How to inject Orgalutran correctly? Instructions for use and review of the drug

The process of in vitro fertilization can take place in different ways, it all depends on the body of a particular woman. Most often, IVF requires hormonal preparation to provoke superovulation, as well as control the growth of the endometrium in the uterus for further implantation of the fetus.

One of the new generation drugs that is used in the IVF process is Orgalutran. This remedy is necessary to properly prepare the body for embryo transfer. Let's look at when Orgalutran is prescribed and how to use it correctly in a successful protocol.

pharmachologic effect

The drug blocks the secretion of pituitary receptors.
Orgalutran solution has the necessary effect on the body by lowering the concentration of gonadotropin. It blocks their secretion by pituitary receptors.

Their connection becomes so strong, and the effect is immediate, that a decrease in gonadotropic hormones, especially luteinizing hormones, becomes possible.

The effectiveness of the drug Orgalutran has found application in special programs for the treatment of infertility.

The solution is intended to control ovulation and prevent its premature development.

Therapy is short-lived, since the use of Orgalutran solution is necessary already at the final stage of follicle growth.

After 2 days, the pituitary gland begins to function normally, and the effect of the drug stops.

The maximum accumulation of the active substance of ganirelix occurs in a period of time from 1 to 2 hours. The drug Orgalutran is partially excreted from the body after 13 hours, mostly in feces and in small quantities in urine.

Orgalutran's analogues

Regarding existing analogues, this drug has the only structural analogue of Cetrotide, when the cost of one injection is 1,200 rubles, 7 pieces - 8,500 - 10,000 rubles.

Based on the therapeutic effect and similar spectrum of influence of the active components, the following analogues can be distinguished: Ganirelix, Cetrotide, Octreotide, Octrestatin, Sandostatin, Signifor. In any case, it is important to coordinate each prescription with the attending physician and take into account the individual characteristics of the body.

Composition and release form

The production of this drug is carried out by the Dutch pharmaceutical company.

The drug Orgalutran is produced in the form of an injection solution with a ganirelix concentration of 250 mcg in one 0.5 ml ampoule.

The following auxiliary components are used:

• Mannitol;
• Sodium hydroxide;
• Glacial acetic acid;
• Purified water.

Photos of substances:

Sodium hydroxide

Mannitol

Glacial acetic acid Purified water

Cross-drug interactions

At the moment, the specifics of using Orgalutran with other medications have not been fully clarified. Therefore, in cases of concomitant use, various unexpected reactions can be expected.

In addition, it must be taken into account that with the synchronous use of Orgalutran and drugs that activate the synthesis of histamine, there is a high probability of unexpected reactions.

In order to prevent the development of unpredictable consequences after the simultaneous use of drugs, it is necessary to inform the doctor about all drugs taken previously and at the time of prescription.

Side effects

Women who use the drug for the first time do not know whether it is normal for the Orgalutran injection site to swell. This local reaction is classified as a side reaction, but there is nothing terrible about it. After some time it will go away on its own.

In addition to such a negative response from the body, others may also occur to the use of Orgalutran solution.

Contraindications

Regarding existing contraindications, these are the following points:

1. Hypersensitivity to the components of the drug, allergic reactions to them.
2. The period of menopause, as well as diseases of the kidneys and liver.
3. Pregnancy and breastfeeding.
4. Children's age up to 16 years.

Therefore, before using the drug, you should make sure that there are no restrictions on its use and assess your individual tolerance, coordinating the course and volume of administration with the treating gynecologist.

Instructions for use

Many women, returning home from the reproductive center, do not remember how to inject Orgalutran into the stomach. Yes, the medicine must be injected under the skin into the abdomen or thigh.

It is important to note that you should definitely pay attention to the color of the solution. Under no circumstances should it be cloudy, with sediment or any other inclusions.

Before injecting Orgalutran, the intended injection site must be thoroughly treated with alcohol .

Do I need to release the air from the syringe? - a question that worries many women. Doctors recommend that before starting the administration of the Orgalutran solution, carefully release the air until the first drop of the drug appears on the tip of the needle.

How to inject the drug correctly:

A lump may appear after administration of Orgalutran in the form of a solution, which is an adverse reaction, but it disappears over time. A lump may also appear on the abdomen, but if you inject the medicine into the thigh, such problems will not bother you. This issue should always be discussed with your doctor.

The correct way to insert the needle is at an acute angle (45°). The skin must be gathered into a fold with two fingers and a needle inserted. Slowly squeeze the Orgalutran solution under the skin. Pull out the syringe and re-treat the injection area with a clean cotton swab and alcohol.

