Diferelin - instructions for use, reviews, analogs and forms of release (injections in ampoules for injection of 0.1 mg, 3.75 mg, 11.25 mg) drugs for the treatment of female infertility (with IVF) and stimulation of ovulation, including of pregnancy

In this article, you can read the instructions for using the drug Diferelin. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Diferelin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Diferelin in the presence of existing structural analogues. Use for the treatment of female infertility (with IVF), endometriosis and stimulation of ovulation, including during pregnancy and lactation.

Diferelin - a synthetic decapeptide, an analog of natural GnRH.

After a short initial period of stimulation of the gonadotropic function of the pituitary gland, tryptorelin (the active substance of the drug Diferelin) has an inhibitory effect on the secretion of gonadotropins, followed by suppression of the function of the testes and ovaries.

In the initial period of application, Diferelin temporarily increases the concentration of LH and FSH in the blood, respectively, the concentration of testosterone in men and estradiol in women increases. Long-term treatment reduces the concentration of LH and FSH, which leads to a decrease in testosterone levels (to levels corresponding to the state after testicularlectomy) and a decrease in estradiol levels (to levels corresponding to the state of postovariectomy) - about 20 days after the first injection and then remains unchanged throughout period of drug administration.

Prolonged treatment with tryptorelin suppresses the secretion of estradiol in women and, thus, prevents the development of endometrioid ectopias.

Composition

Tryptorelin + auxiliary substances.

Pharmacokinetics

After intramuscular injection of the suspension, the initial phase of rapid release of the active substance withfollowed by a phase of constant release. Bioavailability of the drug when administered once a month is 53%.

Indications

• prostate cancer;
• premature puberty;
• genital and extragenital endometriosis;
• fibroids of the uterus (before surgical intervention);
• female infertility, ovarian stimulation in conjunction with gonadotropins (hMG, hCG, FSH) in in vitro fertilization (IVF) programs and embryo transfer, as well as other assisted reproductive technologies.

Forms of release

Lyophilizate for the preparation of a solution for subcutaneous administration of 0.1 mg (injections in ampoules for injection).

Lyophilizate for the preparation of a suspension for intramuscular administration of prolonged action 3.75 mg and 11.25 mg.

Instructions for use and usage diagram

0.1 mg

Short course of treatment

Dipherelin is administered subcutaneously at a dose of 100 mcg per day, starting from the 2nd day of the cycle (simultaneously starting ovarian stimulation), and finishing the treatment 1 day before the planned introduction of human chorionic gonadotropin. The course of treatment is 10-12 days.

Long course of treatment

Diferelin is administered SC at a dose of 100 mcg per day daily, starting from the 2nd day of the cycle. When the pituitary is desensitized (E2 less than 50 pg / ml, about 15 days after the start of treatment), the ovaries are stimulated with gonadotropins and continue injecting dicerelin at a dose of 100 mcg per day, finishing them 1 day before the scheduled the introduction of human chorionic gonadotropin. The duration of treatment is determined by the doctor individually.

Rules for the preparation of solution

The applied solvent is introduced into the vial with lyophilizate and shaken until completely dissolved. Used needles should be placed in a container designed for sharp objects.

3.75 mg

The drug is administered only intramuscularly.

In prostate cancer, Differelin is administered at a dose of 3.75 mg (1 injection) every 4 weeks, for a long time.

In premature puberty, the drug is prescribed to patients with a body weight of more than 20 kg at 3.75 mg every 28 days, patients with a body weight of less than 20 kg - 1.875 mg every 28 days.

With endometriosis, the drug is administered at a dose of 3.75 mg once every 4 weeks. Injection is carried out in the first 5 days of the menstrual cycle. Duration of treatment - no more than 6 months.

With female infertility, the drug is prescribed in a dose of 3.75 mg (1 injection) on the 2nd day of the cycle. Linkage with gonadotropins should be monitored after desensitisation of the pituitary gland (the concentration of estrogens in the blood plasma is less than 50 pg / ml is usually determined 15 days after the injection of the drug Diferelin).

For fibroids of the uterus, the drug should be administered in the first 5 days of the menstrual cycle. The drug is prescribed at 3.75 mg every 4 weeks. Duration of treatment is 3 months for patients preparing for surgery.

The rules for the preparation and introduction of suspension (like pricking Diferelin)

A suspension for intramuscular administration is prepared by dissolving the lyophilizate in the applied solvent just before administration. Mix the contents of the vial with caution until a uniform suspension is obtained.

About incomplete injection, leading to a loss of more suspension than usually remains in the injection syringe, it is necessary to inform the attending physician.

The introduction should be carried out in strict accordance with the instruction.

The patient should be lying down. Disinfect the skin of the buttocks.

