Instructions for the use of Puregon. Stimulation of ovulation with puregon with ovarian dysfunction How to give a puregon injection correctly

Puregon is a follicle-stimulating drug used to treat female infertility.

Release form and composition

Dosage forms of the drug Puregon:

• Solution for intramuscular and subcutaneous administration: colorless, transparent (0.5 ml in glass colorless vials, in a cardboard box of 1, 5 or 10 vials);
• Solution for subcutaneous administration: colorless, transparent (0.36, 0.72 or 1.08 ml each (300/600/900 IU (international units)) in glass colorless cartridges, in a cardboard box 1 cartridge complete with needles: 300 / 600 IU - 6 pcs., 900 IU - 9 pcs.).

Composition of 0.5 ml solution for injection (1 bottle):

• Active ingredient: recombinant follitropin beta - 100, 150 or 200 IU (international units);
• Additional components: methionine - 0.25 mg; polysorbate 20 - 0.1 mg; sucrose - 25 mg; sodium citrate dihydrate - 7.35 mg; hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - to pH 7; water for injection - up to 0.5 ml.

Composition of 0.36 / 0.72 / 1.08 ml solution for subcutaneous administration (1 cartridge):

• Active ingredient: recombinant follitropin beta - 300, 600 or 900 IU;
• Additional components: benzyl alcohol - 4.2 / 7.8 / mg; sodium citrate dihydrate - 6.17 / 11.5 / 17.2 mg; polysorbate 20 - 0.105 / 0.177 mg; sucrose - 21/39 / 58.5 mg; methionine - 0.21 / 0.39 / 0.59 mg; hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - to pH 7; water for injection - up to 0.42 / 0.78 / 1.17 ml.

Indications for use

The drug Puregon is prescribed for the treatment of female infertility in the presence of the following indications:

• Anovulation, including polycystic ovary syndrome (PCOS) with insensitivity to the action of clomiphene;
• Induction of superovulation, for the induction of multiple follicular development during artificial insemination (for example, in IUI (intrauterine insemination), IVF / PE (in vitro fertilization / embryo transfer) and ICSI (sperm injection into the cytoplasm)).

Contraindications

• Primary ovarian failure;
• Severe functional disorders of the kidneys / liver;
• Genital disorders associated with anatomical features that are incompatible with pregnancy;
• Tumors of the pituitary gland, hypothalamus, breast, uterus, ovaries;
• Uterine fibroids incompatible with pregnancy;
• Bleeding (uterine / vaginal) of unknown etiology;
• Ovarian enlargement / cysts that are not associated with polycystic ovary syndrome;
• Decompensated diseases of the endocrine system (for example, disorders of the thyroid gland, adrenal glands or pituitary gland);
• Pregnancy and lactation period;
• Hypersensitivity to the components that make up Puregon.

Method of administration and dosage

Puregon should be prescribed by a specialist experienced in fertility treatment.

The dose of the drug is selected individually, it is determined by the response of the ovaries. The therapy is carried out under the control of ultrasound and the concentration of estradiol.

Compared with urine-derived follicle-stimulating hormone (FSH), Puregon is effective at a lower total dose and a shorter course of therapy, which reduces the risk of ovarian hyperstimulation.

The success of therapy is most likely during the first 4 courses. With further use of the drug, it gradually decreases.

In anovulation, the application of the sequential scheme is shown. Therapy starts with 50 IU Puregon (daily for at least 7 days). If there is no ovarian response, the dose is gradually increased until an optimal pharmacodynamic response is achieved (follicular growth and / or a significant (40-100% daily) increase in plasma estradiol concentration).

A daily dose in the future (usually for 1-2 weeks) is administered until the state of preovulation is reached. It is determined by the presence of one of two factors:

• Dominant follicle with a diameter of at least 0.18 cm (according to ultrasound);
• Plasma concentration of extradiol 1000-3000 pmol / l (300-900 pg / ml).

After reaching the desired state, Puregon is canceled and ovulation is induced with chorionic gonadotropin (CG). In cases where the concentration of estradiol increases too quickly (more than 2 times daily for several consecutive days) or when there are too many follicles, the daily dose is reduced. Each follicle from 0.14 cm in diameter is preovulatory. The likelihood of developing multiple pregnancies increases with the presence of several of these follicles. In this case, gonadotropin is not administered. Also, in order to prevent multiple pregnancies, it is necessary to take measures to prevent conception.

During artificial insemination in order to induce superovulation, various stimulation schemes can be used. For at least 4 first days Puregon is administered at 150-225 ME. Further dose adjustment is determined by the response of the ovaries. In most cases, it is sufficient for this to be applied for 6-12 days with maintenance doses of 75-375 IU. In some cases, it is required to extend the course.

It is possible to use Puregon as monotherapy or in combination with other drugs (antagonist or agonist of gonadoliberin (GnRH)) to prevent a premature peak of ovulation. When using GnRH analogues, Puregon can be prescribed in higher total doses.

The ovarian response is monitored by ultrasound and the determination of the plasma concentration of estradiol. In the presence of at least 3 follicles with a diameter of 0.16-0.20 cm, and a good response of the ovaries to therapy (with an estradiol concentration in blood plasma of 1000-1300 pmol / l (300-400 picograms / ml) for each follicle with a diameter more than 0.18 cm), the final phase of follicle maturation is induced by chorionic gonadotropin. Egg aspiration is performed after 34-35 hours.

