Puregon
Puregon: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Drug interactions
- 11. Analogs
- 12. Terms and conditions of storage
- 13. Terms of dispensing from pharmacies
- 14. Reviews
- 15. Price in pharmacies
Latin name: Puregon
ATX code: G03GA06
Active ingredient: Follitropin beta (Follitpopin beta)
Manufacturer: Organon (Netherlands)
Description and photo updated: 2018-26-07
Prices in pharmacies: from 950 rubles.
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Puregon is a drug with a follicle-stimulating effect.
Release form and composition
Dosage forms of release:
- Solution for intramuscular and subcutaneous injection: colorless, transparent (in colorless glass bottles of 0.5 ml, 1, 5 or 10 bottles in a cardboard box);
- Solution for subcutaneous administration: colorless, transparent (in colorless glass cartridges of 0.36, 0.72 or 1.08 ml (300/600/900 IU), 1 cartridge in a cardboard box complete with needles - 6 pcs. (300/600 IU) or 9 pcs. (900 IU)).
The composition of 1 bottle (0.5 ml) includes:
- Active substance: recombinant follitropin beta - 100, 150 or 200 IU (international units);
- Auxiliary components: polysorbate 20 - 0.1 mg, sucrose - 25 mg, sodium citrate dihydrate - 7.35 mg, methionine - 0.25 mg, sodium hydroxide 0.1 N or hydrochloric acid 0.1 N - up to pH 7, water for injection - up to 0.5 ml.
The composition of 1 cartridge includes:
- Active substance (0.36 / 0.72 / 1.08 ml): recombinant follitropin beta - 300, 600 or 900 IU;
- Auxiliary components (0.36 / 0.72 / 1.08 ml): polysorbate 20 - 0.105 / 0.177 / 0.234 mg, sucrose - 21/39 / 58.5 mg, sodium citrate dihydrate - 6.17 / 11.5 / 17.2 mg, methionine - 0.21 / 0.39 / 0.59 mg, sodium hydroxide 0.1 N or hydrochloric acid 0.1 N - up to pH 7, benzyl alcohol - 4.2 / 7.8 / 11, 7 mg, water for injection - up to 0.42 / 0.78 / 1.17 ml.
Pharmacological properties
Pharmacodynamics and pharmacokinetics
Puregon contains recombinant follicle-stimulating hormone (FSH), obtained through recombinant DNA technology. It uses a Chinese hamster cell culture that integrates the genes for subunits of human FSH. The primary acid sequence of the recombinant DNA is the same as that of natural human FSH. However, slight differences were found in the structure of the hydrocarbon chain.
FSH is responsible for the production of sex steroid hormones, normal growth and maturation of follicles. The concentration of this substance in the body of women is a factor that determines the onset and duration of follicular development, as well as their number and maturation time. For this reason, Puregon is used to stimulate estrogen synthesis and follicular formation in certain ovarian dysfunctions. Also, the drug is prescribed to induce the development of multiple follicles during artificial insemination (for example, with intracytoplasmic sperm injection, intrauterine insemination, in vitro fertilization / embryo transfer techniques).
After drug therapy for the induction of the final stage of follicle maturation, resumption of meiosis and ovulation, human chorionic gonadotropin (hCG) is usually administered.
In some cases, Puregon is prescribed to men to treat FSH deficiency, leading to impaired spermatogenesis. With such indications for use, a combination of the drug with the administration of hCG is recommended, and the duration of the course of therapy should not be less than 4 months.
After subcutaneous or intramuscular administration of Puregon, the maximum FSH level in the blood plasma is recorded after 12 hours. In men, after intramuscular injection of the drug, the maximum level of FSH in the blood is reached faster than in women. Due to the gradual intake of recombinant follitropin beta into the body from the injection site and the long half-life (12–70 hours, the average is 40 hours), the FSH concentration remains elevated for 24–48 hours. In the future, the repeated administration of the same dose of the hormone causes a further increase in the level of FSH in the blood by 1.5–2 times as compared with a single administration. This makes it possible to achieve the required concentration of FSH in the blood.
With intramuscular and subcutaneous administration of Puregon, the pharmacokinetic parameters remain practically the same. In both cases, the bioavailability of the drug is approximately 77%. Recombinant FSH is biochemically identical to FSH found in human urine and is similarly distributed, metabolized and excreted from the body.
Indications for use
Puregon is prescribed for the treatment of female infertility in the presence of the following indications:
- Superovulation induction - for the induction of multiple follicular development during artificial insemination (for example, in in vitro fertilization / embryo transfer (IVF / ET), intrauterine insemination (IUI) and sperm injection into the cytoplasm (ICSI));
- Anovulation, including polycystic ovary syndrome (PCOS) with clomiphene insensitivity.
