Puregon injections in the stomach. Puregon - instructions for use

Release form

Compound

1 bottle contains: Active substance: Follitropin beta (recombinant) 100 IU (10 mcg). Excipients: sucrose - 25 mg, sodium citrate dihydrate - 7.35 mg, methionine - 0.25 mg, polysorbate 20 - 0.1 mg, hydrochloric acid 0.1 n or sodium hydroxide 0.1 n - up to pH 7, water d/i - up to 0.5 ml.

Pharmacological effect

Recombinant follicle-stimulating hormone (FSH), which is obtained using recombinant DNA technology using a culture of Chinese hamster ovary cells into which the genes for human FSH subunits are introduced. The primary amino acid sequence of the recombinant DNA is identical to that of natural human FSH. However, there are slight differences in the structure of the hydrocarbon chain. FSH ensures normal growth and maturation of follicles and the synthesis of sex steroid hormones. The level of FSH in women is a factor that determines the onset and duration of follicle development, as well as the time of their maturation. Thus, the drug Puregon can be used to stimulate the development of follicles and estrogen synthesis in certain disorders of ovarian function. In addition, Puregon is used to induce multiple follicular development during artificial fertilization (for example, in vitro fertilization/embryo transfer (IVF/ET), intrauterine insemination (IUI) and intracytoplasmic sperm injection (ICSI). After treatment with Puregon, it is usually human chorionic gonadotropin (CG) is administered to induce the final stage of follicle maturation, resumption of meiosis and ovulation.

Pharmacokinetics

After intramuscular or subcutaneous administration of the drug Puregon, Cmax of FSH in the blood plasma is achieved within 12 hours. Due to the gradual release of the drug from the injection site and the long T1/2 (from 12 to 70 hours, on average 40 hours), the FSH content remains elevated within 24-48 hours, and therefore repeated administration of the same dose of FSH leads to a further increase in FSH concentration by 1.5-2 times compared to a single administration. This allows you to achieve a therapeutic concentration of FSH in the blood. Pharmacokinetic parameters after intramuscular and subcutaneous administration of the drug Puregon do not differ significantly. With both routes of administration, the bioavailability of the drug is approximately 77%. Recombinant FSH is biochemically similar to FSH isolated from human urine and is distributed, metabolized, and excreted from the body in a similar manner.

Indications

Treatment of female infertility in the following cases: - anovulation (including polycystic ovarian syndrome (PCOS) in women who are insensitive to treatment with clomiphene); - induction of superovulation, to induce multiple development of follicles during artificial insemination (for example, in IVF/ET methods, IUI and ICSI).

Contraindications

Tumors of the ovaries, breast, uterus, pituitary gland and hypothalamus; - vaginal and uterine bleeding of unknown etiology; - primary ovarian insufficiency; - ovarian cysts or ovarian enlargement not associated with PCOS; - disorder of the anatomy of the genital organs, incompatible with pregnancy; - uterine fibroids , incompatible with pregnancy; - decompensated diseases of the endocrine system (for example, diseases of the thyroid gland, adrenal glands or pituitary gland); - severe dysfunction of the liver and kidneys; - pregnancy; - lactation; - hypersensitivity to any of the components of the drug.

Use during pregnancy and breastfeeding

The use of Puregon during pregnancy and breastfeeding is contraindicated. Due to the fact that there is insufficient clinical data on the use of the drug during pregnancy, in case of unintentional use during pregnancy, the teratogenic effect of recombinant FSH cannot be excluded.

Directions for use and doses

Treatment with Puregon should be started under the supervision of a physician experienced in the treatment of infertility. The dose should be selected individually depending on the response of the ovaries, under ultrasound control and estradiol concentration. Puregon is effective with a lower total dose and less treatment time required for maturation, compared with FSH obtained from urine, which minimizes the risk of developing ovarian hyperstimulation. Cumulative experience in the treatment of infertility by in vitro fertilization indicates that success is most likely during the first 4 courses of therapy and gradually decreases thereafter. For anovulation, a sequential treatment regimen is recommended , starting with daily administration of 50 IU of Puregon for at least 7 days. In the absence of an ovarian response, the daily dose is gradually increased until follicular growth and/or an increase in plasma estradiol concentration is achieved, indicating that an optimal pharmacodynamic response has been achieved. A daily increase in plasma estradiol concentration by 40-100% is considered optimal. The daily dose thus obtained is then maintained until preovulation is achieved. The preovulation state is determined by the presence of a dominant follicle with a diameter of at least 18 mm (according to ultrasound) and/or a plasma extradiol concentration of 300-900 picograms/ml (1000-3000 pmol/l). Typically, to achieve this state 7-14 days of treatment are required. After this, the administration of the drug is stopped and ovulation is induced by administering hCG. If the number of follicles is too large or the estradiol concentration increases too quickly, i.e. more than 2 times per day for 2-3 consecutive days, then the daily dose should be reduced. Since each follicle with a diameter greater than 14 mm is preovulatory, the presence of several follicles with a diameter greater than 14 mm carries the risk of multiple pregnancies. In this case, hCG is not administered and measures are taken to protect against possible pregnancy to prevent multiple pregnancies. To induce superovulation during artificial insemination, various stimulation schemes are used. For at least the first 4 days, it is recommended to administer 150-225 IU of the drug. After this, the dose can be selected individually, based on the reaction of the ovaries. Clinical studies have shown 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 either alone or in combination with a GnRH agonist or antagonist to prevent premature peak ovulation. When using GnRH analogues, higher total doses of Puregon may be required. The ovarian response is monitored by ultrasound and determining the concentration of estradiol in plasma. If there are at least 3 follicles with a diameter of 16-20 mm (according to ultrasound) and there is a good ovarian response (estradiol concentration in blood plasma 300-400 picograms/ml (1000-1300 pmol/l) for each follicle with a diameter of more than 18 mm), induce the final phase of follicle maturation by administering hCG. After 34-35 hours, aspiration of the eggs is carried out. Rules for using the drug To prevent pain during injection and to minimize leakage of the drug from the injection site, the solution should be slowly administered intramuscularly and subcutaneously. It is necessary to alternate sites of subcutaneous injection to avoid the development of fatty atrophy. Unused solution should be destroyed. Subcutaneous injections of Puregon can be carried out by the woman herself or her partner, who has received detailed instructions from the doctor. Self-administration of the drug is permissible only for patients who have good skills and the constant opportunity to consult with a specialist. The drug, produced in cartridges, is intended for administration using a Puregon Pen injector pen. In this case, the drug is administered subcutaneously. When using the Puregon Pen injector pen, it must be taken into account that the pen is a precise device that releases the dose set on it. It has been shown that using an injector pen delivers 18% more FSH than using a syringe. This may be significant, in particular, when changing an injector pen to a regular syringe, and vice versa, in the same treatment cycle. Some dose adjustment is especially necessary when moving from a syringe to a pen to avoid an unacceptable increase in the administered dose. The drug, available in vials, is intended for administration using a syringe. Step 1 - Preparation of the syringe To administer the drug, disposable sterile syringes and needles should be used. The volume of the syringe must be small enough to deliver the prescribed dose accurately. If the solution is opaque or contains mechanical inclusions, it cannot be used. The contents of the bottle should be used immediately after piercing the rubber stopper. The solution remaining after a single use is discarded. First, remove the valve from the bottle cap. Place the needle on the syringe and pierce the rubber stopper of the bottle with the needle. Draw the solution into the syringe and replace the needle with an injection needle. Holding the syringe with the needle up, gently tap it on the side to displace air bubbles into the upper part of the syringe, then press on the piston until the air is completely removed, until only the Puregon solution remains in the syringe; If necessary, additional pressure on the piston is used to set the volume of the solution intended for administration. Stage 2 - Place of injection The most suitable place for subcutaneous injection is the abdominal area around the navel with movable skin and a layer of fatty tissue. With each injection, you should change the injection site slightly. You can inject the drug into other areas of the body. Stage 3 - Preparing the injection site To reduce discomfort when inserting the needle, you can make several claps at the site of the intended injection. Hands should be washed and the injection site should be wiped with a disinfectant solution (for example, 0.5% chlorhexidine) to remove surface bacteria. Apply approximately 6 cm around the point where the needle will enter and wait about a minute for the disinfectant solution to dry. Step 4 - Inserting the Needle Pull the skin back slightly. With the other hand, insert the needle at a 90° angle under the surface of the skin. Step 5 - Checking the correct position of the needle If the needle is positioned correctly, the plunger is quite difficult to return. Blood entering the syringe indicates that the needle has pierced a vein or artery. In this case, remove the syringe, cover the injection site with a swab containing disinfectant liquid and apply pressure, and the bleeding will stop in 1-2 minutes. Do not use the solution and remove it from the syringe. Start again from step 1, using a new needle and syringe, and a new bottle of the drug. Step 6 - Injecting the solution Lower the plunger slowly and gradually to properly inject the solution and not damage the skin tissue. Step 7 - Removing the syringe Quickly remove the syringe, cover the injection site swab with disinfectant liquid and press. Gentle massage of this area (with constant pressure) helps distribute the Puregon solution and will help avoid discomfort.

