Get your patient on Pregnyl - Choriogonadotropin Alfa (Choriogonadotropin Alfa)

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

1. Prepubertal cryptorchidism not due to anatomical obstruction. In general, hCG is thought to induce testicular descent in situations when descent would have occurred at puberty. hCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following hCG administration is permanent, in most cases, the response is temporary. Therapy is usually instituted in children between the ages of 4 and 9.
2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
3. 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 human gonadotropins.

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.

1. 4000 USP units 3 times weekly for 3 weeks.
2. 5000 USP units every second day for 4 injections.
3. 15 injections for 500 to 1000 USP units over a period of 6 weeks.
4. 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.

Selected cases of hypogonadotropic hypogonadism in males.

1. 500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks.
2. 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.

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. (See also prescribing information for gonadotropins for dosage and administration for that drug product .)

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.)

• Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see ADVERSE REACTIONS ).
• 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.

For males and females:
Immune system disorders
Hypersensitivity reactions, both localized and systemic in nature, including anaphylaxis have been reported. In rare cases, generalized rash or fever may occur (see CONTRAINDICATIONS and WARNINGS ). If a hypersensitivity reaction is suspected, discontinue PREGNYL and assess for other potential causes for the event.

Psychiatric disorders
Irritability
Restlessness
Depression

Nervous system disorders
Headache

General disorders and administration site conditions
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 (see CONTRAINDICATIONS and WARNINGS ).
Edema
Fatigue

In the female:
Vascular disorders
In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see WARNINGS ).

Respiratory, thoracic and mediastinal disorders
Hydrothorax, as a complication of severe OHSS (see WARNINGS ).

Gastrointestinal disorders
Abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS. Ascites, as a complication of severe OHSS (see WARNINGS ).

Reproductive system and breast disorders
Unwanted ovarian hyperstimulation, mild or severe Ovarian Hyperstimulation Syndrome (see WARNINGS ).
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 WARNINGS ).
Painful breasts

Investigations
Weight gain as a characteristic of severe OHSS (see WARNINGS ).

In the male:
Metabolism and nutrition disorders
Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production.

Reproductive system and breast disorders
HCG treatment may sporadically cause gynecomastia.
Precocious puberty

Chorionic gonadotropin, a gonadotropin, is a polypeptide hormone produced by the human placenta and obtained from the urine of pregnant persons. Chorionic gonadotropin is a purified preparation composed of an alpha and a beta subunit. The alpha subunit is essentially identical to the alpha subunits of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha subunit of human thyroid-stimulating hormone (TSH). The beta subunits of these hormones differ in amino acid sequence.

PREGNYL ^® (chorionic gonadotropin) for injection is a sterile, dried powder for intramuscular injection after reconstitution. Each multiple-dose vial is only for use in one patient and contains 10,000 USP units of chorionic gonadotropin with dibasic sodium phosphate (4.4 mg) and monobasic sodium phosphate (5 mg). If required, pH is adjusted with sodium hydroxide and/or phosphoric acid.

Each package also contains a 10-mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL (preservative), WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

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.

Two-vial package containing:
One 10 mL multiple-dose vial for administration by one patient, containing lyophilized powder of 10,000 USP units of chorionic gonadotropin per vial, NDC 78206-150-01.
One 10 mL multiple-dose vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol (preservative) 0.9%, NDC 78206-151-89.