Version May 2024
Hypogonadotropic hypogonadism: Males: IM: Various regimens:
500 to 1,000 units 3 times/week for 3 weeks, followed by the same dose twice weekly for 3 weeks or
4,000 units 3 times/week for 6 to 9 months, then reduce dosage to 2,000 units 3 times/week for additional 3 months.
Ovulation induction: IM: 5,000 to 10,000 units 1 day following last dose of menotropins.
Spermatogenesis induction associated with hypogonadotropic hypogonadism (off-label use): IM, SUBQ: 1,000 to 2,000 units 2 to 3 times/week. Administer chorionic gonadotropin (human) (hCG) until serum testosterone levels are normal (may require 2 to 3 months of therapy), then may add menopausal gonadotropin or FSH if needed to induce spermatogenesis; continue hCG at the dose required to maintain testosterone levels (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Urine-derived human chorionic gonadotropin: Pediatric drug information")
Hypogonadotropic hypogonadism, puberty induction: Limited data available: Children ≥12 years and Adolescents: Males: IM: 500 to 3,000 units 2 to 3 times weekly; adjust dose based on serum testosterone levels, every 3 to 6 months (Ref).
Prepubertal cryptorchidism: Note: Although FDA approved, routine use of hormonal therapy to induce testicular descent is not recommended by experts due to low response rates, and long-term efficacy evidence is lacking (Ref).
Children ≥4 years and Adolescents: Males: IM: Various regimens reported by manufacturer:
Note: Therapy is usually instituted between the ages of 4 and 9 years:
4,000 units 3 times weekly for 3 weeks or
5,000 units every second day for 4 injections or
500 units 3 times weekly for 4 to 6 weeks (if not successful, may repeat course one month later using 1,000 units/dose) or
15 injections of 500 to 1,000 units administered over 6 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Edema
Endocrine & metabolic: Gynecomastia, precocious puberty
Genitourinary: Mastalgia, ovarian hyperstimulation syndrome (including ovarian cyst, rupture of ovarian cyst)
Local: Pain at injection site
Nervous system: Depression, fatigue, headache, irritability, restlessness
Postmarketing:
Genitourinary: Ovarian torsion, testicular neoplasm
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema)
Prior hypersensitivity to chorionic gonadotropin, including human chorionic gonadotropin (hCG), or any component of the formulation; tumors of the hypothalamus, pituitary gland, ovary, breast (females or males), uterus, prostate.
Novarel (additional contraindications): Precocious puberty.
Pregnyl (additional contraindications): Elevated serum follicle-stimulating hormone; uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, pituitary disorders); malformations of the reproductive organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; abnormal vaginal bleeding of unexplained origin.
Canadian labeling: Additional contraindications (not in US labeling): Prepubertal males with signs of anatomical. obstruction
Concerns related to adverse effects:
• Hypersensitivity: Anaphylaxis has been reported with urinary-derived human chorionic gonadotropin (hCG) products.
• Ovarian neoplasms: Benign and malignant neoplasms have been reported (infrequently) in women receiving multiple-drug therapy for controlled ovarian stimulation; causal effect has not been established.
• Ovarian torsion: Has been reported following gonadotropin treatment; may be related to ovarian hyperstimulation syndrome (OHSS), prior ovarian torsion, prior or current ovarian cyst, polycystic ovaries, pregnancy, or prior abdominal surgery. Early diagnosis and prompt detorsion may limit the extent of ovarian damage.
• Pulmonary effects: Serious pulmonary conditions (eg, atelectasis, acute respiratory distress syndrome) have been reported.
• Thromboembolism: Arterial or venous thromboembolism may occur; patients with a history of family history of thrombosis, severe obesity, or thrombophilia are at an increased risk.
Disease-related concerns:
• Asthma: Use with caution in patients with asthma; hCG may cause fluid retention.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease; hCG may cause fluid retention.
• Cryptorchidism: May induce precocious puberty in children being treated for cryptorchidism; discontinue if signs of precocious puberty occur.
• Migraine: Use with caution in patients with a history of migraines; hCG may cause fluid retention.
• Renal impairment: Use with caution in patients with renal impairment; hCG may cause fluid retention.
• Seizure disorders: Use with caution in patients with a history of seizure disorders; hCG may cause fluid retention.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Obesity: Not effective adjunctive therapy in the treatment of obesity.