To prevent painful sensations when the solution is injected and to reduce its leakage from the injection site, Puregon must be injected slowly intramuscularly or subcutaneously. Due to the existing likelihood of fatty atrophy, the sites for subcutaneous injection must be alternated. Unused solution must be destroyed.

After receiving detailed instructions from the doctor, Puregon can be injected subcutaneously on its own.

The drug in cartridges is intended for subcutaneous administration, for which the Puregon Pen injector is used, the solution in vials is injected with a syringe.

For subcutaneous administration of the drug, the most suitable place is the abdominal area around the navel. It is possible to inject the solution into other parts of the body. The injection site should be changed with each injection. First, you need to make sure that the needle does not pierce the vein or artery.

The even distribution of the solution, as well as the reduction of the risk of unpleasant sensations, is facilitated by careful massage (with constant pressure) of the injection site of Puregon.

Side effects

Possible local reactions when using Puregon: edema, hematoma, hyperemia, pain, itching (developed in 3% of women). Typically, these side effects are mild and short-lived.

In 1% of cases, systemic allergic reactions occurred (in the form of urticaria, erythema, itching, rash).

Also, with the use of Puregon, the development of such conditions / diseases was noted:

• Increased likelihood of developing an ectopic and multiple pregnancy;
• Engorgement / tenderness of the mammary glands;
• Spontaneous abortion;
• Ovarian hyperstimulation syndrome (about 4% of cases). The main clinical symptoms of this disorder in a moderate course include nausea, diarrhea, pain and bloating (associated with irritation of the peritoneum and impaired venous circulation), enlargement of the ovaries due to cysts. In some cases, there is the development of a life-threatening severe ovarian hyperstimulation syndrome (characterized by hydrothorax, ascites, the presence of large ovarian cysts prone to rupture, weight gain). In rare cases, the development of thromboembolism (arterial / venous) was noted against the background of ovarian hyperstimulation syndrome.

In rare cases, during combined therapy with hCG or other gonadotropic hormones, thromboembolism may develop.

special instructions

Before the appointment of Puregon, the presence of endocrine diseases should be excluded.

Before starting to use the drug, women need to be warned about the possibility of developing multiple pregnancies. The likelihood of its development increases with the induction of ovulation with the help of gonadotropic drugs. By adjusting the dose of FSH, the development of multiple follicles can be prevented. Multiple pregnancies are characterized by a higher risk of complications, both during pregnancy and in the perinatal period.

The risk of early termination of pregnancy, as well as the incidence of congenital malformations during artificial insemination, is higher in comparison with natural conception.

For the first time, Puregon's solution must be administered under the direct supervision of a specialist.

When performing artificial insemination (especially IVF), in many cases there are abnormalities of the fallopian tubes, which leads to an increase in the likelihood of an ectopic pregnancy. In these cases, it is important to obtain early ultrasound confirmation of the intrauterine position of the fetus.

Before the appointment of Puregon and regularly during treatment, ultrasound should be performed (to monitor follicular development) and the plasma concentration of estradiol should be determined. Transient abnormalities in the results of functional liver tests may indicate abnormal liver function (may be accompanied by morphological changes on liver biopsy (there is evidence of a relationship between this disorder and ovarian hyperstimulation syndrome)).

Puregon may contain traces of streptomycin and / or neomycin, which may cause a hypersensitivity reaction.

The risk of developing venous or arterial thromboembolism is higher in women who belong to generally recognized risk groups for thrombosis (corresponding personal or family history, diagnosed thrombophilia, severe obesity with a body mass index> 30 kg / m 2). The likelihood of developing this disorder does not depend on ovarian hyperstimulation syndrome. Before prescribing therapy, such patients are advised to compare the likelihood of successful induction of ovulation with the possible risk of complications. You also need to take into account that pregnancy itself is accompanied by an increased risk of thrombosis.

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One bottle of Puregon contains 50 or 100 IU of the active ingredient follitropin beta .

One bottle Puregon 150 contains 150 IU follitropin beta .

One bottle Puregon 300 IU contains respectively 300 IU follitropin beta .

One bottle Puregon 600 IU contains respectively 600 IU follitropin beta .

One bottle of the drug Puregon 900 contains 900 IU follitropin beta .

As additional components, the composition of the drug contains: sodium citrate dihydrate, sucrose, polysorbate 20, L-methionine, benzyl alcohol, hydrochloric acid 0.1 N or sodium hydroxide 0.1 N, water.

Release form

The product is produced in the form of a transparent solution without color, contained in glass bottles with rubber stoppers, rolled in aluminum. The drug of 50 or 100 IU is contained in cartons of 1, 5 or 10 pcs.

The medicine is 150, 300, 600 or 900 IU - in cartridges, one cartridge is put into a cardboard box. Also included is a needle.

pharmachologic effect

The active ingredient in Puregon has a follicle-stimulating effect on the body. Under the influence of the agent, the lack of FSH is replenished, the process of normal growth and maturation of follicles is regulated, as well as the synthesis of sex steroid hormones in the body.

Follitropin beta Is a recombinant follicle-stimulating hormone that is genetically engineered.

In the female body, the content of follicle-stimulating hormone determines the process of the onset and duration of maturation of follicles in the ovaries. Also, this hormone regulates the number of follicles and the period of maturation.

The use of Puregon is advisable for the induction of development follicles and steroid hormones in patients diagnosed with ovarian dysfunction. Also, the drug provides stimulation of the development and growth of follicles in those women who plan to undergo artificial insemination, in particular, IVF, embryo transfer, transfer of gametes into the fallopian tubes or intracytoplasmic sperm injection.