Side effects

Local reactions: hematoma, pain, hyperemia, swelling, itching (observed in 3 out of 100 patients treated with Puregon). Most of these reactions are mild and transient. Systemic allergic reactions: erythema, urticaria, rash and itching (observed in 1 in 1000 patients treated with Puregon). The following may also occur: - ovarian hyperstimulation syndrome (in approximately 4 in 100 women, receiving treatment with the drug). Clinical symptoms of moderate ovarian hyperstimulation are nausea, diarrhea, bloating and abdominal pain due to impaired venous circulation and irritation of the peritoneum, as well as enlargement of the ovaries due to cysts. In rare cases, severe ovarian hyperstimulation syndrome was observed, which threatened the patient's life and was characterized by the presence of large ovarian cysts prone to rupture, ascites, hydrothorax and weight gain due to fluid retention in the body. In rare cases, ovarian hyperstimulation syndrome may be accompanied by the development of venous or arterial thromboembolism. - soreness, pain and/or engorgement of the mammary glands; - spontaneous abortion; - increased likelihood of developing multiple pregnancies; - increased likelihood of ectopic pregnancy. When treated with Puregon in combination with hCG , as well as when used with other gonadotropic hormones, in rare cases, thromboembolism may develop.

Overdose

There are no data on acute overdose of Puregon. The use of FSH in high doses can lead to the development of ovarian hyperstimulation syndrome, the symptoms of which are described above. Treatment: if symptoms of unwanted hyperstimulation (not associated with the induction of superovulation during in vitro fertilization) appear, the administration of Puregon should be discontinued. In this case, measures should be taken to protect against the development of pregnancy and the administration of hCG should be abandoned, which may aggravate adverse events. Treatment should be aimed at eliminating the symptoms of ovarian hyperstimulation syndrome.

Interaction with other drugs

The simultaneous use of Puregon and clomiphene may enhance the ovarian response. After desensitization of the pituitary gland with GnRH agonists, a higher dose of Puregon may be required to achieve a sufficient ovarian response. Pharmaceutically incompatible with other drugs.

special instructions

Before starting treatment, the presence of endocrine diseases (for example, diseases of the thyroid gland, adrenal glands or pituitary gland) should be excluded. Induction of ovulation with gonadotropic drugs increases the risk of developing multiple pregnancies. Appropriate adjustment of the FSH dose prevents the development of multiple follicles. In multiple pregnancies, there is a higher risk of complications during pregnancy and in the perinatal period. Before starting treatment, patients should be warned about the possibility of developing multiple pregnancies. The first administration of the drug Puregon should be carried out under the direct supervision of a physician. Women who undergo artificial insemination (especially IVF) often have abnormalities of the fallopian tubes, and therefore the risk of developing an ectopic pregnancy increases. pregnancy. Therefore, it is important to obtain early ultrasound confirmation of the intrauterine location of the fetus. Women undergoing artificial insemination have a higher risk of early miscarriage than with natural conception. The incidence of congenital malformations with assisted reproductive technology (ART) may be slightly higher than with natural insemination . This may be due to the characteristics of the parents (for example, their age or sperm characteristics), as well as the higher incidence of multiple pregnancies when ART is used. There are no indications that an increase in the risk of congenital malformations is associated with the use of gonadotropins. Before starting treatment and regularly during treatment, ultrasound should be performed to monitor the development of follicles and determine the concentration of estradiol in plasma. In addition to the development of too many follicles, the concentration of estradiol in plasma can increase very quickly (i.e., more than 2 times per day for 2-3 consecutive days), reaching excessively high values. The diagnosis of ovarian hyperstimulation can be confirmed by ultrasound. Transient abnormalities in liver function tests may indicate abnormal liver function, which may be accompanied by morphological changes on liver biopsy, as has been reported in association with ovarian hyperstimulation syndrome. Women at recognized risk for thrombosis, for example, with a relevant personal or family history , severe obesity (body mass index > 30 kg/m2) or diagnosed thrombophilia may be at increased risk of venous or arterial thromboembolism when treated with gonadotropins, even without concomitant ovarian hyperstimulation syndrome. When treating such women, it is necessary to compare the likelihood of successful ovulation induction and the possible risk of complications. However, it should be noted that pregnancy itself is accompanied by an increased risk of thrombosis. Puregon may contain traces of streptomycin and/or neomycin. These antibiotics can cause the development of a hypersensitivity reaction. No effect on the ability to drive vehicles or operate machinery has been detected.

