.

Treatment with the drug should be carried out only under the supervision of a doctor with the appropriate specialization and experience in the treatment of infertility. The dose of the drug described below is the same for both the subcutaneous and intramuscular route of administration. The dose should be selected individually depending on the reaction of the ovaries. This requires monitoring the response of the ovaries to the therapy in the form of an ultrasound scan in combination with a determination of the concentration of estradiol in the blood plasma.

· Anovulation (including PCOS for treatment failure with clomiphene)

Recommended starting dose of 75-150 IU / day. Alterpur may be administered daily. The use of the drug should begin during the first 7 days of the menstrual cycle. In the absence of a sufficient ovarian reaction, the dose gradually increases. 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 increasing dose is 37.5 IU, but not more than 75 IU. The maximum daily dose usually does not exceed 225 IU. Adequate ovarian development is usually observed after 7-14 days of therapy. If the therapeutic effect is not achieved within 4 weeks of treatment, injections of the drug Alterpur stop, and then begin a new cycle with a higher dose of the drug.

When an adequate ovarian response is achieved 24-48 hours after the last injection of Alterpur, 5000-10000 IU of human chorionic gonadotropin (hCG) is administered once to induce ovulation. The patient is recommended to have sex on the day of hCG administration and the day after administration. As an alternative method, intrauterine insemination is possible.

In case of excessive ovarian reaction (a large number of follicles more than 14 mm in diameter or an increase in the concentration of estradiol more than 2 times a day for 2-3 days in a row), the administration of the drug Alterpur must be stopped and the administration of hCG should be abandoned. The patient is recommended to use barrier methods of contraception or abstinence from sexual intercourse until the onset of menstruation.

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

· Controlled ovarian hyperstimulation to induce the growth of multiple follicles during BPT.

The widely used protocol for hyperstimulation involves the administration of 150-225 IU of the drug Alterpur daily starting from 2 or 3 days of the menstrual cycle and lasting until until sufficient follicle sizes are achieved. The correction of the daily dose is carried out in accordance with the patient's response to therapy. The daily dose should not exceed 450 IU FSH daily.

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

Gonadotropin releasing hormone agonists (aHnRH) are currently widely used to prevent the release of endogenous LH. In this case, the use of the drug Alterpur should begin approximately two weeks after the start of treatment with GnRH agonists. In the future, both drugs continue to be used together until an adequate level of follicular development is achieved. The dose of the drug Alterpur is adjusted in accordance with the response from the patient's ovaries.

Patients should be closely monitored for two weeks after hCG administration. In case of an excessive reaction to treatment with the drug, therapy should be discontinued, refuse to administer hCG and use barrier methods of contraception until the next menstruation.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and during lactation.

Side effects of

Adverse adverse reactions were classified as follows:

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

system bodies

frequency

Adverse reaction

endocrine system

infrequently

hyperthyroidism

mental health

infrequently

mood lability, depression

nervous system

often

infrequently

headache

lethargy, dizziness

Respiratory

infrequently

shortness of breath, nosebleeds

Gastrointestinal tract

often

infrequently

constipation, bloating nausea, abdominal pain, dyspepsia

Skin and subcutaneous tissue

infrequently

erythema, pruritus

Kidneys and urinary tract infrequent

o

cystitis

Genitals and mammary gland

often

infrequently

ovarian hyperstimulation syndrome

breast enlargement, breast tenderness, 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 data

infrequently

increased mild cases of hemorrhage / HCG.

The frequency of abortion when using gonadotropins is comparable to that in women with other impaired fertility. A small risk of an ectopic pregnancy and multiple pregnancy has been recorded.

Drug Interactions

Baeta® should be used with caution in patients taking orally drugs that require rapid absorption from the gastrointestinal tract, because Baeta® may delay gastric emptying. Patients should be advised to take oral medication, action cat When prescribing a GnRH agonist to lower the pituitary's own activity, the drug should be prescribed in higher doses in order to achieve the desired follicular reaction.

Overdose

In the event of an overdose, the development of CSF and thromboembolic complications may occur. Symptoms of CSF - ovarian enlargement, abdominal pain, nausea, vomiting, diarrhea, weight gain, oliguria, ascites, hydrothorax, hemoperitoneum, hemoconcentration, shortness of breath. Symptoms of mild or moderate severity SSD usually do not require additional treatment and go away for 2-3 weeks on their own. In the case of CSF, hospitalization in the intensive care units of specialized gynecological hospitals is necessary for carrying out complex treatment.

Storage Conditions

In a dark place at a temperature not exceeding 25 РC.

Expiration date

24 months.

Deystvuyushtee substance

Urofollitropin

Prescription conditions

prescription

Dosage form

injection for injection

IBSA Institute Biokimik S.A., Switzerland

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