PREGNYL- choriogonadotropin alfa
Merck Sharp & Dohme LLC
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.
The action of human chorionic gonadotropin (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.
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.
Use hCG in conjunction with gonadotropin therapy only if the physician is experienced with infertility problems and is familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for gonadotropins. Gonadotropin therapy, including hCG, requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see PRECAUTIONS/Laboratory Tests). Safe and effective induction of ovulation with use of PREGNYL requires monitoring of ovarian response with serum estradiol and transvaginal ultrasound on a regular basis.
Human chorionic gonadotropins can crossreact in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of crossreactivity with their gonadotropin assay. Make the laboratory aware that the patient is on hCG, if gonadotropin levels are requested.
The clinical confirmation of ovulation, with the exception of pregnancy, is obtained by direct and indirect indices of progesterone production as well as sonographic evidence of ovulation. The indices most generally used are as follows:
When used in conjunction with the indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following:
Accurate interpretation of the indices of ovulation requires a physician who is experienced in the interpretation of these tests.
Sonographic evaluation of the early pregnancy is also important to rule out ectopic pregnancy.
Long-term studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of chorionic gonadotropin.
PREGNYL is not indicated in pregnancy. PREGNYL may be used for luteal phase support, but is discontinued upon confirmation of pregnancy. There are no data on the use of hCG in pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Induction of androgen secretion by hCG may induce precocious puberty in pediatric patients treated for cryptorchidism. Discontinue therapy if signs of precocious puberty occur.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if hCG is administered to a nursing woman.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PREGNYL and any potential adverse effects on the breastfed child from PREGNYL or from the underlying maternal condition.
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.
Nervous system disorders
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).
In the female:
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).
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).
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.
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.
Selected cases of hypogonadotropic hypogonadism 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 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.)
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.
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 0052-0315-10.
One 10 mL multiple-dose vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol (preservative) 0.9%, NDC 0052-0325-10.
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
PREGNYL manufactured by:
Organon USA Inc. a subsidiary of Merck & Co., Inc.
2000 Galloping Hill Road
Kenilworth, NJ 07033
U.S. License No. 2193
PREGNYL Solvent manufactured by:
Baxter Pharmaceutical Solutions LLC
Bloomington, IN 47403, USA
For patent information: www.msd.com/research/patent
Copyright © 1976-2023 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc.
All rights reserved.
One multiple-dose vial containing
One multiple-dose vial of solvent
Dispense with Full Prescribing Information
choriogonadotropin alfa kit
|Labeler - Merck Sharp & Dohme LLC (118446553)|