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 4,000 USP units three times weekly for three weeks. 5,000 USP units every second day for four injections. 15 injections of 500 to 1,000 USP units over a period of six weeks. 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 500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks. 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 units is recommended in the labeling for menotropins.) IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION. REFRIGERATE AFTER RECONSTITUTION.

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 4,000 USP units three times weekly for three weeks. 5,000 USP units every second day for four injections. 15 injections of 500 to 1,000 USP units over a period of six weeks. 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 500 to 1,000 USP units three times a week for three weeks, followed by the same dose twice a week for three weeks. 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 units is recommended in the labeling for menotropins.) IMPORTANT: USE COMPLETELY WITHIN 60 DAYS AFTER RECONSTITUTION. REFRIGERATE AFTER RECONSTITUTION.

CONTRAINDICATIONS: Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG.

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

DESCRIPTION: Human chorionic gonadotropin (HCG), a polypeptide hormone 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 gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH). The beta sub-units of these hormones differ in amino acid sequence. Chorionic gonadotropin is obtained from the human pregnancy urine. It is standardized by a biological assay procedure. Chorionic Gonadotropin for injection is a sterile lyophilized powder available in multiple dose vials containing 10,000 USP units to be reconstituted with accompanying Bacteriostatic Water for Injection and administered intramuscularly after reconstitution. When reconstituted with 10 mL of the accompanying diluent each vial contains: Chorionic gonadotropin 10,000 USP units benzyl alcohol 0.9% dibasic sodium phosphate 13 mg mannitol 100 mg monobasic sodium phosphate 3 mg water for injection q.s. Buffered with dibasic sodium phosphate and monobasic sodium phosphate. Hydrochloric acid and/or sodium hydroxide may have been used for pH adjustment (6.0-8.0). Nitrogen gas is used in the freeze drying process.

HOW SUPPLIED: Chorionic Gonadotropin, lyophilized powder, is supplied in two-vial packages including Bacteriostatic Water for Injection as diluent as follows: Product Code Unit of Sale Description 325011 NDC 63323-030-11 One carton containing Chorionic Gonadotropin, 10,000 USP units per vial in a 10 mL multiple dose vial (NDC 63323-030-10) with accompanying diluent (NDC 63323-950-01). Store at room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. If needed, the reconstituted vial may be refrigerated between 2°C to 8°C (36°F to 46°F) and must be discarded after 60 days. Do not freeze and do not shake. Manufactured by: www.fresenius-kabi.com/us US License Number 2146 45792J Revised: February 2025 chori-img-01.jpg