Gonal-f

Gonal-f – recombinant follicle-stimulating hormone of the person.

Form of release and structure

Dosage forms:

• Lyophilisate for preparation of solution for hypodermic (п / to) introductions: powder or mass of white color (glass bottles of 3 ml, in a cardboard pack of 1, 3, 5 or 10 bottles complete with solvent in syringes or bottles of 1, 3, 5 or 10 pieces respectively);
• Solution for п / to introduction: transparent, colourless liquid, is possible easy opalescence (the syringe handle on 0,5 ml, 0,75 ml, 1,5 ml, in a plastic container 1 the syringe handle complete with 5, 7 or 14 needles disposable respectively, in a cardboard box 1 container).

Active ingredient Gonala-f – follitropin an alpha:

• 1 bottle – 5,5 mkg, or 75 international units (IU);
• 1 syringe handle – 22 mkg (300 ME), 33 mkg (450 ME), 66 mkg (900 ME).

Excipients:

• Lyophilisate: hydrophosphate sodium dihydrate, sucrose, dihydrophosphate sodium monohydrate, sodium hydroxide, phosphoric acid, polysorbate 20, methionine;
• Solution: sucrose, half-oxameasures 188, methionine, hydrophosphate sodium a dihydrate, dihydrophosphate sodium monohydrate, m cresol, sodium hydroxide, phosphoric acid, water for injections.

Solvent: water for injections.

Indications to use

Use Gonala-f is shown at treatment of infertility at women:

• Ovarian stimulation at inefficiency of therapy by clomifene and lack of growth and maturing of follicles, including against the background of a syndrome of polycystic ovaries;
• The controlled ovarian increased stimulation in the program of auxiliary reproductive technology;
• Ovarian stimulation at hypogonadotropic pathologies (in a combination with lutropin drug).

Besides, drug is used at treatment of a hypogonadotropic hypogonadism at men for stimulation of a spermatogenesis (in combination with a chorionic gonadotrophin).

Contraindications

• Tumors of a hypophysis or hypothalamus;
• Hypersensitivity to drug components.

Besides, contraindications to use for women:

• The volume tumors or cysts of ovaries which are not caused by a syndrome of a polycystosis of ovaries;
• Uterus cancer;
• Ovary carcinoma;
• Cancer of mammary glands;
• Uterine bleedings of an unspecified etiology;
• Ovarian primary insufficiency;
• Fibromyoma of a uterus and anomaly of development of generative organs incompatible with pregnancy;
• Period of pregnancy and breastfeeding;
• Premature menopause.

Men cannot appoint drug with primary testicular insufficiency.

Route of administration and dosage

Gonal-F enter п / to, daily changing the place of an injection.

The mode of dosing and the period of use are appointed by the doctor on the basis of clinical indications.

The recommended dosing for women:

