Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Dosage

In the male

Hypogonadotrophic hypogonadism:

500 - 1,000 Units 2-3 times weekly.

Delayed puberty associated with insufficient gonadotrophic pituitary function:

1,500 Units twice weekly for at least 6 months.

Sterility in selected cases of deficient spermatogenesis:

Usually, 3,000 Units per week in combination with an HMG preparation.

In the female

Sterility due to the absence of follicle-ripening or ovulation:

5000 - 10 000 Units hCG to induce ovulation, following treatment with an HMG (human menopausal gonadotrophins) preparation. Up to 3 repeat injections of up to 5000 Units hCG each, may be given within the following 9 days to prevent insufficiency of the corpus luteum.

In conjunction with HMG, in the promotion of controlled superovulation in medically assisted reproduction programmes:

5000 - 10 000 Units hCG 30 - 40 hours after the last HMG injection. Pregnyl should not be administered if the following criteria have not been met: It is recommended that at least 3 follicles greater than 17mm in diameter are present with 17 oestradiol levels of at least 3500 pmol/L (920 picogram/ml). Oocyte collection is carried out 32 - 36 hours after the hCG injection.

Method of Administration

After addition of the solvent to the freeze-dried substance, the solution should be given immediately by intramuscular or subcutaneous injection. Any unused solution should be discarded. Subcutaneous injection may be carried out by patient or partner, provided that proper instruction are given by the physician. Self administration of Pregnyl should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.

Child Dosage

Contra Indications

• Hypersensitivity to human gonadotropins or any of the substances of Pregnyl.

• Presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders)

• Breast, uterine, ovarian, testicular tumours

• Vaginal bleeding of unknown cause

• Known or suspected androgen-dependent tumours, carcinoma of the prostate or mammary carcinoma in males.

Special Precautions

In the female:

• Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.

• Prior to treating patients for inadequate endogenous stimulation of the gonads, an examination should be performed to exclude anatomical abnormalities of the genital organs or nongonadal endocrinopathies (e.g. thyroid or adrenal disorders, diabetes). Primary ovarian failure should be excluded by the determination of gonadotrophin levels.

• In the pregnancies occurring after induction of ovulation with gonadotrophic preparations, there is an increased risk of abortion and multiplets. Multiple pregnancy, especially high order, carries an increased risk in adverse maternal and perinatal outcomes. The parents should be advised of the potential risks of multiple births before starting treatment.

• The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.

• Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index > 30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis.

• There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.

Unwanted Hyperstimulation

During treatment of female patients, determinations of oestrogen levels and assessment of ovarian size and if possible, ultrasonography should be performed prior to treatment and at regular intervals during treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g. more than doubling on 2 or 3 consecutive days, and possibly reaching excessively high pre-ovulatory values. The diagnosis of unwanted ovarian hyperstimulation may be confirmed by ultrasound examination.

If unwanted hyperstimulation occurs (i.e. not as part of a treatment preparing for IVF/ET or GIFT or other assisted reproduction techniques), the administration of HMG should be discontinued immediately. hCG must not be given, because the administration of an hLH - active gonadotrophin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome. This warning is particularly important with respect to patients with polycystic ovarian disease.

The severe form of ovarian hyperstimulation syndrome may be life-threatening and is characterised by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothrax and occasionally thrombo-embolic phenomena.

In the male:

Treatment with hCG leads to increased androgen production. Therefore:

• Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production.

• hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.

Adverse Reactions

Oedema, headache, tiredness, mood changes, gynaecomastia and local site reactions.

Skin rashes have occasionally been reported. In rare cases generalized rash or fever may occur.

In the female:

• Unwanted ovarian hyperstimulation, ovarian hyperstimulation syndrome (OHSS).

• In rare instances, thromboembolism has been associated with FSH/hCG therapy 

In the male:

• Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.

• HCG treatment may sporadically cause gynaecomastia.

• Acne may occur occasionally during hCG therapy.

Manufacturer

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