Products

Choriomon

Chorionic Gonadotropin
 

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Active ingredient

Chorionic Gonadotropin 5000 I.U.
 

Indications

In Women:
Induction of ovulation after a treatment with (Human Menopausal Gonadotropin, Menotropin) intended for the maturation of the follicle or after a treatment with FSH (Follicle Stimulating Hormone, Urofollitropin) in the following cases of functional sterility:
   - Primary amenorrhoea.
   - Chronic secondary amenorrhoea.
   - Chronic anovulation.
Moreover, Choriomon is indicated in the treatment of sterility due to the shortening of the luteal phase of the cycle, since it induces a delay in the onset of the bleeding, it prolongs the mature phase of the corpus luteum, and thus the most favourable conditions for nidation.
- In patients suffering from chronic amenorrhoea or chronic anovulation, a treatment with HMG (FSH)/HCG is indicated only when a previous progesterone test has given a negative result or when reiterated treatments with ovulation stimulators such as Clomiphene, Cyclofenyl remained unsuccessful.

In Children and Men:
• Cryptorchidism:
- Hypogonadotropic hypogonadism, delayed puberty.
- A treatment of cyrptorchidism with Choriomon is likely to prove successful only in the absence of primary congenital testicular lesions and if the inguinal canal is open. In case of hypogonadotropic hypogonadism, Choriomon is especially due to functional deficiency of the diecephalohypophysial system, in which the testicular tissue remains at the perpubertal stage of development. 
- Combination with menopausal gonadotropin (HMG) also stimulates the tubal function of the testicles with the possibility to improve fertility.

Dosage and Administration

• Choriomon must always be injected intramuscularly. The aqueous solution of gonadotropins has a limited shelf-life. Consequently the solution of Choriomon in the solvent should be prepared directly before the injection. Unused solutions must be discarded.

In Women:
Primary amenorrhoea, chronic secondary amenorrhoea, chronic anovulation: if the genital organs are markedly underdeveloped, it is necessary to start with a preliminary treatment, lasting several months, with an estrogen-progestogen combination in order to stimulate the growth and vascularization of the uterus, the Fallopian tubes and the vagina. 
The administration of gonadotropins is carried out in two phases:
      - 1st phase: Daily intramuscular injection of menopausal gonadotropin (HMG) at a dose of 75 I.U. during 7-12 days, until
the increase of estrogens, the ultrasonography and the changes in the cervical factor indicate the presence of a ripe follicle (plasmatic estradiol 1.1 - 2.9 pmol/ml = 300-800 pg/ml; diameter of the main follicle 18-22 mm; cervical score according to Insler > 8 point out of 12).
     - 2nd phase: In order to induce ovulation, a single dose of 5000 I.U. to 10000 I.U. of Choriomon IM must be administered, 24 to 48 hours after the last HMG (or FSH) administration. Ovulation generally occurs after 32 to 48 hours.
• The patient will be recommended to have sexual intercourses every day from the day before the administration of Choriomon and until the ovulation takes place. If pregnancy does not occur, the treatment may be repeated, following the same method. For more details, it is recommended to refer to the "Informaiton for Physicians" of an HMG or FSH preparation.
Sterility due to the shortening of the luteal phase of the cycle: 5000 I.U. of Choriomon IM on the 21st, 23rd and 25th day of
the cycle.

