INFORMATION FOR HEALTH PROFESSIONALS
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Ampoules of PROFASI contain:
Human chorionic gonadotrophin (HCG) as a white, freeze-dried, sterile powder 2000 or 5000 IU.
| mannitol | 20.00mg |
| sodium phosphate | 0.045mg |
| sodium acid phosphate | 0.070mg |
One IU of chorionic gonadotrophin is defined as the activity contained in
1.279mcg of the 2nd international standard preparation. Each ampoule of PROFASI
is accompanied by a solvent ampoule containing 1mL of isotonic, sterile and
pyrogen-free sodium chloride injection solution. The reconstituted solution has
a clear appearance.
PROFASI is a water soluble glycoprotein derived from human pregnancy urine. Its action is predominantly luteinising. The action of human chorionic gonadotrophin (HCG) is virtually identical to that of pituitary luteinising hormone (LH). It may also have a small amount of follicle stimulating hormone (FSH) activity. However, it is not considered significant enough to produce an FSH effect.
HCG stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function.
During a normal pregnancy HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of oestrogen and progesterone and preventing menstruation. HCG has no known effect on fat mobilisation, appetite or sense of hunger, or body fat distribution.
HCG is a gonadotrophin with predominantly luteinising properties produced by the placenta and is obtained from the urine of pregnant women.
Time to peak effect: Females - ovulation usually occurs within 12-36 hours after the preovulatory surge of LH or administration of exogenous HCG used for ovulation induction.
The metabolic clearance rate of HCG has been measured in normal men and regularly cycling women following the infusion of PROFASI. It was found to be 1.6mL/minute in men and 1.9 mL/minute in women. These volumes are approximately 12 to 25 times lower than the metabolic clearance rate of luteinising hormone (LH).
The urinary excretion of HCG during the treatment of children for cryptorchidism is mainly in the second and third days after an injection and represents 5.4 to 7% of the total dose injected.
The maximum plasma testosterone response to a single injection of HCG is seen 72 hours after the injection and elevated testosterone levels are seen for 5 to 7 days after the injection. In measuring half-life of HCG, two slopes may be seen and different values are given by different investigators of the disappearance after an administered dose, and for different methods of assay. The values for the second slope vary from 23 to 37 hours. These values are much longer than those for LH.
Anovulatory infertility: infertile females following a recognised regimen with human menotrophins or clomiphene.
a) Hypogonadotrophic hypogonadism alone or in combination with menotrophins or clomiphene, secondary to pituitary deficiency in males.
b) Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations where descent would have occurred at puberty.
HCG thus may help predict whether or not orchidopexy will be needed in future. Although in most cases the effect is permanent it may be temporary in some. Therapy is usually instituted between the ages of four and nine.
PROFASI is given by subcutaneous or intramuscular injection. Injections should be reconstituted with the solvent provided immediately prior to use.
Anovulatory infertility: up to 10,000 IU PROFASI is given s.c. or i.m. in mid-cycle, following treatment with METRODIN (urofollitrophin) or PERGONAL (menotrophin) according to a recognised scheme.
a) Hypogonadotrophic hypogonadism: PROFASI 2,000 IU i.m. or s.c. twice a week with concomitant PERGONAL (menotrophin) administration (75 IU three times a week) if necessary for a minimum period of 4 months.
b) Cryptorchidism: PROFASI 500 to 1,000IU i.m. or s.c. on alternate days for several weeks.
Pituitary or ovarian tumour, prostatic carcinoma or androgen dependent neoplasm. Endocrine disorders, such as hypothyroidism, adrenocortical deficiency or hyperprolactinaemia should be corrected prior to PROFASI treatment.
Ovarian dysgenesis, absent uterus, premature menopause, tubal occlusion unless the patient is undergoing superovulation for in-vitro fertilisation.
Active thrombophlebitis.
Prior allergy to PROFASI.
In men, PROFASI will not be effective in cases where the FSH level is raised. This is indicative of primary testicular failure.
