PREGNYL®, manufactured by Organon, contains chorionic gonadotropin (hCG), a polypeptide hormone naturally produced by the placenta during pregnancy. Derived from human sources, this purified preparation consists of an alpha and beta subunit similar to pituitary hormones like luteinizing hormone (LH) and follicle-stimulating hormone (FSH). Its physiological functions mimic those of LH, playing a vital role in stimulating the production of gonadal steroids like testosterone in males and progesterone in females.

PREGNYL is available as a sterile, dried powder for intramuscular injection after reconstitution. It is primarily indicated for managing conditions such as cryptorchidism in prepubertal males, hypogonadotropic hypogonadism, and ovulation induction in women with specific infertility challenges. Its clinical benefits extend to supporting androgen production and facilitating reproductive processes when used under medical supervision.

Composition and Presentation

• Active Ingredient: Chorionic gonadotropin (hCG) – 10,000 USP units per vial.
• Additional Ingredients: Dibasic sodium phosphate, monobasic sodium phosphate, and benzyl alcohol as a preservative.
• Reconstitution Solvent: Water for injection with sodium chloride (0.56%) and benzyl alcohol (0.9%).
• Packaging: Two-vial system: one containing lyophilized powder and the other containing the solvent.

Mechanism of Action

hCG acts as a substitute for LH, stimulating the gonads to produce steroid hormones. In males, it promotes androgen production by Leydig cells and may aid in testicular descent in certain cases of cryptorchidism. In females, hCG triggers ovulation and supports the corpus luteum to maintain progesterone production during early pregnancy.

Indications

PREGNYL is indicated for:

1. Cryptorchidism in Prepubertal Males: Assists testicular descent when no anatomical obstruction is present.
2. Hypogonadotropic Hypogonadism in Males: Treats testosterone deficiency due to pituitary dysfunction.
3. Ovulation Induction in Women: Facilitates pregnancy in anovulatory women with secondary infertility not caused by primary ovarian failure.

Recommended Dosages:

1. Cryptorchidism:
   • 4,000 USP units three times a week for 3 weeks, OR
   • 5,000 USP units every second day for 4 injections.
2. Hypogonadotropic Hypogonadism in Males:
   • 500 to 1,000 USP units three times a week for 3 weeks, then twice weekly for another 3 weeks.
   • For longer-term therapy: 4,000 USP units three times a week for 6–9 months, then reduce to 2,000 USP units for an additional 3 months.
3. Ovulation Induction:
   • 5,000–10,000 USP units one day after the last dose of gonadotropins.

Reconstitution Instructions:

• Use the provided solvent to dissolve the lyophilized powder.
• Agitate gently until fully dissolved.
• Store the reconstituted solution in a refrigerator (2°C–8°C) and use within 60 days. Do not freeze.

Key Features and Benefits

• Androgen Support: Enhances testosterone production in males.
• Fertility Assistance: Stimulates ovulation and supports luteal phase in women.
• Versatile Use: Addresses multiple conditions related to reproductive health.
• Clinically Proven: Widely studied and trusted in reproductive medicine.

Storage and Handling

• Store the lyophilized powder at room temperature (15°C–25°C).
• Refrigerate the reconstituted solution and discard after 60 days if unused.
• Keep out of reach of children and do not freeze.