After the course of Puregon therapy has been carried out, it is recommended that the patient be administered for the induction of the last stage of the follicle maturation process.

The use of Puregon by men is also practiced for the purpose of treating follicle-stimulating hormone deficiency, leading to a decrease in spermatogenesis. In this case, the drug is used in combination with human chorionic gonadotropic hormone, and therapy should last at least 4 months.

Pharmacokinetics and pharmacodynamics

If Puregon is administered subcutaneously, the highest plasma concentration of the active substance is observed after 12 hours. Since the process of absorption of the active ingredient is slow, and its half-life is 12-70 hours, there is a high level of follicle-stimulating hormone in the body for 24-48 hours after the injection was carried out. If a repeated administration of the same dose of the drug was made, a further increase in follicle-stimulating hormone is noted: its level increases by 1.5-2 times when compared with the first administration. Therapeutic plasma doses of follicle-stimulating hormone are observed after repeated administration. The bioavailability level is 77%.

There are practically no differences in the pharmacokinetic profile when the solution is administered intramuscularly and subcutaneously. The biochemical similarity of the follicle-stimulating hormone in the composition of Puregon with the hormone obtained from human urine is noted, it has a similar metabolic profile, is similarly distributed and excreted from the body.

Indications for use

The drug Puregon is prescribed to women in the following cases:

• with female due to anovulation (including when polycystic ovary syndrome whose treatment clomiphene citrate ineffective);
• for the purpose of holding assisted reproduction programs , including IVF, embryo transfer, sperm injection (to induce superovulation).

The agent is also prescribed for the treatment of men who have a lack of spermatogenesis associated with hypogonadotropic hypogonadism .

Contraindications

You can not use Puregon for the treatment of those patients who have noted intolerance to the components of this drug, as well as neomycin or streptomycin (the presence of these components in the solution is possible).

The drug is not used to treat people diagnosed with hormone-dependent tumors ( breast tumors , ovaries or testicles , , uterus , ).

Does not apply to the treatment of patients diagnosed with primary gonadal insufficiency .

You can not prescribe Puregon to women with disorders of the anatomy of the genital organs, as well as with vaginal bleeding of unexplained origin.

It is not prescribed for patients with uterine fibroids, which are incompatible with pregnancy.

You can not prescribe a remedy for the treatment of women suffering ovarian cyst , as well as patients with enlarged ovaries, not associated with polycystic ovary .

Before you start using Puregon, you need to exclude diseases of the endocrine system that are not associated with dysfunctions of the gonads.

Medication is carefully prescribed to women who have had abdominal surgery. In patients with and ovarian cysts, when treated with Puregon, the likelihood of ovarian torsion increases due to hyperstimulation. Therefore, in this case, constant monitoring of the anatomical position of the ovary is needed.

Carefully prescribe medication to women who are at increased risk of developing thrombosis as they are more likely to develop thromboembolism .

Side effects

During treatment with Puregon, some patients may develop a number of local reactions in the place where the solution was injected. It can be hyperemia, pain, swelling, rash.

Systemic allergic manifestations were rarely recorded during treatment.

The use of follitropin beta in women can provoke the manifestation of ovarian hyperstimulation with pain and congestion in the pelvic region, headache, , pain in the abdominal and epigastric region. Also, with this phenomenon in a woman, the size of the ovaries may increase, and chest pain may be felt. Possible metrorrhagia, development of ovarian torsion, , bleeding from the vagina.

There were isolated cases of pronounced ovarian hyperstimulation syndrome - a life-threatening condition. In this condition, a woman can form large cysts, which leads to the risk of rupture, ascites , weight gain due to fluid retention in the body. If such a side effect occurs, you should immediately suspend the treatment and consult a specialist.

There is also data on the development during the period of use of the drug ectopic pregnancy , multiple pregnancy , .

When combined treatment with hCG and Puregon is used, there is a possibility of developing thromboembolism .

If the medicine is used by men, they may experience headaches as side effects. Development is also possible acne , epididymal cyst , gynecomastia , allergic manifestations.

Puregon, application instruction (Way and dosage)

Puregon is administered parenterally - intramuscularly or subcutaneously.

It is impossible to inject the solution into the cavity of the vessels, therefore, before introducing the agent, it is necessary to exclude the possibility of its entering the vessel. Treatment with the agent is carried out under the supervision of a physician who has experience in the treatment of violations of the human reproduction function. It is important to monitor the patient's condition when the solution is first administered.

The solution can be injected using a disposable syringe or a special injector pen. If a syringe is used for injection, it is important to consider that in this case, the patient is injected with 18% less follicle-stimulating hormone compared to using a cartridge using a pen. Puregon Pen... To make such an introduction correctly, the video instruction on Puregon Pen.

It is recommended to inject the solution subcutaneously slowly to avoid pain and leakage of the solution. With repeated injections, it is important to change the injection site in order to prevent adipose tissue atrophy. The patient can inject the agent on his own, but only after the medical professional has instructed him. Before the introduction of the drug, it is necessary to check whether there are foreign particles in it and whether the transparency is not impaired - in such cases, the drug cannot be administered.

After the bottle has been opened, the solution cannot be stored. It is recommended to inject Puregon into the abdomen - in the navel area to achieve the greatest effect. Before injecting the agent, it is important to wash your hands and treat with a disinfectant solution in the area where the agent will be injected.

To inject the agent, you need to pull back the skin, form a fold and insert the needle into it perpendicular to the skin. In this case, you need to make sure that the needle did not hit the vessel. After the drug has been injected, it is necessary to lightly massage the skin at the injection site.

