Elonva solution for leather. injecting 100 mcg 0.5 ml syringe 1 pc. (Koryfollytropyn alpha)

Release form

Injection

Packaging

1 syringe

Pharmacological action

Pharmacological group

Follicle-stimulating agent

Pharmacodynamics

Corifollitropin alpha is a glycoprotein that is produced by Chinese hamster ovary cells using recombinant DNA technology.

Corifollitropin alfa is a growth promoter of prolonged follicles, which is comparable in pharmacodynamic properties to recombinant follicle-stimulating hormone (rFSH), but has a significantly longer duration. The drug causes and supports follicular growth during the week, so a single subcutaneous injection of the recommended dose of Elonva ® can replace the first 7 daily injections of any rFSH drugs during controlled ovarian stimulation. An increase in the duration of follicle-stimulating activity was achieved by attaching the carboxy-terminal peptide of the beta subunit of human chorionic gonadotropin (hCG) to the beta chain of human FSH. Corifollitropin alpha does not have the activity of hCG and luteinizing hormone (LH).

Cardioelectrophysiology

In a randomized, double-blind, placebo-controlled and drug-controlled clinical trial with 4 periods of treatment change, 70 healthy postmenopausal women received a single therapeutic dose of 150 mcg Corifollitropine Alpha subcutaneously, a single dose of Corifolitropinum exceeding 240 mg alpha subcutaneously, 400 mg of moxifloxacin orally and placebo. When using both doses of corifollitropine alpha, the QTc interval did not increase for 216 hours after drug administration. When adjusting for the initial value of the indicator and its value when using placebo, the maximum value of the average change in the duration of the QTc interval after administration of 150 μg of Corifollitropin alpha was 1.4 ms (one-sided 95% upper confidence interval was 3.4 ms). After administering a dose of corifollitropine alpha exceeding the therapeutic (240 μg), the maximum value of the average change in the duration of the QTc interval was 1.2 ms (one-sided 95% upper confidence interval of 3.6 ms).

Pharmacokinetics

The pharmacokinetics of corifollitropine alfa were not dose-dependent over a wide dose range (7.5–240 mcg). Distribution, Metabolism and excretion of Corifollitropin alpha are similar to those of other gonadotropins, such as FSH, hCG and LH.

Absorption

After a single subcutaneous injection of the drug Elonva ®, the maximum concentration of corifollitropine alpha in the plasma was reached after 44 h (34-57 h1). The absolute bioavailability was 58% (48-70% 1).

Corifollitropine alpha exposure is dependent on body weight. In clinical studies, the concentration of corifollitropin alpha in plasma was similar after the administration of corifollitropin alpha at doses of 100 μg and 150 μg to women with body weight 60 kg and> 60 kg, respectively.

Distribution of

After absorption into the blood, Corifollitropin Alpha is distributed mainly in the ovaries and kidneys.

In equilibrium, the volume of distribution and clearance are 9.2 l (6.5-13.1 l1) and 0.13 l / h (0.10-0, 18 l / h1) respectively.

Metabolism

Kidney is primarily involved in the metabolism of corifollitropine alfa. As a result of metabolism, pharmacologically inactive alpha and beta subunits (including the carboxy terminal peptide) are formed, which are mainly excreted by the kidneys.

Excretion

The elimination half-life of corifollitropine alfa is 70 h (59-82 h1).

Corifollitropin alfa is excreted mainly by the kidneys. Excretion rate may be reduced in patients with renal failure. Microsomal liver enzymes are not significantly involved in the metabolism and excretion of corinfolitropin alpha. Although there are no data on the use of corifollitropine alfa in patients with hepatic insufficiency, the effect of hepatic insufficiency on the pharmacokinetic profile of corifollitropin alfa is unlikely.

1 Predicted range in 90% of patients.

Indications

Controlled ovarian stimulation in combination with gonadotropin releasing hormone (GnRH) antagonists to form multiple follicles in women, participating in an assisted reproductive technology (ART) program.

Contraindications

Hypersensitivity to corifollitropine alfa or to any excipient of the drug.

Tumors of the ovaries, breast, uterus, pituitary, or hypothalamus.

Bleeding and spotting from the genital tract (not related to menstruation) of unknown etiology.

Primary ovarian failure.

Ovarian cysts or ovarian enlargement.

In the event that the previous cycle of controlled ovarian stimulation led to the growth of more than 30 follicles to a size of at least 11 mm, detected by ultrasound.

The number of basal antral follicles is more than 20.

Uterine fibroid tumors, in which the onset and further gestation is difficult.

Malformations of the reproductive organs in which pregnancy is impossible.

