PREGNYL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREGNYL (PREGNYL).
Human chorionic gonadotropin (hCG) acts as a luteinizing hormone (LH) agonist, binding to LH receptors in the gonads, stimulating testosterone production in males and ovulation in females.
| Metabolism | Primarily renal metabolism and excretion; limited hepatic metabolism. |
| Excretion | Renal: 10-20% as unchanged drug; hepatic metabolism to inactive metabolites; fecal excretion negligible (<5%) |
| Half-life | Terminal elimination half-life: 23–24 hours; clinically, supports daily or every-other-day dosing; peak effect may lag due to prolonged absorption |
| Protein binding | ~80% bound primarily to albumin; minor binding to sex hormone-binding globulin (SHBG) |
| Volume of Distribution | 0.5–0.7 L/kg; moderately distributed into extracellular fluid; penetrates gonadal tissues |
| Bioavailability | Intramuscular: ~100%; Subcutaneous: comparable (~95-100%); Oral: <5% (not used) |
| Onset of Action | Intramuscular: 2–4 hours (increased serum estrogen/progesterone); Subcutaneous: similar |
| Duration of Action | IM: 36–48 hours (sufficient for ovulation triggering); effects on luteal phase support last up to 72 hours |
Intramuscular injection: 5,000-10,000 IU once weekly for 4-9 weeks for ovulation induction; 1,000-2,000 IU three times weekly for spermatogenesis.
| Dosage form | INJECTABLE |
| Renal impairment | No specific guidelines; use with caution in severe renal impairment (CrCl <30 mL/min) due to limited data. |
| Liver impairment | No specific guidelines for Child-Pugh; use with caution in severe hepatic impairment. |
| Pediatric use | Not indicated for prepubertal children; for delayed puberty in males: 1,000-2,000 IU intramuscularly 2-3 times weekly for 3-6 months. |
| Geriatric use | No specific recommendations; use lowest effective dose due to potential increased sensitivity and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREGNYL (PREGNYL).
| Breastfeeding | Human chorionic gonadotropin (hCG) is normally present in breast milk in low concentrations. Exogenous hCG is likely excreted into breast milk, but the M/P ratio is not established. Due to lack of data and potential for adverse effects in the infant (e.g., hormonal disruption), breastfeeding is not recommended during therapy. The manufacturer advises discontinuing breastfeeding or avoiding the drug. |
| Teratogenic Risk | Pregny (hCG) is not indicated for use during pregnancy. hCG is used to induce ovulation and is not continued after conception. In animal studies, high doses have shown fetal abnormalities, but human data are insufficient. First trimester: No direct fetal risk from therapeutic use as it is discontinued before implantation. Second/Third trimester: Not used. Overall, classified as FDA Pregnancy Category X for ovulation induction (contraindicated in pregnancy) but no teratogenic risk if discontinued before conception. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to hCG or any component","Premature epiphyseal closure in males","Androgen-dependent neoplasia (e.g., prostate cancer)","Undiagnosed uterine bleeding","Ovarian cyst or enlargement due to polycystic ovarian syndrome (PCOS)","Active thromboembolic disorders"]
| Precautions | ["Ovarian hyperstimulation syndrome (OHSS) in women","Arterial thromboembolism","Precocious puberty in males","Fluid retention","Ovarian enlargement or cyst rupture"] |
Loading safety data…
| Fetal Monitoring | During ovulation induction: monitoring of ovarian response via ultrasound and serum estradiol levels to prevent ovarian hyperstimulation syndrome (OHSS). If pregnancy occurs: standard prenatal care. No specific fetal monitoring required beyond routine pregnancy surveillance. |
| Fertility Effects | Pregny is used to induce ovulation in anovulatory women, thereby restoring fertility. It carries a risk of multiple gestation (twins, etc.) and ovarian hyperstimulation syndrome. It does not impair fertility; rather, it is therapeutic for infertility. However, repeated use may lead to ovarian enlargement or cyst formation. |