Universal reference book for medicines
Product name: ORGALUTRAN ® (ORGALUTRAN)

Active substance: ganirelix

Type: Gonadotropin-releasing hormone antagonist

Manufacturer: NV ORGANON (Netherlands) manufactured by Vetter Pharma-Fertigung (Germany)
Composition, form of production and packaging
The solution for the sc administration is
clear, colorless.

1 syringe (0.5 ml)

ganirelix (in the form of acetate) 250 μg

Excipients: mannitol - 23.5 mg, acetic acid ice 99% - 0.1 mg, acetic acid ice and / or sodium hydroxide - to pH 5.0, water q / and - qs to 5.0 ml.

0.5 ml - disposable syringes (1) - blisters (1) - packs of cardboard.

0.5 ml - disposable syringes (1) - blisters (5) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Organolutran ® is a competitive antagonist of GnRH receptors (gonadotropin-releasing hormone), controls the secretion of gonadotropins (luteinizing (LH) and follicle-stimulating (FSH) hormones), inhibits the secretion of LH and FSH by the pituitary gland (the effect is dose dependent).
In the absence of preliminary stimulation, the onset of oppression of the secretory function of the pituitary gland occurs immediately after the administration of the drug and is maintained during the continuation of such treatment. Due to the introduction of multiple doses of 0.25 mg of the preparation of Organolutran ® to female volunteers, the concentrations of LH, FSH and estradiol in the blood serum were shown to decrease by 74%, 32% and 25% at 4, 8 and 16 hours after administration, respectively. The level of hormones in the blood serum returned to the initial values ​​within two days after the last injection.
The average duration of the use of the drug Organlutran ® at a dose of 0.25 mg / day for controlled stimulation of ovulation is 5 days.
With the use of the drug Organlutran ® at a dose of 0.25 mg / day, the average value of the frequency of increase in the level of LH (more than 10 IU / l) with concomitant increase in the concentration of progesterone (more than 1 ng / ml) is 1.2%, which is comparable to the same indicator 0.8% for GnRH agonists. Sometimes, even before the initiation of therapy with the preparation of Organlatran ® , by the 6th day of ovarian stimulation with gonadotropic drugs, in women with severe ovarian response there was an increase in the level of LH, which subsequently did not significantly affect the clinical results. The secretion of LH in these patients was rapidly suppressed immediately after the first administration of the preparation Organolatran ® .
PHARMACOKINETICS

After 1-2 hours after a single subcutaneous injection of 0.25 mg of the preparation, the maximum concentration of ganirelix in the blood plasma is recorded ( Cmaxabout 15 ng / ml).
T 1/2 is approximately 13 hours and the clearance is approximately 2.4 l / h. The drug is excreted through the intestine (about 75% in the form of metabolites) and kidneys (about 22%, ganirelix - the main compound found in the urine). Absolute bioavailability of the preparation of Organolutran ® after subcutaneous administration is 91%.
Pharmacokinetic parameters after repeated subcutaneous administration of the preparation Organlatran ® (once a day daily) are similar to those after a single injection.
After repeated doses of 0.25 mg / day, steady-state concentrations of about 0.6 ng / ml were achieved within 2-3 days. Pharmacokinetic analysis demonstrates the inverse relationship between body weight and concentrations of the preparation of Organolutran ® in serum.
Metabolic profile:

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

- Prevention of premature peak increase in LH secretion in women with induction of ovulation (superovulation) in infertility treatment programs using assisted reproductive technologies (ART).