Puregon contains human FSH (follicle stimulating hormone), obtained recombinantly.

The drug is available in the form of a solution for parenteral administration. It is administered subcutaneously or intramuscularly. In appearance, it is a transparent, colorless solution in bottles. There are different dosages:

• 100 IU;
• 150 IU;
• 200 IU.

Follicle stimulating hormone is obtained from Chinese hamster ovary cells. At the same time, genes for human follitropin subunits are introduced into the cells. The resulting FSH is almost identical to the human hormone. There are only slight differences in the structure of the hydrocarbon chain. The amino acid sequence of the peptide part of the hormone is similar.

pharmachologic effect

Puregon has the same effects as natural follicle-stimulating hormone, which is produced in the human body. It is synthesized in the pituitary gland. FSH is responsible for the growth of follicles and the maturation of the eggs contained within them. It also stimulates the production of sex hormones in the ovaries.

FSH determines:

• beginning of follicle development;
• the duration of their growth;
• ripening time.

FSH preparations, including Puregon, are used to induce ovulation, increase the production of steroid hormones, and also in IVF programs. Prescribing the drug allows for the maturation of many preovulatory follicles during one menstrual cycle, although normally, without drug support, only one follicle matures in women. In ART cycles, Puregon is used in conjunction with hCG drugs.

Pharmacodynamics

The maximum concentration of follitropin in the blood plasma after administration of Puregon intramuscularly or subcutaneously is achieved after 12 hours. The drug is eliminated from the body quite slowly. The half-life depends on many factors and varies from person to person. But the average is 40 hours.

Thus, at the time of administration of the next dose, a large amount of follitropin still remains in the blood. Therefore, there is a cumulative effect. Each subsequent administration of Puregon increases the concentration of FSH in plasma by 50% or more. As a result, after several injections, the required saturation dose required for the maturation of follicles in the ovary is achieved.

It does not matter how exactly the drug is administered: into the muscle or subcutaneously. Because bioavailability is no different. It averages 77%. Puregon is metabolized in the body in the same way as a person’s own FSH, which is synthesized in his body. It is mainly excreted through the kidneys in the urine.

Indications for use

Puregon has two indications for use:

1. Anovulation. In this case, the drug is prescribed to induce ovulation. That is, to stimulate the maturation of follicles with eggs in the ovaries. The purpose of using the drug is the maturation of one follicle in one menstrual cycle. Puregon is not usually prescribed as a first-line drug. It is used in cases of ineffectiveness of clomiphene therapy.
2. ECO. In in vitro fertilization programs, Puregon is used to stimulate superovulation.

Mode of application

Puregon is available by prescription and is used only under the supervision of a physician. This is done by reproductive specialists (infertility specialists).

The dosage of the drug is selected individually. In this case, the doctor proceeds from the following criteria:

1. Purposes of application. To induce ovulation, Puregon is prescribed in a lower dose than in the IVF program. Because when carrying out artificial insemination, the purpose of using the drug is to mature as many follicles as possible. At the same time, when inducing ovulation, it is enough to achieve the maturation of one follicle with an egg that can be fertilized as a result of sexual intercourse.
2. Woman's age. There are different IVF programs. Therefore, stimulation can be pronounced or minimal. For example, in younger women, doses may be higher, allowing for a larger number of eggs to be retrieved. In older patients they may be lower. Because they often have reduced ovarian reserve. It is not possible to grow a large number of follicles. Therefore, the doctor prefers quality over quantity. At lower doses of Puregon they grow more slowly. There will probably be fewer follicles. But at the same time, the eggs in them may be of higher quality.
3. Data from ultrasound and hormonal studies. Based on the level of estrogen, follicle-stimulating hormone, and also after counting the number of antral follicles (ultrasound is used for this) in the first days of the cycle, the doctor can predict the ovarian response to stimulation, as well as assess the risk of hyperstimulation. The dose is selected in such a way as to obtain the maximum number of eggs with a minimum amount of Puregon. This allows you to get the therapy result that the doctor and patient expect. At the same time, the treatment will be safe, and the risk of developing ovarian hyperstimulation syndrome will be minimal.

Basic rules for using Puregon:

• the solution is administered slowly to avoid pain;
• the drug can be administered by the woman’s partner if she has the appropriate skill (it is not necessary to visit a medical facility every time to get the next injection);
• there is no difference whether Puregon is administered intramuscularly or subcutaneously;
• if the drug is administered subcutaneously, the injection site must be constantly changed to prevent atrophic changes in adipose tissue.

Instructions for use of Puregon:

1. Prepare the syringe. It must be disposable and not previously used. It is advisable to use a small syringe. Because this way more of the solution will enter the body and less of it will remain on the walls of the syringe. Before administering the drug, make sure that there are no solid inclusions in it.
2. Draw up the solution. Remove the bottle valve from the cap. Then place the needle on the syringe. Puncture the rubber stopper. After this, draw the solution into the syringe. Holding it with the needle up, tap the body so that all air bubbles are forced out of the solution. Gradually press down on the plunger until all the air leaves the syringe.
3. Select the injection site. The drug is injected intramuscularly into the buttock. For subcutaneous administration, preference should be given to the abdominal area near the navel. Because here is the largest layer of subcutaneous fat. But if desired, Puregon can be injected into other parts of the body. This will not change its effectiveness.
4. Prepare the injection site. The place where the injection will be given is treated with alcohol or chlorhexidine. This is required to kill bacteria in the area. It is advisable to wait one minute before giving the injection.
5. Insert the needle. It is inserted at a right angle. Then you should check whether the injection was carried out correctly. To do this, pull the piston a little. If this is difficult to do, medication can be administered. If blood gets there, it means that you have entered a vessel. In this case, you need to pull out the needle, apply a cotton swab to the puncture site and wait until the bleeding stops. Then - inject in another place.
6. Enter the solution. It is advisable to do this slowly. This will avoid unpleasant sensations. It will also reduce the risk of excess skin damage or bruising.
7. Remove the needle. Do this in a quick motion. The area where the injection was given can be massaged. This will reduce pain because the medicine will be distributed into the tissues. Throw away the used syringe. In this case, the cap must cover the needle, and it, in turn, must be disconnected from the syringe.

Dosage

The doctor can adjust the dose of the drug directly during treatment. Because a woman comes for an ultrasound every 2-3 days. The doctor looks at how many follicles are growing and how quickly this happens. If they grow too slowly, the doctor may increase the dose of Puregon. If it is too fast, the dose is reduced. Because follicles can grow before the endometrium matures. And in this case, the chances of pregnancy will be significantly lower.

