Gonal-f, 22 mcg/0.5 ml, solution for subcutaneous administration, 0.5 ml, 1 pc., Merck Serono Europe Limited buy in Moscow at a low price

Description

The active ingredient of Gonal-F is recombinant FSH (follitropin alfa). Under natural conditions, the hormone promotes the growth and development of follicles in the ovaries. Recombinant FSH of non-human origin is created in the laboratory using genetic engineering methods.

Depending on the concentration of the active substance, Gonal-F is available in two forms, which differ in the method of application. Your doctor will prescribe the most appropriate type of medication and select the right dose.

Today Gonal-F is available in the following dosages:

75 IU;
300 IU;
450 IU;
900 IU;
1050 IU.

The choice of dose depends on what assisted reproductive technology is used to treat infertility, as well as on the individual characteristics of the patient.

Gonal-f Solution, syringe, 12 pcs, 0.75 ml, 450 IU, for injection

Directions for use and doses

Treatment with Gonal-f should be started under the supervision of a medical specialist with experience in treating infertility. The drug Gonal-f is intended for subcutaneous administration. The first injection of Gonal-f should be carried out under the supervision of the attending physician or qualified medical personnel. Self-administration of Gonal-f can only be carried out by patients who are well motivated, trained and have the opportunity to receive specialist advice. It is recommended to change the injection site daily. Women For anovulation (including polycystic ovary syndrome), if clomiphene therapy is ineffective, the drug should be prescribed in a course of daily injections. Treatment begins in the first 7 days of the cycle. Stimulation is carried out under ultrasound control (follicle sizes are measured) and/or estrogen levels. Stimulation begins with a daily dose of 75-150 IU, increasing it by 37.5 IU-75 IU after 7-14 days until an adequate but not excessive response is obtained. The maximum daily injection dose should not exceed 225 IU. If there is no positive dynamics after 4 weeks, treatment is stopped. In the next cycle, stimulation should begin with a higher dose than in the previous cycle. After achieving the optimal response, 24-48 hours after the last injection of the drug Gonal-f, a single dose of recombinant human chorionic gonadotropin (r-hCG) is administered at a dose of 250 mcg or human chorionic gonadotropin (hCG) at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed. If the ovaries respond excessively to stimulation, treatment with follitropin alfa should be discontinued and hCG should be discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of Gonal-f compared to the previous cycle. When carrying out controlled ovarian hyperstimulation in programs of assisted reproductive technologies, Gonal-f is prescribed daily at a dose of 150-225 IU, starting from the 2-3rd day of the cycle. The daily dose may vary, but usually does not exceed 450 IU. Treatment is continued until the follicles reach adequate size according to ultrasound (5-20 days, on average by the 10th day of treatment). 24-48 hours after the last injection of the drug Gonal-f, r-hCG is administered once at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU to induce the final maturation of follicles. To suppress the endogenous LH surge and maintain it at a low level, a GnRH agonist or antagonist is used. In the usual protocol, Gonal-f administration begins approximately 2 weeks after the start of agonist treatment, then both drugs are continued until follicles of adequate size are obtained. For example, after 2 weeks of treatment with an agonist, Gonal-f is prescribed at a dose of 150-225 IU for 7 days. Subsequently, the dose is adjusted depending on the response of the ovaries. The existing experience of ART indicates that, in general, the probability of successful treatment remains during the first 4 attempts and then gradually decreases. When performing ovarian stimulation in women with severe FSH and LH deficiency (in combination with LH drugs), the dose and treatment regimen are selected by the doctor individually. Gonal-f is usually prescribed daily for up to 5 weeks concurrently with LH. Treatment with Gonal-f begins with a dose of 75-150 IU simultaneously with lutropin alfa at a dose of 75 IU. If necessary, the dose of Gonal-f can be increased by 37.5-75 IU every 7-14 days. If there is no adequate response to stimulation within 5 weeks, therapy should be stopped and resumed in a new cycle at a higher dose. After reaching the optimal size of the follicle/follicles, 24-48 hours after the last injection of the drug Gonal-f and lutropin alfa, r-hCG is administered once at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed. If the ovaries respond excessively to stimulation, treatment should be discontinued and hCG should be discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of Gonal-f compared to the previous cycle. Men To stimulate spermatogenesis in hypogonadotropic hypogonadism in men (in combination with human chorionic gonadotropin), Gonal-f is usually prescribed at a dose of 150 IU 3 times a week for at least 4 months in combination with hCG. If there is no positive effect during this time, treatment can be continued for up to 18 months. Rules for administering the drug When using the drug independently, patients should carefully study the instructions. The doctor prescribes the drug in doses in International Units (IU). One package of the drug is intended for use by only one patient. The patient should prepare a prefilled pen and administer the injection. The next injection should be given the next day at the same time. 1. The patient should wash their hands. It is very important that his hands and all objects he uses are as clean as possible. To carry out the injection, you need to lay out 2 alcohol-soaked swabs, a pre-filled syringe pen and an injection needle on a clean surface. 