Choriogonadotropine alfa (chorionic gonadotropin)

INDICATIONS AND USAGE: 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 between the ages four and nine. 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 pretreated with human menotropins.

DOSAGE AND ADMINISTRATION: Intramuscular Use Only The dosage regimen employed in any particular case will depend upon the indication for 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 1. 4,000 USP units three times weekly for three weeks. 2. 5,000 USP units every second day for four injections. 3. 15 injections of 500 to 1,000 USP units over a period of six weeks. 4. 500 USP units three times weekly for four to six weeks. If this course of treatment is not successful, another is begun one month later giving 1,000 USP units per injection. Selected Cases Of Hypogonadotropic Hypogonadism In Males 1. 500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks. 2. 4,000 USP units three times weekly for six to nine months, following which the dosage may be reduced to 2,000 USP units three times weekly for an additional three 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 pretreated with human menotropins (see prescribing information for menotropins for dosage and administration for that drug product). 5,000 to 10,000 USP units one day following the last dose of menotropins. (A dosage of 10,000 USP units is recommended in the labeling for menotropins.) IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION. REFRIGERATE AFTER RECONSTITUTION.

WARNINGS: HCG should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, (2) Rupture of ovarian cysts with resultant hemoperitoneum, (3) Multiple births and (4) Arterial thromboembolism. Anaphylaxis and other hypersensitivity reactions have been reported with urinary-derived HCG products.

ADVERSE REACTIONS: Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia and pain at the site of injection.