Ovitrelle solution for subcutaneous injection 250 mcg/0.5 ml syringe-pen, 1 pc.

Composition

1 syringe contains:

Active ingredient:

choriogonadotropin alpha 250 mcg;

Auxiliary substances:

mannitol — 27.3 mg

. Pharmacological action

Ovitrelle has a gonadotropic, luteinizing effect.

Pharmacodynamics

Ovitrelle® contains choriogonadotropin alpha (HCG alpha), which is produced using recombinant DNA technology. It has the same amino acid sequence as natural human HCG. HCG binds transmembrane LH receptors on the surface of ovarian theca and granulosa cells. Causes initiation of oocytic meiosis, follicle rupture (ovulation), corpus luteum formation, and production of progesterone and estradiol by the corpus luteum.

Pharmacokinetics

Suction and distribution. After intravenous administration, HCG alpha is distributed into the extracellular fluid with a half-life of about 4.5 hours.

Stationary Vd and total clearance are 6 l and 0.2 l / h, respectively.

With subcutaneous administration of HCG alpha, the absolute bioavailability is approximately 40%, the final T_1/2 is about 30 hours.

Elimination and metabolism. The metabolism and excretion of HCG alpha are similar to that of endogenous HCG.

Indications

In the protocol for the induction of multiple follicle maturation (superovulation) for assisted reproductive technologies (including IVF) for the purpose of inducing final follicle maturation and luteinization after stimulation with gonadotropins; in anovulatory or oligovulatory infertility for the induction of ovulation and luteinization at the end of follicle growth stimulation.

Use during pregnancy and lactation

During pregnancy and lactation, the drug Ovitrelle® not assigned. There are no data on the excretion of HCG alpha in breast milk.

Contraindications

• hypersensitivity to the Active ingredient or to any of the auxiliary components of the drug;
• the tumor in the region of the hypothalamus and pituitary;
• voluminous tumors of the ovary or cyst, unrelated to polycystic ovary;
• vaginal bleeding of unknown origin;
• malignant neoplasms of the ovary, uterus, or breast;
• ectopic pregnancy within the previous 3 months;
• thromboembolism;
• primary ovarian failure;
• congenital malformation of sexual organs incompatible with pregnancy;
• fibromyoma of the uterus incompatible with pregnancy;
• postmenopausal.

Caution should be exercised when prescribing Ovitrelle® to patients with serious systemic diseases in cases where pregnancy may lead to their exacerbation.

Side effects

From the immune system: very rarely — mild to severe hypersensitivity reactions, including anaphylactic reactions and shock.

From the central nervous system: often — headache. infrequently — depression, irritability, agitation.

From the vascular system: often-thromboembolism, usually associated with severe ovarian hyperstimulation syndrome (OHSS).

From the digestive system: often – nausea, vomiting, abdominal pain, infrequently-diarrhea.

Skin and subcutaneous tissue disorders: very rarely — mild reversible skin reactions in the form of a rash.

From the side of the reproductive system and mammary glands: often — OHSS of mild or moderate severity, infrequently-severe OHSS, breast tenderness.

General and local reactions: often — fatigue, reactions at the injection site.

How to take, course of administration and dosage

Ovitrelle is administered subcutaneously. Each syringe is intended for single use only.

When used in the protocol of induction of multiple follicle maturation for assisted reproductive technologies (including IVF) in order to induce the final maturation of follicles and luteinization after stimulation with gonadotropin preparations, Ovitrelle at a dose of 250 mcg (contents of 1 syringe) is administered once 24-48 hours after the last administration of FSH or LH and to achieve the optimal level of follicle development.

Overdose

Symptoms: It is possible to develop OHSS, characterized by the formation of large ovarian cysts with the risk of their rupture (perforation), the development of ascites and circulatory disorders.

Treatment: if there is a high risk of OHSS, it is recommended to cancel the administration of human HCG. Patients are advised to refrain from sexual contact or use barrier methods of contraception for at least 4 days.

Special instructions

Before starting treatment, it is necessary to determine the causes of infertility in the patient and her partner and assess the estimated risk factors for pregnancy. The presence of clinically expressed hypothyroidism, adrenal insufficiency, hyperprolactinemia, as well as a history of hypothalamic-pituitary tumors and the specific therapy methods used should be taken into account.

During ovarian stimulation, patients are at risk of developing OHSS due to the simultaneous maturation of a large number of follicles. Severe OHSS can be a serious complication of stimulation. In order to reduce the risk of developing this complication, the follicle growth stimulation protocol recommends careful monitoring of the ovarian response using ultrasound and determining the level of estradiol in the blood before and during treatment.