2. Preparation of a pre-filled syringe pen of the drug Gonal-f for the first use: remove the cap of the pen, put on the needle as described in paragraph 3. Then fill the syringe pen by placing the dose indicator arrow opposite point 37.5 on the black scale to set the dose. Pull out the injection button until it stops, remove the outer needle cap, then the inner needle cap, while holding the syringe pen with the needle vertically (the needle should be pointing up). Gently tap the cartridge location so that any air bubbles collect at the base of the needle. While pointing the needle vertically upward, release the injection button completely. A drop may appear at the tip of the needle. This means the pre-filled pen is ready to be injected. The loss of a small amount of fluid at the tip of the needle does not matter, because... the syringe pen is specially filled with some excess. If liquid does not appear at the tip of the needle, then the preparation process should be repeated. Then the dose should be set as described in paragraph 4. For the next injection, attach the needle and set the dose as described in paragraphs. 3 and 4 respectively. 3. Attaching the needle. Get a new needle. If the needle packaging is broken, you should throw the needle away and get a new one. Remove the protective membrane from the outer needle cap. Holding the needle firmly by the outer cap, insert the needle into the pen onto the threaded tip and turn clockwise until it clicks into place. Only use the needles included with the pen or supplied separately for this pen. 4. Dose setting. Set the required dose by turning the dose setting dial with a black scale until the dose value is opposite the arrow. The dose dial allows you to set the dose in 37.5 IU intervals. The minimum dose and maximum dose range from 37.5 IU to 300 IU. After establishing the required dose, dial it by pulling the injection button all the way. The button should be lifted straight up and not rotated, because this may change the prescribed dose. It is necessary to carefully monitor the set dose on the disk, because Once the injection button is pressed, it can no longer be changed. If, after pressing the injection button and dialing the dose, it turns out that the dose was dialed incorrectly, then the injection should not be given. It is necessary to remove the erroneously dialed dose and repeat the dialing again. The red scale of the dose control dial should be checked to ensure that the correct dose is dialed: when the injection button is pulled out, the number on the red scale of the control dial indicating the dose dialed is opposite the dose set on the black dial of the dose dial against the arrow. If the dialed dose is less than the required one, then dosing is not completed. In this case, you must act in accordance with clause 2. If the same dose is required each time, the dose indicator arrow should remain in the same position. 5. Administration of the drug. The injection site chosen on the doctor's recommendation should be treated with an alcohol swab. The patient should use the subcutaneous injection technique as recommended by a doctor or nurse. Insert the needle into the skin and press the injection button. Make sure that the gray full dose indicator is no longer visible. This position of the indicator indicates delivery of the full dose. You should hold the needle in the skin and keep the button pressed for at least 10 seconds. When removing the needle from the skin, you must continue to hold the button down. 6. Removing the needle. The needle should be thrown away after each injection. Holding the syringe pen firmly by the drug reservoir, carefully place the outer cap on the needle. Clamp the outer needle cap and unscrew the needle by turning it counterclockwise. Throw away the used needle. Place the protective cap on the syringe pen. 7. Storing a pre-filled pen. After injection, remove used needles as described in step 6. Place the protective cap on the syringe pen. The pen syringe should be stored in a safe place, preferably in its original packaging. Once the pen is empty, you should throw it away. Note: The scale visible through the medication reservoir serves as an indicator of the amount of medication remaining in the reservoir. It cannot be used to set the dose. 8. The dose control dial with a red scale on the injection button serves to monitor whether the last dose has been fully injected. It changes its position, indicating the amount of drug in the reservoir. If the collected dose is not sufficient to complete the injection, there are two options: a) inject the dose remaining in the pen, and then take a new pen, set the remainder of the required dose on it and inject it; b) throw away the old syringe pen, take a new one and administer the required dose. Patients should be warned to consult a physician if a larger dose than required is administered or if a dose is missed; Do not administer a double dose of the drug.'}