Instructions in video format:

The drug is always prescribed starting from the sixth day of FSH stimulation. If necessary, the solution can be administered earlier or vice versa later.

Precautionary measures

During the course of Orgalutran, you must adhere to some recommendations for its use:

• The drug should not be used for self-medication.
• Women who are predisposed to allergies should be careful, as negative reactions are possible after the first injection. In patients with severe hypersensitivity, Orgulatran therapy is contraindicated.
• The drug and FSH should be used synchronously. But it is forbidden to mix them in one syringe, and they must be injected into different areas of the body.
• Orgalutran is administered daily until the required number of follicles is formed. For their final maturation, injections of human hCG can be prescribed. The interval between procedures is a maximum of 30 hours, otherwise the LH peak may form too early.
• The next course of Orgalutran is possible only after assessing the proportion of benefits and harms of therapy.
• During therapy or after its completion, the risk of a complication, OHSS, cannot be excluded. Its manifestations of moderate and severe forms are eliminated in the inpatient departments of the clinic. Measures are being taken to restore and maintain the plasma state at a normal level, eliminate hemostasis disorders, activate diuresis, water and electrolyte balance.
• Studies of toxic properties did not record the teratogenic properties of Orgulatran, based on this, a conclusion was made about the safety of the drug.
• There is no data yet on the effectiveness of the product in women with low (up to 50 kg) or overweight (more than 90 kg) weight.
• It is important to make sure in time that the pregnancy that occurs after a course of Orgalutran is intrauterine. It is known that infertility patients who decide to undergo ART (especially IVF) are often diagnosed with abnormalities in the condition of the fallopian tubes, which contributes to ectopic (ectopic) pregnancy. Early detection will help to take adequate measures in time and prevent life-threatening complications.
• A study of the drug Orgalutran using a long protocol of GnRH agonists and the use of only the first drug showed more intense follicle growth in the first stages of stimulation. However, by the end of the procedure, their number decreased, and the plasma estradiol content was reduced. As a result, we can conclude that FSH dosage adjustments should be made depending on the number and growth rate of follicles, and not on the content of estradiol.

special instructions

The drug can provoke ovarian hyperstimulation.
The drug can be reused only as prescribed by a doctor and if the benefit is much greater than the harm.

The drug in the form of a solution can provoke ovarian hyperstimulation.

There are weight restrictions for using the drug Orgalutran. A woman should not have a body weight below 50 kg and above 90 kg.

The percentage of congenital pathologies in a child is not much higher during artificial insemination with the participation of Orgalutran solution than in the case of natural pregnancy.

If for some reason an injection was missed at a certain time, then two injections cannot be given the next day.

Other characteristics

During the period of bearing and feeding a baby, Orgalutran is not used. If the functioning of the kidneys or liver is impaired, the use of the drug is strictly prohibited. The manufacturer did not provide information on drug interactions with other drugs.

Orgalutran requires careful attention before use - if a woman is pregnant during use, the drug can lead to severe forms of complications.

Orgalutran for IVF is included in the standard protocol and is necessary for the correct implementation of the technique. Most patients respond positively to the drug due to the successful procedure and subsequent birth of a healthy baby.

Reviews and results

Vlada, 29 years old : “After the first injection of Orgalutran, the place immediately became swollen and began to itch, aching a little when touched. After 3 days everything went away completely.”

Elena, 25 years old : “My husband and I couldn’t wait to get pregnant, but it still didn’t work out for us. They tried to artificially inseminate 4 times and only the last time everything was successful. Not only drugs that stimulate ovulation, but also drugs that delay it helped us in this. Thanks to the Orgalutran solution, I am now 4 months pregnant.”

Congenital pathologies

Studies of the condition of 283 children born to women receiving drugs with ganirelix revealed:

• 3 cases of serious pathologies in newborns (such as hydrocephalus, omphalocele, etc.)
• 18 children were born with less severe congenital pathologies (hemangioma, skull asymmetry, extra fingers, umbilical and inguinal hernia, hydronephrosis, etc.).

Despite these findings, there is no evidence yet that the drug caused abnormalities in newborns.

How long does stimulation last for IVF?

The same protocol affects women differently, so the timing always varies. Ideally, a short protocol lasts 4 weeks, and the stimulation itself lasts 10–12 days. In this case, the size of the follicles must be monitored. They should increase by 2 mm daily.

