Gonadotrophin, Chorionic

Description

DESCRIPTION Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is 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. NOVAREL (chorionic gonadotropin) for injection is a water soluble glycoprotein derived from human pregnancy urine and administered intramuscularly after reconstitution. The sterile lyophilized powder is stable. When reconstituted with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%, the solution should be refrigerated and used within 30 days. Each 5,000 USP units vial contains: chorionic gonadotropin 5,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg. Each 10,000 USP units vial contains: chorionic gonadotropin 10,000 USP Units, Dibasic Sodium Phosphate 16 mg, Mannitol 100 mg, and Monobasic Sodium Phosphate 4 mg.

What Is Gonadotrophin, Chorionic Used For?

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. Prepubertal cryptorchidism not due to anatomic obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help to 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 of 4 and 9. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males. 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

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. Table 1. Final Concentration after Reconstitution Reconstitution volume of bacteriostatic water for injection 10,000 IU Vial Concentration 5,000 IU Vial Concentration Administration 1 mL 10,000 IU/mL 5,000 IU/mL Administer entire dose at once 10 mL 1,000 IU/mL 500 IU/mL Multiple dose administration, refrigerate between doses NOTE: Prior to diluting NOVAREL with Bacteriostatic Water for Injection (Table 1): Remove the flip caps off the vial of bacteriostatic water and the vial of NOVAREL Wipe the tops of the vials with an alcohol pad or alcohol soaked gauze Do not touch the tops of the vials after you wipe them. 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). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Disposing of Needles and Syringes To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container. Sharps containers should then be taken to a collection center for proper disposal. Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps. In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS (see WARNINGS ) Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.

Contraindications

CONTRAINDICATIONS Precocious puberty, prostatic carcinoma or other androgen-dependent neoplasm, prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

Pregnancy and Breastfeeding

Pregnancy See " CONTRAINDICATIONS " section. Combined HCG/PMS (pregnant mare's serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HCG is administered to a nursing woman.

How Supplied

HOW SUPPLIED NOVAREL (chorionic gonadotropin) for Injection, USP, is available as individually packaged multiple-dose vials containing 5,000 or 10,000 USP Units per vial. Each vial of NOVAREL is accompanied by a vial of sterile diluent containing 10 mL of Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol. NOVAREL is available in the following presentations: NDC 55566-1501-1 : 10,000 USP units of chorionic gonadotropin injection in 1 vial with blue cap and 1 vial of diluent NDC 55566-1502-1 : 5,000 USP units of chorionic gonadotropin injection in 1 vial with aqua cap and 1 vial of diluent Store at room temperature at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [See USP Controlled Room Temperature]. REFRIGERATE RECONSTITUTED PRODUCT AT 2° to 8°C (36° to 46°F) AND USE WITHIN 30 DAYS.