DOSING MODE

The drug Organlutran ® can be prescribed only by a gynecologist.
Controlled stimulation of ovulation with FSH can be started on the 2nd or 3rd day of the menstrual cycle. Organutrolan ® (0.25 mg) is injected subcutaneously once daily, starting from the 6th day of FSH administration (in clinical studies, Orlutran ® was used in conjunction with the recombinant follicle stimulating hormone Puregon ® ). In case of increased ovarian response to stimulation, to prevent premature increase of LH level, treatment with the preparation of Organolutran ® should be started from the 5th day of the use of FSH preparations. In the case of slow growth of follicles, the administration of the preparation of Organolutran ® can be postponed (ie, to start later than the 6th day of FSH administration).
Instructions for the administration of the drug

Organutran ® is intended for subcutaneous administration (preferably in the thigh).
Do not use the solution if it is opaque or contains foreign impurities.
Treatment of the site of administration

Wash your hands with soap and water.
Treat the injection site (a patch of skin approximately 5 cm in diameter around the place where the needle should enter) with a swab impregnated with alcohol and allow to dry for at least 1 minute.
Needle insertion

Remove the cap from the needle.
With your index finger and thumb, take the skin into the crease. Insert the needle into the base of the skin fold at an angle of 45 ° to its surface. After each injection, change the injection site.
Checking the correct position of the needle

Gently pull the plunger toward you to check if the needle is correctly inserted.
If there is blood in the syringe, do not inject the drug, but remove the syringe, and apply a tampon impregnated with alcohol for 1-2 minutes to the injection site. Do not use this syringe. Start the injection with a new syringe.
Solution administration

If the needle is positioned correctly, slowly push the plunger so that the solution is injected subcutaneously.

Extracting the syringe

Remove the syringe and immediately attach a swab impregnated with alcohol, pressing it to the injection site.
Use the syringe only once.
SIDE EFFECT

Local reactions:

Organutrolan ® can cause a local skin reaction at the site of administration (mainly redness, both with swelling, and without it, itching).
In clinical trials, one hour after the injection, the incidence of moderate or severe local skin reactions for treatment was 12% in patients treated with the preparation of Organolatran ® . Local reactions usually disappear 4 hours after the injection.
Systemic reactions:

Feeling of malaise was noted in 0.3% of patients.

From the immune system:

Among the patients who received treatment with the drug Organlatran ® , very rare cases of hypersensitivity reactions (<0.01%) were noted with the introduction of the first dose of the drug, including various symptoms, such as skin rash, face swelling and dyspnea.

From the nervous system:

Headache (0.4%), dizziness.

From the gastrointestinal tract:

Nausea (0.5%), abdominal pain.

Others - weakness.

Other undesirable reactions noted are associated with treatment aimed at achieving controlled stimulation of ovulation using assisted reproductive measures, especially: pain in the small pelvis,

abdominal distention, ovarian hyperstimulation syndrome (OCS) (symptoms: abdominal pain, vomiting, diarrhea, ovarian enlargement, dyspnoea, oliguria, weight gain), ectopic (ectopic) pregnancy and spontaneous abortion.

CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- hypersensitivity to GnRH or any other analogue of GnRH;

renal or hepatic insufficiency;

- Pregnancy;

lactation period.

PREGNANCY AND LACTATION

Use of the drug Organlutran ® during pregnancy and during lactation is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal insufficiency


APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in liver failure


APPLICATION FOR CHILDREN

Not applicable.

APPLICATION IN ELDERLY PATIENTS

Not applicable.

SPECIAL INSTRUCTIONS

Ganirelix should be prescribed only by a doctor who has experience in the treatment of infertility with the use of auxiliary

reproductive technologies.