The dosage of the drug and the duration of its administration is determined by a specialist, taking into account the reaction of the ovaries in women. In the process of therapy, it is imperative to carry out an ultrasound of the ovaries and determine the content in plasma. Clinical experience shows that the effect can be achieved after three or more courses of drug use.

As evidenced by the experience of using Puregon in women before artificial insemination, it is most likely to be successful during the first four courses. Further, the efficiency decreases.

For women diagnosed with anovulation , it is recommended to practice a sequential drug regimen. In the first week of treatment, 50 IU of Puregon should be administered per day. If there is no ovarian response, the daily dose should be gradually increased until the estradiol level or follicular growth is sufficient. The optimal picture of treatment is an increase in the concentration of estradiol in plasma by 40-100%. The dose of the drug, which was selected by this method, is maintained until preovulation ... This condition is usually achieved after 1-2 weeks of Puregon administration. Further, the administration of Puregon solution should be stopped and the introduction of hCG should be started in order to induce ovulation. The dose of Puregon is reduced if a large number of follicles respond to therapy, or if the level of estradiol is increased by more than 2 times for two to three days in a row. If more than one follicle develops that is more than 14 mm in size, there is a chance of developing multiple pregnancy ... HCG should not be given if multiple follicles develop. In this case, measures should be taken to prevent the development of multiple pregnancies.

At induction of hyperovulation different treatment regimens are used. First, for at least 4 days, the agent is administered at a dose of 100-225 IU. Further, the doctor sets an individual dosage, taking into account the response of the ovaries to treatment. As a rule, it is sufficient to administer a maintenance dose of 75–375 IU for 6–12 days. Longer treatments are sometimes practiced.

Puregon is used both as a drug for monotherapy and in combination with an agonist or antagonist of gonadotropin-releasing hormone to prevent premature formation of the corpus luteum. Sometimes this combination requires the use of higher doses of Puregon.

An ultrasound scan should be performed to monitor ovarian response and determine the plasma estradiol concentration. If the presence of at least three follicles with a diameter of 16–20 mm is noted, and there is also evidence of a good response of the ovaries, hCG is injected to indicate the final phase of follicle maturation. Oocytes are aspirated after 34–35 hours.

For the treatment of men the agent is used at a dose of 450 IU per week, it must be administered in three doses of 150 IU each. Puregon is combined with hCG. As a rule, improvement of spermatogenesis occurs not earlier than after 3-4 months. It is necessary to conduct a semen analysis 4-6 months after starting treatment and determine how effective the therapy is. If there is no positive effect, treatment is continued. It may take about 18 months to restore spermatogenesis.

Overdose

There is no information on acute manifestations of follitropin beta overdose. If large doses of the drug are injected, the likelihood of ovarian hyperstimulation increases. In this case, you must immediately stop treatment. If necessary, symptomatic therapy is practiced.

Interaction

With a combination of Puregon and clomiphene citrate ovulation induction may increase.

When receiving GnRH agonists an increase in the dose of follitropin beta may be necessary.

Terms of sale

Puregon can be purchased with a specialist prescription.

Storage conditions

It is necessary to store the solution in a dark place, the storage temperature is 2–8 ° C. Store Puregon only in its original packaging. It is impossible to freeze the medicine; it should be protected from the access of children.

After opening the bottle, the solution cannot be saved. Once the needle has been inserted into the cartridge, the solution can be used for 28 days.

Shelf life

The shelf life of the solution is 3 years.

special instructions

Before starting treatment, you must completely exclude endocrine diseases .

Before starting therapy, the patient should be warned about the possibility of multiple pregnancy. Adjusting the dosage of follitropin beta prevents the development of multiple follicles.

Puregon should be administered for the first time only under the supervision of a specialist. Before driving the solution on your own, you need to consult a doctor and watch a video on how to inject Puregon

Those women who undergo artificial insemination should take into account that they often have abnormalities of the fallopian tubes, which increases the risk of developing an ectopic pregnancy. Therefore, it is necessary to confirm by ultrasound that the fetus is intrauterine. It should also be borne in mind that with artificial insemination, the risk of early termination of pregnancy is higher than in the case of natural conception.

, HuMoG lyophilisate and etc.

Which is better: Gonal or Puregon?

Active ingredient of the drug Gonal - follitropin alpha. This remedy also has a follicle-stimulating effect. There are a number of positive reviews from women who have been treated with this fertility drug. But only a doctor should decide on the choice of medicine.

For children

Puregon is not prescribed for children.

During pregnancy and lactation

During pregnancy, women are prohibited from taking this remedy. There is no information on the penetration of follitropin beta into breast milk, but it is assumed that Puregon may affect lactation. Therefore, it can be used during this period only under the supervision of a doctor.

In modern approaches to the treatment of infertility, Puregon occupies a special place.

This is a new generation drug produced using the most advanced technologies.

The task of the drug is to stimulate the growth of follicles, increase the number of eggs and increase a woman's chance of a long-awaited pregnancy.

pharmachologic effect

Puregon is a drug, the main active ingredient of which is a female follicle-stimulating hormone, obtained by a recombinant (genetically engineered) way. The drug was developed by specialists from the Dutch pharmaceutical corporation "ORGANON", and since 1997 it has been on the market.

The drug is intended to stimulate the production of 2 follicles by the ovaries during ovulation in patients.

The drug is included in the protocol for artificial insemination, intrauterine insemination, and is also prescribed in complex therapy for infertility for patients with diagnoses: hypogonadotropic gonadism, polycystic ovarian syndrome, anovulation.

