Drug Detail:Gonadotropin, chorionic (monograph) (Novarel)
Drug Class:
Usual Adult Dose for Ovulation Induction
Human Chorionic Gonadotropin (HCG): 5000 to 10,000 units IM once 1 day following the last dose of menotropins
Recombinant Chorionic Gonadotropin (r-HCG): 250 mcg subcutaneously once 1 day following last dose of follicle-stimulating agent
Comments:
- Some experts recommended HCG doses of 10,000 units.
- Patients should be appropriately pretreated with human menotropins.
- r-HCG should not be given until adequate follicular development is indicated with serum estradiol and vaginal ultrasonography; treatment should be withheld in patients with excessive ovarian response (e.g., significant ovarian enlargement, excessive estradiol production).
Uses:
- Induction of ovulation (OI) and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure
- Induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an assisted reproductive technology (ART) program (e.g., in vitro fertilization, embryo transfer)
Usual Adult Dose for Hypogonadism - Male
HCG:
500 to 1000 units IM 3 times a week for 3 weeks, then 500 to 1000 units IM 2 times a week for 3 weeks OR
4000 units IM 3 times a week for 6 to 9 months, then 2000 units IM 3 times a week for 3 months
Uses:
- Selected cases of hypogonadotropic hypogonadism in males
- Hypogonadism secondary to a pituitary deficient in males
Usual Pediatric Dose for Prepubertal Cryptorchidism
HCG:
4 years and older:
4000 units IM 3 times a week for 3 weeks OR
5000 units IM every other day for 4 injections OR
500 to 1000 units IM for 15 injections over a period of 6 weeks OR
500 units IM 3 times a week for 4 to 6 weeks; if unsuccessful, patients should be given an additional series using 1000 units starting 1 month later.
Comments:
- Treatment is believed to induce a temporary testicular descent response in patients who would have testicular descent during puberty, but may produce a permanent response in some patients.
- Treatment usually occurs between 4 and 9 years of age.
Use: Prepubertal cryptorchidism not due to anatomical obstruction
Renal Dose Adjustments
Use with caution.
Liver Dose Adjustments
Data not available
Dose Adjustments
r-HCG:
- Patients with tubal obstruction: Patients should be enrolled in an in vitro fertilization program prior to treatment.
Signs/symptoms of precocious puberty: Treatment should be discontinued.
Precautions
Safety and efficacy of HCG have not been established in patients younger than 4 years.
Safety and efficacy of r-HCG gonadotropin have not been established in children.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Self-administration should be limited to patients who are motivated, adequately trained, and have access to advice.
- Prior to administration, patients should be instructed on proper administration techniques, including the principles of sterile techniques.
- Once administered, needles and syringes should be placed in a sealable, puncture-resistant container.
Storage requirements:
- HCG: Once reconstituted, use completely; some reconstituted formulations may be stable for a few days when refrigerated. The manufacturer product information should be consulted for further details.
- r-HCG: Protect from light; store in the refrigerator until just prior to use.
Reconstitution/preparation techniques:
- The manufacturer product information should be consulted.
General:
- Use may aid in predicting whether orchiopexy will be needed in patients with prepubertal cryptorchidism.
- Limitation of use: Use for ovulation and pregnancy should be limited to patients who are receiving a follicle stimulating agents or human menopausal gonadotropins (menotropins).
- Limitation of use: r-HCG has not been studied in male patients and for use in patients with corpus luteum insufficiency.
Monitoring:
- Cardiovascular: Signs/symptoms of thrombotic events
- Endocrine: Estradiol levels
- Genitourinary: Ovarian response to treatment (via transvaginal ultrasound)
- Musculoskeletal: Skeletal maturation in patients treated for delayed puberty
Patient advice:
- Patients should be told to report signs/symptoms of ovarian hyperstimulation syndrome, thrombotic events, and ovarian torsion.
- Patients should be told that use of this drug requires monitoring of ovarian response with/without estradiol levels.
- Patients should be instructed to properly dispose of used needles and syringes.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.