The schedule is drawn up individually

In the presence of ovarian diseases, women require preliminary hormonal treatment. The long protocol provides 30 days of preparatory period and 10 days of active stimulation.

It is worth remembering that hormonal drugs have a strong effect on moral and physical well-being. Severe mood swings, pain in the ovarian area, and increased volume of discharge may occur.

Dosage

Orgalutran is used in combination with other drugs. To stimulate ovulation, medications containing FSH are prescribed. They begin to be used on days 2 or 3 of the cycle. Orgalutran is introduced into the treatment regimen on day 6 after the start of FSH use, which corresponds to days 8 or 9 of the cycle. It is used once a day at a dose of 250 mcg.

Sometimes there is an increased response of the ovaries to stimulation of superovulation. In this case, it is recommended to administer Orgalutran on the 5th day of stimulation with gonadotropins. This corresponds to day 7 or 8 of the menstrual cycle.

It happens that the ovaries react too weakly to stimulation, and the follicles grow more slowly than usual. In this case, it is allowed to use Orgalutran later than 6 days after the first administration of FSH. The optimal timing is determined by the doctor. At the same time, he is guided by the size of the follicles according to ultrasound data, as well as the level of hormones in the blood.

On average, Orgalutran is used for 5 days. When using the drug, the probability of an increase in LH to more than 10 IU/ml, as well as progesterone to 1 ng/ml or more, does not exceed 1.2%. Thus, the effectiveness of Orgalutran is comparable to GnRH agonists. When using them, the risk of achieving a LH peak is about 0.8%.

In women with a pronounced ovarian response to stimulation, an excessive increase in the level of luteinizing hormone is possible until the 6-7th day of the cycle, when Orgalutran is not yet introduced into the therapy regimen. This does not lead to a decrease in the effectiveness of treatment. Because after the additional administration of Orgalutran, the LH level quickly decreases.

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Complications of stimulation

Taking hormonal drugs poses a major risk to a woman's overall health. Therefore, it is very important to initially select the correct dosage and determine the period of administration. Typically, doctors monitor three possible pathologies:

• Ovarian hyperstimulation is the most common problem. Manifested by bloating, decreased urine volume, pain in the ovarian area;
• multiple pregnancy. Doctors try to minimize the risk of multiple pregnancies, as this puts a huge burden on the reproductive system. But to increase the chances of pregnancy, several embryos are implanted into the uterus at once, so there are cases when several take root at once;
• ectopic pregnancy. This complication occurs very rarely with IVF. This problem manifests itself as dizziness, abdominal pain, and weakness. In this case, you should immediately consult a doctor.

IVF helps you get pregnant even with a diagnosis of infertility, so the main thing is not to despair if everything doesn’t work out the first time. The right approach to stimulation will definitely yield results.

Video: infertility is not a death sentence

Pharmacokinetics

Suction and distribution

1-2 hours after a single subcutaneous administration of the drug Orgalutran® at a dose of 250 mcg, the Cmax of ganirelix in the blood plasma is about 15 ng/ml. The absolute bioavailability of the drug Orgalutran® after subcutaneous administration is 91%.

Pharmacokinetic parameters after repeated subcutaneous administration of the drug Orgalutran® (1 time/day daily) are similar to those after a single administration. After repeated administration at a dose of 250 μg/day, Css (approximately 0.6 ng/ml) was achieved within 2-3 days. Pharmacokinetic analysis demonstrates an inverse relationship between body weight and serum concentrations of Orgalutran®.

Metabolism and excretion

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

T1/2 is approximately 13 hours and clearance is approximately 2.4 l/h. The drug is excreted through the intestines (about 75% in the form of metabolites) and kidneys (about 22%; ganirelix is ​​the main compound found in urine).

How to properly inject an injection into the buttock

The rules are almost the same.
There is only one exception: if an oil injection is prescribed, then the ampoule should be preheated (rubbed with your palms, kept in a warm place). Progesterone should not be heated in boiling water. For the procedure, it is best to use a 5 ml syringe. You should prepare everything for the procedure and stop being nervous. Stand in front of the mirror and make room for the injection. The buttock is mentally divided into 4 parts. The prick should be in the upper outer area. The syringe must be inserted sharply at an angle of 90 degrees, sticking the needle almost to the very end. Then slowly introduce the drug, which will be difficult to infuse because it is oily. Don't panic. Then clamp it with an alcohol cotton swab and remove the syringe. Wipe the injection site. Dispose of consumables.

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