When to start treatment with Gonal-f

Treatment with Gonal-F should be started under the supervision of a fertility specialist.

The most common indications for prescribing the drug:

anovulation - in polycystic ovary syndrome and other diseases characterized by the absence of ovulation, provided that treatment with clomiphene citrate was ineffective;
stimulation of superovulation in the IVF program;
hypogonadotropic hypogonadism - to stimulate spermatogenesis in men who have problems with the production of germ cells.

The final decision regarding the advisability of treatment with Gonal-F is made by a reproductologist. He carefully weighs all the advantages and possible risks, takes into account the clinical picture of the disease that caused infertility and the results of additional examination of the patient, as well as a number of factors affecting the functioning of the woman’s gonads.

Gonal F

Gonal F is a drug containing recombinant follicle-stimulating hormone (FSH). It is prescribed mainly to women to stimulate the maturation and growth of germ cells.

With the help of this drug, you can achieve superovulation, that is, the development of several follicles at once, which is necessary for IVF technologies (IVF, ICSI, PIXI).

Release form

The medicine is produced in the form of a lyophilisate for preparing a solution. It is placed in a syringe pen, with which the patient can inject himself independently.

The active ingredient Gonal F is follitropin alfa. Dose – 75 IU. If necessary, the contents of several ampoules can be administered simultaneously. It is also available in doses of 300, 450 and 900 units in the form of a syringe pen.

Gonal F is applied subcutaneously.

Indications

Gonal F is used in women:

with anovulation (absence of ovulation), including those caused by polycystic ovary syndrome (as a second-line drug, if stimulation with clomiphene has not brought results);
to stimulate ovulation with low levels of FSH or LH (luteinizing hormone drugs are prescribed in parallel);
for controlled stimulation of superovulation in an IVF cycle.

For men, Gonal F is prescribed for the treatment of infertility, with the aim of stimulating sperm maturation.

Instructions for use

Gonal F is prescribed to stimulate ovulation from days 2-5 of the menstrual cycle. In the future, injections are carried out every day. Stimulation is carried out under ultrasound control (folliculometry). With its help, the doctor evaluates the process of follicle maturation.

The initial dose of the drug and the maximum permissible single dose are prescribed by the doctor.

If the doctor does not obtain the expected result at the maximum therapeutic dose, stimulation is stopped after 4 weeks.

If the normal, expected size and number of follicles are achieved, hCG is administered 24-48 hours after their maturation to induce ovulation. The next day, sexual intercourse is recommended or intrauterine insemination is performed.

For men, Gonal F is prescribed to stimulate spermatogenesis. Dosage – 150 IU, once a day, 3 times a week. The course of treatment is 4 months. Combination with other drugs (hCG) is possible. The duration of treatment, if necessary, can last up to 18 months.

Gonal F for IVF

Gonal F during IVF is prescribed to stimulate superovulation. The starting dose is prescribed individually. Begin administering the drug daily, from day 2-3 of the cycle. The maximum daily dose of the drug for IVF should not exceed 450 IU. As it increases, the risk of developing OHSS (ovarian hyperstimulation syndrome) increases significantly.

Features of using Gonal F before IVF:

the dry substance, the contents of the ampoule, is diluted immediately before the injection;
the first administration should be carried out by a doctor, or by the patient under the supervision of a doctor or experienced nurse;
further use of the drug can be carried out by the patient independently, provided that all the doctor’s instructions are strictly followed;
The injection site is changed every day.

If the response is excessive, as determined by ultrasound, Gonal F is discontinued. In the next cycle, stimulation begins with smaller doses of the drug.

Security Profile

The IVF drug Gonal F, intended to stimulate ovulation in women, has contraindications. The main ones among them are:

cysts or voluminous tumors of the ovaries;
malignant neoplasms in the mammary glands or uterus;
ovarian carcinoma;
uterine bleeding of unknown origin.

When administering the drug before IVF, some side effects may occur. Among them, women most often experience:

headache;
abdominal pain and dyspeptic symptoms (belching, flatulence, heaviness in the abdomen);
functional ovarian cysts;
hyperstimulation syndrome;
redness at the injection site.

The most common side effects in men:

breast enlargement;
dilation of the veins of the scrotum;
acne on the skin;
increase in body weight;
redness or swelling at the injection site.

When used correctly under the supervision of a physician, Gonal F does not cause irreversible or dangerous health consequences in most patients.

You can buy Gonal F in Moscow at the pharmacy on site.

Direct supplies of original medicines directly from official pharmaceutical representatives, without intermediaries, guarantee the receipt of certified medicines. That is why the price for Gonal F at a pharmacy in Moscow does not contain additional markups from intermediaries.

The price of the drug Gonal F can be found by phone +7 (495) 781-01-10

Precautionary measures

Before starting treatment with Gonal-F

, you need to tell your doctor if you are allergic to the active substance or one of the excipients of the drug, or if you have allergic reactions to other drugs or foods. Be sure to tell your doctor your medical history, especially if there are concomitant pathologies - this will help avoid unwanted side effects.

Patients with hypersensitivity to non-FSH gonadotropins are at high risk of allergic cross-reaction. For this reason, the first injection should be done under the direct supervision of a doctor.

Self-administration of Gonal-F should only be trusted to those patients who are very well motivated and properly trained. The patient should have free access to expert advice. Particular attention should be paid to the instructions for using the pre-filled pen.

Gonal-f 75me 5.5 µg n1 lyophilisate for solution preparation

The drug is administered subcutaneously.

Women

In case of anovulatory infertility with a preserved menstrual cycle or with a violation of its periodicity, treatment begins in the first 7 days of the cycle. Stimulation is carried out under ultrasound control (follicle sizes are measured) and/or estrogen levels. Stimulation begins with a daily dose of 75-150 ME, increasing it by 37.5 ME-75 ME after 7-14 days until the desired effect is obtained. The maximum dose for one injection is 225 IU. If there is no positive dynamics after 4 weeks, treatment is stopped. In the next cycle, stimulation should begin with a higher dose.

After reaching the optimal size of the follicles, 24-48 hours after the last injection of the drug Gonal-F, a single dose of recombinant human chorionic gonadotropin (hCG) is administered at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse.