The pharmacological action of the drug is due to the active active ingredient, which not only promotes the growth and maturation of follicles, but also serves as a stimulator of the synthesis of sex hormones.

Ovulation stimulation scheme

At the next stage, when follicles mature under the action of Puregon injections, chorionic gonadotropic hormone is prescribed, which stimulates the ovulatory process and removes eggs from the ovary.

At this stage, further actions can develop in two directions:

1. Oocyte collection is performed (for assisted reproductive techniques).
2. Active sexual contacts are shown (for the onset of natural conception).

Puregon belongs to the pharmaceutical group of drugs of gonadotropins and other ovulation stimulants.

Useful video:

After injection of Puregon, the maximum plasma concentration is observed for 12 hours, and remains elevated for two days. After the repeated administration of Puregon, the level of follicle-stimulating hormone rises 2.5 times. Thus, with injections, the required therapeutic concentration of the drug in the blood is achieved.

Composition and form of release

According to its physicochemical properties, the drug is a clear, colorless liquid in glass transparent cartridges and vials.

The main active ingredient of the drug for injection is follitropin beta.

Vials with Puregon are produced by the manufacturer with several types of dosages in IU with a concentration of 833 IU / ml:

• Vials with the drug 50,100.
• Drug cartridge 150 (0.18 ml), 300 (0.36 ml), 600 (0.72 ml), 900 (1.08 ml).

Photo of the drug in different dosages:

As auxiliary components, the injection solution is supplemented with polysorbitol, sucrose, methionine, hydrochloric acid, distilled water.

Puregon cartridges are packed in plastic boxes with instructions, a special set of needles for insertion in a plastic container.

Indications for use

The course of Puregon injections is prescribed for female infertility against the background of hypothalamic and pituitary disorders, with anovulation.

The drug is included in the protocol of infertility therapy for superovulation as an adjunct to reproductive technologies:

• IVF (in vitro fertilization);
• IVF / PE (in vitro fertilization with embryonic transfer);
• IUI transfer of gametes into the cavity of the fallopian tubes for a positive IVF result;
• ICSI (intracytoplasmic sperm injection).

Photo gallery of indications for use:

ECO / PE

Injection Puregon is included in the complex therapy for male sperm-forming insufficiency, which developed against the background of hypogonadotropic hypogonadism.

Related Videos:

Contraindications

Injections of the drug are contraindicated in patients with hypersensitivity to individual components, benign neoplasms in the ovaries, mammary glands, uterus, pituitary gland.

Puregon is not prescribed for patients with endocrine pathologies in the decompensated stage and with severe renal and liver dysfunctions.

Injections of the drug are not used if ovarian failure is primary and with malformations of the genital organs, which are considered incompatible with the process of conception.

Side effects

In 1%, a generalized reaction is observed: erythema, itchy rash

Patients with a tendency to allergic manifestations and individual hypersensitivity to the drug may develop local reactions in the injection zone: hyperemia, edema, hematoma.

According to statistics, this is observed in 3% of women, and these reactions to the drug are quite moderate and fast-passing.

Common manifestations:

• In 4% of patients from the drug administration, the development of ovarian hyperstimulation syndrome with nausea, diarrhea, bloating, engorgement and tenderness in the mammary glands is observed.
• In isolated cases, after injections, there is a possibility of spontaneous miscarriage, ectopic, multiple pregnancy.

Drug interactions

The therapeutic efficacy of Puregon can be reduced by parenteral and enteral administration of Dipherelin, Zoladex, Buserelin, Lyukrin-Depo. In this case, the dosage of the drug is increased.

Photos of drugs:

Together with Clomiphene, it enhances the ovarian response.

Puregon is pharmaceutically incompatible with other medicinal products.

Alcohol compatibility

Puregon is incompatible with alcohol and alcohol-containing drugs.

Dosage and overdose

The drug is dosed according to specially designed injection schemes individually for each patient.

With anovulation, the drug is administered daily for 7 days at a dosage of 50 IU. If the ovaries do not respond, the dose is increased by another 50 IU. A gradual increase in the dosage of the drug takes place until the beginning of follicular growth, which is monitored by ultrasound, laboratory tests.

With a positive response of the ovaries to Puregon injections, the concentration in the blood plasma increases daily by 40-100%

In order to achieve a state of preovulation, Puregon injections are given for two weeks, starting on the third day of the menstrual cycle. The introduction of the drug takes place under the regular control of ultrasound and blood tests.

If the amount of estradiol in the analysis doubles every three days and there are a lot of follicles formed, the dosage of the drug is reduced

In the treatment of male infertility, the initial dose of the drug is 450 IU, divided into three injections and administered over one week.

There are no data on cases of Puregon overdose in the literature.

An overestimated dosage of the drug can provoke ovarian hyperstimulation.

Instructions for use

Treatment with the drug takes place as prescribed by a specialist, and the first injection takes place immediately after instruction and under his supervision.

The injection of the drug is carried out with a special pen injector or a special, small-volume syringe with a thin needle intramuscularly or subcutaneously.

In order for the course of injections to take place with minimal pain, the drug must be injected very slowly, with alternating injection sites.