• Anovulatory infertility with the kept menstrual cycle, including at disturbance of its frequency: an initial dose – 75-150 ME 1 time a day, everyone 7 or 14 days (are desirable) it is necessary to raise a dose on 37,5-75 ME to obtaining desirable effect. Treatment needs to be begun in the first 7 days of a menstrual cycle. Stimulation is carried out under control of ultrasonography (ultrasonography), measuring the level of estrogen in blood and/or size of follicles. The dose of one injection should not exceed 225 ME. Therapy is stopped in the absence of positive dynamics after 4 weeks of use of drug, renewing in the following cycle from higher dose. At achievement of optimum reaction 24-48 hours later after the last p / to a drug injection the patient needs single administration of recombinant human choriogonadotropin (r-chHG) in a dose of 250 mkg or a human chorionic gonadotrophin (chHG) in a dose of 5-10 thousand ME. In day of introduction of chHG and next day the sexual contact is recommended to the woman. At the excessive response of ovaries to stimulation introduction of chHG should be cancelled. In the following cycle it is necessary to carry out stimulation in lower dose;
• Controlled ovarian hyper stimulation in the program of the auxiliary reproductive technology (ART): 150-225 ME 1 times a day, since 2-3 days of a cycle. The daily dose can vary, but should not exceed 450 ME. Treatment is continued by from 5 to 20 days, usually by 10th day of administration of drug according to ultrasonography follicles reach the adequate sizes. In 24-48 hours after the last injection single introduction of 250 mkg r-chHG or 5-10 thousand ME chHG for acceleration of final maturing of follicles follows. Suppression of endogenous emission of the luteinizing hormone (LH) and its maintenance is at a low level reached by introduction within 2 weeks of an agonist or the antagonist a gonadotrophin-rileasing of hormone (GNRG). Then therapy is continued within 7 days in combination with Gonalom-f in a dose 150-225 ME before achievement by follicles of the adequate sizes. Further the dose can be adjusted taking into account the answer of ovaries. The probability of successful therapy remains in the course of carrying out the first 4 attempts;
• Ovarian stimulation at hypogonadotropic pathologies in a combination with lutropin drug (LG): the dose and the scheme is selected individually. Usually, an initial dose – 75-150 ME 1 times a day within no more than 35 days along with 75 ME lutropin an alpha. If necessary Gonala-f it is possible to raise a dose each 7-14 days on 37,5-75 ME. If during the specified course stimulation does not give the adequate answer, treatment is stopped and renewed in higher dose in the following cycle. At achievement by follicles of the optimum sizes in 24-48 hours after the last injection of drug and a lutropin an alpha once enter 250 mkg r-chHG or 5-10 thousand ME chHG. The sexual contact is necessary in day of an injection of chHG and next day or it is alternatively possible to carry out intrauterine insemination. At the excessive response of ovaries to stimulation therapy should be stopped and resumed in the following cycle from lower dose Gonala-f.

To men drug is appointed at a hypogonadotropic hypogonadism for stimulation of a spermatogenesis on 150 ME 1 times in 2 days. A course of treatment in combination with chHG – 4 and more months. In the absence of clinical effect treatment can be prolonged up to 18 months.

Side effects

Very often use Gonala-f causes local reactions in the form of bruises, reddenings, pains, hypostasis in the place of an injection of easy or average degree of manifestation.

Both forms of drug can cause side effects in women:

• Reproductive system: very often – cysts of ovaries; often – the syndrome of hyper stimulation of ovaries (SHSO) easy or moderate severity; seldom – at women with a disease of fallopian pipes in the anamnesis – an extrauterine pregnancy, SGYa complication in the form of oothecoma torsion, polycarpous pregnancy;
• Alimentary system: often – abdominal pains, nausea, vomiting, diarrhea;
• Cardiovascular system: very seldom – increase in coagulability of blood (thromboembolism);
• From respiratory system: very seldom – patients with bronchial asthma have an aggravation or deterioration in disease;
• Allergic reactions: very seldom – slight erubescence, rash, puffiness of the person, a small tortoiseshell, the complicated breath, heavy allergic reactions, including an anaphylaxis and shock.

Besides, undesirable effects against the background of use of lyophilisate for women can become:

• Nervous system: often – a headache;
• Cardiovascular system: very seldom – an ischemic stroke, a pulmonary embolism, a myocardial infarction;
• Alimentary system: often – an eructation, colic;
• Reproductive system: seldom – a severe form of SGYa, an ovary apoplexy;
• Others: arthralgia, fever, acute pulmonary insufficiency.

Also solution use Gonala-f can cause side effects in women:

• Nervous system: very often – a headache;
• Alimentary system: often – discomfort in a stomach, weight;
• Reproductive system: infrequently – a severe form of SGYa.

At men use of drug can become the reason of side effects:

• Dermatological reactions: often – an acne;
• Endocrine system: often – a gynecomastia;
• Reproductive system: often – to the varikotsela;
• Others: often – increase in body weight.

