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Important Disclaimer
These statements have not been evaluated by the Food and Drug Administration (FDA). Compounded products are not FDA-approved and are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. The information provided is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting any new treatment.
Clinical Information
Evidence-based details for healthcare providers
For intramuscular use only. Each multiple-dose vial is to be used for one patient. 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. The following regimens have been advocated by various authorities: Prepubertal cryptorchidism not due to anatomical obstruction. Generally, institute therapy in children between the ages of 4 and 9. Selected cases of hypogonadotropic hypogonadism in males. (See.)Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately treated with gonadotropins. 5000 to 10,000 USP units 1 day following the last dose of gonadotropins. (A dosage of 10,000 USP units is recommended in the labeling for gonadotropins.) • 4000 USP units 3 times weekly for 3 weeks. • 5000 USP units every second day for 4 injections. • 15 injections for 500 to 1000 USP units over a period of 6 weeks. • 500 USP units 3 times weekly for 4 to 6 weeks. If this course of treatment is not successful, another series is begun 1 month later, giving 1000 USP units per injection. • 500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. • 4000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 USP units 3 times weekly for an additional 3 months.
The action of human chorionic gonadotropin (hCG) is virtually identical to that of pituitary LH, although hCG appears to have a small degree of FSH activity as well. It 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. This descent is usually reversible when hCG is discontinued. 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 estrogen and progesterone and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.
• Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see). • High serum FSH, indicating primary gonadal failure in women. • Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders). • Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males. • Malformations of the reproductive organs incompatible with pregnancy. • Fibroid tumors of the uterus incompatible with pregnancy. • Abnormal vaginal bleeding of undetermined origin.
Hypersensitivity reactions, both localized and systemic in nature, including anaphylaxis have been reported. In rare cases, generalized rash or fever may occur (seeand). If a hypersensitivity reaction is suspected, discontinue PREGNYL and assess for other potential causes for the event.For males and females: Immune system disorders IrritabilityRestlessnessDepressionPsychiatric disorders HeadacheNervous system disorders PREGNYL may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. Occasionally, allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site (seeand).EdemaFatigueGeneral disorders and administration site conditions In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see).In the female: Vascular disorders Hydrothorax, as a complication of severe OHSS (see).Respiratory, thoracic and mediastinal disorders Abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS. Ascites, as a complication of severe OHSS (see).Gastrointestinal disorders Unwanted ovarian hyperstimulation, mild or severe Ovarian Hyperstimulation Syndrome (see).Mild to moderate enlargement of ovaries and ovarian cysts related to mild OHSS. Large ovarian cysts (prone to rupture), usually associated with severe OHSS (see).Painful breastsReproductive system and breast disorders Weight gain as a characteristic of severe OHSS (see).Investigations Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.In the male: Metabolism and nutrition disorders HCG treatment may sporadically cause gynecomastia.Precocious pubertyReproductive system and breast disorders
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