Use for anovulation

During anovulation, Puregon is usually started with minimal doses. It is administered at 50 IU per day. The minimum course is 7 days. If there is no response from the ovaries, then the daily dose is increased. At the same time, they do blood tests for hormones and monitor whether the amount of estrogen increases. An increase in estradiol levels by one and a half to two times is considered optimal. The growth of follicles is also monitored. If they grow too slowly, this is a reason to increase the dosage of Puregon.

The selected dose is continued until the dominant follicle grows to 18 mm. This period is called preovulatory. The concentration of estradiol in plasma by this time should be 1000-3000 pmol/l. Typically, a course of Puregon therapy lasts 1-2 weeks.

Once the laboratory criteria for preovulation are achieved and the follicle is determined by ultrasound to be of sufficient size, initiation of ovulation is required. To do this, the hormone hCG is administered.

It is important not only to achieve follicle maturation, but also to prevent unwanted consequences of stimulation. First of all, the doctor must avoid hyperstimulation. To do this, he must promptly identify an overly violent reaction of the ovaries to the administration of drugs and take the necessary measures. They may be as follows:

• reducing the dose of Puregon;
• protection against pregnancy in the current cycle.

It is necessary to reduce the dose of Puregon if the concentration of estradiol in the blood doubles for several days in a row (this is a too rapid increase in the level of the hormone). If there is a large number of follicles, the risk of hyperstimulation and multiple pregnancies increases. Therefore, in this case, hCG is not administered. Treatment with Puregon is stopped. Pregnancy in the current cycle is undesirable for two reasons:

• Late hyperstimulation syndrome may develop, which is the result of pregnancy and may have a more severe clinical course than early OHSS;
• Multiple pregnancies are possible, and there is a fairly high probability that there will be more than two fetuses.

In the next cycle, the doctor takes into account the experience of previous stimulation. Therefore, he prescribes smaller doses of Puregon.

Application in IVF program

Puregon is used to stimulate superovulation in an IVF program. Superovulation differs from ovulation in that many follicles with eggs mature in the ovaries.

In the first days, doses of 100 to 225 IU are usually prescribed. The ovarian response is then assessed. Based on the results of the ultrasound, the dosage may be changed. After 4-5 days, a maintenance dose is prescribed. It can fluctuate over a wide range - from 75 to 375 IU per day. The duration of use of this dose is on average from 6 to 12 days. But every woman’s body is individual. Sometimes follicles can grow faster or slower. Accordingly, the course of therapy changes.

Puregon can be used in conjunction with GnRH agonists or antagonists. This turns off the function of the pituitary gland. It stops producing its own gonadotropins. Therefore, higher doses of Puregon are used.

After a course of stimulation, ovulation is induced. The criterion that the follicles are mature is:

• the presence of at least 3 follicles, according to ultrasound, measuring at least 16 mm;
• an increase in estradiol levels by 1000-1300 pmol/l for each follicle with a diameter over 18 mm.

In this case, hCG is administered. And 36 hours after the injection, the follicles are punctured and eggs are collected.

Side effects

One of the most common side effects remains local reactions to the administration of Puregon. They are observed in 3% of patients. Among them:

• skin redness;
• edema;
• pain;
• bruise.

As with any other drugs, allergic reactions to Puregon are possible. It causes side effects related to hypersensitivity reactions in 0.1% of cases. Manifestations may include red spots, itchy skin, and hives-like rashes.

Approximately 4% of patients experience ovarian hyperstimulation syndrome. This is what it says in the instructions for use. But in fact, this side effect is much less common nowadays. This is due to the fact that doctors have accumulated sufficient experience in using assisted reproductive technologies, including IVF. They have learned to prevent hyperstimulation syndrome. The likelihood of this complication largely depends on the clinic where you undergo stimulation and the qualifications of the doctor. If hyperstimulation occurs, the syndrome is usually mild.

Symptoms of this complication of stimulation:

• diarrhea;
• abdominal pain;
• nausea;
• enlargement of the ovaries, determined by ultrasound.

Side effects from the reproductive system are possible. They are reversible and not dangerous. These side effects include:

• soreness of the mammary glands;
• multiple pregnancy (when several follicles mature during stimulation of ovulation or when several embryos are transferred in an IVF cycle).

It has been established that under the influence of Puregon, the risk of ectopic pregnancy is higher than the average in the population.

Contraindications for use

Puregon is not used during pregnancy or lactation. No studies were conducted to determine its safety during this period. Therefore, a negative effect on the fetus is possible. In addition, the use of Puregon during pregnancy does not make sense. After all, the drug is used to treat infertility.

Other contraindications:

• oncological formations of the reproductive system (ovaries, pituitary gland, hypothalamus, uterus, mammary glands) - stimulation can accelerate the growth of tumors;
• bleeding from the genital tract of unknown origin;
• primary ovarian failure (in this case, the follicles will not grow under the influence of Puregon, so the use of the drug becomes pointless);
• uterine fibroids, developmental abnormalities of the organs of the reproductive system or other pathologies that make pregnancy impossible;
• the presence of cysts in the ovaries (except for polycystic disease) or their increase in size;
• diseases of the kidneys, liver, heart, endocrine system organs in the stage of decompensation.

special instructions

Puregon is available in vials and is administered using a syringe. But there is also a drug called Puregon-Pan. This is the same follitropin. Only it comes not in a bottle, but in an injector pen. The drug is administered only subcutaneously. Moreover, it should be borne in mind that compared to using a syringe, the amount of active substance entering the body increases by an average of 18%. The doctor takes this into account when selecting the dose.

It is not advisable to use Puregon together with other medications. Including clomiphene. It may increase the ovarian response to the drug.

Before starting therapy, the origin of infertility must be clarified. A number of causes of impaired fertility should be excluded. These may be diseases of the adrenal glands, thyroid gland, pituitary gland. Pathology of the endocrine system organs can be treated in other ways. After normalization of the level of thyroid hormones, androgens or prolactin, natural pregnancy may occur, without stimulation of ovulation.

Before starting Puregon use, women should be informed that assisted reproductive technologies increase the risk of:

• multiple births;
• ectopic pregnancy;
• spontaneous abortion.

When using assisted reproductive technologies, there is a higher risk of congenital malformations in children. However, this is unlikely to be associated with the use of Puregon or other gonadotropins. Rather, it is a consequence of the poor reproductive health of parents who are forced to resort to ovulation induction or IVF in order to become pregnant.

Terms and conditions of storage

The drug is stored in the refrigerator. The optimal storage temperature is from 2 to 8 degrees. But you can't freeze it. The shelf life of Puregon is 3 years.

