Additional Information

Description

The human placenta produces the polypeptide hormone known as chorionic gonadotropin, which is extracted from pregnant women's urine. An alpha and a beta subunit make up the purified form of chorionic gonadotropin. The alpha subunit is nearly the same as the alpha subunits of human thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), and pituitary gonadotropins. The amino acid sequence of these hormones' beta subunits varies.

After reconstitution, the sterile, dried powder known as PREGNYL® (chorionic gonadotropin) for injection is administered intramuscularly. Each multiple-dose vial contains 10,000 USP units of chorionic gonadotropin along with 4.4 mg of dibasic sodium phosphate and 5 mg of monobasic sodium phosphate, and it is meant for use by only one patient. Phosphoric acid and sodium hydroxide are used to adjust pH if necessary.

A 10-mL vial of solvent, NOT TO BE USED IN NEWBORNS, also comes with each package. It contains water for injection with 0.56% sodium chloride and 0.9% benzoyl alcohol (preservative). Sodium hydroxide and/or hydrochloric acid are used to adjust pH if necessary.

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.

HCG is indicated for 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, potentially helping predict whether orchiopexy will be needed. While descent following hCG administration may be permanent in some cases, the response is typically temporary. Therapy is usually initiated in children between the ages of 4 and 9.

Additional indications include selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to pituitary deficiency) in males and induction of ovulation and pregnancy in anovulatory, infertile women when the cause is secondary (not due to primary ovarian failure) and who have been appropriately treated with human gonadotropins.

Contraindications

PREGNYL® is contraindicated in patients with prior hypersensitivity reactions to human gonadotropins (including hCG) or any excipients. It should not be used in women with high serum FSH indicating primary gonadal failure, or in those with uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders).

Additional contraindications include tumors of the hypothalamus or pituitary gland; ovarian, breast, or uterine tumors in females; breast or prostate tumors in males; reproductive organ malformations incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; and abnormal vaginal bleeding of undetermined origin.

Precautions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of chorionic gonadotropin.

Pregnancy

PREGNYL® is not indicated in pregnancy. While it may be used for luteal phase support, administration should cease upon pregnancy confirmation. There are no data on hCG use in pregnancy. In the U.S. general population, the estimated background risk of major birth defects is 2-4% and miscarriage risk is 15-20% in clinically recognized pregnancies.

Pediatric Use

HCG may induce precocious puberty in pediatric patients treated for cryptorchidism due to stimulation of androgen secretion. Therapy should be discontinued if signs of precocious puberty occur.

Lactation

It is unknown whether PREGNYL® is excreted in human milk. As many drugs are excreted in breast milk, caution is advised when administering to nursing women. The developmental benefits of breastfeeding should be weighed against the mother's clinical need for PREGNYL® and potential adverse effects on the infant.

Geriatric Use

Clinical studies of PREGNYL® (chorionic gonadotropin) for injection did not include subjects aged 65 and over.