How to inject medicine:

1. Wash your hands thoroughly and treat them with a disinfectant.
2. Prepare syringe and injection needles.
3. Remove the plastic cap from the bottle, insert the needle into the rubber stopper, dial the required dose.
4. Change the needle, carefully holding the syringe upright, release the air bubbles.
5. The optimal and convenient site for drug injection is the fold of the abdomen on the sides near the navel. With each new injection, the injection point must be different.
6. Pull the area treated with alcohol or a special agent slightly and form a fold with the fingers of the hand free from the syringe. Insert the needle at a right angle.
7. Inject the drug while advancing the plunger. Actions should be fluid and slow.
8. Withdraw the syringe with a needle, holding the injection site with a sterile cotton swab. Massage lightly in a circular motion.
9. The solution remaining in the vial, the syringe with needles are not used in the future.

Shelf life and storage of the drug

The drug belongs to the list B. Puregon in vials is stored in a cool room without access to light for 36 months. Freezing is not allowed.

The solution cartridge should be stored for no more than 28 days after opening.

special instructions

With stimulation for the entire period of injections, it is necessary to monitor the hormonal parameters of the blood and ultrasound examination for the development of follicles on a daily basis.

If the specialist suspects ovarian hyperstimulation, the drug injections are canceled.

The price of the drug in pharmacies

The cost of the drug in each of the dosage forms in the pharmacy chains in Russia:

Conditions of dispensing from pharmacies

Puregon can be pre-ordered or purchased at any pharmacy.

The solution for intramuscular and subcutaneous administration is transparent, colorless. - 1 fl .:

• Active substances: follitropin beta (recombinant) * - 600 IU;
• Excipients: sucrose - 39 mg, sodium citrate dihydrate - 11.5 mg, polysorbate 20 - 0.177 mg, benzyl alcohol - 7.8 mg, methionine - 0.39 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - up to pH 7, water d / i - up to 0.78 ml.

* - specific biological activity in vivo is equal to approximately 10,000 IU FSH / ml of protein.

0.72 ml - 1.5 ml colorless glass cartridges (1) complete with needles (6 pcs.) - plastic packaging (1) - cardboard packs.

pharmachologic effect

Replenishes FSH deficiency. Regulates the normal growth and maturation of follicles, the synthesis of sex steroid hormones.

Indications for use Puregon

Female infertility with anovulation (including polycystic ovary syndrome refractory to clomiphene citrate); assisted reproduction programs, incl. in vitro fertilization (for the induction of superovulation).

Contraindications to Puregon use

Hypersensitivity, tumors of the ovaries, breast, uterus, pituitary gland or hypothalamus, primary ovarian failure, ovarian cysts or ovarian enlargement not associated with polycystic ovary syndrome, genital anatomy or uterine fibroids incompatible with pregnancy.

Puregon Use during pregnancy and children

Contraindicated in pregnancy. Lactating women should stop breastfeeding.

Puregon Side effects

Ovarian hyperstimulation (abdominal pain, nausea, diarrhea, enlargement of the ovaries and their cysts, rarely - rupture of ovarian cysts, ascites, hydrothorax, weight gain); at the injection site - swelling, pain, redness, itching. After the induction of ovulation, the risk of developing multiple pregnancies increases, and with in vitro fertilization, an ectopic pregnancy.

Puregon dosage

V / m, s / c (slowly). Anovulation - start with daily administration of 50-75 IU for 7 days, in the absence of a response from the ovaries, the dose is gradually increased (optimally, a daily increase in the concentration of estradiol in plasma by 40-100%); when the dominant follicle reaches a diameter of 18 mm or the estradiol level reaches 300-900 pg / ml, Puregon is canceled and human chorionic gonadotropin is administered. Induction of ovarian superovulation during in vitro fertilization in the first 4 days - 100-200 IU, then the dose is selected individually, based on the reaction of the ovaries; usually 75-375 IU per day is sufficient for 1-2 weeks; in the presence of 3 follicles with a diameter of 16-20 mm and a plasma estradiol concentration of 300-400 pg / ml / follicle, the final phase of follicle maturation is stimulated with human chorionic gonadotropin; oocytes are aspirated after 34-35 hours.

Precautionary measures

It is recommended to constantly change the injection site. If symptoms of ovarian hyperstimulation appear (excluding preparation for in vitro fertilization), therapy should be discontinued. Before starting treatment, it is necessary to exclude diseases of the thyroid gland, adrenal glands and pituitary gland.

Pharmacodynamics... Follitropin beta is a recombinant FSH produced by genetic engineering in a Chinese hamster ovary cell culture. The amino acid sequence of the recombinant DNA is identical to that of natural human FSH. This hormone is indispensable for the normal growth and maturation of follicles, as well as for the synthesis of steroid sex hormones. The level of FSH in the body of women determines the onset and duration of development of ovarian follicles and, accordingly, the number of maturing follicles and the time of their maturation. Thus, Puregon can be used to stimulate follicular development during artificial insemination, for example, during in vitro fertilization and embryo transfer into the uterine cavity (IVF / PE), during the transfer of gametes (sperm) into the fallopian tubes (GIFT) or intracytoplasmic sperm injection (ICSI) ... After Puregon treatment, human chorionic gonadotropin (hCG) is usually administered to stimulate the last phase of follicular maturation, continuation of meiosis, and follicular rupture.
In clinical studies, it has been established that when Puregon is used, the preovulatory stage of follicular development is achieved with a shorter course of treatment and a lower total dose of the hormone compared to FSH therapy obtained from the urine of women. Therefore, Puregon treatment can optimize the process of follicular development and reduce the risk of unwanted ovarian hyperstimulation. With FSH deficiency in men, Puregon is used together with hCG for at least 4 months to increase spermatogenesis.
Pharmacokinetics. After intramuscular or subcutaneous administration of Puregon, the maximum concentration of FSH in the blood plasma is reached within 12 hours. Pharmacokinetic parameters for intramuscular and subcutaneous administration of the drug are practically the same, bioavailability in both cases is approximately 77%. Due to the gradual absorption of Puregon from the injection site and a long half-life of 12-70 hours (on average 40 hours), the FSH level remains elevated for 24-48 hours, and therefore repeated administration of the same dose of FSH leads to a further increase in the FSH concentration in 1.5-2 times compared to the first injection. In case of FSH deficiency in men, Puregon is used in conjunction with hCG for at least 4 months to increase spermatogenesis.
Recombinant FSH is biochemically similar to FSH obtained from human urine, therefore it is characterized by a similar distribution, metabolism and excretion profile.