Pregnancy and the period of breastfeeding.

Polycystic Ovary Syndrome (PCOS).

Renal failure.

Use during pregnancy and lactation

hypersensitivity to the active substance or one of the excipients of

tumor of the ovary, breast, uterus, pituitary gland or hypothalamus

abnormal (non-menstrual) vaginal bleeding of the invisible / diagnosed cause

primary ovarian failure

ovarian cysts or ovarian enlargement

history of ovarian hyperstimulation

history of previous polycystic ovary syndrome, which resulted in more than 30 mm of study

number of major dominant follicles> 20

uterine fibroid tumors in which the onset of the best gestation is difficult

def rmatsiya reproductive organs incompatible sberemennostyu

Special instructions

Before starting infertility treatment, couples should be examined for existing or suspected contraindications for pregnancy. In particular, a woman should be screened for hypothyroidism, adrenocortical deficiency, hyperprolactinemia, and pituitary or hypothalamic tumors and receive appropriate treatment.

ElonvaВ® is for single-subcutaneous administration only. During the same cycle, additional injections should not be prescribed.

rFSH should not be administered during the first 7 days after drug administration.

Patients with renal failure may have impaired elimination of corifollitropine alfa. In such women, the use of the drug is not recommended.

Experience with the use of ElonvaВ® in combination with a gonadotropin releasing hormone agonist is limited. The results of a slightly uncontrolled study indicate a more pronounced response of the ovaries compared to that with the introduction of a combination of the drug by the gonadotropin releasing hormone antagonist. In this regard, the use of the drug ElonvaВ® in combination with a gonadotropin releasing hormone agonist is not recommended.

ElonvaВ® has not been studied in women with polycystic ovary syndrome. In such cases, the use of the drug is not recommended.

After administration of the drug, the ovarian response was more pronounced than after daily injections of rFSH. Consequently, patients with established risk factors for severe ovarian reaction may be predisposed to the development of ovarian hyperstimulation syndrome during or after drug administration. If the first cycle of ovarian stimulation is performed and not all risk factors are known, careful monitoring of possible ovarian hyperstimulation is recommended.

Ovarian Hyperstimulation Syndrome (OHS)

OHS differs from uncomplicated ovarian enlargement. Signs of OHS arise from the use of hCG or pregnancy (endogenous hCG). Clinical signs and symptoms of moderate to moderate ovarian hyperstimulation syndrome include abdominal pain, nausea, diarrhea, moderate or moderate enlargement of the ovaries and ovarian cysts. Severe OHSS can be life threatening. Clinical signs and symptoms of severe OHSS include large ovarian cysts (prone to perforation), acute abdominal pain, ascites, pleural effusion, hydrothorax, shortness of breath, oliguria, hematological disorders and weight gain. In rare cases, venous or arterial thromboembolism may occur in connection with OHSS. Early OHSS usually develops within 10 days after the administration of hCG and may be accompanied by an excessive ovarian response to gonadotropin stimulation. Normal early OHSS passes on its own after the onset of menstruation. Late OHSS develops more than 10 days after the administration of hCG as a result of (multiple) pregnancy. Considering the risk of developing OHSS, patients should be observed for at least 2 weeks after the administration of hCG.

To minimize the risk of developing OHSS, prior to treatment, irregular monitoring of growing follicles and / or determination of serum estradiol levels is necessary during treatment. In assisted reproduction programs, the risk of developing OHSS is increased in the presence of 18 or more follicles with a diameter of 11 mm or more. If the total number of follicles is 30, hCG should not be administered.

Depending on the response of the ovaries, the following measures can be taken for the prevention of OHSS:

- delay further gonadotropin stimulation for a maximum of 3 days

- delay the induction of final maturation of the oocyte by hCG until stabilization or reduction of estradiol levels

- take hCG at a dose of less than 10,000 IU for induction oocyte, for example, 5000 IU of hCG or 250 Ојg of hCG, which is equivalent to approximately 6500 IU

- cryopreserve all embryos for further

implantation - do not administer hCG and stop the treatment cycle.

To support the luteal phase, the introduction of hCG should be discarded.

In order to minimize the risk of ovarian hyperstimulation syndrome, it is necessary to adhere to the recommended doses and regimen of the drug and carefully monitor the response of the ovaries.

When using all gonadotropin preparations, cases of multiple pregnancy and the birth of several newborns were observed. Before starting treatment, a woman and her partner should be informed of a possible risk for the mother (complications of pregnancy and childbirth) and the newborn (low body weight). In the treatment of assisted reproductive technologies, the risk of multiple pregnancy mainly depends on the number of transferred embryos.