Price

The cost of 5 bottles of Puregon at a dose of 100 IU is 9-10 thousand rubles in mid-2018. A 900 IU cartridge costs 16 thousand rubles.

Tradename: Puregon ®

International nonproprietary name:

Dosage form:

Compound:

Description: clear, colorless solution.

Pharmacotherapeutic group:

ATX code: G03GA06

Pharmacological properties
Pharmacodynamics
Puregon ® contains recombinant follicle-stimulating hormone (FSH), which is obtained using recombinant DNA technology using a culture of Chinese hamster ovary cells into which the genes for human FSH subunits are introduced. The primary amino acid sequence of the recombinant DNA is identical to that of natural human FSH. However, there are slight differences in the structure of the carbohydrate chain.
FSH ensures normal growth and maturation of follicles and the synthesis of sex steroid hormones. The level of FSH in women is a factor that determines the onset and duration of follicle development, as well as the time of their maturation. Thus, the drug Puregon ® can be used to stimulate the development of follicles and estrogen synthesis in certain disorders of ovarian function. In addition, Puregon ® is used to induce multiple follicular development during artificial insemination (for example, in vitro fertilization/embryo transfer (IVF/ET), intrauterine insemination (IUI) and intracytoplasmic sperm injection (ICSI). After treatment with Puregon ® human chorionic gonadotropin (hCG) is usually administered to induce the final stage of follicular maturation, resumption of meiosis, and ovulation.
Pharmacokinetics
After intramuscular or subcutaneous administration of the drug Puregon ® the maximum concentration of FSH in the blood plasma is achieved within 12 hours. Due to the gradual release of the drug from the injection site and a long half-life (from 12 to 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 concentration FSH 1.5-2.5 times compared to a single injection. This allows you to achieve a therapeutic concentration of FSH in the blood.
Pharmacokinetic parameters after intramuscular and subcutaneous administration of Puregon ® do not differ significantly. With both routes of administration, the bioavailability of the drug is approximately 77%. Recombinant FSH is biochemically similar to FSH isolated from human urine and is distributed, metabolized, and excreted from the body in a similar manner.

Indications
Treatment of female infertility in the following cases:

• anovulation (including polycystic ovary syndrome (PCOS) in women unresponsive to clomiphene treatment);
• induction of superovulation, to induce multiple development of follicles during artificial insemination (for example, in IVF/PE, VMI and ICSI techniques).

Contraindications

• hypersensitivity to any of the components of the drug;
• tumors of the ovaries, breast, uterus, pituitary gland and hypothalamus;
• pregnancy, lactation period;
• vaginal and uterine bleeding of unknown etiology;
• primary ovarian failure;
• ovarian cysts or enlarged ovaries not associated with PCOS;
• malformations of the genital organs incompatible with pregnancy;
• uterine fibroids incompatible with pregnancy;
• decompensated diseases of the endocrine system (for example, diseases of the thyroid gland, adrenal glands or pituitary gland);
• severe dysfunction of the liver and kidneys.

Pregnancy and lactation
The use of Puregon ® during pregnancy and breastfeeding is contraindicated. Due to the fact that there is insufficient clinical data on the use of the drug during pregnancy, in case of unintentional use during pregnancy, the teratogenic effect of recombinant FSH cannot be excluded.

Directions for use and doses
When using an injector pen (Puregon Pen), it must be taken into account that the pen is a precise device that releases the dose set on it. It has been shown that when using an injector pen, 18% more FSH is injected than when using a syringe. This may be significant, in particular, when changing the injector pen to a regular syringe, and vice versa, in the same treatment cycle. Some dose adjustment is especially needed when switching from a syringe to a pen to avoid an unacceptable increase in the administered dose.
Treatment with Puregon ® should be started under the supervision of a physician experienced in the treatment of infertility.
The dosage should be individualized depending on the response of the ovaries, under ultrasound control and estradiol concentration. Puregon ® is effective with a lower total dose and shorter treatment time required for maturation compared to urine-derived FSH, which minimizes the risk of developing ovarian hyperstimulation.
Overall experience in the treatment of infertility by in vitro fertilization indicates that success is most likely during the first 4 courses of therapy and then gradually decreases.
Anovulation
A sequential treatment regimen is recommended, starting with daily administration of 50 IU of Puregon ® for at least 7 days. In the absence of an ovarian response, the daily dose is gradually increased until follicular growth and/or an increase in the concentration of estradiol in plasma is achieved, indicating the achievement of an optimal pharmacodynamic response. A daily increase in plasma estradiol concentration by 40-100% is considered optimal. The daily dose thus obtained is then maintained until the preovulation state is achieved. The state of preovulation is determined by the presence of a dominant follicle with a diameter of at least 18 mm (according to ultrasound) and/or a plasma estradiol concentration of 300-900 picograms/ml (1000-3000 pmol/l).
Typically, 7-14 days of treatment are required to achieve this state. After this, the administration of the drug is stopped and ovulation is induced by administering hCG. If the number of follicles is too large or the estradiol concentration increases too quickly, i.e. more than 2 times per day for 2-3 consecutive days, then the daily dose should be reduced. Since each follicle with a diameter greater than 14 mm is preovulatory, the presence of several follicles with a diameter greater than 14 mm carries the risk of multiple pregnancies. In this case, hCG is not administered and measures are taken to protect against possible pregnancy to prevent multiple pregnancies.
Induction of superovulation during artificial insemination.
Various stimulation schemes are used. For at least the first 4 days, it is recommended to administer 100-225 IU of the drug. After this, the dose can be selected individually, based on the reaction of the ovaries. Clinical studies have shown 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 either alone or in combination with a gonadotropin-releasing hormone (GnRH) agonist or antagonist to prevent premature peak ovulation. When using GnRH analogs, higher total doses of Puregon ® may be required.
The reaction of the ovaries is monitored by ultrasound and determination of the concentration of estradiol in plasma. If there are at least 3 follicles with a diameter of 16-20 mm (according to ultrasound data) and there is a good ovarian response (estradiol concentration in blood plasma 300-400 picograms/ml (1000-1300 pmol/l) for each follicle with a diameter of more than 18 mm), induce the final phase of follicle maturation by introducing hCG. After 34-35 hours, oocyte aspiration is performed.

Mode of application
The drug, produced in cartridges, is intended for administration using an injector pen (“Puregon Pen”). In this case, the drug is administered subcutaneously. To prevent pain during injection and to minimize leakage of the drug from the injection site, the solution should be injected slowly. It is necessary to alternate subcutaneous injection sites to avoid the development of lipoatrophy. Unused solution should be destroyed.
Subcutaneous injections of the drug Puregon ® can be carried out by the woman herself or her partner, who has received detailed instructions from the doctor. Self-administration of the drug is permissible only for patients who have good skills and a constant opportunity to consult with a specialist.