• Ovulation induction: Appropriate use: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management. May cause OHSS. OHSS is a rare, exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; Shmorgun 2017). Multiple births may result from the use of these medications; advise patients of the potential risk of multiple births before starting the treatment. Risk of ectopic pregnancy or spontaneous abortion may be increased.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Novarel: 5000 units (1 ea); 10,000 units (1 ea) [contains benzyl alcohol]
Pregnyl: 10,000 units (1 ea) [contains benzyl alcohol]
Pregnyl: 10,000 units (1 ea) [contains benzyl alcohol, sodium chloride]
Generic: 10,000 units (1 ea)
Yes
Solution (reconstituted) (Chorionic Gonadotropin Intramuscular)
10000 unit (per each): $374.70
Solution (reconstituted) (Novarel Intramuscular)
5000 unit (per each): $194.76
10000 unit (per each): $389.52
Solution (reconstituted) (Pregnyl Intramuscular)
10000 unit (per each): $204.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Pregnyl: 10,000 units (10 mL) [contains benzyl alcohol]
IM: For IM administration.
May be administered SUBQ for spermatogenesis induction associated with hypogonadotropic hypogonadism (Ref).
Parenteral: Administer IM only.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020). Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.
Hypogonadotropic hypogonadism: Treatment of hypogonadism secondary to a pituitary deficiency in males.
Ovulation induction: Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not caused by primary ovarian failure, and who has been appropriately treated with human menotropins.
Prepubertal cryptorchidism: Treatment of prepubertal cryptorchidism not caused by anatomic obstruction.
Spermatogenesis induction associated with hypogonadotropic hypogonadism
None known.
There are no known significant interactions.
When needed for ovulation induction, should only be used by physicians who are thoroughly familiar with infertility problems and their management. Multiple births may result from use of this medication.
When administered for spermatogenesis induction associated with hypogonadotropic hypogonadism in patients planning a pregnancy, also evaluate fertility status of the female partner (AACE [Petak 2002]). Treatment with chorionic gonadotropin (human) is continued after conception and may be continued after a successful pregnancy if an additional pregnancy is desired in the future (Prior 2018).
Testicular tumors in otherwise healthy patients have been reported when treating secondary infertility.
Studies in animals have shown evidence of fetal abnormalities at doses intended to induce superovulation (used in combination regimens).
It is not known if chorionic gonadotropin (human) is present in breast milk.
The manufacturer recommends that caution be exercised when administering chorionic gonadotropin (human) to patients who are breastfeeding.
Hypogonadotropic hypogonadism: Serum testosterone levels, semen analysis (AACE [Petak 2002]).
Ovulation induction:
Monitor sufficient follicular growth and maturation. This may be directly estimated by transvaginal sonographic visualization of the ovaries and endometrial lining. The combination of both ultrasonography and measurement of estradiol levels is useful for monitoring for the growth and development of follicles and timing human chorionic gonadotropin (hCG) administration.
The clinical evaluation of estrogenic activity (changes in vaginal cytology and changes in appearance and volume of cervical mucus) provides an indirect estimate of the estrogenic effect upon the target organs and, therefore, it should only be used adjunctively with more direct estimates of follicular development (ultrasonography and serum estradiol determinations).
The clinical confirmation of ovulation is obtained by direct and indirect indices of progesterone production as well as sonographic evidence of ovulation. Direct or indirect indices of progesterone production most generally used are: rise in serum or urine luteinizing hormone, rise in basal body temperature, increase in serum progesterone, and menstruation following the shift in basal body temperature. Sonographic evidence of ovulation includes collapsed follicle, fluid in the cul-de-sac, features consistent with corpus luteum formation, and secretory endometrium.
Monitor for signs and symptoms of ovarian hyperstimulation syndrome for at least 2 weeks following hCG administration.
Ovarian hyperstimulation syndrome: Monitoring of hospitalized patients should include abdominal circumference, albumin, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, serum creatinine, urine output, urine specific gravity, vital signs, weight (all daily or as necessary), and liver enzymes (weekly) (Shmorgun 2017).
Human chorionic gonadotropin (hCG) is produced by the human placenta; available preparations provide purified luteinizing hormone obtained from the urine of pregnant women. hCG stimulates production of gonadal steroid hormones by causing production of androgen by the testes and the development of secondary sex characteristics in males. In females, hCG acts as a substitute for luteinizing hormone (LH) to stimulate ovulation.
Duration: IM: ~36 hours
Distribution: Distributes mainly into the testes in males and into the ovaries in females
Half-life elimination: Biphasic: Initial: 6 to 11 hours; Terminal: 23 to 37 hours
Time to peak, plasma: IM: Within 6 hours
Excretion: Urine (~10% to 12 %) within 24 hours
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