In Children and Men Cryptorchidism:
• The treatment should be given before the age of two years, as after this age the physiologically abnormal position of
the testicle can lead to irreversible lesions, which become more seriuos with time.
• On the other hand, it is unadvisable to start a hormonal therapy in newborn babies before the age of three months, because the spontaneous descent of the testicles is still possible. 
• The recommended duration of the treatment is of 5 weeks (10 injections) as follows:
      - To 12 months: 250 or 3000 I.U. IM, twice weekly.
      - 1 to 6 years: 500 I.U. (1/2 vial of 1000 I.U.) IM, twice weekly.
      - Over 6 years: 1000 I.U. IM, twice weekly. 
• In the treatment proves unsuccessful or only partly successful, it may be repeated after 2-3 months (also after 6 months). If complete success is not obtained after the second course of treatment, surgical correction will be necessary.
• Delayed Puberty: If puberty has not started by the age of 15 years, the process of maturation of the gonads may be stimulated by a course of treatment with Choriomon, which induces the onset of puberty and the development of the physical characteristics of maturity. 
• Dosage: 1000 I.U., twice weekly for 8-12 weeks. 
• The treatment may be repeated, if necessary, after 3 months.
• Hypogonadotropic hypogonadism: Usually the treatment starts with a dosage of 500 to 1000 I.U. of Choriomon IM every 2 days for 4-6 weeks in order to bring Leydig's cells to full ripeness.
• Subsequently, 500 I.U. of Choriomon are administered in concomitance with 75 IU of FSH IM twice or three times weekly for 3 months or more.
• In order to monitor the response to the treatment, a spermiogram is carried out at least once a month.
• In certain cases, once the spermatogenesis is induced, it is possible to continue the treatment with Choriomonalone, at
a dosage of 5000 I.U. weekly.
• If sterility is acknowledged in case of secondary hypogonadism, it is advisable to resort to alternative therapies with
the administration of an androgen, in order to establish and maintain a virile habitus.

Contraindication

In Women:
Pregnancy: 
• Sterility without attainment of a normal follicle maturation (e.g. of tubal or cervical origin).
• Ovarian cysts not related with polycystic ovarian syndrome.
• Uterine bleeding of unknown etiology.
• Hyperprolactinemia.
• Ovarian, endometrium or breast carcinoma. 
In Men:
Infertility unrelated to hypogonadotropic hypogonadism.
• Androgenic tumors, such as prostate or breast carcinoma.
In Both Sexes:
Known hypersensitivity to HCG or to other gonadotropins (HMG, FSH), hyperprolactinemia, pituitary gland tumor, thyroid or adrenal endocrinopathy which are not being treated.

Side effects

  • In rare cases the following side effects occurred: headache, irritability, tiredness, restlessness, depression and pain on the injection site.
  • Allergic reactions to chorionic gonadotropin have been observed. Occasionally, reiterated treatments with HCG may cause the formation of antibodies and can also be the cause of therapeutic failure. In men, the androgenic effect of high doses of Choriomon can cause edemas.
  • In such cases, but especially in patients suffering from lately cardiac insufficiency, hypertension and migraine (as reported in the anamnesis), asthma or epilepsy, Choriomon should be administered cautiously and only at low doses.
  • All severe complications occurring during a treatment with gonadotropins are generally due to ovarian hyperstimulation (in women) and are androgenic (in men). Arterial thromboembolism and peripheral and cerebral vascular occlusions (e.g. embolia, lung infactus, cerebral ictus) have been associated with HMG/HCG treatment only in rare cases, also not related to ovarian hyperstimulation.

Drug Interaction

No interactions with other drugs have been reported so far.

Pregnancy and Lactation

  • Pregnancy category C: No controlled studies in animals and in pregnant women are available. The administration of HCG at the early stage of pregnancy due to luteal insufficiency, as well as, follicle ponction and embryo transfer, supports the development of the endometrium in the periimplantation phase. There are no indications for HCG beyond this usage. 
  •  It is not known whether HCG penetrates into the milk and which could be the effects on breast-fed babies.
  • This drug has no indications concerning breast-feeding women.

Warning and Precaution

In Women:
• Choriomon must only be administered after the age of sexual maturity, since before puberty it could induce undesirable stimulation of the ovaries. On the other hand, after the menopause the ovaries are no longer sensitive to gonadotropins.

In Men:
• In patients suffering from Klinefelter syndrome, which is accompanied by an increased urinary excretion of gonadotropins
, the treatment with Choriomon is unsuccessful. During a treatment of hypogonadism and hypogonadotropic eunuchoidism, especially in young subjects, a clinical and endocrinological examination must be carried out, to avoid an excessive development of the gonads.
• The treatment must be discontinued if symptoms of a premature puberty should appear. In order to avoid a possible desensitization of Leydig's cells following a treatment with HCG, the testosterone level must be controlled during the whole course of treatment and the posology must be adapted to that level.

Package and Storage

Choriomon 5000: 3 vials of lyophilized substance 5000 I.U. and 3 ampoules of solvent.

Mother Company

Manufactured by IBSA