Side effect
The use of the drug Puregon ® may be accompanied by the development of local reactions: hematoma, pain, redness, swelling, itching, which were observed in 3 out of 100 patients treated with the drug. Most of these local reactions are mild and transient. Generalized hypersensitivity reactions, including erythema, urticaria, rash and pruritus, occurred in 1 in 1000 patients treated with Puregon ® .
May also be noted:

• ovarian hyperstimulation syndrome (approximately 4 out of 100 women receiving treatment with the drug). Clinical symptoms of moderate ovarian hyperstimulation are nausea, diarrhea, bloating and abdominal pain due to impaired venous circulation and irritation of the peritoneum, as well as enlargement of the ovaries due to cysts. In rare cases, severe ovarian hyperstimulation syndrome was observed, which threatened the patient’s life and was characterized by the presence of large ovarian cysts prone to rupture, ascites, hydrothorax and weight gain due to fluid retention in the body. In rare cases, ovarian hyperstimulation syndrome may be accompanied by the development of venous or arterial thromboembolism.
• soreness, pain and/or engorgement of the mammary glands;
• spontaneous abortion;
• increasing the likelihood of developing multiple pregnancies;
• increased likelihood of ectopic pregnancy;
• nausea, vomiting (approximately 1 in 100 women receiving treatment with the drug);
• when treated with Puregon ® in combination with hCG, as well as when used with other gonadotropic hormones, in rare cases, thromboembolism may develop.

Overdose
There are no data on acute overdose with Puregon ®. High doses of FSH can lead to ovarian hyperstimulation. Symptoms: see section.
Treatment: If symptoms of unwanted hyperstimulation (not related to the induction of superovulation during in vitro fertilization) appear, the administration of Puregon ® should be discontinued. In this case, measures should be taken to protect against the development of pregnancy and the administration of hCG should be abandoned, which may aggravate adverse events. Treatment should be aimed at eliminating the symptoms of ovarian hyperstimulation syndrome.

Interaction with other drugs
The simultaneous use of Puregon ® and clomiphene may enhance the ovarian response. After desensitization of the pituitary gland with GnRH agonists, a higher dose of Puregon ® may be required to achieve a sufficient ovarian response.
Pharmaceutically incompatible with other drugs.

special instructions

• before starting treatment, the presence of endocrine diseases (for example, diseases of the thyroid gland, adrenal glands or pituitary gland) should be excluded;
• induction of ovulation using gonadotropic drugs increases the risk of developing multiple pregnancies. Appropriate dose adjustment of follitropin beta prevents the development of multiple follicles. In multiple pregnancies, there is a higher risk of complications during pregnancy and in the perinatal period. Before starting treatment, patients should be warned about the possibility of developing multiple pregnancies;
• the first administration of Puregon ® should be carried out under the direct supervision of a physician;
• Women who undergo artificial insemination (especially IVF) often have fallopian tube abnormalities, which increases the risk of developing an ectopic pregnancy. Therefore, it is important to obtain early ultrasound confirmation of the intrauterine location of the fetus;
• in women who undergo artificial insemination, the risk of early miscarriage is higher than with natural conception;
• The incidence of congenital malformations with the use of assisted reproductive technologies (ART) may be slightly higher than with natural fertilization. This may be due to the characteristics of the parents (for example, their age or sperm characteristics), as well as the higher incidence of multiple pregnancies when ART is used. There has been no evidence that an increased risk of congenital defects is associated with the use of gonadotropins;
• ovarian hyperstimulation syndrome (OHSS). Before starting treatment and regularly during treatment, ultrasound should be performed to monitor the development of follicles and determine the concentration of estradiol in plasma. In addition to the development of too many follicles, the concentration of estradiol in plasma can increase very quickly (i.e., more than 2 times per day for 2-3 consecutive days), reaching excessively high values. The diagnosis of ovarian hyperstimulation syndrome can be confirmed by ultrasound. Transient abnormal liver function tests may indicate liver dysfunction, which may be accompanied by morphological changes on liver biopsy, as has been reported in association with ovarian hyperstimulation syndrome;
• Women from recognized risk groups for thrombosis, such as those with a relevant personal or family history, significant obesity (body mass index > 30 kg/m2) or diagnosed thrombophilia, may be at increased risk of venous or arterial thromboembolism when treated with gonadotropins, even without concomitant OHSS. When treating such women, it is necessary to compare the likelihood of successful ovulation induction and the possible risk of complications. However, it should be noted that pregnancy itself is accompanied by an increased risk of thrombosis;
• Puregon ® may contain traces of streptomycin and/or neomycin. These antibiotics may cause a hypersensitivity reaction.

Impact on the ability to drive a car and operate machinery
Not detected.

Release form
Solution for subcutaneous administration 900 IU/1.08 ml. 1.08 ml in a 1.5 ml type I (EF) flint glass cartridge, sealed on one side with a rubber (bromobutyl/isoprene) stopper and crimp cap, and a rubber piston on the other side.
1 cartridge in plastic packaging, instructions for use and 3 cardboard boxes, each containing 3 sterile needles in individual plastic containers, covered with a foil paper membrane, placed in a cardboard box.

Best before date
3 years
Once the needle is inserted into the cartridge, the solution can be stored for a maximum of 28 days.
Do not use after the expiration date stated on the packaging.

Storage conditions
List B.
At a temperature of 2-8°C, in a place protected from light, out of reach of children. Do not freeze.

Conditions for dispensing from pharmacies:

Manufacturer
N.V. Organon, Netherlands
Kloosterstraat 6, 5349 AB Oss, the Netherlands
Kloosterstraat 6, 5349 AB Oss, The Netherlands
Consumer complaints should be sent to:
LLC "Shering-Plough" 119049, Moscow, st. Shabolovka, 10, building 2

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 .

The additional ingredients in the medicine are: 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 clear, colorless solution contained in glass bottles with rubber stoppers rolled in aluminum. The drug 50 or 100 IU is contained in cardboard packs of 1, 5 or 10 pieces.

The medicine is 150, 300, 600 or 900 IU - in cartridges, one cartridge is placed in a cardboard box. The kit also includes a needle.

pharmachologic effect

The active substance that is part of the drug Puregon has a follicle-stimulating effect on the body. Under the influence of the drug, the deficiency 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 obtained using genetic engineering.

In the female body, the content of follicle-stimulating hormone determines the process of the beginning and duration of maturation of follicles in the ovaries. This hormone also regulates the number of follicles and the maturation period.