In case of excessive ovarian response to stimulation, the administration of human chorionic gonadotropin should be discontinued. In the next cycle, a lower dose is prescribed compared to the previous one.

When conducting controlled ovarian hyperstimulation for assisted reproductive technologies, Gonal-F® is prescribed daily at a dose of 150-225 IU, starting from the 2-3rd day of the cycle. The daily dose may vary, but usually does not exceed 450 IU. Treatment is continued until the follicles reach adequate size according to ultrasound (on average 5-20 days). 24-48 hours after the last injection of Gonal-F®, a single dose of recombinant hCG is administered at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU to induce the final maturation of follicles.

GnRH analogues are used to suppress the endogenous LH surge and maintain it at a low level.

In case of anovulatory infertility with absence of the menstrual cycle as a result of FSH and LH deficiency, the doctor determines the dose of the drug and treatment regimen individually. Typically, Gonal-F® is prescribed daily for up to 5 weeks concomitantly with LH. Treatment with Gonal-F® begins with a dose of 75-150 IU simultaneously with lutropin alfa at a dose of 75 IU. If necessary, the dose of Gonal-F® can be increased by 37.5-75 IU every 7-14 days. If there is no adequate response to stimulation within 5 weeks, therapy should be stopped and resumed in a new cycle at a higher dose.

After reaching the optimal size of the follicle/follicles, 24-48 hours after the last injection of Gonal-F® and lutropin alfa, a single dose of recombinant hCG is administered at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed.

If the ovaries respond excessively to stimulation, treatment should be discontinued and hCG should be discontinued. Stimulation is repeated in the next cycle, starting with a lower dose compared to the previous cycle.

Men

Gonal-F® is prescribed, as a rule, at a dose of 150 IU 3 times a week for at least 4 months in combination with hCG. If there is no positive effect during this time, treatment can be continued for up to 18 months.

Rules for administering the drug

When using the drug independently, patients should carefully study the instructions.

The packaging of the drug is intended for individual use. After the first injection, the next injection should be given the next day at the same time.

1. The injection should be carried out in compliance with the rules of asepsis and antisepsis.

2. To carry out the injection, you need to lay out 2 alcohol-soaked swabs, a pre-filled syringe pen and an injection needle on a clean surface.

Preparing a pre-filled syringe pen of the drug Gonal-F® for the first use: remove the cap of the pen, put on the needle as described in step 3. Then fill the syringe pen by placing the dose indicator arrow opposite point 37.5 on the black disk to set the dose. Press the injection button all the way, remove the outer needle cap, then the inner needle cap, while holding the syringe pen with the needle vertically (the needle should be pointing up). Gently tap the cartridge location so that any air bubbles collect at the base of the needle. While pointing the needle vertically upward, release the injection button completely. A drop may appear at the tip of the needle. This means the pre-filled pen is ready to be injected. The loss of a small amount of fluid at the tip of the needle does not matter, because... the syringe pen is specially filled with some excess. If liquid does not appear at the tip of the needle, then the preparation process should be repeated. Then the dose should be set as described in paragraph 4.

For the next injection, attach the needle and set the dose as described in paragraphs. 3 and 4 respectively.

3. Attaching the needle. Get a new needle. If the needle packaging is broken, you should throw the needle away and get a new one. Remove the protective label from the outer needle cap, remove the protective label from the inner needle cap. Holding the needle firmly by the inner cap, insert the threaded tip into the needle and turn clockwise until it clicks into place. Only use the needles included with the pen or supplied separately for this pen.

4. Dose setting. Set the required dose by turning the dose setting dial until the dose value is opposite the arrow. The dose dial allows you to set the dose in 37.5 IU intervals. The minimum dose and maximum dose range from 37.5 IU to 300 IU. After establishing the required dose, dial it by pressing the injection button all the way. It is necessary to carefully monitor the set dose on the disk, because Once the injection button is pressed, it can no longer be changed. If, after pressing the injection button and dialing the dose, it turns out that the dose was dialed incorrectly, then the injection should not be given. Delete the erroneously dialed dose and repeat the dialing again. The red dose control dial should be checked to ensure that the correct dose is dialed: when the injection button is released, the number on the red control dial indicating the dose dialed is opposite the dose set on the black dose dial against the arrow. If the dialed dose is less than the required one, then dosing is not completed. In this case, you must act in accordance with clause 2.

If the same dose is required each time, the dose indicator arrow should remain in the same position.

5. The injection site chosen on the doctor’s recommendation should be treated with an alcohol swab. Insert the needle into the skin and press the injection button. Leave the needle in the skin for at least 10 seconds. Keep the button pressed as long as the needle remains in the skin. This ensures that the required dose is completely administered.

6. Removing the needle. The needle should be thrown away after each injection. Holding the syringe pen firmly by the drug reservoir, carefully place the outer cap on the needle. Clamp the outer needle cap and unscrew the needle by turning it counterclockwise. Throw away the used needle. Place the protective cap on the syringe pen.