Contraindications
- Anatomical disorders of the genital organs that are incompatible with pregnancy;
- Severe functional disorders of the liver / kidneys;
- Bleeding (vaginal / uterine) of unknown origin;
- Tumors of the uterus, breast, ovaries, hypothalamus, pituitary gland;
- Ovarian cysts / enlargement not associated with polycystic ovary syndrome;
- Uterine fibroids incompatible with pregnancy;
- Primary ovarian failure;
- Decompensated diseases of the endocrine system (for example, disorders of the thyroid gland, pituitary gland or adrenal glands);
- Pregnancy and the period of breastfeeding;
- Hypersensitivity to the components of the drug.
Instructions for the use of Puregon: method and dosage
Therapy should be prescribed by a physician experienced in infertility treatment.
The dose must be selected individually, based on the response of the ovaries, under the control of the concentration of estradiol and ultrasound.
Puregon works at a lower total dose and a shorter course of therapy required for maturation, in comparison with urine-derived follicle-stimulating hormone (FSH), which minimizes the likelihood of ovarian hyperstimulation.
The success of treatment is most likely during the first 4 courses, then it gradually decreases.
For anovulation, it is recommended to use a sequential therapy regimen, starting with the daily administration of Puregon at a dose of 50 IU for at least 7 days. In the absence of a response from the ovaries, a gradual increase in the daily dose is shown until follicular growth and / or an increase in the concentration of estradiol in plasma is achieved, which indicate the achievement of an optimal pharmacodynamic response - a daily significant (by 40-100%) increase in the concentration of estradiol in plasma.
Then the daily dose is maintained until the state of preovulation is reached, which is determined by the presence of a dominant follicle with a diameter of at least 0.18 cm (according to ultrasound) and / or the concentration of estradiol in blood plasma 1000-3000 pmol / l (300-900 pg / ml).
In most cases, to achieve this condition, a treatment course of 1-2 weeks is necessary.
After reaching the desired state, the administration of Puregon is stopped and ovulation is induced by the administration of chorionic gonadotropin (CG). If the concentration of estradiol increases too quickly (more than 2 times daily over several consecutive days) or the number of follicles is too large, the daily dose is reduced. Since each follicle with a diameter of 0.14 cm or more is preovulatory, the presence of several such follicles increases the likelihood of developing multiple pregnancies. In this case, gonadotropin should not be administered. Also, to prevent multiple pregnancies, you need to take measures to prevent pregnancy.
In order to induce superovulation during artificial insemination, it is possible to use various schemes for stimulating ovulation with Puregon. For at least the first 4 days, it is recommended to administer 150-225 IU of the drug. In the future, the dose is selected individually, based on the reaction of the ovaries. As a rule, maintenance doses of 75-375 IU are sufficient for 6-12 days, but sometimes longer treatment courses are required.
Puregon is used as monotherapy or in combination with other drugs (gonadoliberin agonist or antagonist (GnRH)) to prevent premature ovulation peak. In cases where GnRH analogues are used, higher total doses of Puregon may be prescribed.
Monitoring the reaction of the ovaries is carried out using ultrasound and determining the concentration of estradiol in plasma. In the presence of at least 3 follicles with a diameter of 0.16-0.20 cm according to ultrasound data, and a good reaction of the ovaries (at a concentration of estradiol in the blood plasma of 1000-1300 pmol / l (300-400 picograms / ml) for each follicle with a diameter greater than 0.18 cm), the introduction of hCG induce the final phase of follicle maturation. Egg aspiration is performed after 34-35 hours.
In order to prevent painful sensations when the solution is injected and to minimize its leakage from the injection site, Puregon should be injected slowly intramuscularly or subcutaneously. Due to the existing risk of developing fatty atrophy, subcutaneous injection sites should be alternated. The unused solution is destroyed.
You can enter the drug subcutaneously on your own after receiving detailed instructions from your doctor.
The solution produced in cartridges is intended for subcutaneous injection using the Puregon Pen injector pen, in vials - for injection using a syringe.
The abdominal area around the navel is the most suitable place for subcutaneous administration of the drug. The injection site should be changed with each injection. It is possible to inject the solution into other parts of the body.
When the drug is injected, the needle is inserted under the skin surface at an angle of 90 °. Before using, make sure that the needle has not pierced an artery or vein.
Gentle massage of the injection site (with constant pressure) contributes to an even distribution of the solution and helps to reduce the risk of developing unpleasant sensations.
Side effects
During the use of Puregon, local reactions may develop in the form of hematoma, pain, hyperemia, edema, itching (observed in 3% of patients). In most cases, these violations are of a short-term and moderate nature.
In 1% of cases, the development of systemic allergic reactions was observed - erythema, urticaria, rash and itching.
Also, during therapy, the development of such diseases / conditions was noted:
- Ovarian hyperstimulation syndrome (about 4% of cases). The main clinical symptoms of this disorder (with a moderate course): diarrhea, nausea, bloating and abdominal pain (associated with impaired venous circulation and irritation of the peritoneum), enlargement of the ovaries due to cysts. In some cases, a life-threatening severe ovarian hyperstimulation syndrome develops. It is characterized by ascites, large, ruptured ovarian cysts, hydrothorax, and weight gain (due to fluid retention). Against the background of ovarian hyperstimulation syndrome, in rare cases, the development of thromboembolism (venous or arterial) was noted;
- Spontaneous abortion;
- Soreness, engorgement and / or pain of the mammary glands;
- Increased likelihood of developing multiple and ectopic pregnancies.
