Pregnyl
CHORIOGONADOTROPIN ALFA · KIT · Organon LLC
Pregnyl is a kit containing choriogonadotropin alfa. Manufactured by Organon LLC.
Key Facts
- Brand Name
- Pregnyl
- Generic Name
- CHORIOGONADOTROPIN ALFA
- NDC Code (Product)
78206-150- Manufacturer
- Organon LLC
- Dosage Form
- KIT
- Marketing Status
- Application #
- BLA017692
- Marketing Start
- 06/02/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 & Administration
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 cau…
Warnings
WARNINGS 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. Anaphylaxis Anaphylaxis has been reported with urinary-derived hCG products. Ovarian Hyperstimulation Syndrome (OHSS) Ovarian Hyperstimulation Syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of the dev…
Contraindications
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
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…
Frequently Asked Questions
What is Pregnyl used for?
Pregnyl contains CHORIOGONADOTROPIN ALFA. It is a kit taken as directed. Consult your doctor for specific uses.
Is Pregnyl a controlled substance?
Pregnyl is not classified as a controlled substance by the DEA.
What is the generic name for Pregnyl?
The generic name for Pregnyl is CHORIOGONADOTROPIN ALFA. There are 2 other brand versions of CHORIOGONADOTROPIN ALFA.
What is the NDC code for Pregnyl ?
The NDC (National Drug Code) for Pregnyl is 78206-150, listed by Organon LLC.