7. Storing a pre-filled pen. After injection, remove used needles as described in step 6. Place the protective cap on the syringe pen. The pen syringe should be stored in a safe place, preferably in its original packaging. Once the pen is empty, you should throw it away.

Note: The scale visible through the medication reservoir serves as an indicator of the amount of medication remaining in the reservoir. It cannot be used to set the dose. The red dose control dial on the injection button is used to monitor whether the last dose has been fully injected. It changes its position, indicating the amount of drug in the reservoir. If the collected dose is not sufficient to complete the injection, there are two options: a) inject the dose remaining in the pen, and then take a new pen, set the remainder of the required dose on it and inject it; b) throw away the old syringe pen, take a new one and administer the required dose.

Patients should be warned to consult a physician if a larger dose than required is administered or if a dose is missed; Do not administer a double dose of the drug.

How to use

Despite the fact that Gonal-F is available in different doses, its preparation and use are the same in all cases. If a woman is undergoing an IVF cycle, the medical center staff will teach her step by step how to administer the drug.

How to use the Gonal-F syringe pen

Gonal-F injection

To use the medicine correctly you should:

dissolve the product by mixing the liquid with the powder until the solution becomes homogeneous, without suspended particles - the drug cannot be used if it contains flakes, grains and other impurities;
change the dilution needle to a hypodermic needle and set the desired dose;
Before giving the injection, treat the desired area with an alcohol swab;
administer Gonal-F subcutaneously or intramuscularly, in accordance with the doctor’s recommendations;
remove the needle, press a cotton swab moistened with alcohol to the injection site and massage lightly - this will promote better absorption of the medicine;
Dispose of needles and syringe according to instructions.

Gonal-F should be administered once a day, at the same time, every day. To reduce the negative impact on the skin, the injection site should be changed. If you miss a shot or get the wrong dose, contact your doctor immediately.

Preparing the injection

Injection administration

Syringe pen Gonal-F

To facilitate the administration of the drug and for the purpose of precise dosage, scientists have developed a syringe pen that clearly regulates the dose of the drug. Today we will tell you about the features of using such a pen and how to use it correctly.

So, in order to figure out how to correctly set the dosage in pens, I would like to briefly talk about its basic scheme. The cartridge with the drug is already inserted into the pen, so you do not have to do it yourself. In order to use it, you need to remove the cap from the pen and connect a sterile needle to it. For each manipulation, an individual needle is taken, the tightness of which must not be broken. If it becomes depressurized, it is not recommended to use it. After the needle is connected to the cartridge, the syringe pen must be lifted vertically to remove air bubbles and scroll the pen body to the 25 UNIT mark in the window. Then remove the inner cap from the needle and lightly tap the syringe to shake off the air, and then press the injection button. The number 0 in the window on the handle will indicate that the air has been removed.

On the prescription sheet, the doctor notes the drug administration schedule - when and how much it costs to administer gonal, you look at the date and dose of the drug that you need. Using the injection button, make turns until the number assigned to you appears in the window. Under no circumstances should you push, press or pull up on the injection button. After making sure that the dose of the drug has been administered correctly, prepare the injection site. The best place for injection will be the anterior abdominal wall or thigh. After treating the injection site with alcohol, give a few seconds for the alcohol to evaporate and carry out the manipulation. In order for the injection to be painless, the woman gathers the subcutaneous tissue into a fold and pierces it all the way so that the needle goes completely under the skin. Then press the injection button and do not remove the needle for 10 seconds so that the drug completely enters the subcutaneous tissue. After removing the needle, apply a sterile napkin and massage the injection site.

The used needle must be disposed of, and the syringe pen must be closed and stored at room temperature in places away from children and the sun for 28 days.

How to use bonuses remaining in pens? Many women, after a course of treatment, note that there is some drug left in the syringe and decide that somewhere they made a mistake and panic begins. In fact, everything is not like that at all. The fact is that the dosage of drug administration in each specific case is different, so some may have 100 IU left, while others may have more or less IU. What to do about it? There is no need to panic, as it is easy to calculate how much of the drug is needed for the subsequent injection, which is placed in a new pen syringe and administered.

The doctor controls the stimulation of ovulation and the growth of follicles not only using the ultrasound method, but also using the hormonal method.

Preparing the pen syringe

Using a pen syringe

Gonal-f, 1 piece, 0.5 ml, 22 mcg/0.5 ml, solution for subcutaneous administration

Since the drug can cause various adverse reactions, GONAL-f® should be prescribed only by a medical specialist who is directly involved in infertility problems. The start of therapy should be preceded by an examination of the infertile couple, in particular, examinations should be carried out to exclude hypothyroidism, adrenal insufficiency, hyperprolactinemia, hypothalamic-pituitary neoplasms, and, if necessary, appropriate therapy should be prescribed.

It is necessary to assess the patency of the fallopian tubes in order to select the ART method. Tubal obstruction should be excluded if the patient is not participating in an in vitro fertilization program.

In patients with porphyria, as well as with a history of porphyria, careful monitoring is required during therapy with GONAL-f®. If the condition worsens or the first signs of this disease appear, it may be necessary to discontinue therapy.