In rare cases, during combination therapy in combination with hCG or other gonadotropic hormones, thromboembolism may develop.
Overdose
There are no data on acute overdose. The introduction of FSH into the body in high doses can cause ovarian hyperstimulation. In this case, the drug is canceled and measures are taken to prevent pregnancy, which is undesirable in this situation. If necessary, symptomatic therapy is prescribed.
special instructions
Before using Puregon, you must exclude the presence of endocrine diseases.
When carrying out the induction of ovulation with the help of gonadotropic drugs, the risk of developing multiple pregnancies increases. The development of multiple follicles is prevented by appropriate dose adjustment of FSH. With multiple pregnancies, there is a higher risk of complications during pregnancy and in the perinatal period. Before starting therapy, women should be warned about the possibility of developing multiple pregnancies.
The first administration of the drug must be carried out under the direct supervision of a specialist.
With artificial insemination, the risk of early termination of pregnancy, as well as the incidence of congenital malformations, is higher (in comparison with natural conception).
During artificial insemination (especially IVF), there are often abnormalities of the fallopian tubes, which increases the likelihood of developing an ectopic pregnancy. Therefore, it is important to obtain early ultrasound confirmation of the intrauterine position of the fetus.
Before the start of ovulation stimulation with Puregon and regularly during therapy, it is necessary to perform ultrasound in order to monitor the development of follicles and determine the concentration of estradiol in plasma. The diagnosis of ovarian hyperstimulation can be confirmed by ultrasound. Transient abnormalities in the results of liver function tests may indicate functional disorders of the liver, which may be accompanied by morphological changes on liver biopsy (there is information about the relationship of this disorder with ovarian hyperstimulation syndrome).
The women of the recognized risk groups with respect to thrombosis (with an appropriate personal or family history, severe obesity with a body mass index> 30 kg / m 2 or diagnosed with thrombophilia) the risk of arterial or venous thromboembolism above (even without concomitant ovarian hyperstimulation syndrome during therapy). In this regard, before the appointment of Puregon, such patients need to compare the likelihood of successful induction of ovulation with the possible risk of complications. It should be borne in mind that pregnancy itself is accompanied by an increased risk of thrombosis.
Puregon may contain traces of neomycin and / or streptomycin, which may cause a hypersensitivity reaction.
Influence on the ability to drive vehicles and complex mechanisms
According to the instructions, Puregon does not significantly affect the ability to drive a car, other vehicles, and work with mechanisms of increased complexity.
Application during pregnancy and lactation
It is prohibited to use Puregon during pregnancy. Due to the lack of a sufficient amount of clinical data regarding the appointment of the drug during this period, in case of accidental administration of the drug to a pregnant woman, the teratogenic effect of recombinant FSH on the fetus cannot be completely ruled out.
Despite a number of clinical studies and animal trials, there is currently no reliable information on the penetration of follitropin beta into breast milk. It is unlikely that this substance is excreted in breast milk due to its high molecular weight. If this happens, it is likely that follitropin beta will be degraded in the baby's GI tract. Also Puregon can affect milk secretion.
Drug interactions
Puregon is pharmaceutically incompatible with other drugs.
When combined with clomiphene, the ovarian response may increase.
To achieve a sufficient ovarian response after desensitization of the pituitary gland with GnRH agonists, the doctor may prescribe higher doses of Puregon.
Analogs
There is no information about Puregon analogues.
Terms and conditions of storage
Store in a dark place, out of reach of children, at a temperature of 2-8 ° C, without freezing.
The shelf life is 3 years.
The maximum shelf life of the solution after inserting the needle into the cartridge is 28 days.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Puregon
Most women who have undergone the appropriate course of therapy leave positive reviews about Puregon. The drug has helped many patients, is well tolerated, convenient and easy to use. Patients note that the drug successfully activates the process of follicular growth and increases the likelihood of conception and pregnancy.
Negative opinions are rare, and complaints about the high cost of the drug dominate.
Price for Puregon in pharmacies
The price of Puregon in the form of a solution for subcutaneous and intramuscular administration of 100 IU is approximately 9,700–11,000 rubles, with a dosage of 600 IU - 11,400–11,600 rubles, and with a dosage of 900 IU - 16,000–17,000 rubles.
Puregon: prices in online pharmacies
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Drug name Price Pharmacy |
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Puregon Peng injection pen for drug administration 1 pc. RUB 950 Buy |
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Puregon 300 IU solution for subcutaneous administration 0.36 ml 1 pc. 5045 RUB Buy |
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Puregon 100 IU solution for intramuscular and subcutaneous administration 0.5 ml 5 pcs. RUB 8174 Buy |
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Puregon 600 IU solution for subcutaneous administration 0.72 ml 1 pc. RUB 10373 Buy |
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Puregon 900 IU solution for subcutaneous administration 1.08 ml 1 pc. 15345 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