Compared to natural insemination, stimulation increases the risk of multiple pregnancies. In most cases, twins are born. When using assisted reproduction methods, the number of babies born corresponds to the number of embryos transferred to the uterine cavity.

The statistics of miscarriages after treatment of anovulatory infertility (including with the help of ART) exceeds the population average, but is comparable with other types of infertility.

Administration of Ovitrelle® may affect the immunological picture of human XH levels in blood serum and urine for 10 days and lead to a false positive reaction during a pregnancy test.

During therapy with Ovitrelle®, there may be a slight stimulation of thyroid function.

Before starting treatment, it is necessary to determine the causes of infertility in the patient and her partner and assess the estimated risk factors for pregnancy. Especially consider the symptoms of hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, the presence of pituitary or hypothalamic tumors, and the specific therapy methods used.

Ovarian Hyperstimulation syndrome (OHSS)

Ovarian stimulation increases the risk of OHSS due to the simultaneous maturation of a large number of follicles. OHSS can be a serious complication characterized by the formation of large ovarian cysts with a risk of rupture, weight gain, shortness of breath, oliguria, or the presence of ascites in the clinical picture of circulatory disorders. In rare cases, severe OHSS may be accompanied by hemoperitoneum, acute pulmonary distress syndrome, ovarian torsion, and thromboembolism.

In order to reduce the risk of OHSS, the follicle growth stimulation protocol recommends careful monitoring of the ovarian response using ultrasound and determining the level of estradiol in the blood before and during treatment.

With anovulation, the risk of OHSS increases if the plasma estradiol concentration is >1500 pg / ml (5400 pmol/L) and there are more than 3 follicles with a diameter of 14 mm or more. In ART, the risk of OHSS increases if the estradiol concentration is >3000 pg / ml (11000 pmol / L) or if there are 18 or more follicles with a diameter of 11 mm or more.

OHSS caused by an excessive ovarian response can be avoided if the administration of human HCG is discontinued. Therefore, if the serum estradiol level is >5500 pg/ml (20000 pmol/L) and/or when 30 or more follicles are present, the use of human HCG should be avoided. Patients are advised to refrain from coitus or use barrier methods of contraception for at least 4 days.

Multiple pregnancies

Compared to natural insemination, stimulation increases the risk of multiple pregnancies. In most cases, twins are born. When using assisted reproduction methods, the number of babies born corresponds to the number of embryos transferred to the uterine cavity.

The use of recommended doses of Ovitrelle®, treatment regimens, and careful monitoring during therapy minimize the risk of OHSS and multiple pregnancies.

Miscarriage of pregnancy

The statistics of miscarriages after anovulatory infertility treatment, including ART, is higher than the population average, but is comparable to other types of infertility.

Ectopic pregnancy

Patients with a history of fallopian tube diseases have an increased risk of ectopic pregnancy, regardless of whether the pregnancy was obtained in the usual way or during infertility treatment. The probability of ectopic pregnancy after the use of assisted reproductive technologies is higher than in the general population.

Congenital malformations

The frequency of congenital malformations after the use of ART programs may be slightly higher than during natural pregnancy and childbirth. However, it is not known whether this is due to a specific feature of the parents (for example, the mother’s age, sperm quality) and multiple pregnancies, or directly to ART procedures.

Thromboembolic complications

In patients with recent or ongoing thromboembolic diseases, as well as with a probable risk of their occurrence in the presence of a history of the disease or in relatives, the use of gonadotropins may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy should be correlated with the possible risk.

It should be noted that pregnancy itself, like OHSS, carries an increased risk of thromboembolic disorders, such as pulmonary embolism, ischemic stroke, or myocardial infarction.

Impact on laboratory parameters

Administration of Ovitrelle® may affect the immunological picture of hCG levels in the blood serum and urine for 10 days and lead to a false positive reaction during a pregnancy test.

Other information

During therapy with Ovitrelle®, there may be a slight stimulation of thyroid function.

If the manifestations of adverse reactions increase or develop side effects that are not mentioned in the instructions, you should inform your doctor about this.

During the shelf life, the drug can be stored outside the refrigerator at a temperature not exceeding 25 °C for 30 days. If the drug has not been used after 30 days of such storage, it must be destroyed.

Impact on vehicle management. Practically does not affect the operation of the vehicle or any other mechanism.

Form of production

Solution for subcutaneous administration

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Choriogonadotropin alpha

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as prescribed by a doctor, For women of childbearing age

Indications

Infertility Treatment

Weight

Weight: 26 gr.