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Urine-derived human chorionic gonadotropin: Pediatric drug information

Urine-derived human chorionic gonadotropin: Pediatric drug information
(For additional information see "Urine-derived human chorionic gonadotropin: Drug information" and see "Urine-derived human chorionic gonadotropin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Novarel;
  • Pregnyl
Brand Names: Canada
  • Pregnyl
Therapeutic Category
  • Gonadotropin;
  • Ovulation Stimulator
Dosing: Pediatric
Hypogonadotropic hypogonadism, puberty induction

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 [Petak 2002]; Sato 2015; Sperling 2014)

Prepubertal cryptorchidism

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Urine-derived human chorionic gonadotropin: Drug information")

Hypogonadotropic hypogonadism

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

Ovulation induction: IM: 5,000 to 10,000 units 1 day following last dose of menotropins.

Spermatogenesis induction associated with hypogonadotropic hypogonadism

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 (AACE [Petak 2002]; Prior 2018; Saal 1991).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosage Forms: US

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)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

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]

Administration: Pediatric

Parenteral: Administer IM only.

Administration: Adult

IM: For IM administration.

May be administered SUBQ for spermatogenesis induction associated with hypogonadotropic hypogonadism (Prior 2018; Saal 1991).

Hazardous Drugs Handling Considerations

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.

Storage/Stability

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).

Use

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

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program

There are no known significant interactions.

Reproductive Considerations

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.

Pregnancy Considerations

Studies in animals have shown evidence of fetal abnormalities at doses intended to induce superovulation (used in combination regimens).

Monitoring Parameters

Male: Serum testosterone levels; Adults: Semen analysis (AACE [Petak 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)

Reference Range

Depends on application and methodology; <3 milli international units/mL (SI: <3 units/L) usually normal (nonpregnant)

Mechanism of Action

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.

Pharmacokinetics (Adult data unless noted)

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

Pricing: US

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

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.

Brand Names: International
  • Choragon (CR, DO, GT, HN, NI, PA, SV, UA);
  • Corion (IN);
  • Forstrong Lyo-Inj (TW);
  • Gonacor (PE, PY);
  • Hucog-5000 HP (PH);
  • Pregnyl (AE, AR, AT, AU, BE, BG, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EG, FI, GB, GR, GT, HK, HN, HU, ID, IE, JO, KR, KW, LB, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, UY, VE, ZA);
  • Pregnyl w/diluent (BB);
  • Primogonyl (DE);
  • Profasi (AE, AT, DK, EG, FI, GB, GR, HU, IN, NL, NZ, PK, PL, RU, SA, SI);
  • Profasi HP (IT, PT)


For country abbreviations used in Lexicomp (show table)
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]
  3. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm [PubMed 6810084]
  4. Corbett S, Shmorgun D, Claman P, et al; Reproductive Endocrinology Infertility Committee. The prevention of ovarian hyperstimulation syndrome. J Obstet Gynaecol Can. 2014;36(11):1024-1033. doi: 10.1016/S1701-2163(15)30417-5. [PubMed 25574681]
  5. Fiedler K, Ezcurra D. Predicting and preventing ovarian hyperstimulation syndrome (OHSS): the need for individualized not standardized treatment. Reprod Biol Endocrinol. 2012;10:32. doi: 10.1186/1477-7827-10-32. [PubMed 22531097]
  6. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  7. Novarel (chorionic gonadotropin) [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; May 2018. [PubMed 22416285]
  8. Petak SM, Nankin HR, Spark RF, Swerdloff RS, Rodriguez-Rigau LJ; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients--2002 update. Endocr Pract. 2002;8(6):440-456. [PubMed 15260010]
  9. Practice Committee of the American Society for Reproductive Medicine (ASRM). Prevention and treatment of moderate and severe ovarian hyperstimulation syndrome: a guideline. Fertil Steril. 2016;106(7):1634-1647. doi:10.1016/j.fertnstert.2016.08.048 [PubMed 27678032]
  10. Pregnyl (chorionic gonadotropin) [prescribing information]. Roseland, NJ: Organon USA Inc; January 2015.
  11. Pregnyl (chorionic gonadotropin) [product monograph]. Kirkland, Quebec, Canada: Merck Canada Inc; October 2019.
  12. Prior M, Stewart J, McEleny K, Dwyer AA, Quinton R. Fertility induction in hypogonadotropic hypogonadal men. Clin Endocrinol (Oxf). 2018;89(6):712-718. doi:10.1111/cen.13850 [PubMed 30194850]
  13. Saal W, Glowania HJ, Hengst W, Happ J. Pharmacodynamics and pharmacokinetics after subcutaneous and intramuscular injection of human chorionic gonadotropin. Fertil Steril. 1991;56(2):225-229. [PubMed 1712735]
  14. Sato N, Hasegawa T, Hasegawa Y, et al. Treatment situation of male hypogonadotropic hypogonadism in pediatrics and proposal of testosterone and gonadotropins replacement therapy protocols. Clin Pediatr Endocrinol. 2015;24(2):37-49. [PubMed 26019400]
  15. Shmorgun D, Claman P. No-268-The diagnosis and management of ovarian hyperstimulation syndrome. J Obstet Gynaecol Can. 2017;39(11):e479-e486. doi: 10.1016/j.jogc.2017.09.003 [PubMed 29080733]
  16. Sperling MA, ed. Pediatric Endocrinology. 4th ed. Canada: Elsevier; 2014.
  17. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.
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