Label: PREGNYL- choriogonadotropin alfa
- NDC Code(s): 0052-0315-10
- Packager: Organon USA Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
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Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta subunit. The alpha sub-unit 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 USP) is a highly purified pyrogen-free preparation obtained from the urine of pregnant females. It is standardized by a biological assay procedure. It is available for intramuscular injection in multiple dose vials containing 10,000 USP units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. 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, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.Close
- CLINICAL PHARMACOLOGY
The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
Androgen stimulation in the male leads to the development of secondary sex characteristics and may stimulate testicular descent when no anatomical impediment to descent is present. This descent is usually reversible when HCG is discontinued.
During the normal menstrual cycle, LH participates with FSH in the development and maturation of the normal ovarian follicle, and the mid-cycle LH surge triggers ovulation. HCG can substitute for LH in this function. During a normal pregnancy, HCG secreted by the placenta maintains the corpus luteum after LH secretion decreases, supporting continued secretion of estrogen and progesterone and preventing menstruation. HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.Close
- 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 pretreated with human menotropins.
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.
Anaphylaxis has been reported with urinary-derived HCG products.
The principal serious adverse reactions during this use are: (1) ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) rupture of ovarian cysts with resultant hemoperitoneum, (3) multiple births, and (4) arterial thromboembolism.Close
- ADVERSE REACTIONS
Hypersensitivity reactions, both localized and systemic in nature, have been reported.Close
- DOSAGE AND ADMINISTRATION
For intramuscular use only. 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:
- 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.
- 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 pretreated with human menotropins. (See prescribing information for menotropins for dosage and administration for that drug product.)
Directions for Reconstitution
Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1–10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution.
- HOW SUPPLIED
Chorionic gonadotropin 10,000 USP units Monobasic sodium phosphate 5 mg Dibasic sodium phosphate 4.4 mg Sodium chloride 0.56% Benzyl alcohol 0.9%
- SPL UNCLASSIFIED SECTION
PREGNYL® manufactured by: Baxter Oncology GmbH, Halle 33790, Germany
For patent information: www.merck.com/product/patent/home.html
- PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
10-mL multidose vial
with 10-mL vial of solvent
for injection USP)
- INGREDIENTS AND APPEARANCE
choriogonadotropin alfa kit
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0052-0315 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0052-0315-10 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, MULTI-DOSE 10 mL Part 2 1 VIAL 10 mL Part 1 of 2 PREGNYL
choriogonadotropin alfa injection, powder, lyophilized, for solution
Product Information Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHORIOGONADOTROPIN ALFA (CHORIOGONADOTROPIN ALFA) CHORIOGONADOTROPIN ALFA 10000 [USP'U] in 10 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC SODIUM HYDROXIDE PHOSPHORIC ACID Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 VIAL, MULTI-DOSE; Combination Product Type = C112160 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017692 10/20/1976 Part 2 of 2 PREGNYL SOLVENT
water, sodium chloride and benzyl alcohol injection, solution
Product Information Route of Administration INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength WATER SODIUM CHLORIDE BENZYL ALCOHOL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 mL in 1 VIAL; Combination Product Type = C112160 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017692 10/20/1976 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017692 10/20/1976 Labeler - Organon USA Inc. (078796541) Establishment Name Address ID/FEI Business Operations Aspen Oss B.V. 491013870 API MANUFACTURE(0052-0315) Establishment Name Address ID/FEI Business Operations BAXTER PHARMACEUTICAL SOLUTIONS, LLC 604719430 MANUFACTURE(0052-0315) Establishment Name Address ID/FEI Business Operations Aspen Oss B.V. 491017488 API MANUFACTURE(0052-0315) Establishment Name Address ID/FEI Business Operations Merck Sharp & Dohme Corp. 101740835 PACK(0052-0315) Establishment Name Address ID/FEI Business Operations Baxter Oncology GmbH 344276063 MANUFACTURE(0052-0315)