When treating with GONAL-f®, it is necessary to assess the condition of the ovaries using ultrasound, both separately and in combination with the determination of estradiol in the blood plasma.

The response to FSH may vary between patients, so the minimum effective dose should be used in both women and men.

The drug GONAL-f® contains less than 1 mmol (23 mg) sodium in 1 dose, i.e. not a significant source of sodium.

OHSS must be differentiated from uncomplicated ovarian enlargement. Clinical symptoms of OHSS may appear with increasing severity. Characterized by a significant increase in the size of the ovaries, high levels of sex hormones, increased vascular permeability, leading to the accumulation of fluid in the abdominal, pleural and, less commonly, pericardial cavities.

The following symptoms are most typical for severe OHSS: pain and a feeling of fullness in the abdomen, a marked increase in the size of the ovaries, increased body weight, shortness of breath, oliguria, gastrointestinal symptoms (nausea, vomiting, diarrhea); hypovolemia, hemoconcentration, electrolyte imbalance, ascites, hemoperitonium, pleural effusion, hydrothorax, acute respiratory distress syndrome may occur. In very rare cases, severe OHSS may be complicated by ovarian torsion and thromboembolic events such as pulmonary embolism, ischemic stroke or myocardial infarction.

Independent risk factors for the development of OHSS are polycystic ovary syndrome or high concentrations of estradiol in the blood plasma. During anovulation, the risk of developing OHSS increases with an estradiol concentration of >900 pg/ml (3300 pmol/l) and the presence of more than 3 follicles with a diameter of 14 mm or more. With ART, the risk of developing OHSS increases with an estradiol concentration of >3000 pg/ml (11,000 pmol/l) or the presence of 20 or more follicles with a diameter of 12 mm or more.

Strict adherence to the recommended dosage of GONAL-f®, as well as careful monitoring of therapy, minimize the risk of developing OHSS and multiple pregnancies.

There is reason to believe that hCG plays a key role in the occurrence of OHSS. When pregnancy occurs, the severity of OHSS may worsen and its duration may increase. When estradiol levels are >5500 pg/mL (20,200 pmol/L) or when there are 40 or more follicles, hCG should be avoided. The patient is advised to abstain from coitus for 4 days or use barrier methods of contraception.

OHSS can progress quickly (from a day to several days) to a severe condition. Most often, OHSS occurs after cessation of hormonal therapy and reaches its maximum after 7-10 days, therefore, after the introduction of hCG, observation for at least two weeks is necessary.

The likelihood of OHSS in patients undergoing controlled ovarian hyperstimulation for ART is reduced by aspiration of all follicles.

Mild to moderate OHSS resolves spontaneously. If severe OHSS develops, gonadotropin therapy, if still ongoing, should be discontinued. The patient should be hospitalized and given OHSS-specific therapy.

Multiple pregnancy

The frequency of multiple pregnancies and births during ovulation induction is higher compared to natural conception. The most common option for multiple pregnancy is twins. Multiple pregnancies, especially those with a large number of embryos, increase the risk of adverse outcomes for the mother and fetus. To minimize the risk of multiple pregnancies, careful monitoring of the ovarian response is necessary. With ART, the risk of multiple pregnancy is mainly related to the number of embryos transferred, their viability and the age of the patient.

Miscarriage

The incidence of miscarriage or spontaneous abortions (miscarriages) after ovulation induction and ART programs is higher than in the general population.

Ectopic pregnancy

Patients with a history of fallopian tube disease have an increased risk of ectopic pregnancy. The likelihood of ectopic pregnancy after the use of assisted reproductive technologies is higher than in the general population.

Neoplasms of the reproductive system

There are reports of benign and malignant neoplasms of the ovary and other reproductive organs in women after repeated courses of infertility treatment with various drugs. Currently, no connection has been established between gonadotropin therapy and an increased risk of neoplasms in infertility.

Congenital malformations

The incidence of congenital anomalies after the use of ART programs may be slightly higher than during natural pregnancy and childbirth. However, it is unknown whether this is due to parental characteristics (eg maternal age, sperm quality) and multiple pregnancies or directly to ART procedures.

Thromboembolic complications

In patients with recent or current thromboembolic diseases, as well as at a probable risk of their occurrence, the use of gonadotropins may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy must be weighed against the possible risks. It should be noted that pregnancy itself carries an increased risk of thromboembolic disorders.

Treatment for men

An increased concentration of FSH in the blood serum of men may indicate primary testicular failure. In this case, treatment with r-hFSH/xCG is ineffective and GONAL-f® should not be prescribed.

4–6 months after the start of therapy, it is recommended to monitor the spermogram. Patients should be aware of the above risks before starting therapy.

It is necessary to inform the doctor about all types of allergic reactions that the patient has, as well as about all drugs used before starting treatment with GONAL-f®.

It is necessary to mark the date of first use on the handle with the drug.

After the first use, the drug can be stored for no more than 28 days at a temperature not exceeding 25 °C. Do not use the drug after this period. Within the expiration date, the drug can be stored at a temperature not exceeding 25 °C for up to 3 months. After 3 months it should be destroyed if not used. Re-refrigeration is not permitted.