In infertile women who are offered treatment with assisted reproductive technologies (especially in vitro fertilization - IVF), tubal pathology is common, which can lead to an increased risk of ectopic pregnancy. In this regard, an ultrasound examination in early pregnancy should be performed to confirm the uterine and to exclude an ectopic pregnancy.

The incidence of congenital malformations after assisted reproductive technologies is slightly higher than after natural fertilization. it who are offered treatment with assisted reproductive technologies (especially in vitro fertilization - IVF), tubal pathology is common, which can lead to an increased risk of ectopic pregnancy. In this regard, an ultrasound examination in early pregnancy should be performed to confirm the uterine and to exclude an ectopic pregnancy.

The incidence of congenital malformations after assisted reproductive technologies is slightly higher than after natural fertilization. it who are offered treatment with assisted reproductive technologies (especially in vitro fertilization - IVF), tubal pathology is common, which can lead to an increased risk of ectopic pregnancy. In this regard, an ultrasound examination in early pregnancy should be performed to confirm the uterine and to exclude an ectopic pregnancy.

The incidence of congenital malformations after assisted reproductive technologies is slightly higher than after natural fertilization. it

The incidence of congenital malformations after assisted reproductive technologies is slightly higher than after natural fertilization. it

The incidence of congenital malformations after assisted reproductive technologies is slightly higher than after natural fertilization. itassociated with the characteristics of the parents (for example, the age of women, the properties of sperm), the increased frequency of multiple pregnancies, and also with the number of transplanted embryos.

In women who received various treatment regimens for infertility, cases of the development of ovarian tumors and other organs of the reproductive system are described. It has not been established whether treatment with gonadotropins can increase the risk of developing these tumors in infertile women.

In women with risk factors for thromboembolic complications, such as a history of thromboembolism, a history of family history, obesity (body mass index> 30 kg / m2), or thrombophilia, treatment with gonadotropins may further increase this risk. In such cases, the benefits and risks of gonadotropins should be weighed. It should be noted, that pregnancy alone increases the risk of thrombosis.

Composition

Each vial contains: Active ingredient: Corifollitropin alfa 100 mcg.

Excipients: Sodium citrate dihydrate 3.68 mg, sucrose 35.0 mg, L-methionine 0.25 mg, Polysorbate-20 0.10 mg, hydrochloric acid 0.1 M or sodium hydroxide 0.1 M to pH 7 , 0, water for injection (extractable volume) up to 0.50 ml.

Dosage and Administration

The use of the drug Elonva® should be carried out under the supervision of a physician with experience in the treatment of infertility.

The drug can be used, only if the solution in the syringe is clear.

The dose of Elonva® depends on the body weight and age of the woman.

A single administration of the drug at a dose of 100 mcg is recommended in women with body weight? 60 kg aged? 36 years.

A single dose of 150 mcg is recommended for women: - with body weight> 60 kg, regardless of age

- with body weight? 50 kg and over 36 years old.

Information on the use of the drug in women older than 36 years and with a body weight of less than 50 kg is not available.

Side effects of

Often (from 1% to 10%)

- ovarian hyperstimulation syndrome (OHS)

- pain and discomfort in the pelvic area

- soreness of the mammary glands

- headache

- fatigue snotlrd 0 1% to 1%)

- dizziness

- abdominal pain, vomiting, diarrhea, constipation, bloating

- twisting of the ovaries

Additionally, an ectopic pregnancy, spontaneous abortion and multiple pregnancies were reported. It is assumed that this is associated with the procedure for using assisted reproductive technology or subsequent pregnancy.

Drug Interactions

Interactions with other drugs have not been studied. Corifollitropin alpha is not a substrate for isoenzymes of cytochrome P450, therefore, interaction with other drugs is not expected.

Overdose

Administration of more than one recommended dose of Elonva ® during a single cycle of controlled ovarian stimulation and / or administration of RFFS at too high doses may increase the risk of developing CSF. After the introduction of the drug Elonva ® up to the 8th day of stimulation, it is not necessary to additionally use drugs containing FSH, as it can also increase the risk of developing CSF. Measures to reduce the risk of development and treatment of CSF are described in the section “Special instructions”.

Storage Conditions

At 2 to 8 ° C, in a dark place. Do not freeze.

Keep out of the reach and sight of children.

Shelf life

3 years.

Deystvuyushtee substance

Korifollitropin alyfa

Terms and conditions

prescription



injection solution

Possible product names

ELONVA RVRED FOR P 100 mcg 0, 5 ML N1 SYRINGE



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