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|Chorionic Gonadotropin

Chorionic Gonadotropin

Trade Names:
Chorionic Gonadotropin
- Powder for injection 5000 units/vial with 10 mL diluent (to make 500 units/mL)
- Powder for injection 10,000 units/vial with 10 mL diluent (to make 1000 units/mL)

Trade Names:
Novarel
- Powder for injection 10,000 units/vial with 10 mL diluent (to make 1000 units/mL)

Trade Names:
Pregnyl
- Powder for injection 10,000 units/vial with 10 mL diluent (to make 1000 units/mL)

Trade Names:
Profasi
- Powder for injection 5000 units/vial with 10 mL diluent (to make 500 units/mL)
- Powder for injection 10,000 units/vial with 10 mL diluent (to make 1000 units/mL)

Mechanism of Action

Pharmacology

Stimulates production of gonadal steroid hormones by stimulating interstitial cells (Leydig cells) of the testis to produce androgens and corpus luteum of the ovary to produce progesterone.

Pharmacokinetics

Absorption

A detectable rise in human chorionic gonadotropin (hCG) is seen in 2 hr; peak levels are reached in 6 hr and remain at this level for 36 hr.

Elimination

hCG levels begin to decline at 48 hr and approach baseline at 72 hr.

Indications and Usage

Prepubertal cryptorchidism not caused by anatomical obstruction; selected cases of hypogonadotropic hypogonadism (eg, hypogonadism secondary to pituitary deficiency) in men; induction of ovulation in anovulatory, infertile women in whom the cause of anovulation is secondary and not caused by primary ovarian failure and who have been appropriately pretreated with human menotropins.

Contraindications

Precocious puberty; prostatic carcinoma or other androgen-dependent neoplasm; prior allergic reaction to hCG.

Dosage and Administration

IM (1) 4000 USP U 3 times/wk for 3 wk, (2) 5000 USP U qod for 4 injections, (3) 15 injections of 500 to 1000 USP U over a period of 6 wk, or (4) 500 USP U 3 times/wk for 4 to 6 wk (if not successful, another course is begun 1 mo later using 1000 USP U/injection).

IM 500 to 1000 USP U 3 times/wk for 3 wk, followed by same dose twice a week for 3 wk, or 4000 USP U 3 times/wk for 6 to 9 mo, following which the dosage may be reduced to 2000 USP U 3 times/wk for an additional 3 mo.

General Advice

• Follow manufacturer"s instructions for reconstituting the Powder for Injection.
• Do not administer if particulate matter or discoloration noted.
• With patient lying down or sitting, administer drug by IM injection. Rotate injection sites.
• To minimize bleeding, do not rub site after injection.
• Discard any unused reconstituted material.

Storage/Stability

Store vials at controlled room temperature (59° to 86°F). Store reconstituted solution in refrigerator (36° to 46°F) and use within 30 or 60 days per manufacturer"s recommendations.

Drug Interactions

None well documented.

Laboratory Test Interactions

Interference with radioimmunoassay for gonadotropins, particularly luteinizing hormone.

Adverse Reactions

CNS

Headache; irritability; restlessness; depression; fatigue.

Genitourinary

Precocious puberty; gynecomastia.

Metabolic

Edema.

Miscellaneous

Pain at injection site.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children less than 4 yr not established.

Special Risk Patients

Because chorionic gonadotropin may cause fluid retention, use with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.

Exams

Ensure that women have had a thorough gynecological and endocrinological evaluation before starting therapy. Ensure that men have had a thorough medical and endocrinological evaluation before starting therapy.

Health care provider use

Use in conjunction with human menopausal gonadotropins only by health care provider experienced with infertility problems.

Precocious puberty

May induce precocious puberty in patients treated for cryptorchidism.

Patient Information

• Explain name, dose, action, and potential side effects of drug. Review the treatment regimen including duration and monitoring that will be required.
• If patient will be administering at home, teach patient how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
• Warn women that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, or infrequent urination.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.