Women with signs or symptoms of active allergic conditions should be especially careful.
In the reported cases, hypersensitivity reactions occurred when the first dose of the drug was administered (see the "Side effects" section). In the absence of clinical practice, treatment with the drug Organlutran ® is not indicated for women with severe allergic conditions. Packing material for the preparation in its composition contains a natural rubber latex, which can cause allergic reactions.
Organutrolan ® should be administered subcutaneously.
The injection site should be changed. The patient may administer the drug on his own, provided that he is adequately instructed and can consult with a specialist.
Organutrolan ® and FSH should be administered at approximately the same time.
Preparations should not be mixed in the same syringe, and for their introduction should use different parts of the body.
Daily use of the drug Organlutran ® should continue until the formation of a sufficient number of preovulatory follicles.
The final maturation of the follicles can be initiated by administering a human chorionic gonadotropin (hCG) preparation. Considering T 1/2 ganirelix, the interval between injections of the preparation of Organolutran ®, as well as the time between the last injection of the preparation of Organolutran ® and the injection of hCG, should not exceed 30 h, otherwise a premature LH peak may occur. Therefore, with the administration of the preparation Organolutran ® in the morning its use should be continued, including, including the day of administration of hCG. In the appointment of the drug Organlutran ® in the evenings, the last injection should be done on the evening of the day preceding the day of administration of hCG.
Support for the luteal phase should be carried out in accordance with the technique adopted in the clinic of infertility treatment.

The drug with repeated courses of treatment should be used only after a thorough assessment of the degree of potential risk and the effectiveness of treatment.

During or after the stimulation of ovulation, the ovarian hyperstimulation syndrome (OSS) may occur.

The risk of this complication should always be considered when stimulating gonadotropins.

In the case of severe and severe severe hypoglycemia, intensive therapy with intravenous administration during

several days of electrolyte and colloidal solutions, heparin.

Preclinical data, based on the study of general toxicity and genotoxicity, indicate the safety of the drug in humans.
Teratogenic properties of the drug have not been identified.
The safety and effectiveness of the drug has not been established for women with a body weight of less than 50 kg or more than 90 kg.

The incidence of congenital malformations after the use of assisted reproductive technologies (ART) may be slightly higher than in the population.
It is believed that this insignificant increase is due to the characteristics of the parents (for example, the mother's age, the characteristics of the sperm) and the higher frequency of multiple pregnancies after ART. There is no indication that an increased risk of congenital malformations is associated with the use of GnRH antagonists during ART.It was shown that the incidence of congenital malformations in children (more than 1000 newborns) born after the therapy of controlled stimulation of ovulation with the preparation of Organolutran ® is comparable with the previously noted frequency after the therapy of controlled stimulation of ovulation with the use of GnRH agonists.
Important is the early ultrasound confirmation that pregnancy is an intrauterine device.
Since infertile women undergoing assisted reproductive technologies and in particular in vitro fertilization (IVF) often have a pathology of the fallopian tubes, hence the frequency of ectopic pregnancy can be increased.
In controlled studies of the preparation of Organolutran ® using the long protocol of the GnRH agonists (the beginning of the protocol from 21-23 days of the menstrual cycle preceding the stimulation), as a comparison, the treatment with the preparation of Organolutron ® led to a faster growth of follicles on the days of stimulation, but the number of growing follicles at the end of stimulation was somewhat less and the average level of estradiol in the blood was lower.
This particular pattern of follicular growth requires that FSH dose adjustments are made based on the number and size of the growing follicles, and not on the basis of the amount of circulating estradiol.
If you miss the time of drug administration:

Do not administer a double dose of the drug in order to make up for the missed injection.
If the patient recalled that she forgot to inject the drug, then the drug should be administered as soon as possible. If the delay with the introduction of the preparation of Organolatran is more than 6 hours (ie, the interval between injections of the drug is more than 30 hours), the patient should immediately enter the drug and consult a doctor as soon as possible.
Influence on the ability to drive and work with machinery

Not studied.

OVERDOSE

Overdose of the preparation Organlatran ® may lead to an increase in the time of its action.

In this case, the administration of the drug Organlutran ® should be (temporarily) discontinued and the patient should consult a doctor.

DRUG INTERACTION

The combined use of the drug Organlutran ® with other medications has not been studied sufficiently, therefore, the probability of drug interaction can not be ruled out.

Therefore, the attending physician should be informed about the medicines that the patient took shortly before the start of treatment with the drug Orlutran ® or continues to take in parallel with his appointment.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

At a temperature of 2-30 ° C in the dark place.
Do not freeze. Keep out of the reach of children. Shelf life - 3 years.
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