Besides, use of solution for men causes side reactions:

• Immune system: very seldom – system allergic reactions easy and moderate severity (erubescence, a small tortoiseshell, puffiness of the person, rash, the complicated breath), anaphylactic reactions, shock;
• Respiratory system: very seldom – deterioration in a current or an exacerbation of bronchial asthma.

Special instructions

It is necessary to use drug under control of the doctor with experience of treatment of infertility.

The first injection of drug is carried out by the qualified specialist. Independent introduction is allowed only if the patient is well trained, motivated and has an opportunity to get advice of the specialist.

Prior to therapy it is necessary to inspect sterile couple regarding an exception of insufficiency of bark of adrenal glands, a hypothyroidism, gipotalamo-pituitary new growths, giperprolaktinemiya.

Assessment of passability of fallopian pipes is necessary.

At a porphyria, including at close relatives, treatment has to take place under careful monitoring of a condition of the patient, in case of his deterioration or emergence of the first symptoms of a disease therapy can be stopped.

Use of drug demands regular assessment of a condition of ovaries with ultrasonography use, including definition of oestradiol in a blood plasma.

Treatment of men and women should be carried out using minimal effective doses.

The Syndrome of Hyper Stimulation of Ovaries (SHSO) should be differentiated from uncomplicated increase in ovaries. Essential increase in the sizes of ovaries and vascular permeability, the considerable level of sex hormones causes accumulation of liquid in belly, pleural or pericardiac cavities that is characteristic of clinical symptoms of SGYa.

At a severe form of SGYa the feeling of a raspiraniye and an abdominal pain, an asthma, significant increase in the size of ovaries, an oliguria, increase in body weight, nausea, vomiting, diarrhea, haemo concentration, a hypovolemia, disturbance of electrolytic balance, a hemoperitoneum, ascites, a pleural exudate, an acute respiratory distress syndrome, a hydrothorax appears. Very seldom SGYa can become the reason of torsion of an ovary, an embolism of a pulmonary artery, an ischemic stroke or myocardial infarction.

High level of oestradiol in a blood plasma and a polycystosis of ovaries treat risk factors of development of SGYa.

At strict observance of the mode of dosing and careful monitoring of therapy the risk of development of SGYa and polycarpous pregnancy is minimized.

Patients with the excessive response of ovaries to stimulation of chHG should not appoint and within 4 days the unprotected sexual contact is prohibited them.

At controlled ovarian hyper stimulation for VRT the risk of development of SGYa is reduced by aspiration of all follicles.

Frequency of polycarpous pregnancy, misbirths and ectopic pregnancy after the VRT programs and induction of an ovulation is higher, than at natural conception. The probability of polycarpous pregnancy at VRT depends on quantity of the postponed embryos, their viability and age of the woman.

Repeated carrying out courses of therapy at women can become the reason of benign and malignant tumors of reproductive organs, including an ovary.

As pregnancy increases probability of thromboembolic disturbances, to the women who recently transferred or with the current thromboembolic pathology, it is necessary to compare advantage of therapy with possible risk.

The increased level of follicle-stimulating hormone in blood serum of men can indicate primary testicular insufficiency. Use Gonala-f in this case is not effective. Control of a spermogram for assessment of the response to stimulation is recommended to be carried out after 4-6 months of therapy.

Before purpose of drug the doctor has to be informed on all allergic pathologies of the patient and the drugs used prior to treatment.

Gonal-f does not exert impact on ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

Response of ovaries is strengthened by a drug combination to chHG, clomifene citrate. At desensitization of a hypophysis GNRG analogs Gonala-f is required to increase a dose as the response of ovaries to stimulation decreases.

Terms and storage conditions

To protect from children.

To store in the place protected from light at a temperature: lyophilisate to 25 °C, solution – 2-8 °C, after opening of the syringe handle – no more than 28 days at a temperature not above 25 °C not to freeze.

Period of validity – 2 years.