Pregnyl

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 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 in children 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 treated with human gonadotropins.

DOSAGE AND ADMINISTRATION For intramuscular use only. Each multiple-dose vial is to be used for one patient. The dosage regimen employed in any particular case will depend upon the indication for the 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. Generally, institute therapy in children between the ages of 4 and 9. 4000 USP units 3 times weekly for 3 weeks. 5000 USP units every second day for 4 injections. 15 injections for 500 to 1000 USP units over a period of 6 weeks. 500 USP units 3 times weekly for 4 to 6 weeks. If this course of treatment is not successful, another series is begun 1 month later, giving 1000 USP units per injection. Selected cases of hypogonadotropic hypogonadism in males. 500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. 4000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 USP units 3 times weekly for an additional 3 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 treated with gonadotropins. (See also prescribing information for gonadotropins for dosage and administration for that drug product .) 5000 to 10,000 USP units 1 day following the last dose of gonadotropins. (A dosage of 10,000 USP units is recommended in the labeling for gonadotropins.) Directions for Reconstitution Withdraw sterile air from vial with lyophilized powder and inject into vial with solvent. Remove 1 to 10 mL of solvent and add to vial with lyophilized powder; agitate gently until powder is completely dissolved in solution. Do not shake. PREGNYL is a white, dry powder / cake. The solvent is a clear and colorless aqueous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If there is a discoloration or particulates, do not use. IMPORTANT: IF NEEDED, THE RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED. DO NOT FREEZE. USE THE RECONSTITUTED SOLUTION WITHIN 60 DAYS OF RECONSTITUTION. IF THE RECONSTITUTED SOLUTION IS NO LONGER NEEDED, DISCARD UNUSED PORTION.

CONTRAINDICATIONS Prior hypersensitivity reactions to human gonadotropins, including hCG, or any of the excipients (see ADVERSE REACTIONS ). High serum FSH, indicating primary gonadal failure in women. Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders). Tumors of the hypothalamus or pituitary gland and ovary, breast, or uterus in females and breast or prostate in males. Malformations of the reproductive organs incompatible with pregnancy. Fibroid tumors of the uterus incompatible with pregnancy. Abnormal vaginal bleeding of undetermined origin.

ADVERSE REACTIONS For males and females: Immune system disorders Hypersensitivity reactions, both localized and systemic in nature, including anaphylaxis have been reported. In rare cases, generalized rash or fever may occur (see CONTRAINDICATIONS and WARNINGS ). If a hypersensitivity reaction is suspected, discontinue PREGNYL and assess for other potential causes for the event. Psychiatric disorders Irritability Restlessness Depression Nervous system disorders Headache General disorders and administration site conditions PREGNYL may cause reactions at the site of injection, such as bruising, pain, redness, swelling and itching. Occasionally, allergic reactions have been reported, mostly manifesting as pain and/or rash at the injection site (see CONTRAINDICATIONS and WARNINGS ). Edema Fatigue In the female: Vascular disorders In rare instances, thromboembolism has been associated with FSH/hCG therapy, usually associated with severe OHSS (see WARNINGS ). Respiratory, thoracic and mediastinal disorders Hydrothorax, as a complication of severe OHSS (see WARNINGS ). Gastrointestinal disorders Abdominal pain and gastrointestinal symptoms such as nausea and diarrhea, related to mild OHSS. Ascites, as a complication of severe OHSS (see WARNINGS ). Reproductive system and breast disorders Unwanted ovarian hyperstimulation, mild or severe Ovarian Hyperstimulation Syndrome (see WARNINGS ). Mild to moderate enlargement of ovaries and ovarian cysts related to mild OHSS. Large ovarian cysts (prone to rupture), usually associated with severe OHSS (see WARNINGS ). Painful breasts Investigations Weight gain as a characteristic of severe OHSS (see WARNINGS ). In the male: Metabolism and nutrition disorders Water and sodium retention is occasionally seen after administration of high dosages; this is regarded as a result of excessive androgen production. Reproductive system and breast disorders HCG treatment may sporadically cause gynecomastia. Precocious puberty

DESCRIPTION Chorionic gonadotropin, a gonadotropin, is a polypeptide hormone produced by the human placenta and obtained from the urine of pregnant persons. Chorionic gonadotropin is a purified preparation 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. PREGNYL ® (chorionic gonadotropin) for injection is a sterile, dried powder for intramuscular injection after reconstitution. Each multiple-dose vial is only for use in one patient and contains 10,000 USP units of chorionic gonadotropin with dibasic sodium phosphate (4.4 mg) and monobasic sodium phosphate (5 mg). If required, pH is adjusted with sodium hydroxide and/or phosphoric acid. Each package also contains a 10-mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL (preservative), WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

HOW SUPPLIED Two-vial package containing: One 10 mL multiple-dose vial for administration by one patient, containing lyophilized powder of 10,000 USP units of chorionic gonadotropin per vial, NDC 78206-150-01. One 10 mL multiple-dose vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol (preservative) 0.9%, NDC 78206-151-89. Storage: Store unopened vial at controlled room temperature 15°C to 25°C (59°F to 77°F). If reconstituted solution in vial is not used immediately, then store refrigerated [2°C to 8°C (36°F to 46°F)] until use and discard after 60 days. Do not shake. Do not freeze.