Indications for the use of Puregon

women- infertility due to anovulation (including polycystic ovary syndrome), when clomiphene citrate therapy is ineffective; controlled ovarian hyperstimulation in assisted reproductive technologies (ART) programs (for example, IVF / PE, GIFT, ICSI);
men- failure of spermatogenesis due to hypogonadotropic hypogonadism.

Application of the drug Puregon

The drug must be taken under the supervision of a physician experienced in infertility treatment.
When using a syringe, it should be borne in mind that 18% less FSH is injected than when using a pen-injector. This must be taken into account when switching from a syringe to an injector pen and, conversely, in one treatment cycle. Dose adjustments are especially necessary when changing from a syringe to a pen to avoid overdose.
Dosage for women. Due to the high variability of the ovarian response to the introduction of exogenous gonadotropins, the dose of the drug is set individually. For this, changes in the ovaries are assessed during therapy with chorionic gonadotropin (Pregnil) using ultrasound and determining the level of estradiol in the blood plasma. To achieve a therapeutic effect, a maximum of 3 courses of treatment are required. In general, the experience of using technologies for artificial insemination indicates that the degree of probability of successful treatment remains constant during the first 4 courses of therapy and then gradually decreases.
Anovulation: a consistent treatment regimen is recommended. Usually start with a daily dose of 50 IU Puregon for 7 days. In the absence of an ovarian response to treatment, the daily dose is gradually increased (a daily increase in plasma estradiol concentration of 40-100% is considered optimal) until follicular growth or estradol level is achieved, indicating a sufficient response from the ovaries. The dose established in this way is maintained until the state of preovulation is reached, as evidenced by the presence of a dominant follicle with a diameter of 18 mm (according to ultrasound) and / or the concentration of estradiol in the blood plasma of the order of 30,000 pg / ml (1000-3000 pmol / l). Usually this condition is achieved within 7-14 days after starting treatment. After that, Puregon is canceled and ovulation is induced by the administration of hCG. If the number of follicles that reacted to the treatment is too large or the concentration of estradiol rises very quickly (that is, for 2-3 consecutive days more than 2 times during the day), then the daily dose should be reduced. Since follicles with a diameter of more than 14 mm are capable of fertilization, then in the presence of several such follicles, there is a high probability of multiple pregnancy.
Controlled ovarian hyperstimulation in ART programs: use different stimulation schemes. For at least the first 4 days, the drug is recommended to be administered in a dose of 100-225 IU. After that, the dose can be set individually, based on the reaction of the ovaries. Clinical studies have found that a maintenance dose of 75-375 IU for 6-12 days is usually sufficient, but in some cases longer treatment may be required. Puregon can be used alone or in combination with a gonadotropin-releasing hormone (GnRH) agonist or antagonist to prevent premature corpus luteum formation. When using a GnRH agonist, it may be necessary to administer Puregon at higher doses to achieve the necessary follicular growth. The ovarian response is monitored by ultrasound and the determination of the concentration of estradiol in the blood plasma. In the presence of at least 3 follicles with a diameter of 16-20 mm (according to ultrasound) and a good reaction of the ovaries (each follicle with a diameter of 18 mm determines the concentration of estradiol in the blood plasma of the order of 300-400 pg / ml (1000-1300 pmol / l)), the final the phase of follicle maturation with the help of hCG administration. Oocytes are aspirated after 34-35 hours.
Dosing for men. Puregon should be used at a dose of 450 IU / week, divided into 3 doses of 150 IU each. Treatment must be carried out in combination with hCG. An improvement in spermatogenesis is noted no earlier than 3-4 months after the start of treatment, if there is no effect, the combination therapy can be continued. Clinical experience indicates that the treatment period should be ≥18 months to restore spermatogenesis.
Mode of application. To prevent painful sensations during the injection and to minimize leakage from the injection site, Puregon solution should be injected slowly intramuscularly or subcutaneously.
It is necessary to alternate the sites of subcutaneous injection in order to prevent the development of fatty atrophy. Subcutaneous administration of Puregon may be performed by the patient or family member following appropriate instructions from the physician. Properly trained patients can independently use Puregon, but under the supervision of a specialist.
Instructions for administering the drug
Solution cannot be used if it contains foreign particles or if it is opaque. The contents of the bottle must be used immediately after piercing the rubber stopper with a needle. The rest of the solution after the injection must be poured out.
Step 1 - preparing the syringe
Sterile disposable syringes and needles should be used to administer Puregon. The volume of the syringe should be small so that the required dose can be drawn with greater accuracy. Do not use solution if it contains foreign particles or if it is opaque.
First remove the cap from the bottle. Connect the syringe to the needle and pierce the rubber stopper of the vial with the needle. Draw the solution into a syringe and replace this needle with an injection needle. Hold the syringe with the needle up and tap it gently to raise air bubbles. Then press the plunger until all air bubbles exit the needle and make sure that only Puregon's solution remains in the syringe. If necessary, the plunger can be pushed further to precisely set the injection volume.
Step 2 - injection site
The best place for subcutaneous injection is the part of the abdomen around the navel, where the skin is not taut and there is a layer of fatty tissue. With each next injection, it is necessary to change the injection site. The drug can be administered to other places as well. The doctor or nurse should advise the patient about the best place to inject.
Step 3 - preparing the introduction area
Even a slight irritation of the area of ​​the skin selected for the injection stimulates the nerve endings and reduces discomfort when the needle is inserted. Hands should be washed, and the injection site should be wiped with a disinfectant solution (for example, 0.5% chlorhexidine) to remove surface bacteria. The disinfectant solution should be applied to an area with a diameter of about 5 cm around the site of the future injection and left on the skin to dry for at least 1 minute.
Step 4 - inserting the needle
Pull the skin back a little, forming a fold of skin at the needle insertion site. With the other hand, insert the needle into the fold of the skin at a 90 ° angle.
Step 5 - checking the correct position of the needle
If the needle is inserted correctly, the syringe plunger will be difficult to pull back.
Step 6 - introduction of the solution
During the introduction of the solution, it is necessary to press the piston slowly with the same force.
Step 7 - removing the needle and syringe from the skin
With a quick motion, remove the needle and syringe and press the disinfectant swab to the injection site.
Instructions for administering the drug using an injector pen are in the Puregon Pen package.

