Orgalutran - Instructions For Use, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Orgalutran

Orgalutran: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. In case of impaired renal function
11. 11. For violations of liver function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Orgalutran

ATX code: H01CC01

Active ingredient: ganirelix (ganirelix)

Producer: Vetter Pharma-Fertigung (Germany)

Description and photo update: 2018-26-10

Prices in pharmacies: from 1290 rubles.

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Orgalutran is a hormonal drug used in the treatment of female infertility to stimulate ovulation.

Release form and composition

The dosage form of Orgalutran is a solution for subcutaneous administration: colorless, transparent (0.5 ml in disposable syringes, 1 syringe is placed in blisters, 1 or 5 blisters in a cardboard box).

Composition of 0.5 ml solution (1 syringe):

• active substance: ganirelix (in the form of acetate) - 0.25 mg;
• auxiliary components: mannitol - 23.5 mg; glacial acetic acid and / or sodium hydroxide - up to pH 5; 99% glacial acetic acid - 0.1 mg; water for injection - up to 5 ml.

Pharmacological properties

Pharmacodynamics

Orgalutran is a competitive antagonist of GnRH receptors (gonadotropin-releasing hormone). It controls the secretion of gonadotropins - LH and FSH (luteinizing and follicle-stimulating hormones), inhibits their secretion by the pituitary gland (the effect is determined by the dose). The onset of suppression of the secretory function of the pituitary gland in the absence of preliminary stimulation occurs immediately after the introduction of Orgalutran and, provided that such treatment is continued, it is maintained.

According to the research results, with repeated administration of 0.25 mg of the drug, the greatest value of the decrease in the concentrations of LH, FSH and estradiol in the blood serum - 74, 32 and 25% (after 4, 8 and 16 hours after administration, respectively). After the last injection, the level of hormones in the blood serum returns to its initial values within two days.

The duration of use of Orgalutran in a daily dose of 0.25 mg for controlled stimulation of ovulation is, as a rule, 5 days. If this dosing regimen is observed, the average frequency of an increase in LH levels (more than 10 IU / L) with a concomitant increase in the concentration of progesterone (more than 1 ng / ml) is 1.2%, which is comparable to the same indicator for GnRH agonists (0.8%) …

In some cases, even before the use of Orgalutran, by the sixth day of stimulation of the ovaries with gonadotropic drugs against the background of a pronounced reaction of the ovaries, an increase in the level of LH is observed, which does not significantly affect the clinical results in the future. LH secretion in these groups of patients is suppressed immediately after the first administration of Orgalutran.

Pharmacokinetics

After a single subcutaneous injection of 0.25 mg of the solution after 1-2 hours, the achievement of the maximum concentration of the substance in the blood plasma (approximately 15 ng / ml) is recorded. T _1/2 (half-life) is approximately 13 hours, clearance is about 2.4 l / h.

Excretion of the substance occurs through the intestines (approximately 75% in the form of metabolites) and the kidneys (approximately 22%, ganirelix is the main compound found in urine). The absolute bioavailability of Orgalutran is 91%.

The pharmacokinetic parameters of the substance after multiple subcutaneous administration (once a day) are similar to those after a single administration. Stationary concentrations after repeated dosages of 0.25 mg per day are approximately 0.6 ng / ml, the time to reach is 2-3 days. According to pharmacokinetic analysis, there is an inverse relationship between the patient's body weight and the serum concentrations of Orgalutran.

The main compound circulating in plasma is ganirelix. Metabolism occurs by enzymatic hydrolysis with the subsequent formation of peptide fragments.

Indications for use

Orgalutran is prescribed for the prevention of a premature peak increase in LH secretion in women during ovulation induction (superovulation) during fertility therapy programs using ART (assisted reproductive technologies).

Contraindications

• renal / hepatic impairment;
• pregnancy and lactation;
• individual intolerance to any component of the drug, as well as GnRH or any other analog of GnRH.

Instructions for the use of Orgalutran: method and dosage

Orgalutran should be prescribed exclusively by a gynecologist.

Controlled stimulation of ovulation with FSH should be started on the second or third day of the menstrual cycle.

Orgalutran is injected subcutaneously once a day, starting from the sixth day of FSH administration (during clinical trials, Orgalutran was used in combination with a recombinant follicle-stimulating hormone - Puregon). In cases of increased ovarian response to stimulation, in order to prevent a premature increase in LH levels, Orgalutran should be used from the fifth day of FSH therapy. With slow follicular growth, administration can be postponed (i.e., start therapy after the sixth day of using FSH preparations).

It is preferable to inject Orgalutran into the thigh. It is impossible to use an opaque solution or a solution containing impurities. The injection site should be changed after each injection. The syringe can only be used once.