1. Break the neck of the ampoule (dot on the front side from above).
2. Pour the solvent into the syringe with the needle.
3. Remove the protective plastic cover from the top of the bottle.
4. Transfer the solvent to a vial of lyophilizate.
5. Pull the needle so that it remains in the vial, but does not touch the suspension.
6. Do not turn the bottle over, gently shake the contents until a uniform suspension is obtained.
7. Check the absence of agglomerates before dialing the suspension into the syringe (in the absence of agglomerates, shake until completely homogeneous).
8. Do not flip the vial, put the entire suspension into the syringe.
9. Remove the needle used to prepare the suspension, and firmly attach the other needle to the tip of the syringe. Hold on only for the colored tip.
10. Remove air from the syringe.
11. Immediately inject into the gluteus muscle.
12. Dispose of the needles in containers designed for sharp objects.

11.25 mg

In prostate cancer, Diferelin is administered intramuscularly at a dose of 11.25 mg every 3 months.

In endometriosis, the drug is administered intramuscularly at a dose of 11.25 mg every 3 months. Treatment should be started in the first 5 days of the menstrual cycle.The duration of treatment depends on the severity of endometriosis and the observed clinical picture (functional and anatomical changes) on the background of therapy. As a rule, treatment is carried out for 3-6 months. It is not recommended to repeat a course of treatment with tryptorelin or another analogue of GnRH.

Side effect

• when combined with gonadotropins, it is possible to hyperstimulate the ovaries (enlargement of the ovaries, abdominal pain);
• tides;
• dryness of the vagina;
• decreased libido;
• nausea, vomiting;
• increase in body weight;
• emotional lability;
• impaired vision;
• headache;
• demineralization of bones;
• increased risk of osteoporosis (with prolonged use of the drug);
• arthralgia;
• myalgia;
• increased blood pressure;
• hives;
• skin rash;
• itching;
• angioedema;
• pain in the injection site.

Contraindications

• pregnancy;
• lactation period (breastfeeding);
• hormone-independent prostate cancer and condition after previous surgical testicularectomy (in men);
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Dipherelin is contraindicated in pregnancy.However, practice has shown that after ovulation, stimulated in the previous cycle, in some cases, pregnancy comes without stimulation, and a further course of ovulation stimulation continued.

Two qualitatively performed experimental studies on animals showed no teratogenic effects of Dipherylin.

Thus, the use of the drug is not expected to develop congenital anomalies in humans.

Results of clinical trials involving a small number of pregnant women who received an analogue of GnRH showed no developmental or fetotoxic malformations. Nevertheless, further study of the effects of the drug on pregnancy is necessary.

special instructions

The response of the ovaries to the administration of Dipherylin in combination with gonadotropins can significantly increase in predisposed patients, in particular, in the case of polycystic ovaries.

The response of ovaries to the administration of the drug in combination with gonadotropins in patients may differ, in addition, the reaction may be different in the same patients for different cycles.

Stimulation of ovulation should be performed under the supervision of a physician and conducting regular analysis with the help of biological and clinical methods: an increase in the content of estrogens in the plasma and ultrasound echography. If the response of the ovaries is excessive, it is recommended to interrupt the stimulation cycle and stop gonadotropin injections.

In the treatment of endometriosis

Before starting treatment, pregnancy should be excluded.

Non-hormonal contraceptives should be used during the first month of therapy.

Intramuscular injection of the drug leads to persistent hypogonadotropic amenorrhea (no monthly).

Treatment should not be recommended for more than 6 months. It is not recommended to repeat a course of therapy with tryptorelin or another analogue of GnRH.

The emergence of metrorrhagia during treatment, not counting the first month, is not the norm, in connection with which it is necessary to determine the concentration of estradiol in the blood plasma. When the concentration of estradiol is lower than 50 pg / ml, other organic lesions are possible.

The function of the ovaries is restored after the completion of therapy. The first menstruation occurs an average of 134 days after the last injection.Therefore, contraceptive measures should be started 15 days after discontinuation of treatment, that is, 3.5 months after the last injection.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and control mechanisms.

Drug Interactions

The drug interaction Dipherylin is not described.

Analogues of drug Diferelin

Structural analogs for the active substance:

• Decapeptil;
• Decapeptil depot.

Analogues for the pharmacological group (drugs for the treatment of endometriosis):

• Buserelin;
• Buserelin depot;
• Buserelin Long FS;
• Byzanne;
• Danazol;
• Danoval;
• Dianodiol;
• Danol;
• Derinat;
• Duphaston;
• Zoladex;
• Indinol;
• Lucrin Depot;
• Nemestran;
• Norkolut;
• Omnadren 250;
• Organometr;
• Prim is Nor;
• The prostate;
• Epigallate.

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