Chorionic Gonadotrophin (Human)

Indications

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.

Dosage and administration (summary)

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.

Contraindications

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

Warnings and precautions

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: Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain and/or pleural effusion, Rupture of ovarian cysts with resultant hemoperitoneum, Multiple births and Arterial thromboembolism.

Pregnancy

Pregnancy Teratogenic Effects: Chorionic gonadotropin may cause fetal harm when administered to a pregnant woman. Defects of forelimbs and central nervous system and alterations in sex ratio have been reported in mice receiving combined gonadotropin and chorionic gonadotropin therapy in dosages to induce superovulation.

Storage and supply

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 acc…

Source: Chorionic Gonadotropin (Chorionic Gonadotropin) — US FDA prescribing information, 2025-04-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.