Side effects

• immune system: hypersensitivity reactions with the introduction of the first dose of Orgalutran, occurring with skin rash, facial edema and dyspnea;
• digestive system: abdominal pain, nausea;
• nervous system: dizziness, headache;
• systemic reactions: feeling unwell;
• local reactions at the injection site: redness with / without swelling, itching (usually, violations disappear 4 hours after injection);
• others: weakness.

Other observed disorders are associated with therapy aimed at achieving controlled stimulation of ovulation using ART. These include bloating, pelvic pain, spontaneous abortion, ectopic (ectopic) pregnancy, as well as OHSS (ovarian hyperstimulation syndrome), manifested as lower abdominal pain, vomiting, diarrhea, ovarian enlargement, dyspnea, oliguria, weight gain body.

Overdose

In case of an overdose, an increase in the duration of action of Orgalutran is observed. In such cases, the use of the hormonal agent is temporarily stopped, the patient needs to consult a doctor.

special instructions

Orgalutran should only be used as directed by a physician experienced in the treatment of infertility using ART.

If there are signs of active allergic conditions, the drug should be used with extreme caution. There is information about the development of hypersensitivity reactions with the introduction of the first dose.

The patient can independently inject Orgalutran only on condition that she is properly instructed and has the opportunity to consult with a specialist.

FSH and Orgalutran should be administered at approximately the same time. Do not mix drugs in one syringe. For their introduction, different parts of the body should be used.

It is necessary to carry out daily therapy until a sufficient number of preovulatory follicles are formed. The final maturation of the follicles can be initiated by the administration of a preparation of human chorionic gonadotropin (hCG). Taking into account the T _{1/2 of} ganirelix, the interval between Orgalutran injections, as well as the time between the last Orgalutran injection and hCG injection, should not be more than 30 hours, otherwise a premature LH peak may occur.

The luteal phase should be maintained in accordance with the methodology adopted in the fertility clinic.

Before carrying out repeated courses of treatment, it is necessary to carefully assess the degree of potential risk and the effectiveness of the use of Orgalutran.

When performing stimulation with gonadotropins, it is always necessary to take into account the risk of developing OHSS. With the development of a syndrome of moderate and severe severity, treatment is carried out in stationary conditions. Measures are prescribed to restore / maintain the volume of circulating plasma, correct hemostasis and water-electrolyte balance, and stimulate diuresis.

No teratogenic properties have been identified in ganirelix. According to preclinical data, Orgalutran is safe. For women weighing up to 50 kg / from 90 kg, the safety profile has not been studied.

After the use of ART, the incidence of congenital malformations may be slightly higher than in the population. This is associated with the characteristics of the parents (for example, the mother's age, sperm characteristics) and with the higher frequency of multiple pregnancies after ART. There is no indication that the increased risk of congenital malformations is caused by the use of GnRH antagonists during ART. It has been shown that the incidence of congenital malformations in children born after controlled ovulation stimulation therapy with Orgalutran is comparable to the previously noted incidence after controlled ovulation stimulation therapy with GnRH agonists.

It is important to confirm with ultrasound as early as possible that the pregnancy is intrauterine. In infertile women undergoing ART, tubal abnormalities are often noted, thus, the frequency of ectopic pregnancy may increase.

If the patient remembered that she forgot to inject in a timely manner, the drug should be injected as soon as possible. To make up for the missed dose, no additional dose should be administered. If the delay is more than 6 hours (i.e., the interval is more than 30 hours), the dose should be administered immediately. Medical consultation required.

Application during pregnancy and lactation

According to the instructions, Orgalutran is not prescribed during pregnancy / lactation.

With impaired renal function

With renal failure, therapy is contraindicated.

For violations of liver function

In hepatic insufficiency, therapy is contraindicated.

Drug interactions

There are no data on interactions with other drugs.

Analogs

The analogue of Orgalutran is Cetrotide.

Terms and conditions of storage

Store in a place protected from light at a temperature of 2-30 ° C. Do not freeze. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Orgalutran

According to reviews, Orgalutran is a safe and effective drug used in IVF programs. Women after training can inject the solution on their own. The development of ovarian hyperstimulation syndrome has been reported infrequently. In rare cases, the development of short-term local adverse reactions at the injection site is noted.

Orgalutran price in pharmacies

The approximate price for Orgalutran (5 disposable syringes of 0.5 ml per package) is 6300–6600 rubles.

Orgalutran: prices in online pharmacies

Drug name Price Pharmacy

Orgalutran 0.25 mg / 0.5 ml solution for subcutaneous administration 0.5 ml 1 pc. 1290 RUB Buy

Orgalutran 0.25 mg / 0.5 ml solution for subcutaneous administration 0.5 ml 5 pcs. 6265 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!