The effect of the drug on driving a car and operating other mechanisms.

The drug GONAL-f® does not affect the ability to drive a car or operate other mechanisms.

Recommendations for self-administration of the drug

When using the drug yourself, you must first carefully read the instructions. The doctor will prescribe the patient a dose in IU. One package of the drug is intended for use by only one patient. The patient should prepare a prefilled pen and administer the injection. The next injection should be given the next day at the same time.

1. Wash your hands. It is very important that the hands and all objects used by the patient are as clean as possible. Gather everything you need to perform the injection. On a clean surface, lay out everything that will be used: 2 alcohol-soaked swabs, a pre-filled pen and an injection needle.

2. Prepare the pre-filled GONAL-f® pen for the first use: remove the pen cap and insert the needle as described in step 3. Then refill the pen by placing the dose indicator arrow opposite point 37.5 on the black scale of the dose setting disk. Pull out the injection button until it stops, remove the outer needle cap, then the inner needle cap, while holding the handle with the needle vertically (the needle should be pointing up). Gently tap the location of the cartridge so that any air bubbles collect at the base of the needle. Pointing the needle vertically upward, press the injection button. A drop should appear at the tip of the needle. This means the pre-filled pen is ready for injection. If liquid does not appear at the tip of the needle, repeat the preparation process. Then set the dose as described in paragraph 4. For the next injection, put on the needle and set the dose as described in paragraph. 3 and 4 respectively.

3. Attaching a needle

Get a new needle. If the needle packaging is broken, you should not use it, you must take a new one. Remove the protective membrane from the outer needle cap. Holding the needle firmly by the outer cap, insert the needle into the pen onto the threaded tip and turn clockwise until it clicks into place.

Attention:

Use only the needles included with the pen or supplied separately for this pen.

4. Dose setting

Set the required dose by turning the dose dial with a black scale until the dose value is opposite the arrow (the dose dial allows you to set the dose in intervals of 37.5 IU. The minimum dose and maximum dose are in the range from 37.5 to 300 IU ). After setting the required dose, dial it by pulling the injection button all the way. Try to lift the button straight and not rotate it, because... this may change the prescribed dose.

Attention:

You should carefully monitor the set dose on the disk, because after pulling out the button for injection, it will no longer be possible to change the dose, because it's already dialed. If an error is detected after pulling out the injection button and dialing the dose, do not inject. Remove the dialed dose and repeat the dial again.

Check the red scale of the dose control dial to ensure that the correct dose is dialed: when the injection button is pulled out, the number on the red scale of the control dial indicating the dose dialed is opposite the dose set on the black scale of the dose dial against the arrow. If the dialed dose is less than the required dose, dosing is not completed. In this case, you must follow the instructions given in paragraph 2.

If the same dose is required each time, the dose indicator arrow should remain in the same position.

5. Dose administration

Select the injection site in accordance with your doctor's recommendations. Wipe the injection site with an alcohol swab. Use the insertion technique recommended by your doctor or nurse. Insert the needle into the skin and press the injection button. Make sure that the gray full dose indicator is no longer visible. This position of the indicator indicates delivery of the full dose. You must hold the needle in the skin and keep the injection button pressed for at least 10 seconds. When removing the needle from the skin, you must continue to hold the button down.

6. Removing the needle

Remove the needle after each injection and throw it away. Hold the handle firmly by the drug reservoir. Carefully place the outer cap on the needle. Clamp the outer needle cap and unscrew the needle by turning it counterclockwise. Throw away the used needle. Place the cap on the pen.

7. Storing a pre-filled pen

After the injection, remove the used needles as described in paragraph 6. Put the protective cap on the pen. Store the pen in a safe place, preferably in its original packaging. Once the pen is empty, throw it away.

Note.

The scale, which can be seen through the drug reservoir, serves as an indicator of the amount of drug remaining in the reservoir. It cannot be used to set the dose.

8. The dose control dial with a red scale on the injection button is used to monitor whether the last dose has been fully injected or not. It changes its position, indicating the amount of drug in the reservoir. If the collected dose is not sufficient to complete the injection, there are two options:

A. Inject the dose remaining in the pen, and then take a new pen, set the remaining portion of the required dose on it, and administer it.

b. Throw away the old pen, take a new one and administer the required dose.

If more is administered than required, see “Side effects” and “Overdose”.

If a dose is missed, do not administer a double dose.

Dosage

The dose of Gonal-F varies depending on the specific case and the purpose of treatment.

Dose of the drug for artificial insemination

In artificial insemination cycles, doctors practice mild ovarian stimulation. The goal of treatment is not to stimulate the ovaries, but to induce ovulation. In order for the procedure to be successful, it is enough to obtain 2-3 mature follicles.

The dose of Gonal-F for artificial insemination is 75-150 IU. Rarely does the daily dose exceed 225 IU.

