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 (AACE 2002; Sato 2015; Sperling 2014)
Prepubertal cryptorchidism: 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.
(For additional information see "Urine-derived human chorionic gonadotropin: Drug information")
Ovulation induction: Females: IM: 5,000 to 10,000 units 1 day following last dose of menotropins
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
Spermatogenesis induction associated with hypogonadotropic hypogonadism (off-label use): Males: IM: 1,000 to 2,000 units 2 to 3 times/week. Administer hCG until serum testosterone levels are normal (may require 2 to 3 months of therapy), then may add menopausal gonadotropin of FSH if needed to induce spermatogenesis; continue hCG at the dose required to maintain testosterone levels (AACE 2002).
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.
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, sodium chloride]
Generic: 10,000 units (1 ea)
Yes
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]
Parenteral: Administer IM only.
IM: For IM administration only.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloves and a protective gown are required during administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
Store at intact vials at 15°C to 30°C (59°F to 86°F). Following reconstitution, solution is stable when refrigerated (2ºC to 8ºC [36ºF to 46ºF]) for 30 days (Novarel) or 60 days (Pregnyl).
Treatment of prepubertal cryptorchidism (FDA approved in males ages ≥4 years); treatment of hypogonadotropic hypogonadism secondary to a pituitary deficiency in males (FDA approved in adults), induce ovulation and pregnancy in anovulatory, infertile women (FDA approved in adults); has also be used for puberty induction in patients with hypogonadotrophic hypogonadism
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Arterial thrombosis, edema
Central nervous system: Depression, fatigue, headache, irritability, restlessness
Endocrine & metabolic: Gynecomastia, ovarian hyperstimulation syndrome
Genitourinary: Precocious puberty, rupture of ovarian cyst
Local: Pain at injection site
<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction (local or systemic; including angioedema, dyspnea, erythema, skin rash, urticaria), testicular neoplasm
Hypersensitivity to chorionic gonadotropin or any component of the formulation; precocious puberty; prostatic carcinoma or other androgen-dependent neoplasms
Canadian labeling: Additional contraindications (not in US labeling): Prepubertal males with signs of anatomical obstruction; sex hormone-dependent tumors (eg, ovary, breast and uterine carcinoma in females; breast carcinoma males); malformations of the reproductive organs incompatible with pregnancy; fibroid tumors of the uterus incompatible with pregnancy; abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
Concerns related to adverse effects:
• Hypersensitivity: Anaphylaxis has been reported with urinary-derived human chorionic gonadotropin (hCG) products.
• 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 ovarian hyperstimulation syndrome (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.
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.
Testicular tumors in otherwise healthy men 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).
Male: Serum testosterone levels; Adults: Semen analysis (AACE 2002)
Female: Adults: Ultrasound and/or estradiol levels to assess follicle development; ultrasound to assess number and size of follicles; ovulation (basal body temperature, serum progestin level, menstruation, sonography)
Depends on application and methodology; <3 milli international units/mL (SI: <3 units/L) usually normal (nonpregnant)
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
Solution (reconstituted) (Chorionic Gonadotropin Intramuscular)
10000 unit (per each): $374.70
Solution (reconstituted) (Novarel Intramuscular)
5000 unit (per each): $180.07
10000 unit (per each): $360.13
Solution (reconstituted) (Pregnyl Intramuscular)
10000 unit (per each): $127.87
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