PROFASI is not effective and is not indicated for weight reduction.
a) Ovarian Hyperstimulation Syndrome: In women undergoing ovulation induction, an excessive ovarian response to follicular stimulating agents may lead to the development of ovarian hyperstimulation syndrome, if HCG is given to induce ovulation or to support the corpus luteum. It is of primary importance that HCG should be withheld in such cycles.
The ovarian hyperstimulation syndrome is generally categorised as:
Mild and Moderate:
Symptoms: abdominal distension; nausea, vomiting, occasional diarrhoea, ovaries enlarged to about 5 to 12cm 3-6 days after HCG administration.
Therapy: rest, close observation.
Pelvic examination of enlarged ovaries should be gentle, in order to avoid rupture of ovarian cysts. Symptoms subside spontaneously over 2-3 weeks.
Severe:
Symptoms: pronounced abdominal distension, ascites with or without pleural effusion, enlarged ovaries (>12cm), decreased blood volume, sometimes cardiovascular shock.
Therapy: hospitalisation, treatment should be conservative focusing on restoring fluid depletion and preventing shock.
Use of diuretics should be avoided in the primary phase of the syndrome, since they may precipitate cardiovascular shock in some patients. They may however be used during the resolution phase of the ovarian hyperstimulation syndrome.
The risk of ovarian hyperstimulation syndrome developing in women undergoing superovulation for an assisted conception technique may be lessened if all the follicles are aspirated prior to ovulation.
b) Multiple Pregnancies: The incidence of multiple pregnancies and births is increased by follicular stimulation and ovulation induction in patients attempting in-vivo conception. However, the majority of multiple pregnancies are twins. Multiple pregnancies might result in premature deliveries.
The risk of multiple pregnancy following assisted conception techniques is related to the number of oocytes/embryos replaced.
c) Pregnancy, Breast Feeding: Controlled studies in women have not demonstrated any risk for the foetus during the first trimester of gestation. PROFASI should not be administered to a woman who is breast-feeding.
d) Pregnancy Test: A false result might be obtained if the test is carried out in a patient who has recently undergone (over the last 7 days) or is still having HCG administration.
a) Androgens may cause fluid retention in the male if high doses of HCG are administered. In such cases dosage should be considerably reduced particularly in patients with cardiac or renal disease, epilepsy, migraine or asthma.
b) Sexual Precocity: HCG may cause sexual precocity when administered in young patients for cryptorchidism. If signs are observed, treatment should be stopped. If continued therapy is considered necessary, a reduced dosage regimen should be instituted.
Adverse effects reported are: headache, irritability, restlessness, depression, fatigue, oedema, precocious puberty, gynaecomastia.
Not known.
Since the medicine is given by a doctor, overdosage is an unlikely event. There are no reports of toxic effects occurring as a result of overdosage.
Overdosage may lead to:
Advise your patients to immediately contact their doctor or the Poisons Information Centre (in Australia telephone 131 126, in New Zealand telephone 0800 764 766) if they are concerned that they have given themselves too much PROFASI.
Store below 25°C. Protect from light. When reconstituted, the solution should be used immediately. Keep out of reach of children.
Prescription Medicine.
PROFASI 2000: Each packet contains three ampoules of hCG 2000 IU and three ampoules of sodium chloride injection (1 mL) as solvent.
PROFASI 5000: Packets containing one or ten ampoules of hCG 5000 IU and one or ten ampoules of sodium chloride injection (1 mL) as solvent.
Human chorionic gonadotrophin (HCG), a polypeptide produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha sub-units of the human pituitary gonadotrophins, luteinising hormone (LH) and follicle stimulating hormone (FSH), as well as the alpha sub-unit of human thyroid-stimulating hormone (TSH).
The beta sub-units of these hormones differ in the amino acid sequence. The specific activity of HCG resides in the beta sub-unit.
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Revision date: 29 May 2007