Dosage in the IVF program

Unlike artificial insemination cycles, IVF patients undergo controlled ovarian stimulation. The doctor's goal in this case is to obtain 8-15 mature follicles with eggs, which can be collected using a puncture.

The dose of the drug in IVF cycles can range from 150 to 450 IU per day.

Regardless of your fertility treatment, your doctor will schedule a series of follow-up visits to assess estradiol levels and monitor follicle growth. The administered dose may be changed depending on the results of the examination.

Contraindications for use

Gonal-F should not be used if you are hypersensitive to follitropin alfa, FSH or any of the excipients of the drug.

In addition, the drug is contraindicated in the following cases:

tumors of the hypothalamus or pituitary gland;
large ovarian cysts not caused by PCOS;
vaginal bleeding of unknown origin;
cancer of the reproductive system or mammary glands;
period of lactation or pregnancy;
with primary ovarian or testicular failure;
developmental anomalies of the female reproductive organs incompatible with pregnancy;
uterine fibroids, which prevents pregnancy.

Gonal-F should not be used to treat children and the elderly.

Contraindications for use

GONAL-F® (Gonal-F®)

It is necessary to assess the patency of the fallopian tubes in order to select a method of assisted reproductive technology. Tubal obstruction should be excluded if the patient is not participating in an in vitro fertilization program.

In patients with porphyria, as well as in the presence of porphyria in relatives, careful monitoring is required during therapy with GONAL-f®. If the condition worsens or the first signs of this disease appear, it may be necessary to discontinue therapy.

When treating with GONAL-f®, it is necessary to assess the condition of the ovaries using ultrasound (ultrasound), both separately and in combination with the determination of estradiol in the blood plasma. Reaction to introduction

Follicle stimulating hormone levels may vary between patients, so the minimum effective dose should be used in both women and men.

The drug GONAL-f® contains less than 1 mmol (23 mg) sodium in 1 dose, that is, it is not a significant source of sodium. Ovarian hyperstimulation syndrome (OHSS)

In order to minimize the risk of OHSS and multiple pregnancies, it is recommended to regularly use ultrasound and evaluate the concentration of estradiol in the blood plasma for early identification of risk factors. Independent risk factors for the development of OHSS are polycystic ovary syndrome or high concentrations of estradiol in the blood plasma. During anovulation, the risk of developed OHSS increases with estradiol concentrations > 900 pg/ml (3300 pmol/l) and the presence of more than 3 follicles with a diameter of 14 mm or more. With ART, the risk of developing OHSS increases with estradiol concentrations > 3000 pg/ml (11,000 pmol/l) or the presence of 20 or more follicles with a diameter of 12 mm or more.

Strict adherence to the recommended dosage of GONAL-f®, as well as careful monitoring of therapy, minimizes the risk of developing OHSS and multiple pregnancies.

OHSS can progress quickly (from a day to several days) to a severe condition. Most often, OHSS occurs after cessation of hormonal therapy and reaches its maximum after 7-10 days, therefore, after the administration of hCG, observation for at least two weeks is necessary.

The likelihood of ovarian hyperstimulation syndrome in patients undergoing controlled ovarian hyperstimulation for ART is reduced by aspiration of all follicles.

Multiple pregnancy

Miscarriage

The incidence of miscarriage or spontaneous abortions (miscarriages) after ovulation induction and ART programs is higher than in the general population. Ectopic pregnancy

Patients with a history of tubal disease have an increased risk of ectopic pregnancy. The likelihood of ectopic pregnancy after the use of assisted reproductive technologies is higher than in the general population.

Neoplasms of the reproductive system

Congenital malformations

The incidence of congenital anomalies after the use of ART programs may be slightly higher than during natural pregnancy and childbirth. However, it is unknown whether this is due to parental characteristics (eg, maternal age, sperm quality) and multiple pregnancies or directly to ART procedures.

Thromboembolic complications

Treatment for men

An increased concentration of follicle-stimulating hormone in the blood serum of men may indicate primary testicular failure. In this case, treatment with r-hFSH/hCG is ineffective and GONAL-f® should not be prescribed.

4-6 months after the start of therapy, it is recommended to monitor the spermogram. Patients should be aware of the above risks before starting therapy.

It is necessary to inform the doctor about all types of allergic reactions that the patient has, as well as about all drugs used before starting treatment with GONAL-f®. It is necessary to mark the date of first use on the handle with the drug.

After the first use, the drug can be stored for no more than 28 days at a temperature not exceeding 25 °C. Do not use the drug after this period.

Within the expiration date, the drug can be stored at a temperature not exceeding 25 ° C for up to 3 months. After 3 months it should be destroyed if not used. Re-refrigeration is not permitted.

Interactions and side effects

No clinically significant drug interactions have been reported during treatment with Gonal-F. GnRH may interact with the drug, increasing the dose required for an adequate ovarian response. When using the drug, local reactions are very rarely possible, such as redness, irritation, soreness, swelling of soft tissues at the injection site, headaches or the development of ovarian cysts. Severe side effects, which occur less frequently than 1/10,000, include ovarian hyperstimulation syndrome, allergies or episodes of thromboembolism.