The use of Puregon is advisable for the purpose of inducing the development follicles And steroid hormones in patients diagnosed with ovarian dysfunction. The medicine also stimulates the development and growth of follicles in those women who are planning artificial insemination, in particular, IVF, embryo transfer, gamete transfer into the fallopian tubes, or intracytoplasmic sperm injection.

After a course of Puregon therapy has been completed, it is recommended to administer to the patient for induction of the last stage of the follicle maturation process.

Puregon is also used by men to treat follicle-stimulating hormone deficiency, leading to a decrease in spermatogenesis. In this case, the medicine 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 concentration of the active substance in plasma is observed after 12 hours. Since the absorption process of the active component 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. If the same dose of the drug is repeated, a further increase in follicle-stimulating hormone is noted: its level increases by 1.5-2 times when compared with the first injection. Therapeutic doses of follicle-stimulating hormone in plasma 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 Puregon with the hormone obtained from human urine is noted; it has a similar metabolic profile, is distributed and excreted from the body in a similar way.

Indications for use

The medicine 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 carrying out assisted reproduction programs , including IVF, embryo transfer, sperm injections (to induce superovulation).

The drug is also prescribed for the treatment of men who have insufficient spermatogenesis associated with hypogonadotropic hypogonadism .

Contraindications

Puregon should not be used to treat those patients who have an 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 , ).

Not used to treat patients who have been diagnosed primary gonadal failure .

Puregon should not be prescribed to women with disorders of the anatomy of the genital organs, as well as vaginal bleeding of unknown origin.

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

The drug should not be prescribed for the treatment of women suffering from ovarian cyst , as well as patients with enlarged ovaries not associated with polycystic ovary syndrome .

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

Prescribe the medicine with caution to women who have undergone 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 necessary.

Prescribe the medicine with caution to women who have an increased risk of developing thrombosis as they are more likely to develop thromboembolism .

Side effects

When treated with Puregon, some patients may develop a number of local reactions in the place where the solution was injected. This may be hyperemia, pain, swelling, or the appearance of a 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 area, headache, , pain in the abdominal and epigastric region. Also, with this phenomenon, a woman may experience an increase in the size of her ovaries and experience chest pain. Possible metrorrhagia, development of ovarian torsion, , bleeding from the vagina.

There have been isolated cases of severe ovarian hyperstimulation syndrome – life-threatening condition. In this condition, a woman may develop large cysts, which leads to the risk of their rupture, ascites , weight gain due to fluid retention in the body. If such a side effect occurs, you should immediately stop 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 using combined treatment with hCG and Puregon, there is a possibility of developing thromboembolism .

If the medicine is used by men, they may experience headache as a side effect. It is also possible to develop acne , epididymal cyst , gynecomastia , allergic manifestations.

Puregon, instructions for use (Method and dosage)

Puregon is administered parenterally - intramuscularly or subcutaneously.

The solution cannot be injected into the vascular cavity, therefore, before injecting the product, it is necessary to exclude the possibility of it getting into the vessel. Treatment with the drug is carried out under the supervision of a doctor who has experience in the treatment of human reproductive disorders. It is important to monitor the patient's condition when the solution is first administered.

The solution can be administered using a disposable syringe or a special injector pen. If a syringe is used for administration, it is important to note that in this case, 18% less follicle-stimulating hormone is injected into the patient compared to using a cartridge using a pen Puregon Pen. The video instructions at Puregon Pen.

It is recommended to administer the solution subcutaneously slowly to avoid pain and leakage of the solution. With repeated injections, it is important to change the injection site to prevent atrophy of the adipose tissue. The patient can self-administer the medication, but only after being instructed by a healthcare professional. Before administering the drug, you need to check whether there are any foreign particles in it and whether the transparency is broken - in such cases the medicine cannot be administered.

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

To introduce the product, you need to pull back the skin, form a fold and insert a needle into it perpendicular to the skin. In this case, you need to make sure that the needle does not get into the vessel. After the drug has been administered, it is necessary to lightly massage the skin at the site of injection of the solution.

The dosage of the drug and the duration of its administration are determined by a specialist, taking into account the reaction of the ovaries in women. During therapy, it is imperative to perform an ultrasound of the ovaries and determine the content in plasma. Clinical experience shows that it is possible to achieve an effect after three or more courses of medication.

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 efficiency decreases.

Women who have been diagnosed anovulation , it is recommended to practice a sequential regimen of medication use. 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 estradiol levels or follicular growth are sufficient. The optimal treatment pattern is an increase in plasma estradiol concentrations by 40-100%. The dose of the drug that was selected using this method is maintained until the preovulation . This state is usually achieved after 1-2 weeks of Puregon administration. Next, the administration of the Puregon solution should be stopped and the administration of hCG should be started to induce ovulation. The dose of Puregon is reduced if a large number of follicles respond to therapy or if there is an increase in estradiol levels by more than 2 times for two or three days in a row. If several follicles that are larger than 14 mm develop, there is a possibility of developing multiple pregnancy . HCG should not be administered if multiple follicles are developing. In this case, measures should be taken to prevent the development of multiple pregnancies.

At induction of hyperovulation Different treatment regimens are used. First, the drug is administered at a dose of 100–225 IU for at least 4 days. Next, 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. Sometimes longer treatment is practiced.

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

Ultrasound should be performed to monitor the ovarian response and determine plasma estradiol concentrations. 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 ovarian response, hCG is administered to indicate the final phase of follicle maturation. After 34–35 hours, oocyte aspiration is performed.

For the treatment of men the drug is used at a dose of 450 IU per week, it must be administered in three doses of 150 IU. Puregon is combined with hCG. As a rule, improvement in spermatogenesis occurs no earlier than after 3–4 months. It is necessary to conduct a semen analysis 4-6 months after the start of treatment to 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 about acute manifestations of an overdose of follitropin beta. If large doses of medication are administered, the likelihood of ovarian hyperstimulation increases. In this case, you must stop treatment immediately. If necessary, symptomatic therapy is practiced.

Interaction

When combining Puregon and clomiphene citrate ovulation induction may be enhanced.

Upon admission GnRH agonists An increase in the dose of follitropin beta may be necessary.

Terms of sale

You can buy Puregon with a specialist prescription.

Storage conditions

The solution should be stored in a dark place, storage temperature 2–8 °C. Store Puregon only in its original packaging. The medicine should not be frozen; it should be kept out of the reach of children.

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

Best before date

The shelf life of the solution is 3 years.

special instructions

Before starting treatment, you need to completely eliminate endocrine diseases .

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

Puregon should be administered for the first time only under the supervision of a specialist. Before you administer the solution yourself, 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 taken into account that with artificial insemination the risk of early pregnancy termination is higher than in the case of natural conception.

Which is better: Gonal or Puregon?

