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Pregnyl general information
Human chorionic gonadotropin (HCG) is a hormone that supports the normal development of an egg in a woman's ovary, and stimulates the release of the egg during ovulation.
HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men. HCG is also used in young boys when their testicles have not dropped down into the scrotum normally. This can be caused by a pituitary gland disorder.
HCG - Pregnyl dosage and administration
For intramuscular use.
The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician’s preference.
And Method of Administration
Dosage
In the male
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 gonadotropin) 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 combination with HMG, in the promotion of controlled super ovulation in medically assisted reproduction programs.
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 17β estradiol levels of at least 3500 pmol/L (920 picogram/ml).
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 instructions 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.
Contraindications
• Hypersensitivity to human gonadotropin or any of the substances of Pregnyl.
• Presence of uncontrolled thyroid, adrenal or pituitary disorders.
• Breast, uterine, ovarian, testicular tumors.
• Vaginal bleeding of unknown cause.
• Known or suspected androgen-dependent tumors, carcinoma of the prostate or mammary carcinoma in males.
Special Warnings and Precautions for Use
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 non gonadal thyroid or adrenal disorders, diabetes. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
• In the pregnancies occurring after induction of ovulation with gonadotrophic preparations, there is an increased risk of abortion and multiplets. Multiple pregnancies, especially high order, carry 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 recognized 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 events, during or following treatment with gonadotropin. 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 neoplasm, 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 gonadotropin increases the baseline risk of these tumors in infertile women.
Unwanted Hyper stimulation
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 hyper stimulation may be confirmed by ultrasound examination.
The severe form of ovarian hyper stimulation syndrome may be life-threatening and is characterized by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothorax 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 epiphysis closure or precocious sexual development. Skeletal maturation should be monitored regularly.
Undesirable Effects
Edema, 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 hyper stimulation, ovarian hyper stimulation syndrome (OHSS). Characteristic symptoms of unwanted ovarian hyper stimulation and OHSS are included under
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 gynacomastia (female characteristics)
• Acne may occur occasionally during HCG therapy.
Overdose
The toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead to hyper stimulation of the ovaries.
HCG - Pregnyl side effects
Stop using HCG and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.
Some women using this medicine have developed a condition called ovarian hyper stimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:
* Severe pelvic pain;
* swelling of the hands or legs;
* Stomach pain and swelling;
* Shortness of breath;
* Weight gain;
* Diarrhea;
* Nausea or vomiting; or
* urinating less than normal.
This medication can cause early puberty in young boys. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth, and increased acne or sweating.
Less serious side effects may include:
* Headache;
* feeling restless or irritable;
* Mild swelling or water weight gain;
* Depression;
* Breast tenderness or swelling; or
* Pain, swelling, or irritation where the injection is given.
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