Contraindications to the use of Puregon

Hypersensitivity to one of the components of the drug; a tumor of the ovary, breast, uterus, pituitary gland, or hypothalamus; vaginal bleeding of unknown etiology; ovarian cyst or ovarian enlargement (but not polycystic ovary syndrome); developmental anomalies of the genital organs and / or benign tumors (fibroids and fibroids) of the uterus, incompatible with pregnancy; During pregnancy and breastfeeding; primary testicular hypofunction.

Side effects of Puregon

Possible mild and transient local reactions (bruising at the injection site, hyperemia, swelling, soreness, itching); very rarely - generalized allergic reactions (flushing of the skin and skin rash).
They may also note:
Among women: the development of ovarian hyperstimulation syndrome (in 3% of cases), manifested by the following symptoms: lower abdominal pain, nausea, diarrhea, a slight increase in the ovaries, the development of ovarian cysts; in some cases (rarely): the occurrence of large ovarian cysts (prone to rupture), ascites, hydrothorax; weight gain and, in rare cases, thromboembolism. The likelihood of multiple and ectopic pregnancies increases.
In men In the treatment of Puregon in combination with hCG, gynecomastia and / or acne (due to the use of hCG) is sometimes noted.

Special instructions for the use of Puregon

Before starting treatment, the presence of extragenital endocrinopathies (caused, in particular, by tumors of the thyroid gland, adrenal glands, pituitary gland) should be excluded. After the induction of ovulation, the risk of multiple pregnancies increases, which in turn increases the risk of complications during the birth and perinatal period. Therefore, the dose of FSH should be carefully set to prevent the development of multiple follicles.
Women who undergo artificial insemination are often diagnosed with abnormalities of the fallopian tubes, therefore, the risk of developing an ectopic pregnancy is increased. In this regard, it is very important at an early stage of pregnancy to confirm the intrauterine position of the fetus using ultrasound. With artificial insemination, the risk of termination of pregnancy is also higher. The incidence of congenital malformations after ART programs is slightly higher than with natural fertilization, which is due to differences in the characteristics of parents, as well as a slight increase in the risk of multiple pregnancies during ART. However, there is no evidence that the use of gonadotropic hormones is associated with an increased risk of congenital malformations.
Ovarian hyperstimulation syndrome: before starting and regularly during treatment, an ultrasound scan should be performed to monitor the development of follicles and to determine the level of estradiol in the blood plasma. There is a possibility of the development of a large number of follicles, as well as a rapid increase in the concentration of estradiol by more than 2 times during the day for 2-3 days in a row (but not in the case of controlled ovarian hyperstimulation during artificial insemination). In this case, Puregon treatment is immediately canceled, measures are taken to prevent pregnancy and hCG is canceled.
Women with common risk factors for thrombosis (personal or family history, high obesity with a body mass index of 30 kg / m2, thrombophilia, etc.) have an increased risk of developing venous or arterial thromboembolism when treated with gonadotropins, even without developing ovarian hyperstimulation syndrome. Therefore, in these women, the benefits of assisted reproduction, with the associated risks, should be considered. It should also be borne in mind that the actual pregnancy causes an increased risk of thrombosis.
In case of hypersensitivity to streptomycin or neomycin, it should be borne in mind that Puregon may contain residual amounts of these antibiotics.
In men, an elevated level of endogenous FSH indicates primary testicular hypofunction. In these patients, Puregon / hCG treatment is ineffective.
Influence on the ability to drive and work with other mechanisms. Does not affect.

Puregon drug interactions

The simultaneous use of Puregon and clomiphene citrate can increase the stimulation of ovulation. After the use of GnRH agonists, higher doses of Puregon may be required for treatment.

Overdose of Puregon, symptoms and treatment

There are no data on acute Puregon overdose. Administration of too high a dose of FSH can lead to unwanted ovarian hyperstimulation. In this case, Puregon must be temporarily canceled.

Storage conditions of the drug Puregon

In a dark place at a temperature of 2-8 ° C. Do not freeze.

List of pharmacies where you can buy Puregon:

• St. Petersburg