PREGNYL®

(chorionic gonadotropin for injection, USP)

Dosing

Product facts

  • Individual dosing varies from 5000 to 10000 USP units hCG.
  • Can be stored at room temperature (15°C–30°C or 59°F–86°F) prior to reconstitution.
  • Reconstituted solution is stable for 60 days when refrigerated.

Pregnyl pregnyl-vials  

Induction of ovulation

  • For intramuscular use only. The dosage regimen employed in any particular case will depend upon the age and weight of the patient.
  • The recommended dosages for PREGNYL administration are for 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.
  • 5000 to 10000 USP units one day following the last dose of menotropins. A dosage of 10000 USP units is recommended in the labeling for menotropins.

Directions for reconstitution

  • IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
  • 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.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Indication

PREGNYL is indicated for the 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.

Selected Safety Information

Contraindications

PREGNYL is contraindicated in patients with prior allergic reaction to human chorionic gonadotropin (hCG).

Warnings and Precautions

PREGNYL should be used in conjunction with human menopausal gonadotropins. Only physicians experienced in infertility treatment should prescribe PREGNYL.

Anaphylaxis has been reported with urinary-derived hCG products.

The principal serious adverse reactions associated with PREGNYL 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.

Adverse Reactions

Other adverse reactions associated with PREGNYL use include headache, restlessness, depression, fatigue, edema, and pain at the site of injection.

Hypersensitivity reactions, both localized and systemic in nature, have been reported.

Before prescribing PREGNYL, please read the accompanying Prescribing Information.

Copyright © 2018 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.

WOMN-1154693-000303/18