Active component 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 about 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.

Some facts about the product:

Instructions for use

Price in online pharmacy website: from 1 100

Pharmacological properties

The drug Puregon is considered a product created on the basis of a hormone in the female body. This substance belongs to follicle-stimulating structures. The main task of the product is to stimulate the formation of formations with eggs in the female gonads - the ovaries. The product is actively used in the process of artificial insemination. There are cases when the drug is prescribed for infertility, ovulation dysfunction, and pathology of polycystic ovaries.

The production of the drug is based on the use of not only materials taken from the human body, but also cellular organizations of the Chinese hamster. As a result of the interaction of the two structures, hybrid buildings will be obtained. After this, the cells are placed in special growing conditions. All the necessary microelements, vitamins, and minerals for their full development are presented there.

Research has shown that hybrid organizations are capable of producing the necessary hormone suitable for humans. Puregon affects the female body in such a way that several follicular formations begin to mature in the system and the synthesis of reproductive hormones increases. After the follicles have matured, the time comes to administer a medication with human chorionic gonadotropin.

Composition and packaging of the release

The product is available in two forms - lyophilisate and ready-to-use solution. In the first case, it is recommended to prepare material for injections. Products are sold in varying sizes. With their help, it is easy to select the appropriate amount of the drug. The substance is injected into the muscle and under the skin. The pharmacy offers Puregon with a cartridge for sale. This device allows the patient to use the medicine independently. For this, a person does not require special medical education. The structure includes a recombinant substance. This means that the product was produced using bioengineering techniques and not from urine. Modern material is more effective and safer than products of previous generations. The composition is supplemented with auxiliary elements in the form of sodium citrate, polysorbate 20, sucrose, benzyl alcohol and other chemical components.

Indications for use

The drug is prescribed for the treatment of women and men. The substance is effective for infertility in the former, which is caused by dysfunction of the hypothalamus, pituitary gland system, with the absence of ovulatory processes. The product is also used during unnatural fertilization. For men, the product is prescribed in case of insufficient sperm production, when the functionality of the reproductive glands decreases.

International Classification of Diseases (ICD-10)

N97 Female infertility.

Side effects

Basically, Puregon causes the same accidental symptoms in both the weaker and stronger sex. Most often, symptoms manifest themselves in the form of swelling, itching, hives, and redness in the injection area. Women also experience: abdominal pain, constipation, nausea, diarrhea; bleeding from the uterus, destruction of the gonads; miscarriages, cystic formations; thromboembolism, ascites, weight gain and others. Men experience acne, breast development, cysts, and skin rashes.

Contraindications

The use of the product must be preceded by a thorough medical examination. This will avoid complications or painful symptoms during therapy. The patient should be aware of the prohibitions that apply to taking the substance. First of all, it is not prescribed in cases of increased sensitization to certain components of the product. This restriction applies to both men and women. The latter are not prescribed medication if there are any tumors in the body on the ovaries, mammary glands, hypothalamus or pituitary gland structure, primary insufficient functioning of the gonads, pathology of depletion of paired glands of the reproductive sphere, ovarian cysts not caused by polycystic disease. It is also not recommended to administer the product in case of abnormal processes in the genital organs, fibroids, some pathologies of the thyroid organ, or hormonal dysfunctions. Puregon is dangerous in the development of liver and kidney failure, which manifests itself in severe form. It is prohibited to prescribe the drug during bleeding from the vagina or uterus, while pregnant or during breastfeeding.

Use during pregnancy

The substance is not prescribed during pregnancy and breastfeeding.

Method and features of application

The therapeutic drug can only be used under the supervision of experts. The rate of administration is developed individually, taking into account the severity of the dysfunction. Before using Puregon, you must undergo an ultrasound to determine the amount of hormones in the blood substance. As practice shows, the improved hormone acts on the body much faster and does not require taking increased doses of the drug, as was the case with its materials isolated from urine. If a woman does not ovulate, it is recommended to administer the drug in an amount of 50 IU every day for 7 days. In some cases, the gonads do not respond to this dosage. Then it is increased to 100 IU. The increase occurs until the development of formations with eggs begins. Their growth is determined using ultrasound, and the volume of hormones is determined through laboratory tests. If estradiol increases by 40-100% every day, it means that the body is taking the medication well. Doctors try to achieve a preovulation state when at least one main follicle appears in the system. This can be achieved within 7-14 days. The use of Puregon begins on the 2-3rd day of menstruation. Monitoring the patient plays an important role. The body of the stronger sex requires a higher dosage. Therefore, men are administered a solution of 150 IU once a day, every other day. Over the course of 7 days, the patient should receive 450 IU of the drug. The duration of therapeutic effect is no more than 4 months. It is recommended to conduct a spermogram 30 days after starting to use the medication. This will help evaluate the effectiveness of the product. The medicine must be administered with the thinnest needles and small syringes. The liquid is injected slowly into the muscle or under the skin. Most often they resort to using the latter method. The injection is given each time in a new area of ​​the body, so as not to cause irritation and the formation of hematomas and fatty atrophy. If after the procedure there is residual medication in the syringe, it must be disposed of immediately. In this case, it is prohibited to reuse Puregon. Particular attention should be paid to the transition from an injector to a syringe or vice versa. In the first option, the rate of the product should be increased by 18%, in the second - reduced.

Alcohol compatibility

No studies have been conducted regarding the interaction of the product and alcohol compounds. However, doctors strongly recommend not to combine these two components. Therefore, during the course of therapy you should avoid drinking alcohol in any form.

Interaction with other drugs

According to some data, the compound clomiphene can increase the reaction of the gonads to the substance Puregon. If the product is administered in combination with Diferelin, Zoladex, Lucrin-depot and other GnRH agonists, then the effectiveness of the material may decrease. Therefore, the doctor should review the dosage of the drug or change the treatment regimen.

Overdose

It is unknown how an increased amount of Puregon affects the body. There is evidence that overdose can cause negative hyperstimulation of the gonads in women. In this case, the product is canceled. If other reactions occur, you should immediately consult a doctor.

Analogs

Puregon can be replaced by other medications that have similar qualities. Their list includes Follitropin, Gonal-F, FSH-super, Metrodin. There are also known therapeutic agents that produce a similar effect on the body, but differ significantly in the main substance. The doctor will determine which drug is suitable for the patient. Replacing it yourself is dangerous.

Terms of sale

The drug Puregon belongs to a group of medications that are sold by prescription.

Storage conditions

The instructions for use indicate the conditions for correct maintenance of the product. It should not be stored in direct sunlight or frozen. Access to the product should also be prohibited to minors. Temperature range – from 2 to 8°C. If any defects or damage are found on the packaging, the medication should be discarded immediately.